Essure May Get Black Box For Risks; FDA Orders Bayer To Do Post-Marketing Study

(March 1, 2016, 2:22 PM EST) -- SILVER SPRING, Md. — The Food and Drug Administration on Feb. 29 ordered Bayer HealthCare Corp. to conduct a clinical study on the safety of the Essure birth control device and said it intends to require a black box warning and a Patient Decision Checklist about the device’s risks....

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