FDA warns against procedure
to remove uterine fibroids;
says it could spread hidden cancer
The Food and Drug Administration on Thursday took the rare step of urging doctors to stop performing a surgical procedure
used on tens of thousands of women each year to remove uterine growths,
saying the practice risks spreading hidden cancers within a woman’s
body.
The procedure, known as
power morcellation,
has long been used in laparoscopic operations to remove fibroid tumors
from the uterus, or to remove the uterus itself. It involves inserting
an electric device into the abdomen and slicing tissue in order to
remove it through a small incision. The surgery is far less invasive
than traditional abdominal operations.
But the FDA on Thursday agreed with a growing chorus of
researchers and clinicians who oppose the procedure, saying that it can
recklessly spread undetected cancers throughout the body and make the
disease more lethal in the process. The agency is not seeking to ban the
practice or the roughly two dozen FDA-approved devices used to perform
it, but hospitals and gynecologists are likely to abandon the procedure
because of potential liabilities.
The FDA said its analysis
determined that an estimated 1 in 350 women who undergo morcellation
have an unsuspected form of uterine cancer called uterine sarcoma.
“The
existence of the risk is not new,” said William Maisel, chief scientist
at the FDA’s Center for Devices and Radiological Health. “What is new
is that the magnitude of the risk appears to be higher than was
appreciated by the clinical community.”
Maisel acknowledged that
the agency was spurred to action — or at least moved more quickly —
because of a high-profile campaign waged in recent months by a
Massachusetts couple, both doctors, for a moratorium on the practice.
Anesthesiologist
Amy Reed, a mother of six who last spring treated Boston Marathon
bombing victims as well as one of the suspected bombers, underwent what
was supposed to be a routine procedure last fall to end bleeding from
fibroids. The procedure spread undetected, cancerous tumor fragments
throughout her abdomen. Now she is battling stage-four leiomyosarcoma, a
rare and aggressive form of uterine cancer.
Her husband, Hooman Noorchashm, a Harvard-affiliated cardiothoracic surgeon, responded by launching a campaign
to ban the widely used procedure. He has e-mailed numerous regulators,
doctors and lawmakers, written to medical journals and lobbied
hospitals. The couple started a Change.org petition to end the practice.
Noorchashm
said Thursday that he appreciated the FDA’s relative speed in
addressing the problem. “You don’t even have to be a doctor to recognize
that if tissue or a tumor has malignant potential, you should not mince
it up inside someone’s body,” he said. “That’s just bad medicine.”
Many women develop uterine fibroids — benign growths that originate in
the muscle tissue in the wall of the uterus. Although many fibroids do
not cause problems, others can result in frequent urination, prolonged
menstrual bleeding and pelvic pain.
Of the more than 500,000
hysterectomies performed in the United States each year, about 11
percent, or more than 50,000, involve morcellation, according to the American Congress of Obstetricians and Gynecologists.
Some doctors advocate performing a morcellation only when using an
“isolation bag” in an effort to minimize the spread of tissues, but that
method is not foolproof, as the bags can break.
“When you
consider what the benefit is, which is a shorter hospital stay and less
pain, then consider what the risk is — this could kill you — most women
would not choose that risk if they really understood what is at stake,”
said Diana Zuckerman, president of the Cancer Prevention and Treatment
Fund.
Even before Thursday’s announcement by the FDA, the push to limit uterine morcellations had gained traction.In February, Temple University Hospital issued guidelines
instructing surgeons not to perform the procedure on fibroids over a
certain size. Doctors may use the procedure for smaller fibroids only
after informing patients about the risks and, in most cases, using
isolation bags. Even before that, prompted by Noorchashm’s campaign,
Massachusetts General Hospital and Brigham and Women’s Hospital in
Boston took similar measures.
On Thursday, the heads of
obstetrics and gynecology at both Boston hospitals promptly notified
their staffs to suspend use of power morcellation until further notice.
Margaret
Jacobson, the medical director of Whatcom Hospice in Bellingham, Wash.,
cried upon hearing of FDA’s action on Thursday. In March 2012,
her sister, Elizabeth Jacobson, had a hysterectomy by morcellation.
Elizabeth Jacobson did not want to miss much work, and the promise of a
minimally invasive procedure appealed to her.
But inside the
large fibroid that a doctor shredded lurked malignant cells that spread
throughout her abdomen, her sister said. Soon, Elizabeth Jacobson was
diagnosed with aggressive uterine cancer. She then had a second surgery,
rounds of chemotherapy and long stretches of misery. She died Jan. 8,
2013.
“She suffered terribly,” Margaret Jacobson said. “It devastated our family.”
Thursday’s
news brought a measure of relief, she said, that other women might
avoid the same fate, especially given that safer surgical alternatives
already exist.
“It’s a victory ,” Jacobson said. “It’s not okay to tolerate these deaths. . . . My sister’s life was extraordinary; she was beautiful and loving. She does not deserve to be an easily dismissed statistic.”
BLOGGER'S NOTE: This is so scary. Most of us have believed, for years, that almost any "minimally invasive" procedure was safer than one that required a large incision. And I guess it still is, IF you know for absolute certain that there is no cancer in your body that could be disturbed from a single (in situ*) location and spread throughout the body.