The FDA wishes to acknowledge the numerous stakeholders who testified at the September Advisory Committee meeting and the many others who have expressed their viewpoints and shared 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.
- Intends to require that a boxed warning and Patient Decision Checklist be added to the product labeling to help ensure that a woman receives and understands information regarding the benefits and risks of this type of device. In addition, FDA issued the draft guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” to provide the public an opportunity to comment on the proposed language to be included in these warnings.
- Is in the process of completing its evaluation of the trade complaint.