According to MedPage Today, the FDA Obstetrics and Gynecology Devices panel offered suggestions for best practices, stronger patient education, and increased collection of data regarding the Essure sterilization implant. Panel members recommended changing the label language to indicate that the implantation is a “surgical” rather than “nonsurgical” procedure.
These changes take place after an estimated 5,093 medical device reports — indicating adverse effects in women receiving the device — were filed with the FDA as of June 1, 2015. FDA staff indicate that an unusually large proportion of recent reports were submitted voluntarily by patients as opposed to the manufacturer.
FDA Panel Urges New Label, More Guidance on Female Sterilization Device.
