On Thursday, a panel of health experts met at the Food and Drug Administration (FDA)’s Maryland campus to review the safety of Essure permanent contraceptive device and consider whether Essure use should be restricted.
The FDA’s Obstetrics and Gynecology Devices Advisory Panel heard presentations from doctors and scientists as well as accounts from women who felt they had been harmed by the device. The panel has been asked to consider possible changes to the product’s label and whether further clinical studies should be conducted, Reuters reports.
Bayer HealthCare Pharmaceuticals acquired Conceptus, the device’s original manufacturer in 2013. About 750,000 Essure devices have been sold worldwide, most of them in the United States. Essure, which consists of small, flexible metal coils, can be inserted in a doctor’s office. Essure is an alternative to tying the fallopian tubes, a surgical procedure. The coils cause scar tissue to form in the tubes, blocking them and preventing pregnancy.
Bayer says that Essure is safe, but some 17,000 women have posted on the Facebook group “Essure Problems,” with descriptions of complications and injuries they attribute to Essure. They have described chronic pain, heavy bleeding, fatigue, painful intercourse, and allergic reactions to the nickel in the coils, Reuters reports. Women have become pregnant despite the coils, and there have been ectopic pregnancy, which can be life threatening.
The complaints-more than 5,000 made to the FDA in the 13 years Essure has been on the market-have led some physicians to re-examine their use of the device. Dr. Sebastiaan Veersema, a gynecologist at St. Antonius Hospital Nieuwegein in the Netherlands, was an early adopter. He has implanted nearly 1,400 Essure devices and has trained other practitioners in its use. But Veersema now believes more research is needed into the relationship between Essure and the problems patient report. Veersema suggests a stronger screening process might be necessary to avoid implanting the device in women who already have a uterine problem, such as fibroids, according to Reuters.
Angela Lynch, the woman who started “Essure Problems,” had Essure implanted when she was 28. Lynch had three children and did not want any more. At first, she thought the symptoms she experienced were due to her body adjusting to the device. But the symptoms persisted and she began losing hair and teeth and she said her whole body hurt. She had the device removed in 2012 and also underwent a hysterectomy. A few days after the surgery Lynch said she felt like she “woke up from a five-year flu,” according to Reuters.
Some doctors say the panel should consider not only the implantation of the device but also how it is removed. Dr. Shawn Tassone, who practices in Austin, Texas, said there is no standardized method for removal, Reuters reports. In addition, Tassone thinks there should be changes to how doctors counsel patients who are considering having Essure implanted. “Instead of saying Essure is an easy procedure with no side effects,” Tassone says doctors should tell patients this is a surgery and some patients have complications.