FDA Review of Essure
After receiving thousands of complaints ― including adult deaths, fetal deaths, unintended pregnancies and pregnancy loss ― the U.S. Food and Drug Administration announced in June 2015 that it would review the safety and effectiveness of the Essure birth control device.
Several months later, the FDA held a meeting to hear scientific and expert opinions about the risks and benefits of the device, as well as from women who were seriously injured by Essure. While the victims demanded Essure be removed from the market, the FDA opted for something less drastic.
On February 29, 2016, the FDA announced three primary actions, included that Bayer, the manufacturer, put a “black box warning” on Essure’s product packaging label. The agency also required a checklist for doctors to discuss potential risks of the device with patients. Further, the FDA ordered Bayer to conduct a post-market surveillance study to assess the risks of the device in a real-world environment.
Unsatisfied with the FDA’s recommendations, Essure victims continue to rally against this dangerous device. They are pursuing legislative and legal angles in an effort to get the device removed from the market and make the manufacturer pay.
Don’t suffer in silence. Turn to McDonald Law Firm get your questions answered and learn your legal options.