FDA Takes New Measures to Inform Women of Essure Risks

In April 2018, a national movement of women suffering from painful side effects caused by Essure achieved two major victories: On April 9th, the FDA ruled that health care providers can no longer implant Essure unless the doctor and patient review and sign an FDA-approved document outlining the risks. The following week, the FDA announced new guidelines in approving medical devices for U.S. patients.

FDA Commissioner Scott Gottlieb noted that some women receiving Essure have not been fully informed about the risks associated with it: “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”  Even with warnings in place, Essure is still available in the U.S., though it has been removed from the market in other countries.

If you or a loved one has been hurt by the Essure implant, please call our attorneys at 888-985-7228 for a confidential evaluation of your potential claim.

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