After 20 Years, FDA Takes Back its Approval of Power Morcellators
Since 1991, power morcellators have been used by doctors for fibroid tissue removal during hysterectomies. Not until November 2014, however, did the FDA administer a warning that these surgical tools may spread hidden uterine cancer. At least 10 surgical devices manufactured by different companies have cleared FDA approval through a controversial, streamlined approach whereby a device-maker may seek regulatory clearance by showing that its product is similar to a pre-approved device already on the market. Though morcellator use was granted through this comparative approval process over two decades, the FDA did not start to study how morcellators might cause harmful effects until December 2013—which was followed by “black box” warning labels 11 months later. “There are too many approved moderate and high-risk devices that get on the market lacking high-quality evidence that they are safe and effective,” says Rita Redberg, a University of California, San Francisco, cardiologist who studies device regulation. Read more here.