The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with the Essure contraceptive device and information about the potential need for removal.
Hailed as the next generation of contraception, Essure consists of implantable coils that are permanently inserted via a catheter into a woman’s fallopian tubes, to prevent pregnancy. It has been on the market since 2002.
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Bayer has 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.
The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes. 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.