The Food and Drug Administration said Monday that it will require German drug maker Bayer AG to undertake new safety studies on its permanent birth-control device Essure, after thousands of women complained about suffering complications from the controversial implant. The agency also recommended a “black box” label warning about the device’s potentially serious side effects, plus a risks checklist for doctors to discuss with patients.
“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,” William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health, said in a statement. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
The agency’s decision Monday drew immediate criticism from at least one lawmaker on Capitol Hill, as well as from a community of women who have said the device caused devastating health problems — including pelvic pain, stomach swelling, dizziness, cramping, bleeding and fatigue. They have waged a relentless social media campaign to have Essure pulled from the market.
“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,” Rep. Mike Fitzpatrick (R-Pa.),who has pushed the agency to halt the device’s use, said in a statement Monday. “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 tens of thousands of women members, posted the news on its page along with a harsh assessment: “FDA has dropped the ball again.”
Bayer has maintained that Essure, which the FDA approved in 2002, has a solid safety record and should remain available as an option to women seeking permanent birth control.
“Essure is an important permanent birth control option with a positive benefit-risk profile, which is based on a comprehensive clinical development program,” the company said in a statement Monday. “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 device itself is little more than a small, flexible coil made in part from an alloy of nickel and titanium. A doctor inserts a coil through the cervix and into each Fallopian tube, in a procedure that typically takes less than 15 minutes. Over roughly three months, tissue is supposed to form around the inserts, blocking the tubes and preventing pregnancy. During that initial period, women must use alternative forms of birth control.
The FDA held a much-anticipated public meeting on Essure last fall amid growing reports of complications. The women who spoke detailed harms they attributed to the device, including unplanned pregnancies when it failed and surgeries to remove it after suffering painful side effects.
Bayer, which is facing several lawsuits over Essure, has insisted the device is 99 percent effective when inserted properly and when women use birth control until a follow-up visit several months after the procedure. The company says about a million of the devices have been sold worldwide, the vast majority of them in the United States, and that complications happen in only a small fraction of patients.
“Clearly, the data for Essure shows the benefits outweigh the risks,” Edio Zampaglione, the company’s vice president of medical affairs for women’s health, told the Post in an interview last year. “There’s nothing [we’ve seen] with the product itself that says we’ve got a defective product or something that needs to be taken off the market.”
The FDA largely has agreed, even as it periodically has required updates to the product’s labeling based on clinical trial information, patient reports and other medical literature about the device.
On Monday, the agency said it believes “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control,” but it acknowledged the risk of serious complications for some women. Officials said it believes the black-box warning it is recommending for Essure will help patients and doctors better understand the potential risks. In addition, the agency is recommending a new “patient decision checklist” that can help doctors discuss the risks and individual patients decide whether to opt for the device.
Monday’s action requires Bayer, which acquired rights to Essure in 2013, to conduct a new study designed to “provide important information about the risks of the device in a real-world environment.” The company will have to follow patients who receive the device and monitor for problems such as unwanted pregnancy, pelvic pain and other symptoms. The study also must evaluate how complications affect patients’ quality of life.
The agency said Monday it will seek public comment on the new recommendations for 60 days.