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FDA Medwatch Alert: Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes
Posted 16 Nov 2016 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 ...