FDA announces actions to manage the risks of using Essure, a device to control fertility- Bayer

The FDA announced 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 labelling, 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 The FDA has issued a draft guidance to provide the public an opportunity to comment on the proposed language to be included in these warnings.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 take additional steps and follow the agency’s careful evaluation of available information.

The FDA has ordered Bayer, the company that manufactures Essure, to conduct a new postmarket surveillance study designed to provide important information about the risks of the device in a real-world environment. Bayer will be required to develop and conduct a post-market study that will provide data to help the agency to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. This includes the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate how much these complications affect a patient’s quality of life. Additionally, it will collect information to identify reasons for why some patients don’t have a confirmation test to ensure that Essure has been properly placed three months after insertion. The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health.