STORY FROM: Drugs & Medical Devices
Conn. Woman Alleges Injuries, Hysterectomy Caused By Bayer’s Essure Birth Control Device
February 17, 2016
BRIDGEPORT, Conn. — A Connecticut woman has sued Bayer Corp., alleging that its Essure contraceptive device caused her to sustain pain, heavy bleeding and blood clots, and forced her to undergo a hysterectomy.
In a Feb. 16 complaint filed in the U.S. District Court for the District of Connecticut, the plaintiff accuses Bayer of failing to adequately report adverse events associated with the device to the Food and Drug Administration and failing to comply with the device’s Conditional Premarket Approval Conditions.
Essure is a Class III device that was approved in 2002 via the FDA’s premarket approval process. The ...
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