year Martha Montalvo-Ariri underwent a routine hysterectomy to
help treat painful uterine fibroids. During surgery, her
doctor used a morcellator, a device that cuts the tissue into
pieces so it can be removed through small incisions.
after the procedure, Montalvo-Ariri was diagnosed with a rare
and aggressive form of uterine cancer called leiomyosarcoma.
Even more devastating, the rotating blade of the morcellator
had scattered cancerous tissue fragments around her abdomen
and pelvic area, accelerating the diseaseís progression.
of the forms I signed mentioned anything about cancer,"
said Montalvo-Ariri, a 46-year-old mother of four in
Riverside, Calif. "They said it was in and out, very
easy, and youíre back to your life. Instead, they took my
such as Montalvo-Aririís have raised significant concerns
over the use of power morcellation to remove a womanís
uterus or fibroids. Cleared for gynecological surgeries in
1995, morcellators facilitate minimally invasive procedures
that can reduce womenís pain, recovery time and
April, however, after reviewing new data, federal regulators
urged doctors to stop using morcellators, because if cancer is
present the device can spread malignant cells beyond the
uterus and worsen a patientís chance for long-term survival.
In response, a leading manufacturer of morcellators, Johnson
& Johnsonís Ethicon subsidiary, suspended sales of the
medical providers are wrestling with a difficult decision:
Should they offer a procedure that has proven benefits for the
majority of patients but also carries a rare but deadly risk
for a small number?
could be tested for all uterine cancers beforehand, doctors
could avoid morcellation with some patients. But without doing
surgery, thereís no reliable way to predict whether a woman
with fibroids has a uterine sarcoma, notably leiomyosarcoma,
according to the U.S. Food and Drug Administration.
hospitals around the country have stopped using morcellation
at least temporarily.
others have said morcellation still has a role in
gynecological surgery and that, with appropriate counseling,
patients can decide for themselves. Last month Northwestern
Memorial Hospital reinstated the technique under
"controlled circumstances" and for those who might
be at higher risk with a traditional open procedure. Advocate
Health Care lifted a systemwide ban in May.
professional medical associations acknowledge the risk but say
morcellation should be an option in some cases because
minimally invasive procedures cause fewer complications,
injuries and deaths than open surgery.
the FDA held a public meeting to discuss how to make
morcellation safer, including whether a black box warning
should be added to the product labeling. The agency has not
yet publicly announced any conclusions.
a growing chorus of doctors, clinicians and leiomyosarcoma
patients and their families want the device banned, arguing
that morcellation is reckless and viable alternatives exist.
been seeing women harmed by this thing for the last eight
years," said Dr. Robert Lamparter, a pathologist at a
small Pennsylvania hospital who wrote a letter to the FDA
requesting the deviceís clearance be revoked. He said he has
analyzed tissue in five cases in which an unanticipated cancer
just horrified," Lamparter said in an interview. "Itís
not just another complication. There is no acceptable injury
or death rate for an elective surgical device, even if itís
wonderful for those who arenít harmed."
600,000 hysterectomies are performed in the U.S. each year.
Research suggests about 40 percent are done to remove
presumably benign or noncancerous fibroids that are causing
heavy bleeding, pelvic pressure or pain, or other symptoms.
number of morcellations is not tracked, prompting calls for a
nationwide registry of gynecological surgeries that would
include information on the devices used.
safest and most cost-effective way to remove the uterus is
through a vaginal incision, according to the American College
of Obstetricians and Gynecologists. But that isnít possible
with enlarged uteruses or large fibroids unless the tissue is
cut into small pieces with a power morcellator or by hand
using a scalpel.
traditional surgical choice involves a 5- to 7-inch incision
in a womanís abdomen. This method offers doctors the
clearest view but like all surgeries carries a higher risk of
infection and complications such as blood clots. Though the
overall mortality risk is low, research suggests abdominal
hysterectomy patients die three times more often than those
who undergo a laparoscopic procedure.
risks of morcellation are difficult to assess. The FDA
estimates that about 1 in 350 women who undergo a hysterectomy
or fibroid surgery have an undetected form of uterine cancer.
But those numbers have been questioned because the studies are
small, leiomyosarcoma is extremely rare and the data arenít
broken down by age.
the issue: Even without morcellation, the outlook for women
with leiomyosarcoma is grim. The five-year survival rate for
women at stage 1, when the cancer is confined to the uterus,
is approximately 50 percent, according to the National Cancer
Institute. (Once the cancer has spread, the rate is about 15
percent.) For most other gynecologic cancers, the five-year
survival rate is 90 percent if the tumor is contained.
morcellation "would set us back to offering procedures
with larger incisions and be a detriment to women
surgically," said Dr. Jessica Shepherd, director of
minimally invasive gynecology at the University of Illinois at
Chicago College of Medicine. "There is always risk in a
procedure. The most important part is the discussion women
have with the physician before having it."
morcellation controversy gained national attention after Amy
Reed of Boston underwent an elective hysterectomy at Brigham
and Womenís Hospital last October. Reed, an anesthesiologist
at Harvard Medical School who has six children, said she had
preoperative biopsies, ultrasounds and MRIs to rule out
cancer. After the procedure, however, she was diagnosed with
advanced leiomyosarcoma; morcellation had seeded her abdomen
then, Reed and her husband, cardiothoracic surgeon Hooman
Noorchashm, have been lobbying against morcellation. The
technique is not only unnecessary and avoidable but violates a
basic tenet of oncological safety because women cannot be
diagnosed preoperatively, Reed said.
the tissue thatís removed also can make it difficult to
detect a small area of cancer under a microscope or to
determine the initial size of a tumor.
intention of a morcellator is to disrupt tissue, which is not
a sound practice," she said. "You never cut up
tissue where you donít know if a cancer lurks within. Itís
who calls morcellation "a historic error in surgical
practice," knows his strong views have alienated some
friends and colleagues. A major problem, he said, is that
gynecologists tend to assume that all symptomatic uterine
fibroids are benign. "This is the diametric opposite of
how general surgeons are trained to think," he said.
"Itís a major judgment error because it totally ignores
the women with hidden or missed uterine cancers."
hospitals have strengthened informed consent procedures and
patient counseling, Noorchashm said that will not protect a
woman with a hidden or missed cancer. Informed consent, he
said, is "a weak and unethical medico-legal defense
mechanism for doctors and hospitals."
Charles Miller, a reproductive endocrinologist at Advocate
Lutheran General Hospital, credited Noorchashm with putting
the issue on his radar but finds fault with Noorchashmís
person who says I feel comfortable morcellating any patient is
as wrong as the doctor who says morcellation has no place in
minimally invasive surgery," said Miller, who performs up
to 250 morcellations a year. "Patient safety goes beyond
just risk of sarcoma that has spread. You cannot deny the
absolute advantages that we realize."
minimize risk, some doctors are returning to manual
morcellation ó using a scalpel or scissors to remove the
masses. Miller is a proponent of containing the tissue thatís
removed during morcellation in a specimen "bag."
Memorial Hospital began using the bags in April, said Dr.
Magdy Milad, chief of gynecologic surgery at Northwestern
Universityís Feinberg School of Medicine. Under a revised
policy, open morcellation will be performed only when itís
in the best interest of the patient, he said, adding that
"weíll probably be transitioning into some kind of
truly closed morcellation system in the future."
acknowledges that the bag technique does not always prevent
tissue from being spread. Bags also occasionally tear or
perforate, and they can compromise the doctorís vision.
American College of Obstetricians and Gynecologists,
meanwhile, says there is no conclusive evidence that either
manual morcellation or use of a bag eliminates the risk.
Kimberly Kho, an assistant professor of obstetrics and
gynecology at the University of Texas Southwestern Medical
Center, encourages surgeons to avoid morcellation until more
safety data are available. If morcellation is under
consideration, "itís imperative to tell patients it
could spread undetected cancer, worsen prognosis and that the
device itself can cause injuries," she said.
who is now on her fourth type of chemotherapy treatment, said
she would have welcomed that information.
had four cesarean sections, and I bounce back from surgery
pretty quickly; I would have had no problem with them opening
me up the old-fashioned way," Montalvo-Ariri said.
"That was the most devastating thing."