June 6, 2016

FDA used faulty data to approve Essure contraceptive coil: study

The U.S. Food and Drug Administration has used faulty data to approve many high-risk ob-gyn medical devices in the last 15 years, a new study says, including the controversial contraceptive device Essure.        

“Recent controversies surrounding obstetrics and gynecology devices” including among other things, the Essure contraceptive coil device, “highlight the need for deeper understanding of obstetrics and gynecology medical device regulation,” the study’s authors, based at Northwestern University, said. “Our results reveal significant weaknesses in the preapproval and post approval regulation of high-risk obstetrics and gynecology devices.”

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