Today the FDA announced actions to provide important information about the risks of Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. This also includes ordering Bayer to conduct a postmarket surveillance study to obtain more data to better define and understand certain outcomes and events associated with Essure, and issuing a draft guidance to require manufacturers of all permanent hysteroscopically-placed tubal implants intended for sterilization include key information in patient and physician labeling. Additional information about the Agency’s actions can be found on the Essure Permanent Birth Control website.
Essure is a permanent birth control method for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and 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.
Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.
The FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015, to hear expert scientific and clinical opinions as well as patients’ experiences regarding the benefits and risks of Essure. In addition, a public docket soliciting comments on the device remained open from July 22, 2015 until October 24, 2015. FDA received more than 2,800 comments in this docket and reviewed each comment and considered all views and perspectives expressed.
The panel meeting and docket provided valuable information to inform the FDA’s decision-making and consideration of potential risk mitigation strategies for Essure. Additional information about the Agency’s next steps can be found on our status update page and in the FDA Activitiessection of this website.
Additional Resources
- 2015 Meeting Materials of the Obstetrics and Gynecology Devices Panel
- Federal Register: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
- Information about the September 24th Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting
- CDRH FOIA Electronic Reading Room
- FDA Office of Women’s Health: Women’s Health Topics
- Birth Control: Medical Devices
- Benefits and risks of sterilization. Practice Bulletin No. 133. American College of Obstetricians and Gynecologists. Obstet Gynecol 2013; 121:392–404
- American College of Obstetricians and Gynecologists. Hysteroscopic Sterilization: Frequently Asked Questions
- September 24: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (6/24/15)
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