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FDA to require “black box” warning, but leaves controversial Essure implant on market

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 plans to require a "black box" label warning about the device's potentially serious side effects, plus a checklist for doctors to discuss potential risks with patients.

"The agency has carefully reviewed all the available evidence ... While there are risks associated with the use of Essure, there are also benefits," William Maisel, chief scientist at FDA's Center for Devices and Radiological Health, said in a call with reporters Monday. "We believe informed women should have this as an option available to them."

The agency's decision Monday drew immediate criticism from at least one lawmaker of each party 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. Rep. Rosa DeLauro (D-Conn.) agreed, saying the agency must make sure the company does the follow-up studies and that "Essure should be off the market until the requested studies are completed."

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.

"These studies could take several years, and leaving the device on the market will only put more women's lives at risk," the group said in a statement, which also questioned why the agency would allow Bayer itself to conduct safety studies of Essure. "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."

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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. The company vowed to work with the FDA to put the agency's recommendations in place.

“Patient safety and appropriate use of Essure are our greatest priorities,” Dario Mirski, senior vice president and head of medical affairs Americas at Bayer, said in a statement. “A woman’s decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about 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. On Monday, Maisel said that among the thousands of reports the FDA had received about Essure,  there were 631 reports of women becoming pregnant after receiving an Essure implant; of those, 294 included pregnancy loss. Still, he said, the device overall had proven "extremely effective at preventing pregnancies."

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 1 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 thinks "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 thinks 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. Maisel said the FDA will require Bayer to follow at least 2,000 women for a minimum of three years.

The agency said Monday it will seek public comment on the new recommendations for 60 days.

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