The Food and Drug Administration (FDA) is requiring Bayer Healthcare to conduct a clinical study for its nonsurgical permanent birth control device Essure to determine any heightened risks for particular women. Bayer was ordered to collect data on its contraceptive device following an FDA safety review prompted by a growing number of complaints involving the implant. The agency is also requiring a black box warning be placed on the contraceptive’s safety label. A boxed warning is the strongest warning the FDA can issue and is reserved for products where, if used, there is reasonable evidence of a serious health consequence or ... Read More
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