GAO report says FDA ignored evidence on surgical device for women
The FDA underestimated harmful effects of a surgical device initially approved for use in 1991, according to a report from the Government Accountability Office.
The FDA had received reports since at least 2013 that laparoscopic power morcellator devices, which are used to cut tissue into small pieces during minimally invasive surgeries, are associated with a difficult-to-detect uterine cancer, USA Today reported.
- Reports from the FDA and GAO have not estimated the number of women adversely affected by power morcellator surgery, but they likely numbers in the thousands, according to USA Today.
Power morcellators have been a concern for a while. The recent report from the GAO was 18 months in the making, according to an article posted by the Regulatory Affairs Professionals Society. A dozen members of Congress requested an investigation into the link between power morcellator surgery and cancer in August 2015.
Results of the investigation reveal that the FDA faces limitations when it comes to postmarket surveillance. Following medical device approval, FDA relies on spontaneous reports from manufacturers, providers, and patients to identify issues with approved medical devices. There were few reports regarding power morcellator devices submitted through 2015, so issues may have gone unnoticed.
While cancer risk associated with power morcellator devices should not be minimized, the issues highlights a dilemma that regulatory agencies encounter. The FDA and other agencies are criticized for failure to bring medical devices to the market quickly, but they are prone to harsh criticism when those devices produce unintended consequences.
- Government Accountability Office Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling
- USA Today GAO confirms FDA underestimated risk of morcellators in women's surgeries
- Regulatory Affairs Professionals Society GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators - See more at: http://www.raps.org/Regulatory-Focus/News/2017/02/08/26794/GAO-Adverse-Event-Reporting-Limitations-Delayed-FDA-Action-on-Power-Morcellators/#sthash.7IVgAGjY.dpuf