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, including that it be described as a surgical procedure in the product labeling.
The panel made their recommendations following a 12-hour hearing that stretched into the evening Thursday, as patients, experts and Bayer representatives gave testimony. Throughout the hearing, in which patients described a variety of negative side effects they experienced after device implantation, the common refrain from panel members was that more information — more data — was needed.
“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. “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 device 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.
However, several women who have used the product have reported severe adverse side effects. Today, 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.
During the meeting, Bayer argued its product was both necessary and met a “most stringent” premarket approval process for Class III medical devices.
After their testimony, the panel made the following recommendations to the FDA:
- 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.
In addition, the panel stated 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.
Representatives from the FDA said they would take the panel’s recommendations, as well as the testimony, into consideration in deciding what future steps to take.
Also during the hearing, Richard J. Chappell, PhD, of the University of Wisconsin, said a possible reason the panel was discussing such negative side effects, 13 years after Essure’s FDA approval, was that the device was approved on the basis of a “so-called pivotal trial,” and not on data from a randomized, controlled trial. He added that it served as an example to the FDA, and urged the agency not to repeat this mistake in the future.
Edio Zampaglione, MD, vice president of U.S. Medical Affairs for Bayer HealthCare, said the company looks forward to working with the FDA on the recommendations. He added that company representatives “learned a lot” from the patient testimony, and that it underscores the need for “more options, not less” in the field of female birth control.
“We really want to ensure the safe and appropriate use of all our products,” Zampaglione said. “We don’t deny that adverse events occur, and we make every attempt to mitigate them as much as possible, and we sympathize with any patient who has experienced an adverse event.” – by Jason Laday