A Food and Drug Administration advisory committee will meet this week to discuss whether laparoscopic power morcellator devices, which are used to remove uterine fibroids or a patient's uterus, should be reclassified as high-risk medical devices.
If morcellator devices were reclassified as high-risk, they would be subject to a premarket approval application. Power morcellation devices, made by a few companies including Johnson & Johnson and Karl Storz, have been in use since the early 1990s, but there has been a recent spate of safety concerns about whether the devices can cause the spread of cancerous tissue in a patient's body.