Essure contraceptive device – Update on FDA post-approval study

The U.S. Food and Drug Administration (FDA) have published an update with the interim results from the Essure Postmarket Surveillance (“522”) Study. Although Essure is no longer being manufactured or distributed, the FDA had required the manufacturer undertake a post-market surveillance study.

Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding as compared to women who had laproscopic tubal ligation. The rate of additional gynecologic surgical procedures, which includes device removal, was higher for Essure patients than tubal ligation patients. The pregnancy rates are similar for patients with Essure and laparoscopic tubal ligation.

Further details can be found at: FDA In Brief: FDA Posts Interim Results from Required Essure Postmarket Surveillance Study