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Patient Advocacy Group Calls On Congress To Investigate FDA’s Role In Essure Approval



The group – called Essure Problems – is now urging Congress to step in and probe the regulatory agency.

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May 2, 2016 | by Sarah Massey, M.Sc.

A women’s advocacy group for patients who experienced adverse reactions associated with Bayer’s contraceptive implant, Essure, have criticized the US Food and Drug Administration (FDA) for its alleged lack of oversight for the medical device. The group – called Essure Problems – is now urging Congress to step in and probe the regulatory agency.

Representative Jason Chaffetz, the leader of the U.S. House Committee on Oversight and Government Reform, was recently contacted by the patient advocacy group who asked him to investigate the FDA’s regulation of Essure. In a letter to Chaffetz, the group puts forth a number of reasons why Congress should step in.

According to the letter, clinical trials for Essure “were inadequate and inappropriate from the beginning.” Bayer’s Premarket Approval for Essure was based on just two studies with a total enrollment of 926 women. Around 25 percent of the participants – 197 women – were reassessed two years after the clinical trial was completed.

Essure Problems also alleges that the FDA failed to respond to reports of serious adverse events associated with the contraceptive device. “As long ago as 2010, the FDA was aware of thousands of complaints regarding Essure made to Conceptus, but which were never reported to the FDA," the group said. And there are about 10,000 side effect reports filed with the agency, a number that is "well recognized as under-reported,” said the letter.

Amid safety concerns associated with the device, the FDA began requiring that Essure display a black box warning on their packaging. The regulator is also asking Bayer to conduct more clinical trials to assess the risk of side effects in certain women.

Essure Problems says that it is “irrational and illogical” to allow Bayer to continue marketing the device while they carry out new safety studies. The patient advocates also said it puts “a whole new group of unsuspecting women on a path to being harmed by the device with absolutely no legal recourse.”

The device has also sparked controversy in Canada, where regulators are investigating complaints associated with its use. Health Canada began a safety review of Essure in 2015, with results of the inquest expected next month.

Keywords: FDA, Clinical Trial, Medical Device


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