Evidence-Based. Clearly Delivered.
Evidence-Based. Clearly Delivered.
The FDA was notified on July 20, 2018 that Essure permanent birth control would no longer be sold or distributed in the US after December 31, 2018. This notification followed earlier actions on the part of the FDA related to this device. As of December 31, 2019, there should no longer be any unused Essure units on the market – i.e., they should have all been returned to Bayer.
The FDA statement (January 2020) includes additional information (see ‘Primary Sources – Learn More’ below) that addresses the ending of the sale and distribution of Essure and states the following
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.
FDA (January 2020): Essure Permanent Birth Control
Bayer Information Booklet Including Patient – Doctor Discussion Checklist and Black Boxed Warning
ACOG Practice Bulletin 208: Benefits and Risks of Sterilization
FDA: Problems Reported with Essure
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