GAO Report: Weak Reporting System Allowed Continued Use Of Risky Surgical Devices.

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.” https://www.nytimes.com/2017/02/08/health/morcellator-gao-report-fda.html?_r=0