FDA takes additional action to better understand safety of Essure, inform patients of potential risks
The U.S. Food and Drug Administration announced today actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.
The FDA issued a new, mandatory clinical study for Essure to determine heightened risks for particular women. The FDA also intends to require changes to product labeling, including a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of this type of device. The FDA has issued a draft guidance to provide the public an opportunity to comment on the proposed language to be included in these warnings.