DeLauro Statement on FDA’s Review of Essure

WASHINGTON, DC (February 29, 2016) —Congresswoman Rosa DeLauro (CT-03) today released the following statement regarding the U.S. Food and Drug Administration's new measures to evaluate the risk of Essure, a permanent form of contraception. DeLauro secured language in the FY 2016 Omnibus bill requiring FDA to complete a review of the device by the end of February.

"Women and their doctors have filed more than 5,000 adverse events reports to the FDA regarding the negative side effects of Essure, yet the device is still on the market. While conducting a postmarket study and issuing labeling recommendations are positive developments, these actions mean nothing unless the FDA is able to take action.

"Last year, the GAO released its findings on a report I commissioned, showing that the FDA's requests for postmarket safety studies often take a long time to be completed, and that companies lack incentive to find participants for their studies. Now, the FDA is asking Bayer to do a postmarket study, all while there is no evidence that the FDA has remedied the issues found within the GAO report. FDA needs to take accountability in ensuring that these manufactures are completing these postmarket studies in a timely manner. In the meantime, Essure should be off the market until the requested studies are completed.

"I will continue to monitor the situation and will hold the FDA accountable to guarantee that it is doing due diligence in reviewing the postmarket studies and taking the necessary actions to address safety issues. The FDA cannot continue to drag its feet on medical device safety when women are suffering. Women's lives depend on it."

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