Come February 2016, the FDA will decide what action to take over Bayer’s permanent birth control device Essure. The official safety review will be based on information gathered at the FDA’s Obstetrics and Gynecology Devices Panel held this past September in addition to numerous studies and scientific data. The Panel meeting was convened this past September after the FDA received 5,000 reports of adverse events linked to Essure, including patient death and miscarriage. Moreover, thousands of women have reported a number of unwanted side-effects related to the Essure implant—risks for which they claim they were never informed—including painful sex, organ perforation by the device, and severe allergic reactions leading to and autoimmune disorders. Numerous administrators and advocates spoke at the September panel urging the FDA to remove Essure from the marketplace, alleging that Bayer falsified clinical trial data prior to Essure’s approval.
If you or a loved one experienced complications after being implanted with Essure, please call us at 888-985-7228 to speak with an experienced attorney about your potential claim.