More Limits for Bayers' Controversial Essure Device?

Some women are less suitable for the Essure device, according to an FDA panel, which examined thousands of complaints over the past decade.

Chris Newmarker

A U.S. FDA advisory panel is recommending more limited use of Bayer's Essure contraceptive device amid complaints of health problems from thousands of women.

The nickel and titanium Essure coils are implanted in women's fallopian tubes. The panel agreed that such hysteroscopic sterilization should remain an option for women who are not good candidates for laparoscopic or general surgery, such as women who are obese or can't tolerate anesthesia.

But the panel also said the Essure device should be considered less suitable for patients experiencing other problems including known metal allergies, autoimmune disease, a history of pelvic inflammatory disease, and/or a history of abnormal uterine bleeding, according to an FDA summary of the meeting last Thursday.

FDA is not bound by its panels' advice, but often follows such recommendations.

The FDA's Obstetrics and Gynecology Devices Panel heard sometimes emotional testimony on Thursday as a string of women blamed a Bayer's Essure contraceptive device for ruining their health, according to media reports.

For example, 33-year-old Chandra Farmer said she experienced muscle weakness so severe that she collapsed in front of her kids; she finally had a hysterectomy to remove Essure last year, according to The New York Times. Gabriella Avina once worked for the company and helped explain Essure to women, she has since changed her mind after going through celiac disease and myasthenia gravis.

Planned Parenthood and the American College of Obstetricians and Gynecologists still back the device, saying there have been few problems overall. And Bayer argues that complications have been rare.

About 750,000 women have had Essure implanted since FDA approved it in 2002, according to The Associated Press.

FDA has received nearly 6000 reports of problems related to Essure. The advisory panel on Thursday discussed Essure-related complaints including persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, allergy or hypersensitivity reaction, and cases of pregnancy still occurring. Such problems have sometimes required device removal.

Many panel members agreed that a randomized controlled trial of Essure, while ideal, would be impractical. They instead suggested that ongoing trials be reviewed, with some panel members calling for the creation of a registry to follow implanted patients.

Other recommendations included more information and access to health services for women getting Essure implants, as well as the need for additional physician training.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.