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A government report revealed limitations in the U.S. Food and Drug Administration’s adverse event reporting system led to a 23-year delay in warning the public about serious risks linked to surgical devices called power morcellators.
In 2015, the Government Accountability Office began investigating the FDA and power morcellators at the request of Representatives Mike Fitzpatrick and Louise Slaughter and others over concerns the device could spread uterine cancer.
The GAO report released on Feb. 7, 2017 found doctors, hospitals and individuals did not properly report morcellator problems to the FDA through its adverse event reporting system, causing a delay in the agency’s action to warn the public.
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