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 Data showed that the procedure, laparoscopic power
morcellation, could significantly worsen a patient's chance of
long-term survival, the regulator said. (http://r.reuters.com/dug68v)
Laparoscopic, or minimally invasive, power morcellation involves the
use of an electric device that minces the fibroid into small pieces
that can then be pulled out through a tiny incision in the abdomen.
Uterine fibroids are benign tumors that usually pose no risk.
However, certain women suffer from symptoms that include heavy or
prolonged menstrual bleeding, pelvic pressure and frequent
urination, which could warrant medical or surgical intervention.
An estimated 50,000 procedures are performed using laparoscopic
power morcellation devices in the United States every year, said
William Maisel, chief scientist for the FDA's Center for Devices and
Radiological Health.
The procedure reduces risk of infection, lowers post-surgical pain
and enables quicker recovery compared with traditional surgeries.
About 1 in 350 women who are undergoing certain surgeries for
fibroids could suffer from a type of uterine cancer, the agency
said, but added there exists no reliable tests to determine if they
are cancerous prior to the removal.
Some risk of cancer spreading as a result of the procedures has been
known for many years to surgeons, Maisel said.
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"(But) the magnitude of the risk is higher than had been
appreciated by the medical community," he said on a conference call
with journalists on Thursday.
"The vast majority of patients that have undergone this procedure
have done so safely," he added.
(Reporting by Natalie Grover and Ransdell Pierson;
editing by Kirti
Pandey and Sriraj Kalluvila)
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