The FDA’s approval of morcellators put women’s health at risk, says a report from the Government Accountability Office.
Over two decades, the FDA approved 25 power morcellators, although the agency knew they could spread uterine cancer, according to the report.
The agency was aware of the risk, but decided the danger — estimated to affect 1 in 350 hysterectomy or fibroid surgery patients — was not sufficient to warn women or doctors.
The report faults the FDA reporting system for devices as a whole, noting that procedural gaps either kept doctors and hospitals from alerting regulators to risks or kept regulators from reading those warnings.
The FDA did not issue a warning about gynecological morcellators’ risk of exacerbating uterine cancer until 2014, more than 20 years after approving the first device. After receiving the first adverse event reports concerning the devices in December 2013, the FDA updated its safety guidance for the devices and encouraged manufacturers to update their labeling protocols. By December 2015, the agency had begun hospital inspections to ensure compliance with device reporting rules.
Beyond the inspections, the FDA assembled a team to evaluate and respond to morcellator safety issues and conducted a literature review to improve its understanding of the risks of uterine fibroid surgeries. In addition to the initial guidance update, the agency issued a safety communication in April 2014 discouraging the use of morcellators for myomectomies and hysterectomies.
Despite the steps taken by the FDA, the report notes numerous questions remain about the devices and the relative risks they pose. For example, there is a lack of information on how manual morcellation using a scalpel affects the risk of spreading cancer as compared to using power morcellators.