The U.S. Food and Drug Administration recommended a new “black box warning” label for Essure, an implantable permanent contraceptive device.
A black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks,” according to the FDA website.
The FDA issued a new, mandatory clinical study for Essure to determine heightened risks for particular women. William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said,
“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them. They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
Essure is a permanent form of birth control that involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. Over a period of about three months, scar tissue forms around the inserts and creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. While the scar tissue forms, women must use an alternative form of birth control.
The draft FDA guidance also includes proposed language for the “patient decision checklist,” for doctors to discuss with patients to better communicate risks and help to ensure an informed decision-making process.
The FDA has also ordered Bayer, the company that manufactures Essure, to conduct a new postmarket surveillance study designed to provide important information about the risks of the device in a real-world environment.
Essure said the following in a statement.
“Essure is an important permanent birth control option with a positive benefit-risk profile, which is based on a comprehensive clinical development program. Bayer will continue to closely work with the FDA to address their latest recommendations and to ensure the safe and effective use of Essure.”
The FDA announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths, and severe pain and bleeding after an Essure implantation, reports the CNN.
Rep. Mike Fitzpatrick (R-Pa.), who has pushed the agency to halt the device’s use, said in a statement Monday,
“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and to ask the manufacturer to perform another study while leaving Essure on the market. If the FDA is going to order another study, then at minimum they should take Essure off the market during that time.”
A Facebook group called Essure Problems, which has thousands of female members who have shared stories about health problems they experienced after receiving the device, said Monday it was “outraged” by the agency’s decision, reports the Washington Post. The group also questioned why the agency would allow Bayer itself to conduct safety studies of Essure. It said in a statement,
“These studies could take several years, and leaving the device on the market will only put more women’s lives at risk. We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.”
Madris Tomes, a former FDA contractor whose business, Device Events, analyzes FDA public data, said,
“I feel as if the FDA truly failed these women. My hope was that they would recommend a recall. How can we trust the FDA to make good decisions regarding safe and effective devices?”
The FDA is seeking comment from the public, industry, and other stakeholders on this draft guidance on Essure use. The docket will be open for 60 days.
[AP Photo/Julio Cortez]