All Essure units should be returned to Bayer by the end of 2019
On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers could implant Essure up to one year from the date the device was purchased. Bayer has informed their customers that all Essure units that have not been implanted should be returned to Bayer by the end of 2019. Health care providers and facilities which have purchased Essure units from Bayer in the past should have already been contacted by the manufacturer about how to return Essure units. Health care providers and facilities should contact Bayer Customer Care Call Center (1-888-842-2937) immediately to arrange return of any Essure units.
The FDA remains committed to collecting long-term safety information following the full discontinuation of the device to better evaluate its safety profile when used in the real world. This includes ensuring that Bayer continues to meet its mandated postmarket study obligations for Essure beyond 2019. The FDA will continue providing regular updates on our ongoing postmarket evaluation of Essure to patients and health care providers.
What is Essure?
Essure is a permanently implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision.
In the procedure, a health care provider places flexible inserts 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 and prevents conception.
Essure is a permanent form of birth control and is not intended to be removed.
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Women are encouraged to discuss all available sterilization and birth control options and carefully consider the benefits and risks of each, with their health care provider before deciding on the method that is right for them.
Protecting patients by ensuring the safety and effectiveness of medical products on the U.S. market is an agency priority and the core of our consumer protection role. Learn more about the benefits and risks of Essure.
The FDA continues to take concerns about Essure very seriously. Our most recent activities include:
November 04, 2019: The FDA updated the FDA Activities: Essure webpage and Essure Permanent Birth Control: Information for Health Care Providers webpage with the most up-to-date information from the ongoing postmarket review of medical device reports and postmarket study information about removal of the device from women who received it. The FDA also provided an update on the status of the 522 study. The FDA will continue to collect long-term safety information following the full discontinuation of the device to better evaluate its safety profile when used in the real world and will ensure that Bayer continues to meet its mandated postmarket study obligations for Essure beyond 2019.
May 15, 2019: The FDA updated the information on the FDA Activities: Essure webpage about medical device reports received in 2018. The FDA continues to post the latest information about the manufacturer's postmarket surveillance study on the 522 study webpage.
December 2018: The FDA approved a revised postmarket surveillance ("522 study") plan that extends Bayer's mandatory follow up of women enrolled in the study from three years to five years. The FDA provided an update related to the ongoing postmarket review of Essure, including the status of the 522 study and information about device removal from medical device reports and an ongoing post-approval study.
April 2018: The FDA restricted sale and distribution of Essure by requiring that the device only be sold to health care providers that share and sign the Bayer's Patient-Doctor Discussion Checklist in the Patient Information booklet with all women who choose to get Essure placed.
The FDA restricted the sale and distribution of Essure to health care providers who agree to review Bayer's Patient-Doctor Discussion Checklist [PDF] with patients, and give them the opportunity to sign it, before Essure implantation. The FDA approved this new safety measure to ensure that the device meets our standards for providing a reasonable assurance of safety and effectiveness.
- FDA provides updates on our ongoing postmarket activities for Essure
- FDA provides updates on the agency's continued commitment to evaluating postmarket safety of Essure device (05/15/19)
- Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales (12/20/2018)
- Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review of Essure and keeping women informed (07/20/2018)
- FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information (04/09/2018)
- Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA's commitment to keep women informed (03/07/2018)
- FDA Consumer Update. What women should know about Essure permanent birth control (11/15/2016)
- FDA takes additional action to better understand safety of Essure, inform patients of potential risks (02/29/2016)