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Interim FDA-Mandated Postmarket Study Finds Essure Has Significantly Higher Rates Of Adverse Events

As expected based on retrospective data, new results from an ongoing postmarket study has found Bayer’s Essure birth control device has significantly higher rates of major adverse events compared to women who undergo tubal ligation.

BERLIN, FEBRUARY 2: Pedestrian bridge over the street on the Bayer Headquarters in Berlin on February 2, 2016.

Women implanted with Bayer’s Essure birth-control device have significantly higher rates of pelvic pain, uterine bleeding and hypersensitivity compared to women who undergo tubal ligation, according to initial results from a government-mandated postmarket study.

Since pulling all Essure devices from the market following a slew of cases where women reported severe injuries, the US Food and Drug Administration required the device maker to conduct...

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