By Jennifer Levitz
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 study in the Journal of the American Medical Association
also reinforces an earlier government assessment that use of the
device, called a laparoscopic power morcellator, is risky.
In April, the Food and Drug Administration advised doctors to
stop using morcellators for removing fibroids in the uterus. The
agency concluded that the device could spread previously undetected
cancerous tissue inside a woman's body, significantly worsening the
patient's odds of survival.
The new study by Columbia University doctors found that 1 in 368
women who are undergoing hysterectomies have a hidden uterine
cancer that is at risk of being spread by using a morcellator.
Significantly, the research examined the records of a much larger
group of women than the earlier FDA report.
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 serious 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 their 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 that the procedure presents
the risk of spreading other types of cancer beyond the uterine
sarcomas that had been the focus of concern. The JAMA 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 Dr. Wright.
Sarcomas can masquerade as benign fibroids and are notoriously
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, said Jason D. Wright, the lead author
of the new report and director of gynecologic oncology at the
Columbia University College of Physicians and Surgeons.
"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
both undetected cancerous and precancerous conditions before
undergoing the procedure.
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 say the risk is too high for an elective procedure
with alternatives. They note there other minimally invasive
surgical techniques for removing fibroids, including vaginal
hysterectomies and the mini-laparotomy, in which the tissue
typically is removed through a small incision above the pubic
bone.
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 the concerns in December. Although
power morcellators have been on the market for two decades, scant
data existed about the tool, he said.
Some gynecologists who defend the morcellator have suggested
limiting its use among older, postmenopausal women because they
face a higher cancer risk. They maintain that it is still a
valuable option for younger women. But the study found that of the
women with cancer, 80% were younger than 50, Dr. Wright noted. The
risk of having an underlying malignancy increased with age.
Some patients 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 widower Glenn
Davies, of Salem, N.H. In the fall of 2012, a doctor diagnosed his
wife, 59-year-old gliding instructor Nancy Lincoln Davies, with a
fibroid and used a morcellator during a hysterectomy, according to
her records. 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.
Write to Jennifer Levitz at jennifer.levitz@wsj.com
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