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FDA Medwatch Alert: Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes
Posted 19 days ago by Drugs.com
ISSUE: 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. BA ... Read more