More than 300 fetal deaths and at least five adult deaths have been linked to the nonsurgical, permanent birth control method Essure, according to a private analyst’s review of FDA medical device reports. Madris Tomes, founder and chief executive officer for Device Events, pored through thousands of complaints made to the FDA’s Adverse Events database as part of an FDA safety review on the contraceptive. The agency is expected to decide later this month whether to recommend additional clinical trials or update the safety label of Essure. The FDA review was prompted in part by thousands of reports of adverse ... Read More
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