Latest Bayer Report Shows Thousands More Essure Adverse Events

Latest Bayer Report Shows Thousands More Essure Adverse Events

When Bayer announced in July 2018 that it would stop selling the permanent birth control device Essure, the U.S. Food and Drug Administration (FDA) required the company to continue to evaluate long-term safety information in women who received the device.

According to the latest analysis from Bayer covering the period of June 1, 2020, through August 31, 2020, there were an additional 7,509 events related to the Essure reported to the FDA’s medical database, including 7,332 serious injury reports, 104 malfunction reports, and 73 death reports. The most common patient problems reported included pain, perforation, foreign body/device fragment in the patient, pregnancy, and heavier periods.

The FDA added that the limited information on the reports provided by Bayer “prevents the ability to draw any conclusions as to whether the device or its removal, caused or contributed to any of the reported deaths or other events in the reports.”


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This post originally appeared here: https://newyork.legalexaminer.com/health/latest-bayer-report-shows-thousands-more-essure-adverse-events/

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