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# Bayer Warned About FDA Essure Scrutiny: Report
- URL: https://www.fdaweb.com/bayer-warned-about-fda-essure-scrutiny-report/
- Published: 2020-08-20T12:00:00.000Z
- Updated: 2026-09-14T16:25:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147479

A Bayer official warned the company of increased FDA scrutiny of injuries from its Essure implanted contraceptive device before it was withdrawn from the market, according to recently unsealed court documents reported by *Bloomberg News*. The news service [reports](https://www.bloomberg.com/news/articles/2020-08-19/bayer-warned-of-essure-complaint-surge-years-before-sales-halted?ref=fdaweb.com) that a company product surveillance senior manager said in an internal e-mail that Bayer would see “a large increase in the number of \[side-effect reports\] filed” that “will certainly be noticed” by FDA.

That warning came four months after Bayer’s 2013 purchase of Cenceptus, the Essure developer.

The unsealed documents reportedly are part of about 38,000 individual lawsuits against Bayer. The company recently said it has set aside $1.47 billion primarily to resolve Essure claims.  
  
Meanwhile, Bayer announced 8/20 that it has reached agreements with plaintiff law firms to resolve about 90% of the nearly 39,000 total filed and unfiled U.S. Essure injury claims. Under the agreement, Bayer will pay about $ 1.6 billion to resolve the claims, including an allowance for outstanding claims. The company says it is still in “resolution discussions” with counsel for the remaining plaintiffs.