The FDA wishes to acknowledge the numerous stakeholders who testified at the September 2015 Advisory Committee meeting and the many others who continue to express their viewpoints and share their experiences with us. Patient health and well-being is our first priority regarding this device and all medical devices.
We reviewed concerns identified by the public speakers and the feedback and recommendations provided by the panel (see Advisory Committee meeting summary and panel transcript), comments submitted to the public docket, and additional medical literature and adverse event reports which have been published or received since the Advisory Committee meeting. After careful review of this information, the FDA:
- Ordered Bayer to conduct a postmarket surveillance study to obtain more data about Essure’s benefits and risks.
- Issued the final guidance, "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization" after carefully considering public comments on the language in the boxed warning and Patient Decision Checklist for inclusion in the product labeling.
- Completed its evaluation of the trade complaint regarding allegations initially made in a Citizen Petition.