STORY FROM: Drugs & Medical Devices

Bayer Adds Boxed Warning, Patient Checklist to Essure Labeling

WASHINGTON, D.C. — Bayer Corp. has revised the labeling of its Essure permanent birth control product to include a boxed warning that outlines risks associated with the device, including perforation of the uterus and/or fallopian tubes, pain, and allergic reactions.

According to a Nov. 15 announcement by the Food and Drug Administration, Essure labeling will also include a Patient Decision Checklist, which “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 has also incorporated modifications to the ...

Associated Documents
FDA Guidance

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