Tag Archives: Essure recalled

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...
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FDA Releases Statement on Essure Review

On March 7, 2018, FDA Commissioner Scott Gottlieb released a statement regarding the agency's ongoing monitoring and investigations into issues related to Bayer‘s controversial birth control device Essure. More than 750,000 women have received the implant since Essure’s approval in 2002. As of December 31, 2017, the FDA has received 26,773 medical...
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Essure Banned and Recalled in Brazil

In February 2017, Brazilian public health agency Agencia Nacional da Vigilancia Sanitaria (“ANVISA”) recalled permanent contraceptive device Essure and banned the sale of the device in Brazil. ANVISA suspended the importation, distribution, use and dissemination of Essure, and recalled units that had already been distributed. Though Essure bears a “black-box” warning, the strongest issued by...
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