Permanent Birth Control
The FDA plans to convene a public meeting of the Obstetrics and Gynecology Devices Panel on September 24, 2015 to discuss scientific data regarding Essure’s safety and effectiveness. At this meeting, the FDA invites feedback from presenters, panel members and the public to inform recommendations and next steps about Essure.
What Is Essure?
Essure is a permanent birth control method for women (female sterilization). A health care provider inserts soft, flexible coils into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.
FDA Approval for Essure
Instructions for Use
The Essure System is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
The FDA takes reports of safety concerns seriously. Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement. Topics discussed include: complaints submitted to Bayer, device removal difficulties and other health effects. We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.
FDA’s Review of Reported Problems
Some women have reported to the FDA that they have experienced pain or other health problems after Essure placement. Problems have also been reported in clinical studies, and they are addressed in the Essure product information (labeling for physicians and patients). Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.
The FDA relies on a variety of postmarket surveillance data sources to monitor the safety and effectiveness of medical devices. The FDA conducted a thorough review of the available information about Essure and the experiences of patients who have had Essure since the FDA approved it in 2002. This includes experiences of patients who have had positive outcomes with Essure as well as those who have experienced problems.
The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database.
- From Nov. 4, 2002, Essure’s approval date, through May 31, 2015, the FDA received 5093 medical device reports related to Essure.
- The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.
The most frequently reported patient problems during this period were pain/abdominal pain (3353), heavier menses/menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient device incompatibility (941) (for example, possible nickel allergy), migration of the device or device component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133). Multiple device problems can also be listed in each report.
Seventeen of the reports received were coded as death reports. Six of these reports were mistakenly coded as death, but no death occurred. Five reports involve fetal deaths that occurred in women who became pregnant following placement of Essure. The remaining six death reports were related to a total of 4 adult deaths: one death due to Group A Strep infection post-procedure, one death reportedly due to uterine perforation during device placement, one death related to an air embolism during device removal surgery and one death from suicide. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.
Learn about Essure Procedure
September 24, 2015: Meeting Materials FDA Generated
- Agenda: September 24, 2015
- (DRAFT) Discussion Questions: September 24, 2015
- Roster: September 24, 2015
- Executive Summary and Appendix A: September 24, 2015
- Appendix B Essure Physician Labeling: September 24, 2015
- Appendix C Essure Patient Labeling: September 24, 2015
- Appendix D. Mandatory Medical Device Reporting: September 24, 2015
- Appendix E. Summary of Safety and Effectiveness Data Original Approval (P020014): September 24, 2015
September 24, 2015: Meeting Materials Non-FDA Generated
- Executive Summary: September 24, 2015
Obstetrics and Gynecology Devices
Download Access Links to the FDA Advisory Committee Meeting Materials
Serious Issues over Essure Birth Control
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Last Updated: 2015-09-23
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