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Essure Permanent Birth Control, Effectiveness and Safety: A French Survey

NCT03955822 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 642

Last updated 2020-07-16

No results posted yet for this study

Summary

Since 2002, in CHU Amiens, Essure implants started to be used for women in need of voluntary sterilization in accordance with French national recommendations. Recently patient committees emerged to alert health agency and governments about various symptoms possibly link to the Essure implants. New studies have been launched in order to determinate if Essure implants were involved with the symptoms described. According to the scientific literature no solid link between Essure and the symptomatology was highlighted. French National College of Gynecologists and Obstetricians send a letter of information for patient and gynecologists. French National agency of medicament suspended Essure authorization in august 2017 for 3 months. Bayer industry decided to withdraw from the market the Essure implants in autumn 2017. Currently Essure procedures have been stopped to be used in CHU Amiens since august 2017. But, in CHU Amiens, health institutions still have to manage patients with Essure implants and potential adverse effects.

The purpose of this study is to determine if the patients treated between 2002 and 2017 with Essure implant present complications, had a proper follow up after the Essure implantation, and that the Essure implantation respected the medical guidelines in order to offer the best medical care with these new informations.

Medical data from patients who received Essure procedure will be collected with medical file and a survey about adverse effects will be submitted to patients by phone if they agree to take part of the study after loyal information.

Conditions

  • Contraception

Interventions

OTHER

Phone survey

Phone Survey in order to evaluate adverse effect of the permanently implanted birth control device for women (Essure) will be proposed to wmen Treated between 2002 and 2017 with Essure.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • fabrice sergent, Pr · CHU Amiens

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2019-01-16
Completion
2019-01-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03955822 on ClinicalTrials.gov