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Sunday, August 17, 2014

Study Finds New Cancer Risk From Hysterectomy Device Tool Might Spread Wider Range of Cancers Than Previously Believed

Updated July 23, 2014 8:14 a.m. ET

A surgical device commonly used in hysterectomies has the potential to spread more types of cancer in a woman's body than previously thought, new research released Tuesday shows.

The report in the Journal of the American Medical Association also reinforces an earlier government assessment that use of the device, a laparoscopic power morcellator, is risky.

In April, the Food and Drug Administrationadvised doctors to stop using morcellators for removing fibroids in the uterus. The agency concluded the device could spread previously undetected cancerous tissue inside the body, significantly worsening the patient's odds of survival.
The new study by Columbia University doctors found that 1 in 368 women undergoing hysterectomies have a hidden uterine cancer that is at risk of being spread by a morcellator. 

Significantly, the research examined the records of a much larger group of women than the FDA did in its main analysis.
Many gynecologists disputed the FDA data and its assessment of the device's danger. The agency held a two-day hearing on the issue earlier this month and is expected to decide this year whether to restrict or even ban use of morcellators.

Doctors not involved in the new study said its findings make clear that the device puts a segment of women at risk. "This just confirms it," said David Mutch, chief of gynecologic oncology at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis.

Morcellators deploy spinning blades to slice uterine fibroids or the uterus itself into fragments that can be removed through tiny laparoscopic incisions. Johnson & Johnson, the largest maker of the tool, suspended sales after the FDA's warning in April.

Using a database of insurance information, the authors of the new study, which was funded by the National Cancer Institute, identified more than 36,000 women treated with the device at 500 U.S. hospitals over seven years. The research found a level of hidden-cancer risk similar to the FDA report.