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FDA Finalizes Essure Warning Label and Checklist


November 1, 2016 — The FDA has finalized stronger warning labels and a checklist to make sure women know about serious side effects of Essure sterilization coils.

The FDA received 9,900 reports from women who had problems with Essure between 2002 and 2015.

In March 2016, the FDA posted draft recommendations for new warning labels and ordered Bayer to conduct new studies. After receiving over 1,000 comments, the FDA published its final recommendations (PDF) on October 31.

It includes an example of the “Patient Decision Checklist” for women considering sterilization with Essure. It must be signed by the woman and her doctor before Essure is implanted.

The checklist is an easy-to-read description of the safety risks associated with Essure — chronic pain, pregnancy, vaginal bleeding, itching, rashes, headache, weight changes, hair loss, perforation of the uterus or fallopian tubes, surgery to remove Essure, and more.

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

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.”

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