FDA hearing July 10 & 11 (deadline)
Jane Brody on health and aging.
Many patients assume that, like prescription drugs, surgical procedures
and instruments undergo extensive testing and must be government-approved. It’s
not necessarily so.
Developers, of course, do test new
instruments, and practitioners often train with an expert before using them
unsupervised to treat patients. And the Food and Drug Administration must
confirm an instrument’s safety and effectiveness before it can be marketed —
but only if the device is deemed significantly different from others already
approved.
Surgical techniques, however, are
not subject to the stringent approval process that drugs go through. And as
with drugs, problems with
new procedures may not become apparent until after they have been used many
hundreds or thousands of times.
Such is the case with a popular
treatment for a very common medical problem: uterine fibroids. The technique, called
electric or power
morcellation, has widespread appeal for both surgeons and patients. It
is used during laparoscopic or robotic-assisted operations that are fast and
effective, require only a tiny incision or none at all, and involve less pain,
a shorter hospital stay and a quicker recovery. In most cases, these operations
are safer than traditional surgery.
As recent reports have shown, however, power
morcellation can also cause serious
and sometimes life-threatening complications. Experts say that prospective patients are often
not told about these risks before consenting to the operation.
The technique involves insertion of
a tiny instrument with a rapidly rotating blade, the morcellator, that breaks
up the fibroid so that it can be sucked out through the small opening of a
laparoscope. But problems can arise months or years later if pieces of tissue
escape into the pelvic cavity and seed themselves on other organs.
This problem is all the more
serious if the fibroid that was morcellated happens to have contained a hidden cancer. Although the overwhelming majority of
fibroids are benign, there is no certain way to tell before their removal if they harbor a cancer,
which happens in 1 in 400 to 1 in 1,000 cases.
One such case involves a
41-year-old Bostonian, Dr. Amy J. Reed, an anesthesiologist and a mother of six, who now has a Stage 4 leiomyosarcoma
after undergoing uterine morcellation. It is a rare but particularly aggressive
uterine cancer. Dr. Reed and her husband, Dr. Hooman Noorchashm, a
cardiothoracic surgeon, are waging a campaign through Change.org to halt use of
the technique.
Despite several preoperative tests,
neither Dr. Reed nor her surgeon suspected that cancer lurked within the
fibroids that were removed. If
she had had a traditional operation in which the fibroids were cut out or the
entire uterus removed intact, it is highly unlikely that the cancer would have
spread.
From 1983 through 2010, 13 unexpected uterine sarcomas were reported
after uterine surgery on 5,666 patients. Among 1,192 women who underwent
morcellation, two developed sarcoma that spread within the abdomen.
After reviewing the medical records of more than 1,000 women who
received morcellation for fibroids, specialists at Brigham & Women’s
Hospital in Boston found a ninefold higher rate of unexpected sarcoma
than is now quoted to patients considering the procedure.
“These data suggest uterine morcellation carries a risk of
disseminating unexpected malignancy with apparent associated risk of mortality
much higher than appreciated currently,” the researchers wrote in the journal
PLOS One in 2012.
Even benign uterine tissue, when it
is spread to other parts of the abdomen during morcellation, can grow in places
it doesn’t belong and cause pain, infection or bowel obstruction.
There is a technique that could
make morcellation safer: encasing the tissue to be removed in a bag before it
is broken up. But thus far, the procedure is infrequently used, and few
surgeons are skilled in the technique.
Other established ways to treat
bothersome fibroids are free of this potential risk, though complications like
wound infection are possible.
Fibroids are extremely common, affecting
half or more women during their reproductive years, when hormones foster their
growth. They develop from the smooth muscle tissue of the uterus, ranging in
size from tiny to huge, and often
shrink after pregnancy and menopause.
Most women with fibroids are
unaware they have them, but others can experience symptoms like prolonged heavy
periods, bleeding between periods, pelvic pressure, constipation, frequent urination, backaches
and anemia. They can sometimes cause infertility
or miscarriage.
Fibroids are typically detected
through a pelvic exam, sonogram or M.R.I., sometimes with saline solution or a
dye used to better define their size and location.
Nothing needs to be done about a fibroid that causes no distress.
Large, bothersome fibroids can often be shrunk by several months of treatment
with medications that block estrogen and progesterone, causing temporary menopause and
its attendant symptoms.
The drug mifepristone (RU-486) also can shrink fibroids, and Evista
may do likewise, but only in postmenopausal women. Sometimes a low-dose oral
contraceptive is used to reduce bleeding caused by fibroids without shrinking
their size.
Noninvasive ultrasound surgery under M.R.I. guidance can
be used to heat and destroy a fibroid without damaging the uterus. A fibroid
also can be destroyed by injecting small particles into uterine arteries to cut
off its blood supply.
Fibroids can be removed laparoscopically
or robotically without damaging the uterus. If the fibroid is contained within
the uterus, it can often be removed with surgical instruments inserted through
the vagina and cervix. Some fibroids may be destroyed by applying heat or
electric current to the uterine lining.
Very large, multiple or deep
fibroids may require more traditional surgery, called an abdominal myomectomy,
that spares the uterus, or with a hysterectomy, a more serious operation
involving removal of the entire uterus, ending a woman’s menstrual periods and
ability to bear children.
If you are contemplating treatment
for symptomatic fibroids, your doctor should answer several important questions
before you choose a method:
What is the nature of the problem,
and how necessary is it to treat it?
What procedures are known to be
effective, and what are the risks and benefits of each?
What is the approach you recommend,
and how much experience do you have with it?
What are its possible
complications, and how often do they occur?
Without a clear understanding of treatment options, their potential
hazards as well as their effectiveness, it is not possible to for you to give
informed consent.
http://en.wikipedia.org/wiki/Morcellator
Morcellator
From Wikipedia, the free
encyclopedia
Jump to: navigation, search
A morcellator is a surgical instrument
used for division ("morcellation")
and removal of large masses of tissues during laparoscopic
surgery.[1] It can consist of a
hollow cylinder that penetrates the abdominal wall, ending with sharp edges[1] or cutting jaws,[2]
through which a grasper can be inserted to pull the mass into the cylinder to
cut out an extractable piece.[1][2]
Morcellation devices in surgery[edit]
Laparoscopic morcellation is commonly used at surgery
to remove bulky specimens from the abdomen using minimally invasive techniques. Historically,
morcellation was performed using a device that required the surgeon or
assistant to manually 'squeeze' the handle. Other reports describe using a
scalpel directly through the abdomen to create small specimens that can be
drawn out of the abdominal cavity. In 1993, the first electric morcellator was
introduced in the US market. It was initially used for uterine extraction, but later applied to
other organs. The use of morcellators at surgery has now become commonplace,
with at least 5 devices
currently on the US market. Despite decades of experience, there remains
limited understanding
of the short-term and long-term sequelae
of morcellation. Concerns have been raised about injury to surrounding organs including
bowel, bladder, ureters, pancreas, spleen and major vascular structures.
Long-term issues may include parasitic growth of retained tissue with the
potential to cause adhesions, cause bowel dysfunction and potentially disseminate
unrecognized cancer.
Safety concerns of morcellation devices in
gynecologic surgery[edit]
Morcellation is associated with
spreading of cellular material of the morcellated tissue. In gynecologic
surgery for benign pathologies there is approximately a 0.09% risk of an
unexpected leiomyosarcoma.
After morcellation 64% of
such cases may develop disseminated disease which is of particular concern
because of the considerable mortality of leiomyosarcoma. Morcellation of
the more frequent benign leiomyoma variants may also cause disseminated
disease, which while not associated with increased mortality is frequently
inoperable and therefore more difficult to manage than the original disease.[3][4]
On April 17, 2014 the Food and Drug
Administration issued a warning that morcellators may spread occult
cancer in the course of fibroid removal.[5] Johnson & Johnson
subsequently suspended sale of its morcellators until the role of morcellation
"is redefined by the FDA
and the medical community."[5]
2.
^ Jump
up to:
a b Morcellator,
Jude S. Sauer, Roger J. Greenwald, Mark A. Bovard, John F. Hammond - US Patent
5562694. Issue date: Oct 8, 1996.
4.
Jump up
^ Cucinella, G.; Granese, R.; Calagna, G.; Somigliana, E.;
Perino, A. (2011). "Parasitic myomas after laparoscopic surgery: An
emerging complication in the use of morcellator? Description of four
cases". Fertility and Sterility 96 (2): e90–e96. doi:10.1016/j.fertnstert.2011.05.095.
PMID 21719004. edit
