FDA to Assess Power Morcellators This Week
Power Morcellators Linked to Spread of Uterine Cancer
The FDA has said it will meet on July 10 and 11 to discuss power morcellators, a device used in laparoscopic uterine surgeries to remove fibroids. An estimated 50,000 surgical procedures in the U.S. each year utilize the device.
Power morcellators work by slicing up fibroid and uterine tissue which can then be removed laparoscopically. Use of the device was considered to be less invasive, associated with shorter recovery times, and had fewer wound site infections than other methods of fibroid removal.
However, concerns were raised in April after the FDA issued a warning discouraging the use of the devices due to the risk of spreading a rare, undetected uterine cancer. An estimated 1 in 350 women, according to the FDA, who undergo fibroid removal surgery have an unsuspected uterine cancer that could be spread by the morecellation process. When the advisory committee meets this week, the group will review ways to “mitigate these risks and potential changes to the design of the devices” as well as consider changes to the label and directions of the device.
In the wake of the April alert, some hospitals suspended use of power morcellators or placed restrictions on the procedure. Johnson & Johnson, the largest producer of the the devices, also suspended the sales, distribution, and promotion of power morcellators.