GAO: FDA Overlooked Cancer Risks in Medical Devices

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.