December 16, 2014 — The FDA did not study the cancer risks of morcellators until 18 years after the surgical tools were approved for gynecological surgery, according to the Wall Street Journal.
The FDA did not start studying how morcellators might spread uterine cancer until December 2013, after the WSJ highlighted the hazard.
The report raises additional concerns about the FDA approving dangerous medical devices through the 510(k) approval process, adding morcellators to a long list of devices that also includes vaginal mesh and metal-on-metal hip implants.
The 510(k) loophole allows manufacturers to introduce new devices without conducting expensive, rigorous clinical trials — so long as the device is “substantially equivalent” to another device on the market.
In 1991, Cook Medical Inc. convinced the FDA that power morcellators were equivalent to hand-operated morcellators, which have been used in hysterectomies and fibroid surgeries for decades. Over the next two decades, the FDA approved 10 more devices from various manufacturers through the same loophole.
Cancer concerns were raised as early as 1995, when FDA medical officer Daniel Schultz warned that the tool could raise dangerous cells, according to application documents:
“The same day, he wrote in a summary for the record that the device ‘must be used with an appropriate tissue extraction bag for malignant and other tissues which are potentially harmful if disseminated within a body cavity.’”
While power morcellators may seem similar to hand-held devices in theory, in practice they were used much differently. One major difference was that surgeons rarely used power morcellators with protective surgical bags because they were too flimsy and cumbersome.
Another difference was that power morcellators gained popularity when used in combination with robotic surgery, which dramatically increased the number of women who were treated with a power morcellator. As recently as last year, the devices were used in 70,000 hysterectomies per year.
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