The FDA says it will hold a meeting on September 24 to re-examine the safety of Essure, a birth-control method that was approved in 2002. Essure is marketed as the only permanent birth control method that does not require surgery. While Bayer has acknowledged side effects including pelvic pain, migration of the device or rash, women have said they have experienced other unlisted side effects.
Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement. We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.
Bayer says it appreciates the opportunity to discuss the matter with the FDA.
While there are risks with all medical devices and procedures, our highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure.