FDA Office of Women's Health
November 2016 | www.fda.gov/womens
On November 15, 2016, the U.S. Food and Drug Administration approved important labeling changes for Bayer Healthcare’s Essure permanent birth control device and completed our investigation of the trade complaint regarding allegations first made in a Citizen Petition.
Bayer revised the physician instructions for use and patient labeling consistent with FDA’s recently finalized guidance: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization. Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal.
The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.
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FDA Office of Women’s Health
10903 New Hampshire Avenue
WO32 - Room 2333
Silver Spring, MD