Last week, the Obstetrics and Gynecology Devices Panel of the FDA’s Medical Devices Advisory Committee made several recommendations regarding Bayer HealthCare’s permanent female sterilization device, Essure:

• that the insertion of the device be labeled a surgical procedure;
• that patients are equipped with more information about Essure, including what materials the device is made of, and that it may have to be removed at some point due to possible complications;
• that patients give informed consent prior to the procedure;
• that a registry be established to keep track of patients who have had the procedure, in order to better study any negative side effects over the next 5 years and, possibly, beyond;
• that there be clear guidelines for when the implants should be removed; and
• that there should be more data on patients who develop hypersensitivity to metal or autoimmune disorders following the procedure.

Additionally, panel members noted that the “ideal patient” for the procedure includes women at high risk for possible dangers of other forms of surgical, permanent birth control, and who understand the risks of Essure. They stated Essure should not be recommended for patients with hypersensitivity to metal or with nickel allergies, those with autoimmune disorders, a history of inflammatory diseases or abnormal uterine bleeding, and those who have had previous uterine surgery.

The panel’s recommendations followed a 12-hour hearing that stretched into the evening last Thursday, as patients, experts and Bayer representatives gave testimony. Throughout the hearing, patients described a variety of negative side effects they experienced after device implantation, some of which were considered serious adverse events. At this meeting, the FDA committee specifically studied and heard testimony on implant perforation and migration, bleeding, chronic abdominal pain, headaches, allergic reactions and unintended pregnancy. The panel also discussed incidents in which women opted to remove the implants, whether due to adverse side effects or for other reasons.

The common refrain from panel members was that more information — more data — was needed.

Essure gained FDA approval in 2002 for women aged 21 to 45 years. It consists of a delivery system and a pair of soft, nitinol — a nickel-titanium alloy — spring implants. The implants are inserted through the vagina into each fallopian tube, causing scar-tissue growth, which over the course of months causes tubal occlusion, preventing eggs from being fertilized or from moving to the uterus.

“I feel that the answer from the patient’s point of view is still out there,” Jo-Ellen De Luca, of the FDA Patient Representative Program, said during the meeting. She added, “I think this has been a great opportunity to find some possible answers, but I think there’s still some great unknowns. I lead a very large support group, and I know a lot of patients will be — while they’re not here today — concerned around the country, looking for answers when this comes out. I think we’ve had plenty of patients that have been here that don’t have their questions answered, and I feel that will continue.” 

The FDA is not bound by their advisory committees’ recommendations; however, they are often followed.

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