September 28, 2015 — At a public meeting Thursday, FDA's Obstetrics and Gynecology Devices Panel unanimously recommended that FDA limit the use of the medical device Essure, a nonsurgical sterilization method for women, Modern Healthcare reports.
The panel did not take a formal vote. Benjamin Fisher, director of FDA's Division of Reproductive, Gastro-Renal and Urological Devices, said making a decision about the device is a high priority, but the organization does not have a timeline for when it might issue new guidance (Dickson, Modern Healthcare, 9/24).
Essure is a nickel-titanium coil inserted into the fallopian tubes in a 15-minute procedure. Over three months, tissue builds up around the device and blocks off the tubes. FDA approved Essure in 2002 but has since required updates to Essure's labeling, including risk disclosures for a chance of pregnancy after implantation and for chronic pain, as well as a warning to women with sensitivity to nickel (Women's Health Policy Report, 9/23).
According to the New York Times, FDA fast-tracked Essure's approval because it was the first alternative to surgical sterilization (Tavernise, New York Times, 9/24).
Bayer HealthCare Pharmaceuticals acquired Essure in 2013 and has since faced several lawsuits. In addition, a Facebook group with more than 20,000 members shares stories of women who have experienced issues with the device (Women's Health Policy Report, 9/23). Bayer estimates that about one million women have received the implant worldwide, a majority of whom live in the U.S. As of June, FDA counted 5,093 adverse event reports related to Essure (Modern Healthcare, 9/24).
FDA said it has examined multiple studies about the implant and has "found no conclusive evidence in the literature indicating any new or more widespread complications definitely associated with Essure." However, the agency said it will continue "to make certain that its benefits of providing women with a non-incisional sterilization choice continue to outweigh its risks" (Women's Health Policy Report, 9/23).
In addition to limiting Essure's use, the panel recommended that physicians receive more training on how to place and remove the sterilization device. The panel also suggested establishing a system to monitor physicians whose patients have more adverse reactions to the device.
According to the panel, clinical trials on the device were not informative because they did not have a control group and were not random. Some panelists suggested a new, randomized trial with a control group consisting of tubal ligation patients (Modern Healthcare, 9/24).
During the meeting, many women testified about their adverse reactions to the device.
Meanwhile, Edio Zampaglione, a Bayer vice president, said thousands of women have been involved in long-term studies that show the device's "safety and efficacy." He said the rise in complaints stemmed from a rise in use.
Separately, Planned Parenthood and the American College of Obstetricians and Gynecologists said they will continue to offer the device to women. Planned Parenthood CMO Raegan McDonald-Mosley said the organization found few problems in its independent analysis, but she also called for more studies into Essure (New York Times, 9/24).