Essure is marketed as a non-surgical alternative to tubal ligation (“getting tubes tied”). It consists of a pair of metal coils that are inserted into each fallopian tube, promoting scarring that blocks a woman’s egg from fertilization.
Bayer marketed Essure as a 10-minute outpatient procedure for busy women with less pain and a faster recovery time than tubal ligation. By December 2015, over 9,900 women reported chronic pain, bleeding, organ damage, and other side effects.
Instead of banning Essure, the FDA decided to strengthen warning labels and require Bayer to conduct new safety studies.
On October 31, the FDA finalized a “Patient Decision Checklist” that must be signed by the woman and her doctor before Essure is implanted. It includes easy-to-read information about side effects.
Women must acknowledge long-term risks like persistent pain, rashes, itching, headaches, fatigue, weight-changes, hair loss, mood changes, depression, organ perforation (1-4% risk), pregnancy, or needing a hysterectomy to remove Essure.
The FDA also finalized the “Black Box” warning label for Essure, which would also be required on all similar devices:
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.”
At least a dozen lawsuits accuse Bayer of misleading women about the safety of Essure. Bayer claims it is immune from lawsuits due to a loophole in the way Essure was approved. That immunity is now being challenged by lawyers and consumer advocates like Erin Brockovich.