After thousands of problems associated with permanent contraceptive device Essure were reported to the FDA, the device regulator ordered the device’s manufacturer Bayer to submit plans for a postmarket surveillance study. The FDA requires these kinds of studies for devices that have posed significant adverse health problems or are permanent implants.
The parameters for Bayer’s study were given the green-light by the FDA in September 2016—with a final report due in 2023. 1,400 women who received the Essure implant will be studied, along with 1,400 who chose another permanent sterilization procedure. Various data points will be collected including abdominal pain, allergic reactions, and abnormal bleeding. The effectiveness of Essure in preventing pregnancy will also be studied, which will allow the FDA to further evaluate the risks of Essure.
If you or a loved one experienced complications after being implanted with Essure, call us at 888-985-7227 to speak confidentially with an attorney about your potential claim.