FDA takes additional action to better understand safety of Bayer's Essure

The US Food and Drug Administration has announced actions to provide important information about the risks of using German pharma major Bayer’s (BAYN: DE) birth control implant 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 The FDA has issued a draft guidance to provide the public an opportunity to comment on the proposed language to be included in these warnings. Since Essure’s approval in 2002, the agency has continued to monitor Essure’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. The new actions announced yesterday take additional steps and follow the agency’s careful evaluation of available information.

“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications,” added Dr Maisel, who on a conference call said the agency “continues to believe the product should remain available to women who are informed of the risks."