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The findings of new research warn that women over 50 may face increased risk of a deadly form of uterine cancer that can be spread by laparoscopic morcellation procedures, but raises questions about the overall cancer risk of power morcellators.
The study was published online last week by the American Journal of Obstetrics & Gynecology, providing an updated analysis about the laparoscopic morcellation cancer risks after a number of FDA safety communications issued in recent years.
Laparoscopic morcellation involves the use of a medical tool to cut up and remove the uterus or uterine fibroids through a small incision in the abdomen. The use of morcellators became increasingly popular over the past decade, providing a minimally invasive procedure that was often recommended as a way to limit the risk of complications and reduce recovery time. However, the use of power morcellators has been largely abandoned by the medical community after it was discovered that the devices may spread undiagnosed cancer cells contained within the uterus, leading to rapidly advanced and difficult to treat cases of leiomyosarcoma, endometrial stromal sarcoma and other cancers.
In November 2014, the FDA decided to add a black box warning to power morcellators about the cancer risk, and provided guidance on the limited instances where laparoscopic hysterectomies may be warranted.
In the latest study, researchers from Cedars-Sinai Medical Center in Los Angeles, the University of Washington and the University of North Carolina looked at data from 11 studies published since the FDA safety communication and found 539 cases of leiomyosarcoma (LMS) following 318,006 surgeries. Overall, mortality rates between women who underwent morcellation compared to those who had an abdominal hysterectomy were about the same, with only two fewer deaths among those who did not have morcellation procedures.
Researchers found that in women under 50 who underwent laparoscopic hysterectomy with morcellation, there were 16 more deaths linked to leiomyosarcoma, but 21 fewer deaths from the procedure overall when compared to abdominal hysterectomy, for a total difference of five fewer deaths among women who underwent morcellation. However, among women ages 50 and older, there was a steep increase in leiomyosarcoma deaths.
Women 50 and older suffered 91 more deaths associated to leiomyosarcoma if they underwent the laparoscopic hysterectomy with morcellation. Once surgical deaths and complications were accounted for, 70 fewer women died among the abdominal hysterectomy group.
“Varying the rates of LMS incidence and hysterectomy mortality, most scenarios favored laparoscopy,” the researchers concluded. “Importantly, we were able to incorporate age as a risk factor into our model and propose that risk associated with morcellation is significantly higher in women over 50.”
Since warnings were issued by federal regulators in April 2014, the medical community has largely stopped using of morcellators, and Johnson & Johnson’s Ethicon unit, which was previously the main manufacturer of the device, stopped selling the tool.
Johnson & Johnson has faced dozens of hysterectomy morcellation lawsuits brought on behalf of women who suffered upstaged uterine cancer after a laparoscopic procedure, and wrongful death claims by family members who had died of such cancers.
While most of those cases have been resolved through morcellator settlement agreements, a number of other morcellator manufacturers continue to face claims alleging that they failed to warn the medical community about the cancer risks.