Medical Malpractice

GAO report: Weak reporting system allowed continued use of risky surgical devices

The New York Times (2/8, Grady, Subscription Publication, 13.9M) reports a Government Accountability Office report issued Wednesday found that doctors failed to inform the FDA “about cases in which cancer was spread around inside women’s bodies” by power morcellators – a surgical tool that “was widely used for more than 20 years before the F.D.A. acted to limit it, after being alerted to the problem in 2013 by a patient who was harmed.” The device is “a spinning blade that shreds tissue” and is used “to help remove benign uterine tumors called fibroids, or to remove the entire uterus” by “slicing up tissue so it could be removed through tiny incisions.” According to the Times, the GAO report found “a major flaw in the system for detecting harm” – “It is passive, relying on ‘adverse event’ reports.” However, the report calls for tighter regulations “just as the Trump administration has suggested that drug and device regulations should be loosened, not tightened.”

According to the Wall Street Journal (2/8, Levitz, Kamp, Subscription Publication, 6.37M), the FDA knew the devices had the potential to spread cancer when it first approved one in 1991, but thought the risk was much lower than new research shows. The agency began investigating the risk of morcellators spreading women’s cancer in 2013 after a series of WSJ articles reporting hazards associated with the devices. US Reps Brian Fitzpatrick (R-PA) and Louise Slaughter (D-NY) said in a statement, “The release of this long-awaited report won’t do anything to help women battling cancer who have had their lives devastated by power morcellators, or provide much comfort to the families of those already lost. It does, however, shed light on the broken system that allowed this devastation to happen.” An FDA spokesperson said Tuesday the agency “has noted the shortcomings of the current passive postmarket surveillance system and has been taking steps to establish a better system to evaluate device performance in clinical practice.”

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