STORY FROM: Drugs & Medical Devices
FDA Orders Bayer to Conduct Postmarket Surveillance Study for Essure, Recommends Boxed Warning Label
February 29, 2016
WASHINGTON, D.C. — The U.S. Food and Drug Administration says it has ordered Bayer to conduct a new postmarket surveillance study for its Essure permanent birth control device in order to determine heightened risks in a real-world environment.
The agency has also published a draft guidance with labeling recommendations for Essure, including a boxed warning label, according to a March 1 press release that was released a day earlier. These actions will “provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of ...