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FDA Informs Patients of Potential Essure Risks

FDA website; 2016 Feb 29; news release

The US Food and Drug Administration (FDA) announced actions to provide important information about the risk of using Essure (Bayer) and to help women and their physicians be better informed of the potential complications associated with implantable forms of sterilization. The FDA issued a new, mandatory clinical study for Essure, a permanent form of birth control that involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes, to determine heightened risks for particular women and 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. Essure is a permanent form of birth control and is not appropriate for all women of child-bearing age, but it may be appropriate for those women who:

• Do not want any more children.

• Want a permanent form of birth control.

• Seek a sterilization procedure that does not require an incision.

• Want a permanent birth control method that does not involve hormones.

Citation: US Food and Drug Administration. FDA takes additional action to better understand safety of Essure, inform patients of potential risks. FDA Web site. February 29, 2016. Accessed March 1, 2016.