By Jennifer Levitz and Jon Kamp
An advisory from the Food and Drug Administration that strongly
cautioned doctors against performing a common surgical procedure on
women is upending the landscape of care across the U.S.
The FDA surprised gynecologists last month when it issued an
advisory against using a device called a power laparoscopic
morcellator, saying it can spread a dangerous hidden cancer. The
bladed tools are used in minimally invasive surgeries to slice up
and remove uterine growths called fibroids, sometimes as part of a
hysterectomy.
No figures are available on how many doctors have chosen to heed
the nonbinding warning, which the agency plans to revisit in a
hearing this summer. But dozens of interviews show the advisory has
divided hospitals and gynecologists, many of whom are still using
the device, and left women puzzling over their options. The tool
was being used in an estimated 50,000 uterine surgeries each
year.
The FDA said women undergoing surgery for what look like benign
fibroids actually have a 1 in 350 risk of hosting an undetected
cancer called a uterine sarcoma. Morcellating these tumors can
significantly worsen the odds of long-term survival, the agency
said. Johnson & Johnson, the largest morcellator maker,
suspended global sales soon afterward.
Many doctors believe the FDA overreached, and think the cancer
risk is so small that gynecologists can go an entire career without
seeing a case.
Hospitals and private practices are taking an array of
approaches. The University of Pittsburgh Medical Center system,
which has more than 50 obstetrics and gynecology practices, opted
to continue morcellating.
The medical system changed its informed-consent forms to include
wording on cancer risk and told doctors to discuss the risk with
patients. But Allen Hogge, chairman of Obstetrics, Gynecology and
Reproductive Sciences there, questioned the data behind the FDA's
estimate. The FDA began looking at the issue after media reports
late last year about a prominent Boston doctor who discovered she
had sarcoma after morcellation.
"I think this is mostly public relations and not science," Dr.
Hogge said. In response, the FDA said it conducted a rigorous
analysis of published literature.
Duke University Health System is also continues to use the power
morcellator after gaining a patient's informed consent. HCA
Holdings Inc., a major for-profit health-care company with
hospitals and surgery centers in 20 states, recommended its
affiliated doctors follow the FDA's guidance, a spokesman said.
I
n upstate New York, Unity Health System, a community hospital
with multiple offices throughout Rochester, declared a moratorium
on power morcellators six weeks ago but said it plans to revisit
the issue next month.
Other doctors say their move away from the device may be
permanent. "I probably will not ever use it again," said Plano,
Texas, gynecologist Keith Reisler, who said the rare exception
might be an obese patient who would have a higher risk from a large
incision. "The recent numbers made me uncomfortable because the
question is: what are we going to find out next?"
The advisory roiled Florida Hospital, an Orlando-based system
that is home to one of the primary J&J training centers for the
tool. "There [were] very strong emotions on all sides of the fence
and a lot of people quite frankly upset with the FDA's warning,"
said Chief Medical Officer Neil Finkler, a gynecologic oncologist
who said he treated two patients who died from sarcomas after
morcellations performed by other doctors, and agrees with the FDA's
guidance. The system chose to suspend the practice.
The conflicting views are confounding some women who wonder if
they should opt for another choice such as open abdominal surgery,
which has a long recovery time and carries its own risks, or
vaginal procedures that many gynecologists don't know how to
do.
After three years of painful fibroids, Terri Keeler, a
44-year-old school aide and spinning instructor in Wexford, Pa.,
was heading for a laparoscopic hysterectomy. But she paused this
month to balance the FDA's advisory against comments from her
University of Pittsburgh doctor, who she said told her that a
hidden sarcoma was very rare.
Suketu Mansuria, Ms. Keeler's doctor and the assistant director
of gynecologic minimally invasive surgery at the medical center,
acknowledged the conversation, one he holds all such patients. "I
say that in my opinion, one in 350 is an overestimation," he said.
He said the choice is always up the patient.
The FDA move "has totally confused things," Ms. Keeler said.
"I'm questioning what I'm going to do."
Medical societies, including the influential American College of
Obstetricians and Gynecologists, recently further complicated the
debate. ACOG issued a statement on May 9 defending morcellation for
many patients. The group acknowledged the cancer-spreading risk,
which they said should be disclosed, but said the procedure spares
women from more invasive surgery.
ACOG's view carries weight with doctors, hospitals, health
insurers and another significant stakeholder: malpractice liability
insurers.
Doctors Co., the largest doctor-owned malpractice insurer, plans
to note both the FDA advisory and the ACOG response in the next
issue of a publication it sends to 75,000 physicians, said David
Troxel, the insurer's medical director.
"I don't want to pre-empt the national medical specialty society
when they get on this right away," Dr. Troxel said.
His Napa, Calif.-based company hasn't advised doctors on whether
to perform surgery with morcellators, but will advise them to
discuss the risks, benefits and alternatives with patients, Dr.
Troxel said.
Another liability insurer, ProAssurance Corp. of Birmingham,
Ala., said it has received many questions on morcellation from
insured hospitals and doctors. The insurer doesn't give clinical
advice but also is stressing the need for informed-consent
discussions with patients, a spokesman said. This includes making
sure patients are aware of the FDA advisory, he said.
Write to Jennifer Levitz at jennifer.levitz@wsj.com and Jon Kamp
at jon.kamp@wsj.com
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