June 17, 2014 — The U.S. Food and Drug Administration (FDA) will meet to discuss whether to ban the use of power morcellators in hysterectomies, according to the Wall Street Journal.
The FDA has already recommended against the procedure due to the risk of spreading uterine cancer, which is undiagnosed in about 1 in 350 women who have a hysterectomy to treat fibroids. Soon after this announcement, Johnson & Johnson, the largest manufacturer of power morcellators, stopped sales of power morcellators.
An advisory panel will meet on July 10-11 to debate the pros and cons of further regulatory action. The FDA does not always follow recommendations of advisory panels, but they give heavy weight to its guidance.
According to the WSJ, gynecology groups plan to argue that power morcellators remain a valuable surgical tool. They point out that women under 35 are much less likely to have undiagnosed uterine cancer than older women. The use of a power morcellator can save time during a minimally-invasive surgery. Risks can also be minimized if surgeons use a containment bag to avoid leaving pieces of tissue behind after surgery.
However, these benefits must be weighed against the risk of uterine cancer and leiomyosarcoma (LMS). When morcellators grind up fibroids, they can leave behind cancerous cells — essentially “seeding” a woman’s abdomen with aggressive cancer.
Instead of banning morcellators, the FDA could re-classify them as a “high-risk,” Class III medical device instead of “moderate-risk” devices. This would require manufacturers of existing devices to conduct studies to evaluate the safety risks of their products. Clinical trials are expensive and time-consuming, and it is possible that some companies will not find it economically worthwhile.
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