FDA receives backlash after not banning power morcellators, despite cancer risks
After power morcellators were linked to the spread of undiagnosed cancer following laparoscopic hysterectomies and myomectomies, the FDA’s decision to allow these devices to remain on the market has incited harsh criticism from consumers and activism groups alike. The leaders of this backlash, a Massachusetts couple directly affected by the controversial device, are petitioning to ban morcellators—which were originally approved through the FDA’s 510(k) program, allowing fast-track approval of certain devices without clinical trials or tests. No public statements, recalls, or black box warnings have been made by the FDA, but a number of uterine cancer morcellation lawsuits have been filed, raising questions as to why the unreasonably dangerous devices were not properly accompanied by manufacturers’ warnings, and why alternative treatment options were not given to patients. Read here to learn more about the petition.