The US Food and Drug Administration has announced that it will order a meeting of the Obstetrics and Gynecology Devices advisory panel on September 24, 2015 to consider the data and other problems surrounding Bayer’s Essure implant as the number of patients reporting complications continues to rise. The FDA has received 5,093 reports of adverse medical events connected to the Essure device from it’s approval by the regulatory agency in November 2002 to May 31st, 2015. Most of the reports were made voluntarily by patients.
Bayer’s Essure implant is a form of long-term birth control provided to women on an outpatient basis through medical facilities and doctor’s offices. The procedure is executed by a physician placing flexible coils into a patient’s fallopian tubes; Essure coils then stimulate the formation of scar tissue sealing the tubes and preventing pregnancy.
However, patients report having encountered menstrual irregularity, headaches, fatigue, and weight loss and gain, and in at least four cases, death. Two of the deaths were directly linked to a uterine perforation and an air embolism caused by the Essure coils. The other two fatalities were caused by a secondary infection and a suicide. The death from uterine perforation was reported to the FDA by Bayer in February 2015 following the submission of a recall petition reached the FDA.
Bayer has attempted to mitigate the concerns of the Essure coils’ safety. If you or a loved one had Essure coils implanted and suffered injury, you may be eligible for compensation. Please fill out the contact form on this page, or call Arentz Law Group at 1-800-305-6000 for free review of your case.