December 21, 2018 — The FDA will require Bayer to conduct long-term oversight of women with Essure after thousands of women were injured and the controversial implant was pulled off the market in the U.S.
FDA Commissioner Dr. Scott Gottlieb announced that the agency will “revise and strengthen” the post-marketing safety studies that Bayer was ordered to complete in 2016.
Those studies must now follow women with Essure for 5 years instead of 3 years, which will give the FDA “longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.”
Furthermore, women with Essure will need additional blood-testing to check for signs of inflammatory reactions and immune system reactions — a common complaint among women with Essure.
Bayer is now facing over 16,000 lawsuits from women who developed severe side effects after being implanted with Essure. They accuse Bayer of downplaying long-term safety risks and inadequately testing Essure before advertising it as a quick and safe sterilization implant.
A wide range of debilitating long-term side effects have been linked to Essure, including inflammatory reactions, heavy or prolonged menstrual bleeding, chronic pain, allergic or hypersensitivity reactions, perforated fallopian tubes, migration or fracture of Essure, and more.