Prognosis
Bayer Accused of Underreporting Contraceptive Issues to FDA
- Audit warned in 2008 about backlog of injury reports: filing
- Essure was marketed as safe alternative to surgical methods
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Bayer AG failed to report thousands of complaints of injuries allegedly caused by its Essure contraception device to the U.S. Food and Drug Administration, according to newly unsealed documents.
After acquiring original Essure maker Conceptus in 2013, the German conglomerate continued the California-based company’s practice of not reporting complaints to the FDA, according to an unsealed court filing by the lead attorney in the coordinated lawsuits by thousands of women in California.