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Alerts

FDA: Essure Update

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SUMMARY:

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.

Patients Currently Using Essure

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.

Learn More – Primary Sources:

FDA (January 2020): Essure Permanent Birth Control

FDA 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

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

FDA News Release: FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information

Bayer Information Booklet Including Patient – Doctor Discussion Checklist and Black Boxed Warning

ACOG Commentary: Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance

ACOG Practice Bulletin 208: Benefits and Risks of Sterilization

FDA: Problems Reported with Essure

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Related ObG Topics:

CDC Resources: Contraception in Women with Medical Conditions (US MEC)
Practical info for your gynecology practice
Hormonal Contraception Benefits – Beyond Pregnancy Prevention
Optimizing Contraception for the HIV-positive Woman

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