Essure “Black Box” Warning and Patient Checklist Finalized

November 1, 2016 — The FDA has published its final recommendations for a “Black Box” warning label and a “Patient Decision Checklist” regarding serious safety risks of Essure.

Essure is a permanent sterilization implant made by Bayer. Since it was approved in November 2002, over 9,900 women have reported serious side effects to the FDA.

Earlier this year, the FDA asked Bayer to conduct new safety studies. The agency also posted draft recommendations for new warning labels. After receiving comments from over 1,300 members of the public, the FDA published final recommendations (PDF) on October 31.

The “Patient Decision Checklist” must be signed by the woman and her doctor before implanting Essure. It includes an easy-to-read description of side effects like pregnancy, chronic pain, itching, rashes, headaches, hair loss, organ damage, needing surgery, and more.

The following “Black Box” warning label for Essure was also finalized:

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.”