Today the FDA announced actions to provide important information about the risks of Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. This also includes ordering Bayer to conduct a postmarket surveillance study to obtain more data to better define and understand certain outcomes and events associated with Essure, and issuing a draft guidance to require manufacturers of all permanent hysteroscopically-placed tubal implants intended for sterilization include key information in patient and physician labeling. Additional information about the Agency’s actions can be found on the Essure Permanent Birth Control website.
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