By Jennifer Levitz
From: wsj.com
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.
Beyond that, the researchers found the procedure presents the risk of spreading other types of cancer beyond the uterine sarcomas that had been the focus of concern. The study included all cases of women who were found to have uterine cancer after they underwent morcellation, including endometrial cancer, which is far more common.
The study didn’t say whether their cancer was worsened by the procedure. “Certainly that is the next step, to answer those questions,” said Jason D. Wright, the lead author of the report and director of gynecologic oncology at the Columbia University College of Physicians and Surgeons.
Sarcomas can masquerade as benign fibroids and are difficult to diagnose and treat. Doctors can test before surgery for endometrial cancer, which begins in the lining of the uterus. But endometrial cancer isn’t always detectable, particularly when women have few symptoms, Dr. Wright said. “I think this provides important information showing that there is certainly a risk of cancer, not only sarcomas, but endometrial cancer at the time of morcellation,” he said.
Moreover, other types of gynecologic cancer and precancerous tissue were found to have been missed before surgery and morcellated, Dr. Wright said.
The authors said patients should be counseled about the risks of undetected cancerous and precancerous conditions before undergoing the procedure.
Estimates dating to the 1990s suggested that the odds of an undetected uterine cancer were rare—as low as 1 in 10,000 cases. But a few studies back then found the risk as high as about 1 in 500 cases. A recent meta-analysis by the FDA put the risk even higher, at 1 in 352, but that estimate was criticized by many specialists as relying on thin data and not rigorous enough to warrant a crackdown on the device.
Proponents of the surgical tool argue that its benefits—helping doctors perform a less-invasive operation—make it too important to ban. Some gynecologists contend that without morcellators, more women will undergo traditional abdominal hysterectomies, which often result in bigger scars, longer recoveries and more complications.
Opponents call the risk too high for an elective procedure, and note there are alternatives. To that point, the study found that morcellation was performed in only about 16% of the more than 230,000 minimally invasive hysterectomies it looked at.
Dr. Wright said the authors of the JAMA report conducted the study because of publicity about the device, led by The Wall Street Journal, which first reported on the issue in December. Although power morcellators have been on the market for two decades, scant data existed about the tool, he said.
Some families hope the new research will spur sharper restrictions on the device or even a ban. “I just think it’s got to get stopped,” said Glenn Davies, of Salem, N.H. In 2012, a doctor diagnosed his wife, 59-year-old gliding instructor Nancy Lincoln Davies, with a fibroid and used a morcellator during a hysterectomy, her records show. Her mass was actually cancer, and she died 10 months later.
Sarcomas have been in the spotlight because that was the diagnosis last fall of a Boston anesthesiologist whose presumed benign fibroid was inadvertently morcellated during a routine hysterectomy last fall. The hospital that treated her has said the procedure worsened her cancer.
Her case, and her campaign against power morcellation, ignited the national debate. She underwent aggressive surgery and recently completed six months of chemotherapy for advanced cancer.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.