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GAO Report Finds Flaws in FDA Adverse Event Reporting System

A report by the Government Accountability Office (GAO) has found that limitations in the U.S. Food and Drug Administration’s adverse event reporting system led to a 23-year delay in warning consumers about the risk of spreading uterine cancer linked to power morcellators.

The power morcellator is a medical device used to remove uterine fibroid tumors and in hysterectomies. The device cuts the fibroids into small pieces that are then removed via a small abdominal incision. Some fibroids may have undetected cancer cells, which can be spread throughout the body when the morcellator cuts them into fragments.

The GAO report said that doctors and hospitals did not feel obligated to report the spread of uterine cancer via the FDA’s adverse event reporting system because the device itself was not malfunctioning. The report also noted that the FDA has known about the risk posed by power morcellators in spreading uterine cancer since the 1990s but believed the risk was low — between 1 in 500 and 1 in 10,000.

However, the FDA issued a warning about power morcellators in 2014, saying that because approximately 1 in 350 women with fibroids also have uterine sarcoma, the use of power morcellators could pose a dangerous risk of spreading the cancer.

A few months after that announcement, the FDA added a “black box warning” — its most severe — on power morcellators, with the recommendation that they no longer be used for hysterectomies. Johnston & Johnson has already settled almost 70 lawsuits that allege the company’s power morcellator spread cancer in plaintiffs.

A study published in the August 2016 issue of the Journal of the American Medical Association (JAMA) showed that following the FDA’s warnings, the use of power morcellators declined significantly. The study also found that the complication rates from traditional hysterectomies did not increase as supporters of the device had warned if the use of morcellators decreased. Morcellator use decreased from 14% in 2014 to 3% in 2015.

The attorneys of Roberts & Roberts have the skill, experience and resources to fully investigate any serious accident or death. If you have a question about an accident involving a serious injury or fatality, please call 800-248-6000 or contact us for a free consultation.

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