SATURDAY, July 12, 2014 (HealthDay News) -- There's no way to
guarantee that a surgical technique used to grind up uterine
growths and remove them through tiny incisions won't increase the
risk of spreading cancer to other parts of a woman's body, U.S.
health advisers said Friday.
The advisory panel to the Food and Drug Administration also said
that women who do undergo the procedure -- called laparoscopic
power morcellation -- should sign a written consent stating that
they understand the potential risks, the
The panel's advisory opinion follows an April 17 warning from
the FDA that the procedure can inadvertently spread cancerous
tissue beyond a woman's uterus and into other parts of her
The FDA hasn't set a decision date on the use of power
morcellator devices, the
APsaid. The agency isn't obliged to follow the advice or
recommendations of its advisory committees but usually does so.
Surgeons frequently use laparoscopic power morcellation when
they perform a hysterectomy or remove uterine fibroids, which are
noncancerous growths on the smooth muscle tissue on the wall of the
The minimally invasive procedure uses a power tool to chop up
the tissue of the fibroids or, in the case of a hysterectomy, the
uterus itself. These tissue fragments are then removed through tiny
incisions, according to background information from the FDA.
The agency estimates that about one in 350 women undergoing a
hysterectomy or fibroid removal has an unsuspected type of cancer
called uterine sarcoma.
If a surgeon performs power morcellation on these women, there's
a risk the procedure will spread the cancerous tissue within the
patient's abdomen and pelvis.
About 60,000 of these procedures are performed every year,
estimated Dr. William Maisel, deputy director for science and chief
scientist at the FDA's Center for Devices and Radiological
The FDA stopped short in April of banning the power morcellation
devices from the market, but is urging physicians and patients to
weigh the risks prior to their use.
"Women should ask their health care provider if power morcellation will be used during the procedure, and explain why it's the best option," Maisel said at an April 17 news conference.
Women who already have undergone power morcellation don't need
to get a cancer screening, because some of the tissue removed
during the procedure would have been sent for pathologic analysis,
Maisel said. If cancer had been detected, they would have been
informed, he added.
"We think that most women who have undergone these procedures require routine care," he said. "If they don't have any ongoing or recurrent symptoms, they should be fine."
Most women will develop uterine fibroids at some point in their
lives, according to the U.S. National Institutes of Health. These
fibroids can cause symptoms such as heavy or prolonged menstrual
bleeding, pelvic pain or frequent urination.
Women who need a hysterectomy or fibroid removal can still
undergo traditional or laparoscopic surgery, just without the use
of a power morcellator, Maisel said.
The agency has instructed manufacturers of power morcellators to
review their current product labeling for accurate risk information
for patients and health care professionals.
The FDA approved the first power morcellator for use in 1995,
Maisel said. A non-power version of the morcellator received FDA
approval in 1991.
The medical community has been aware of the risk of cancer
spread during power morcellation since the devices came onto the
market, Maisel said, but "the magnitude of the risk appears to be
higher than what was appreciated in the clinical community."
For more about uterine sarcoma, visit the
U.S. National Cancer Institute.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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