The reason for the approvals, according to the U.S. Government Accountability Office report, was that the devices were deemed so similar to older devices, for surgery on the knee and other joints example, that they were approved for use in gynecologic surgeries without rigorous testing. The ramifications of this long-anticipated report are far reaching.
According to the report, the FDA knew that power morcellators could accidentally spread uterine cancer, but considered the risk too low to warn women and their doctors.
Furthermore, the report found that holes existed in the agency’s reporting systems meant that reports of deaths or serious injuries related to medical devices made by hospitals and doctors either didn’t provide alerts to the government or health regulators didn’t see the incidence reports.
It wasn’t until 2014, more than two decades after the first gynecological morcellator received approval, that the FDA issued a warning about the device, specifically that it could spread and worsen uterine cancer. The agency estimated that 1 in every 350 women who undergo a hysterectomy or fibroid surgery were at risk. Therefore, the device should not be used in the vast majority of cases, the FDA said.
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In 2013, Noorchashm’s wife, Amy Reed, also a doctor, underwent a hysterectomy with a power morcellator, which spread her undetected uterine cancer. Despite aggressive treatment, the mother of six is still battling leiomyosarcoma that has spread to numerous organs.
The FDA has issued a statement saying it "agrees with the findings" of the GAO. The agency noted that it continues to warn that morcellators should rarely be used, that the device labeling now has a warning about the cancer risk, and that the system for monitoring safety problems is being improved.