Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization

Summary

More than 345,000 U.S. women undergo either tubal ligation ("getting her tubes tied") or Essure procedures each year to permanently avoid pregnancy. Both prevent pregnancy by blocking women's Fallopian tubes but neither are 100% effective. Both can have complications, but not enough is known to help women make an informed choice between the two.

Essure is popular because it can be performed without anesthesia in a doctor's office and women can return to work the next day. However, patients have reported that the Essure procedure was unexpectedly painful. Also, women need to use other contraceptives for 3 months and then return for testing, to make sure their tubes are blocked and will prevent pregnancy. Not all women return for this test and some may get pregnant before realizing their Essure didn't work.

Essure was approved by the Food and Drug Administration (FDA) in 2002, but no studies ever compared it to tubal ligation. By 2015, over 9,000 women reported serious complications to the FDA. Women who were unhappy with Essure found each other online and created a Facebook "Essure Problems" support group that now has over 31,000 members. After an FDA Advisory Board expressed concerns about Essure's risks, in 2016 the FDA required stronger warnings about complications and announced that "more rigorous research" was needed, demanding Essure's maker conduct a new study comparing the benefits and risks of Essure to tubal ligation. Unfortunately, that study will not be finished before September 2023.

To provide answers as rapidly as possible for women considering sterilization, we will analyze data from the medical records of thousands of women with sterilization procedures funded by California's Medicaid. As poor women and women of color have different experiences with healthcare, and they more often choose sterilization, comparing these women's experiences with Essure and tubal ligation is very important. We will compare the safety and effectiveness of the 2 sterilization procedures to answer:

* How many women got pregnant afterwards?
* How many operations did each woman need to become infertile?
* Which complications did women have (i.e. chronic pain, depression)? We will also check whether certain women (such as certain age groups or those with diabetes) were most likely to have problems after either procedure.

Conditions

• Sterility, Female
• Contraception
• Contraceptive Device; Complications

Interventions

DEVICE

Essure

Essure hysteroscopic sterilization

PROCEDURE

Laparoscopic sterilization

Laparoscopic sterilization via electrocautery, ring, or clip.

DEVICE

Intrauterine Device (IUD)

Intrauterine Device (IUD)

Sponsors & Collaborators

• University of California, Davis

  collaborator OTHER

• National Center for Health Research

  collaborator UNKNOWN

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Food and Drug Administration (FDA)

  collaborator FED

• Yale University

  lead OTHER

Principal Investigators

• Aileen Gariepy, MD · Yale University

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-09-30

Primary Completion

2021-07-31

Completion

2021-07-31

FDA Device

Yes

Countries

• United States

Study Locations