FDA to Announce Essure Review Decision in February
The U.S. Food and Drug Administration (FDA) has said it will announce its decision about what action it will take on Bayer’s permanent birth control device Essure in February 2016. The FDA decision will be based on information gathered by the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee at a … [Read more...]
Update on FDA Evaluation of the Safety of Essure Birth Control System
The Food and Drug Administration (FDA)’s Office of Women’s Health has issued an update on the agency’s evaluation of the safety of the Essure birth control system. Essure—a form of permanent birth control (female sterilization)—is under FDA review in response to thousands of adverse event reports. The agency is reviewing … [Read more...]