December 21, 2018 — The FDA has ordered stronger long-term oversight of women with Essure after Bayer pulled the controversial birth control implant off the market in the U.S. earlier this year.
FDA Commissioner Dr. Scott Gottlieb said the FDA is requiring Bayer to “revise and strengthen” a mandatory post-market safety study of Essure.
The study must now follow patients for 5 years, giving the FDA “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.”
The FDA will also require additional blood testing for patients with Essure to check for signs of increased inflammation and immune system reactions.
Over 16,000 lawsuits have been filed by women who were injured by Essure. Bayer is accused of selling a defective medical device and downplaying safety risks.
Bayer marketed Essure as a quick sterilization procedure with a fast recovery time, ideal for busy women.
Instead, Essure has been linked to a wide range of debilitating long-term side effects such as abnormal menstrual bleeding, chronic pain, hypersensitivity reactions, and injuries such as perforated fallopian tubes or organ damage.
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