The FDA first announced their intention to provide a safety update about Essure late yesterday evening. Today's much anticipated report comes on the heals of a private citizen petition that raised serious concerns about the Essure Birth Control Implant and resulted in the launch of an FDA investigation into the birth control device.
This afternoon the U.S. Food and Drug Administration (FDA) added a page to their website informing the public of increased risks associated with the Essure Permanent Birth Control Implant. The new page acknowledges the 5,093 adverse events that have been reported to the agency about Essure and provides new information about serious risks associated with the device including: pelvic pain, migration of Essure coils, perforation of the uterus or fallopian tubes, and rash and itching. The page also advises physicians to warn patients about complications that have resulted in women with nickel allergies who have received the Essure Birth Control Implant.
One section of the webpage recognizes reports of miscarriage and ectopic pregnancy following the non-surgical sterilization procedure, stating, "The FDA will continue to monitor the safety of Essure to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks," and "While scientific evidence shows that Essure is a highly effective means of sterilization when health care providers and patients follow the appropriate instructions for use, no form of birth control is 100% effective."
The FDA announced today that there will be a public meeting of their Obstetrics and Gynecology Devices Panel later this year on September 24, 2015, to discuss the safety and efficacy of the device.