Essure (a permanent non-hormonal, non-surgical birth control method) is no longer available in the U.S. – but many women still have the device in place, and a study of the device, mandated by the FDA is ongoing.
Comments on the Draft Guidance: Use of Real-World Evidence to Support Regulatory Decision Making for Medical Devices
Earlier today, the FDA announced that it is taking steps to make it easier for women considering sterilization to get reliable information about Essure, an implanted device. The Network recommended that the FDA take these steps, and we’re pleased that they’re taking action on this important women’s health issue.
NWHN Statement in Response to FDA Draft Guidance
Testimony Delivered at the FDA Meeting of the Obstetrics and Gynecology Devices Panel