July 24, 2018 — Bayer has stopped selling the Essure birth control implant in the United States at the end of this year, making the U.S. the last country to stop selling the controversial device.
Bayer said their decision to stop sales of Essure was a “business decision” that was prompted by declining sales in the U.S., and that the company stands by the safety and effectiveness of Essure.
The U.S. is the last country where Essure is still being sold. In recent years, thousands of women reported serious side effects of Essure and complained that they were not adequately warned of the risk.
Over 16,000 lawsuits have been filed by women who were injured, Bayer reported earlier this year.
Essure was approved in 2002 as a non-surgical alternative to traditional sterilization surgery for women. As the number of complaints grew over the years, the FDA maintained that the benefits of Essure outweighed the risk — but agreed to add stronger warnings.
The FDA added a “Black Box” warning to Essure and took the unusual step of restricting sales of Essure to doctors who agreed to give patients a 3-page checklist the FDA created to outline potential risks.
Those risks include abnormal menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergic or hypersensitivity reactions, or immune-type reactions. In many cases, surgery to remove Essure is the only treatment.