Trial Outcomes & Findings for Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization (NCT NCT03127722)
NCT ID: NCT03127722
Last Updated: 2026-05-22
Results Overview
The proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after insertion of Essure System compared to the proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after laparoscopic tubal sterilization. Statistical analyses were exploratory and descriptive in nature and no confirmatory hypothesis testing was intended to be performed; p-values were to be interpreted as a metric for uncertainty (note: no analysis included in this final analysis provides p-values). Therefore, no adjustment for multiplicity was necessary. All endpoints and variables were analyzed by descriptive statistical methods.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
990 participants
Primary outcome timeframe
Up to 60 months
Results posted on
2026-05-22
Participant Flow
The study was conducted at 60 study centers in United States between 03-May-2017 (first participant first visit) and 31-Dec-2024 (last participant last visit).
990 subjects at 60 investigational sites in U.S. (285 in the Essure group and 705 in the LTS group) signed informed consent and attended the procedure visit. Of those, 280 and 705 had the procedure attempted. Allocation of procedure to a subject was driven by patient preference. Allocation bias must, therefore, be assumed as consequent potential for confounding. This study is not designed or powered to detect statistical differences.
Participant milestones
| Measure |
ESSURE (BAY1454032)
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
285
|
705
|
|
Overall Study
Participants Who Had the Procedure Attempted
|
280
|
705
|
|
Overall Study
COMPLETED
|
83
|
258
|
|
Overall Study
NOT COMPLETED
|
202
|
447
|
Reasons for withdrawal
| Measure |
ESSURE (BAY1454032)
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
12
|
7
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
124
|
333
|
|
Overall Study
Withdrawal by Subject
|
54
|
92
|
|
Overall Study
Other reasons
|
2
|
12
|
|
Overall Study
Missing
|
4
|
2
|
|
Overall Study
Participants who did not have the procedure attempted
|
5
|
0
|
Baseline Characteristics
Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
Baseline characteristics by cohort
| Measure |
ESSURE (BAY1454032)
n=280 Participants
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
n=705 Participants
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
Total
n=985 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.3 Years
STANDARD_DEVIATION 5.47 • n=2 Participants
|
32.7 Years
STANDARD_DEVIATION 5.76 • n=4 Participants
|
33.5 Years
STANDARD_DEVIATION 5.79 • n=6 Participants
|
|
Sex: Female, Male
Female
|
280 Participants
n=2 Participants
|
705 Participants
n=4 Participants
|
985 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=2 Participants
|
91 Participants
n=4 Participants
|
122 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
229 Participants
n=2 Participants
|
559 Participants
n=4 Participants
|
788 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=2 Participants
|
40 Participants
n=4 Participants
|
56 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.
The proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after insertion of Essure System compared to the proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after laparoscopic tubal sterilization. Statistical analyses were exploratory and descriptive in nature and no confirmatory hypothesis testing was intended to be performed; p-values were to be interpreted as a metric for uncertainty (note: no analysis included in this final analysis provides p-values). Therefore, no adjustment for multiplicity was necessary. All endpoints and variables were analyzed by descriptive statistical methods.
Outcome measures
| Measure |
ESSURE (BAY1454032)
n=264 Participants
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
n=264 Participants
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization
|
39 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.
Incidence of new onset or worsening abnormal bleeding events was based on AE reporting. If a potential bleeding AE was reported at a scheduled visit or if the subject spontaneously reports such an event to the site at some other time, the event was to be evaluated per standard AE assessment. If during the course of a scheduled PRO administration the subject indicated that she experienced abnormal bleeding that reached a preset threshold on the questionnaire, the investigator was alerted and instructed to investigate this finding in order to determine whether or not an AE occurred.
Outcome measures
| Measure |
ESSURE (BAY1454032)
n=264 Participants
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
n=264 Participants
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Bleeding: The Proportion of Subjects Reporting AEs of Abnormal Uterine Bleeding (AUB) After Insertion of Essure System Compared to the Proportion of Subjects Reporting AEs of AUB After Laparoscopic Tubal Sterilization
|
59 Participants
|
57 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.
For potential allergic/hypersensitivity reactions, investigators were instructed that an evaluation was to be performed in subjects who presented with symptoms that could have possibly been related to an inflammatory reaction. After the evaluation of the subject was complete, regardless of the investigator's assessment as to whether or not a hypersensitivity/allergic reaction had occurred, all information was to be forwarded to the Adjudication Committee in a blinded fashion. Final determination of whether or not a hypersensitivity/allergic event had occurred was based on the determination of this committee.
Outcome measures
| Measure |
ESSURE (BAY1454032)
n=264 Participants
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
n=264 Participants
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.
Any subject presenting with symptoms indicating a potential autoimmune disorder was to be evaluated per standard medical practice. All effort was to be made to obtain records of any diagnostic workup conducted by outside physicians. NiLPT, chromium LPT, serum or plasma nickel level, and serum or plasma titanium level and serum inflammatory cytokines samples were also to be drawn by the study site. An appropriate human leukocyte antigen (HLA) panel was to be run on previously obtained baseline samples if sufficient sample existed. After the evaluation of the subject was complete, all information was to be forwarded to the adjudication committee in a blinded fashion, regardless of investigator's assessment as to whether or not an autoimmune disorder existed. Final determination of whether or not an autoimmune disorder had occurred was based on the determination of this committee.
Outcome measures
| Measure |
ESSURE (BAY1454032)
n=264 Participants
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
n=264 Participants
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Proportion of Subjects With Newly Diagnosed or Worsening Autoimmune Disorders
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: Adjusted Full Analysis Set (AFAS): Among the PS (Propensity Score) confounder-adjusted population, a subject was included in the Adjusted FAS (AFAS) if both she and her PS-matched partner were included in the FAS.
Outcome measures
| Measure |
ESSURE (BAY1454032)
n=264 Participants
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
n=264 Participants
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Proportion of Subjects Undergoing Invasive Gynecologic Surgery After Essure Placement (Excluding Second Placement Attempts), Including Essure Removal Compared to Subjects Undergoing Invasive Gynecologic Surgery After Laparoscopic Tubal Sterilization
|
64 Participants
|
23 Participants
|
Adverse Events
ESSURE
Serious events: 18 serious events
Other events: 165 other events
Deaths: 0 deaths
Laparoscopic Tubal Sterilization
Serious events: 36 serious events
Other events: 369 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ESSURE
n=285 participants at risk
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
n=705 participants at risk
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Endocrine disorders
Thyroid mass
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Chest pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Pelvic mass
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Influenza
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Sepsis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Septic shock
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Fallopian tube perforation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Laparoscopy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage I
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the small bowel
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Migraine
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Paraesthesia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Seizure
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Major depression
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Product Issues
Device dislocation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
Other adverse events
| Measure |
ESSURE
n=285 participants at risk
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented
|
Laparoscopic Tubal Sterilization
n=705 participants at risk
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
|
|---|---|---|
|
Eye disorders
Dry eye
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Blood and lymphatic system disorders
Leukaemoid reaction
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Cardiac disorders
Bradycardia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Cardiac disorders
Tachycardia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Congenital, familial and genetic disorders
Dolichocolon
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Congenital, familial and genetic disorders
Mobile caecum syndrome
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Ear and labyrinth disorders
Ear pain
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Endocrine disorders
Goitre
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Endocrine disorders
Hypothyroidism
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Endocrine disorders
Thyroid cyst
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Endocrine disorders
Polycystic ovarian syndrome
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Eye disorders
Eye pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Eye disorders
Glaucoma
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Eye disorders
Uveitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Eye disorders
Vision blurred
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Eye disorders
Visual impairment
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Eye disorders
Vitreous floaters
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Eye disorders
Periorbital dermatitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
14/285 • Number of events 15 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
3.3%
23/705 • Number of events 25 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.1%
6/285 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
2.8%
20/705 • Number of events 21 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.6%
11/705 • Number of events 11 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Dental caries
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.4%
10/705 • Number of events 10 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Lip swelling
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
12/285 • Number of events 12 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.7%
12/705 • Number of events 12 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Oral lichen planus
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
5/285 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Uvulitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Burning mouth syndrome
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Lip pruritus
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Mesenteric haematoma
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Gastrointestinal disorders
Faeces soft
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Chest pain
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Fatigue
|
9.1%
26/285 • Number of events 26 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
4.4%
31/705 • Number of events 31 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Influenza like illness
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Malaise
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Oedema peripheral
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Pain
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.3%
9/705 • Number of events 9 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Pyrexia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Peripheral swelling
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Temperature intolerance
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Haemorrhagic cyst
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Inflammation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Complication of device insertion
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Medical device site discomfort
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
General disorders
Vessel puncture site rash
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Hepatobiliary disorders
Biliary cyst
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Immune system disorders
Drug hypersensitivity
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Immune system disorders
Food allergy
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Immune system disorders
Hypersensitivity
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Acute sinusitis
|
0.70%
2/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Bacterial vaginosis
|
2.5%
7/285 • Number of events 8 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.8%
13/705 • Number of events 17 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Breast abscess
|
0.35%
1/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Bronchitis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.1%
8/705 • Number of events 8 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Cellulitis
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Cervicitis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Cystitis
|
0.35%
1/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Dengue fever
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Ear infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Endometritis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Fungal infection
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.1%
8/705 • Number of events 12 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Influenza
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Kidney infection
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Mastitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Nail candida
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Nasopharyngitis
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Otitis media
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Pharyngitis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Pneumonia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.1%
8/705 • Number of events 8 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Pyelonephritis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Sexually transmitted disease
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Sinusitis
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.7%
12/705 • Number of events 14 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Tonsillitis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Tooth abscess
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Trichomoniasis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Urethritis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
15/285 • Number of events 17 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
4.3%
30/705 • Number of events 45 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Vaginal infection
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.4%
10/705 • Number of events 11 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Vaginitis gardnerella
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Viral infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 8 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Vulvovaginitis
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Skin candida
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Papilloma viral infection
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.4%
4/285 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.6%
11/705 • Number of events 15 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Perihepatitis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Candida infection
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
COVID-19
|
4.6%
13/285 • Number of events 14 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
2.7%
19/705 • Number of events 22 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Infections and infestations
Gastrointestinal microorganism overgrowth
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Superficial injury of eye
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
2.3%
16/705 • Number of events 16 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
4.1%
29/705 • Number of events 31 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Incision site inflammation
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Fallopian tube perforation
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Ovarian injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Palate injury
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Incision site discharge
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Injury, poisoning and procedural complications
Traumatic pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Biopsy breast
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Blood cholesterol increased
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Blood prolactin increased
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Full blood count abnormal
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Vitamin B12 decreased
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Weight decreased
|
1.8%
5/285 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Weight increased
|
7.0%
20/285 • Number of events 21 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Dehydroepiandrosterone increased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Angiotensin converting enzyme increased
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Hysteroscopy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Platelet count increased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Troponin increased
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Hormone level abnormal
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Human papilloma virus test positive
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Streptococcus test positive
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Gardnerella test positive
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Helicobacter test positive
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Chlamydia test positive
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Candida test positive
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Liver function test increased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Trichomonal test positive
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
Pulmonary imaging procedure abnormal
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Investigations
SARS-CoV-2 test positive
|
1.1%
3/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.5%
7/285 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.99%
7/705 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Weight fluctuation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Fluid intake reduced
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Latent autoimmune diabetes in adults
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Carbohydrate intolerance
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Metabolism and nutrition disorders
Gluten sensitivity
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.5%
10/285 • Number of events 12 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.3%
9/705 • Number of events 11 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
14/285 • Number of events 14 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.8%
13/705 • Number of events 13 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
8/285 • Number of events 8 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.3%
9/705 • Number of events 10 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Osteochondral defects
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular pain and dysfunction syndrome
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.99%
7/705 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Cataplexy
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Dizziness
|
1.1%
3/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Dysgeusia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Headache
|
3.5%
10/285 • Number of events 10 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.1%
8/705 • Number of events 8 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Hypoaesthesia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Migraine
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.4%
10/705 • Number of events 11 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Narcolepsy
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Paraesthesia
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Presyncope
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Sciatica
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Somnolence
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Syncope
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Tension headache
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Hemihypoaesthesia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Intracranial mass
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Nervous system disorders
Cramp-fasciculation syndrome
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Acute stress disorder
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Affective disorder
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Anorgasmia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Anxiety
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
3.3%
23/705 • Number of events 23 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Depression
|
3.2%
9/285 • Number of events 9 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
2.8%
20/705 • Number of events 20 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Grief reaction
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Insomnia
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Loss of libido
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Mood altered
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Mood swings
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Stress
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Tic
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Bipolar disorder
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Bladder irritation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Dysuria
|
2.5%
7/285 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Haematuria
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Micturition urgency
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Pollakiuria
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Urge incontinence
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Urinary retention
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Urogenital disorder
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Mixed incontinence
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Breast discharge
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Breast inflammation
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Breast mass
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Breast tenderness
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Cervical cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.1%
8/705 • Number of events 9 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.2%
12/285 • Number of events 13 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
7.4%
52/705 • Number of events 53 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Dyspareunia
|
3.2%
9/285 • Number of events 11 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.3%
9/705 • Number of events 9 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Endometriosis
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.99%
7/705 • Number of events 7 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
3.2%
9/285 • Number of events 9 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.85%
6/705 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.3%
9/705 • Number of events 11 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.70%
2/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
2.1%
15/705 • Number of events 18 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Pelvic pain
|
10.2%
29/285 • Number of events 33 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
5.7%
40/705 • Number of events 45 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Retracted nipple
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Uterine inflammation
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Uterine spasm
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.8%
8/285 • Number of events 8 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
1.3%
9/705 • Number of events 9 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vaginal odour
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Haematosalpinx
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Premenstrual dysphoric disorder
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Hydrometra
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Menopausal disorder
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Galactostasis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Coital bleeding
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Ovarian adhesion
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Uterine cervix stenosis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vaginal hyperplasia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Genital paraesthesia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Fallopian tube spasm
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
12.6%
36/285 • Number of events 39 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
14.6%
103/705 • Number of events 112 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
2.1%
6/285 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
3.0%
21/705 • Number of events 21 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar lung disease
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal valve collapse
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.5%
10/285 • Number of events 10 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
5/285 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
6/285 • Number of events 6 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.70%
2/285 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Social circumstances
Menopause
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Hernia hiatus repair
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.43%
3/705 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Knee operation
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Weight control
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Oral surgery
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Endometrial ablation
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Skin cosmetic procedure
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Abdominal panniculectomy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Abdominoplasty
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Varicose vein operation
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Cartilage graft
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Mammoplasty
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Surgical and medical procedures
Sleeve gastrectomy
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.28%
2/705 • Number of events 2 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Vascular disorders
Haematoma
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Vascular disorders
Hypertension
|
1.1%
3/285 • Number of events 3 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.71%
5/705 • Number of events 5 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/285 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.14%
1/705 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Vascular disorders
Hot flush
|
1.4%
4/285 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.57%
4/705 • Number of events 4 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Product Issues
Device breakage
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
|
Product Issues
Device expulsion
|
0.35%
1/285 • Number of events 1 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
0.00%
0/705 • A total of 60 months from the date of study procedure.
The safety analysis set was defined as all subjects who attended the sterilization procedure visit, regardless of whether the procedure was attempted or not, which comprised 285 participants for the Essure group and 705 for the LTS group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No PI publications until after Sponsor's "First Publication", or if First Publication is not published within 18 months of study conclusion or termination at all sites. Proposed publications to be submitted to Sponsor for review at least 90 days prior to submission. Publication may be postponed up to 180 days at request of sponsor in certain scenarios.
- Publication restrictions are in place
Restriction type: OTHER