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 Based on its review of the medical literature, the FDA said 1 in 485
women with so-called uterine fibroids could also have a potentially
lethal hidden cancer, called leiomyosarcoma, which might be spread
by the use of the devices, known as power morcellators.
But Dr. William H. Parker from UCLA School of Medicine, Los Angeles,
California told Reuters Health by email that the FDA’s analysis of
how commonly this kind of cancer is lurking in women having surgery
for presumed fibroids “was flawed, inadequate, and misleading.”
“Their recommendations were not based on science, but rather on
emotional and anecdotal information,” he said.
Writing in Obstetrics and Gynecology, Parker and other top
gynecologists in the Leiomyoma Morcellation Review Group say the
FDA’s review included studies that lacked credibility. Also, they
say, three leiomyosarcoma cases were included that don’t satisfy
current definitions of cancer.
If those three cases and the information in the other unreliable
studies are excluded, there were only eight cases of leiomyosarcoma
among the 12,402 women having surgery for fibroids (leiomyomas, in
medical terms). That’s one in 1,550, or 0.07 percent.
Parker and colleagues say the FDA’s restrictions would eliminate all
the minimally invasive operations for uterine fibroids and leave
open abdominal surgery as the only option.
These doctors claim that forcing women to have open surgery, through
a larger incision, instead of laparoscopic surgery could increase
surgery-related deaths and complications. They back up their claim
with recent information that shows higher rates of surgical
complications and hospital readmissions since the FDA put these
restrictions in place in November 2014.
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Nearly four dozen physicians signed an open letter to FDA that
concludes, “Women have a right to self-determination. Modification
of the FDA's current restrictive guidance regarding power-morcellation
would empower each woman to consider the pertinent issues and have
the freedom to undertake shared decision-making with her surgeon in
order to select the procedure which is most appropriate for her.”
Dr. Jason D. Wright from Columbia University College of Physicians
and Surgeons in New York City, who wrote an editorial related to
this report, thinks the FDA is unlikely to change its policy in the
near term. “I think as more data becomes available the FDA should
ultimately readdress this topic,” he told Reuters Health.
“I think physicians should understand that there is certainly a
safety concern with morcellation and they need to use caution to
minimize the risk of inadvertently morcellating a precancerous or
cancerous lesion,” Wright said. “The corollary is that in some women
the benefits of morcellation may outweigh the risks.”
SOURCE: http://bit.ly/1ICWvsR Obstetrics and Gynecology, online
December 8, 2015.
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