Cancer risk low in women with fibroids removed using morcellator

WASHINGTON — Women who had uterine fibroids removed with or without a medical device that chops up the growths had a low prevalence of cancer, a study found, adding new data to debate over risks from the technique.

Known as power morcellators, the devices have come under scrutiny from regulators as potentially raising the risk of cancer, since fragments of undetected tumors could be spread during the procedure. A study published recently in the journal JAMA Oncology analyzed data on 41,777 women who had fibroids removed, 7.7 percent of whom underwent morcellation.

The study found that among women who had morcellation, 1 in 1,073 developed uterine cancer. In women who didn't have morcellation, 1 in 528 did.

Power morcellators are used to help surgeons remove a woman's uterus or the fibroids by cutting tissue into pieces that can be taken out through a small incision in the abdomen.

The Food and Drug Administration last year warned that most women shouldn't use the devices because of a risk they could spread undetected cancer cells in the uterine tissue. In November, HCA Holdings Inc., which operates 280 hospitals and surgery centers in the U.S. and England, said it would stop use of the devices. Johnson & Johnson, based in New Brunswick, New Jersey, suspended sales of its power morcellators last year after an FDA warning.

The study's conclusion that the surgical approach should be used with caution in women older than 50 is in line with the FDA's recommendation that a young woman who wants to keep her uterus intact may still be a candidate for the technique. The devices had been widely used despite a lack of conclusive data on cancer risk, according to the researchers.

“These events highlight the difficulty of evaluating, using and marketing surgical devices,” said the researchers, led by Jason Wright, a gynecologic oncologist at Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital. “From a public health perspective, these findings highlight the need for more rigorous comparative effectiveness research and heightened regulatory oversight for new devices and procedures.”

Risk also differed by age. Of women younger than 40 who had fibroids removed without morcellation, 0.05 percent had uterine cancer, compared to 3.4 percent in women 60 or older.