FDA to consider scientific data of Essure contraceptive implant-Bayer HealthCare

The FDA plans to convene a public meeting of the Obstetrics and Gynecology Devices Panel on September 24, 2015 to discuss scientific data regarding the Essure contraceptive implant from Bayer HealthCare with regard to its safety and effectiveness. At this meeting, the FDA invites feedback from presenters, panel members and the public to inform recommendations and next steps about Essure. Some women have reported to the FDA that they have experienced pain or other health problems after Essure placement. Problems have also been reported in clinical studies, and they are addressed in the Essure product information (labeling for physicians and patients). Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.

The FDA conducted a thorough review of the available information about Essure and the experiences of patients who have had Essure since the FDA approved it in 2002. This includes experiences of patients who have had positive outcomes with Essure as well as those who have experienced problems.