Social Media Posts Showed Almost 1,500 Adverse Events, 53 Deaths Linked To Essure: FDA Report
Report quantifies social media posts describing adverse events involving the Essure contraceptive device, which was pulled from the market amid safety concerns.
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In a 15 September update of adverse events from Bayer’s now-defunct Essure birth control device, the US agency tallies patients’ unwanted pregnancies and describes serious injuries.
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.
After concerns from the medtech industry that a 2017 final rule requires sponsors with knowledge of off-label use of their product to add it to their label, the US FDA is proposing to delete the confusing text.