FDA Proposes Boxed Warning for Essure

Disclosures

February 29, 2016

The US Food and Drug Administration (FDA) today proposed a boxed warning for Essure permanent contraception, as well as a patient checklist that highlights possible adverse events such as perforation of the uterus or fallopian tubes, device migration, hypersensitivity reactions, and persistent pain.

The FDA also ordered the manufacturer, Bayer Healthcare Pharmaceuticals, to perform a postmarket study comparing adverse events experienced by Essure users with those of women who undergo bilateral tubal ligation.

However, the device should stay on the market for now, the FDA said in the face of vociferous demands to recall it.

"The FDA continues to believe that this product should remain available to women who are adequately informed of the risk," said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, at a news conference today. "It is extremely effective at preventing pregnancy when used correctly."

Marketed as a nonsurgical alternative to tubal ligation, Essure is a small flexible metal coil that fits into each fallopian tube through the cervix and uterus. The ensuing inflammation and scarring permanently seals each tube within 3 months. Until that time, the patient must use another form of contraception.

The FDA received more than 5000 complaints about Essure since its approval in November 2002 through May 2015, an agency study revealed, with 80% of those reports streaming in since late October 2013. The reports included four adult deaths and five fetal deaths, which a recent independent analysis put in the hundreds.. Some patients have required abdominal surgery to remove the device.

The surge of adverse-event reports led an FDA advisory panel in September 2015 to recommend some of the regulatory measures that the agency announced today.

Bayer must begin its postmarketing study in the next 15 months. It will involve some 2000 women, who must be followed for at least 3 years. Dr Maisel noted that findings should start to emerge within the first few months.

The proposed boxed warning states that clinicians should tell patients about the adverse events it mentions. That discussion is supposed to happen with a proposed checklist that asks the patient to initial that she has been told about alternatives to Essure, the increased risk for an ectopic pregnancy, adverse events such as pelvic pain, excessive fatigue, and hypersensitivity reactions, and the need for a confirmation test 3 months after device implantation.

Dr Maisel said that the lack of this test to make sure the device is properly positioned and fallopian tubes occluded is the most common factor in surprise pregnancies.

The public will have 90 days to comment on the labeling and informed-consent requirements proposed by the FDA once they appear on the Federal Registry.

Dr Maisel also said at the news conference that the FDA had wrapped up its investigation of allegations that the results of the original clinical trials for Essure were falsified. He said that the agency found no evidence of systematic or intentional modifications of data.

Bayer said in a news release that it would cooperate with the FDA "to support the continued safe, effective and appropriate use of Essure."

A less cheery response to the FDA announcement came from Rep. Mike Fitzpatrick (R-PA), who has introduced legislation to recall Essure.

"It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market," Fitzpatrick said in a news release. "Frankly, I'd contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering. It's been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths."

More information on today's FDA announcement is available on the agency's website.

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