FDA Guidance on Essure-type Device Labeling and Warnings

FDA has released a guidance on “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” that addresses the necessary warnings and risk information to inform healthcare providers and patients before such procedures are performed. The guidance addresses recommendations made last year by FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee after discussing benefits, risks, and potential mitigation strategies to prevent or reduce the frequency/severity of adverse outcomes associated with Bayer’s Essure System for Permanent Birth Control.

Based on the panel meeting, FDA concluded that some women are not receiving or understanding information regarding the risks and benefits of permanent, hysteroscopically-placed tubal implants that are intended for sterilization. This guidance describes labeling components, namely a Boxed Warning and patient decision checklist, which FDA intends to require for these devices.