Essure will now only be available to doctors who provide patients with a comprehensive FDA-sanctioned brochure and checklist with detailed risk information. The agency said in a statement:
The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device.”
The FDA will also review and monitor Bayer to ensure that it complies with the restriction.
Essure is a birth control device that consists of metal coils that are inserted into a woman’s fallopian tubes, where they trigger an inflammatory reaction that causes the fallopian tubes to scar over.
Essure is designed to prevent sperm from fertilizing an egg, resulting in sterilization for women who choose not to undergo a traditional surgery to “have their tubes tied,” otherwise known as a tubal ligation.
The FDA approved Essure in November 2002. Since then, over 10,000 women have complained about severe side effects, such as abdominal pain, menstrual irregularities, headaches, fatigue, weight changes, and implants that broke, dislodged or dislocated.
Sales of Essure in the U.S. have declined about 70% since 2016, when the FDA placed a mandatory “Black Box” warning on Essure.