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FDA Report: Pain, Menstrual Issues Most Common Essure-Tied Adverse Events

Executive Summary

The US agency has released data on nearly 50,000 adverse events related to Bayer’s withdrawn Essure birth control implant.

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Interim FDA-Mandated Postmarket Study Finds Essure Has Significantly Higher Rates Of Adverse Events

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.

Essure: FDA Grants Bayer Variance From MDR Reporting For Certain Adverse Events Found On Social Media

The US agency in a 24 April letter approved Bayer’s request for a deviation from traditional Medical Device Reporting requirements. The variance applies to MDR-reportable events related to the problem-prone Essure device that Bayer is or becomes aware of from social media between November 2016 and November 2020, as part of ongoing litigation around the product.

Essure Update: Almost All Unsold Units Back To Bayer; Postmarket Study Enrollment Complete

The US FDA says Bayer has successfully recovered unsold Essure units and completed enrollment in a Sec. 522 postmarket study, fulfilling deadlines set at a year from the date the devices were taken off the US market.

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