Essure is a permanently implanted birth control device for women (female sterilization).
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.
Starting in September 2019, Bayer informed their customers that all Essure units that had not been implanted should be returned to Bayer by the end of 2019. Health care providers and facilities that purchased Essure units from Bayer in the past were contacted by Bayer about how to return unused Essure units.
As of December 31, 2019, all unused Essure units should have been returned to Bayer so that they are no longer available for implantation.
Women who have been using Essure successfully to prevent pregnancy can and should continue to do so.
The FDA remains committed to collecting long-term safety information in women who have received the device. This includes ensuring that Bayer continues to meet its mandated postmarket study obligations for Essure beyond 2019. We believe clinical data from this postmarket study will help patients, health care providers, and the agency better understand certain complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. We will continue to provide updates on our ongoing postmarket evaluation of Essure to the public as new information becomes available.
Essure Benefits and Risks
Learn about benefits and risks associated with this implanted birth control device.
Information for Patients and Health Care Providers
Get the most up-to-date information on Essure.
FDA Activities Related to Essue
The FDA remains committed to collecting long-term safety information following the discontinuation of sales and distribution of Essure.
Problems Reported with Essure
Even though Essure is no longer being sold in the U.S., the FDA will continue to evaluate medical device reports related to Essure.