--
A California woman alleges that an untested procedure used by the Nezhat
brothers damaged her
intestinal tract.
Experts dispute some of Nezhat brothers' claims
Inquirer series on medical mistakes
Second of two parts
By Alfred Lubrano INQUIRER STAFF WRITER
Something happened to Stacey Mullen - that much is clear.
Her bowel does not work. When she goes to the bathroom, she inserts a
clear, 14-inch tube into an always-open hole in her abdomen. She has spent
most of her 30s in diapers.
Mullen, who lives in California, contends in a malpractice lawsuit that her
problems were caused by an unnecessary, experimental surgery performed by
two of the nation's best-known gynecologists, brothers Camran and Farr Nezhat.
During the procedure, a woman's rectum is cut loose from its nerve and
blood supply, and pulled inside out through her anus so that doctors can
operate on it outside the body to remove endometriosis, a pelvic disease
that afflicts millions of American women. The rectum is then returned to
the pelvis.
Mullen, whose suit is moving forward after years of delay and is now
drawing attention from medical experts nationwide, said that a foot of her
bowel fell out of her body an that she has been vomiting fecal matter for
years as a result of the surgery, performed in Atlanta in 1991 and known as
a "rectal pull-through."
The Nezhats have denied responsibility for Mullen's injuries.
The suit has contributed to a bitter public controversy within the medical
profession over whether the famous brothers are skilled innovators or
dangerous renegades.
Some of the most eminent names in their field have accused the Nezhats of
performing needless and risky surgeries on women, concealing complications
and making unsupported claims about their treatments.
Doctors critical of the Nezhats cite the rectal pull-through as a prime
example of their alleged disregard for patient safety.
The Nezhats and their lawyers say the procedure is safe, effective and
nonexperimental. The brothers, who practice in Atlanta and at Stanford
University in Palo Alto, Calif., have described it as a surgical innovation
that avoids large incisions and leads to faster recoveries.
Other experts condemn the surgery, saying that it can cause a loss of bowel
control and that endometriosis can be treated with simpler procedures. They
say they worry that because of the Nezhats' influence and renown, doctors
might try to duplicate the operation and harm women.
It is not known whether the Nezhats still do the pull-through or whether
other physicians have attempted it. The brothers have not performed the
procedure at Stanford, the university said.Atlanta's Northside Hospital, at
which the Nezhats performed pull-throughs on Mullen and 16 other women,
declined to comment.
In textbooks and articles, the Nezhats have described the pull-through as a
breakthrough. They also mention it in their resumes, promotional materials
and Web site (http://www.nezhat.com) as a "surgical first."
"Doctors will figure it's a piece of cake, and then we're going to have a
lot of harm done," said Herand Abcarian, executive director of the American
Board of Colon and Rectal Surgery and chief of the department of surgery at
the University of Illinois at Chicago College of Medicine."We're going to
end up with a lot of fecally incontinent women because of this."
Warren Grundfest, a laser-surgery pioneer at Cedars-Sinai Medical Center in
Los Angeles, said: "The pull-through is barbaric. Please quote me on this."
Three surgeons listed as defense witnesses for the Nezhats in Mullen's
lawsuit say the procedure is not experimental - and is safe when performed
by the Nezhats.
"He's a fantastic surgeon," Robert Franklin, a Houston gynecologic surgeon
and defense witness,said of Camran Nezhat.
Experts say the Mullen case underscores a long-held criticism of American
medicine: Because there is no federal oversight of new surgical procedures,
as there is for new medicines, doctors have wide latitude to develop
operative procedures without prior testing.
Mullen and the 16 other women on whom the pull-through was performed in
1991 and 1992 were the first people to get the surgery for endometriosis.
The procedure was not tested on animals first or approved in advance by a
hospital review board - steps often used for new surgical approaches.
Medical records of the 16 other women have been sealed by the judge in the
Mullen case.
Among the most controversial aspects of the Mullen surgery was a form that
the brothers had her sign shortly before the operation. In it, Mullen
waived her right to information about the procedure,its risks and possible
alternatives.
Georgia courts have ruled that Mullen legally consented to the surgery
because she signed the form.
The Nezhats said in their operative report that Mullen had been fully
informed about the procedure, told of the risks and warned that it might
not cure her condition.
Mullen denies this. She also contends that she did not know what she was
signing and that such a waiver is not valid for experimental surgeries.
Physicians and specialists in medical ethics said they considered the
waiver a grave violation of patients' rights.
Arthur Caplan, director of the Center for Bioethics at the University of
Pennsylvania, said that he regarded the pull-through as experimental, and
that therefore the waiver was particularly inappropriate. "You can't do it.
You can't waive these rights - especially with experimental surgery," he said.
People with knowledge of an investigation into the Nezhats by the Georgia
Board of Medical Examiners said the doctors gave the form to at least five
of the 16 other women on whom they performed pull-throughs.
Seeking relief from pain
Mullen, a counselor at a juvenile detention facility in Indio, Calif.,
suffered from chronic pelvic pain.She flew to Atlanta in December 1991 on
her doctor's advice to be treated by the Nezhats at Northside Hospital, a
community hospital at which the brothers run a surgical center.
Mullen said in her complaint that the Nezhats told her she had severe
rectal endometriosis, a rare form of the disease that penetrates all tissue
and muscle in the rectum. Endometriosis occurs when uterine tissue migrates
to other pelvic areas, causing pain and, potentially, infertility.
Mullen said the brothers told her they would use a laser to remove the
endometriosis in her rectum in a simple surgery. Earl Pennington, an
Atlanta colorectal surgeon, assisted in the operation.
After awakening from the operation, Mullen went to the bathroom. "I heard a
splash," she said in an interview. "I looked down and saw over a foot of my
bowels in the bottom of the toilet bowl."
Mullen said that nurses placed her bowel in a sling made of pillowcases
that they taped to her buttocks. Pennington later reinserted the bowel into
her body, Mullen said.
Mullen said she left Atlanta in diapers, vomiting and emitting green stool.
Her medical records,signed by Camran Nezhat, say she was released in
"excellent condition."
In the months and years after the pull-through, Mullen's medical records
show, she went as long as two weeks without a bowel movement, then took
eight to 10 hours to complete one. Her doctors and her medical records say
she became fecally incontinent - unable to control her bowels. Mullen also
contends that the damage to her intestinal tract sometimes made it
impossible for her to void waste, causing her to vomit fecal matter.
Mullen, 38, said the experience has "made me spiral into a hell so deep,
I'll never climb out. Ever."
The Nezhats declined to be interviewed. In court papers, their attorneys
called Mullen's account "rather vivid and fanciful" and said that a nurse
reported that just one inch of Mullen's bowel fell out.
Pennington, a defendant in Mullen's suit, also declined to be interviewed.
His attorney, Robert D. Roll, said: "We're accused of causing damage we
didn't cause. He wasn't trying to do anything to Stacey Mullen but help her."
In their operative report, which is part of the court record in the case,
the Nezhats and Pennington said they found and treated severe endometriosis.
A pathologist's analysis of tissue removed during the surgery reached a
different conclusion. The pathology report, also in the court record,
describes "scant," microscopic traces of endometriosis.
New York gynecologist Harry Reich, a leading expert on the condition, said
it was unheard of to have a surgeon's operative report recount so much
disease when so little was present.
"It doesn't happen," Reich said.
Franklin, the Texas gynecologist serving as an expert witness for the
Nezhats, said it was his understanding that the Nezhats believed Mullen had
endometriosis.
"You don't do this operation unless you see endometriosis there," Franklin
said. "And you can tell if there's endometriosis before you cut the bowel
away."
Back home in California after the pull-through, Mullen sought medical help
for her bowel condition. Ultrasound images were taken of her pelvis and
sent to the Nezhats, as her treating physicians. Mullen said the Nezhats
interpreted the images as showing a dangerous growth on her ovary, and
recommended surgery. On her local doctor's advice, she flew back to Atlanta.
In her lawsuit, Mullen contends that the Nezhats unnecessarily removed her
remaining ovary,leaving her infertile. A pathology report that is part of
the suit indicates that the ovary was not diseased. Nezhat lawyers said in
court papers that the ovary was removed "to relieve endometrial growth
process."
Few support procedure
In court filings, Mullen's lawyers have contended that the Nezhats
performed the pull-through as part of a "scheme" to attract new patients
and promote new surgical stapling devices supplied by Ethicon Endosurgery,
a subsidiary of Johnson & Johnson of New Brunswick, N.J. Attorneys for the
Nezhats deny the allegation. Ethicon has helped to fund the Nezhats'
surgical center at Stanford.
A 1992 news release from Ethicon, which is based in Cincinnati, described
the pull-through as a "revolutionary" procedure that could provide relief
for the 185,000 women who suffer from rectal endometriosis. Ethicon, which
is not a defendant in the case, did not respond to requests for comment.
The Nezhats' attorneys contend that the suit is
groundless and the result of a "vendetta" against the brothers by James
Neal, an Ohio lawyer who represented Mullen at the beginning of the case.
Neal's permission to practice in Georgia as an out-of-state attorney was
revoked by a magistrate who determined that Neal acted unethically in
seeking information from various hospitals about possible complaints
against Camran Nezhat.
In an interview, Neal said his conduct was proper. "I was being passionate
about the case," he said. Neal has not been part of the suit since 1995.
In medical writings, the Nezhats have said that the pull-through's chief
benefit was that it made good use of laparoscopic surgical techniques. Such
surgery involves tiny instruments guided by a video camera inserted through
a small incision. The Nezhats, strong advocates of laparoscopic surgery,
wrote that the pull-through dramatically reduced complications and
patients' recovery time.
Traditionally, when surgeons were faced with endometriosis that deeply
penetrated the bowel, they would have to cut open the abdomen to perform
surgery, the brothers wrote. This could lead to recovery periods of a month
or longer.
Richard Goldstein, a Langhorne colorectal surgeon and an expert witness for
Mullen, said in an affidavit that a Pennsylvania gynecologist asked him in
1996 whether he should try the pull-through surgery on a patient. In an
interview, Goldstein said he persuaded his colleague that the surgery was
"an abomination without parallel."
The Inquirer contacted 26 highly regarded colorectal surgeons and other
doctors nationwide and asked them to study a May 1992 journal article in
which the Nezhats and Pennington described the procedure.
All of the doctors consulted by The Inquirer expressed concerns about the
surgery. A common observation was that the procedure had the potential to
damage the patient's anal sphincters and the nerves controlling the rectum,
thus causing a loss of bowel control.
Most of the physicians consulted said they were not surprised to hear
Mullen's contention that part of her bowel fell out.
"There's nothing to hold the bowel in," said Alan Thorson, a colorectal
surgeon at Creighton University in Omaha, Neb.
Robert Fry, chief of colon and rectal surgery at Thomas Jefferson
University Hospital in Philadelphia, said: "This is a variation of an old
operation for rectal cancer that's not done anymore [because] of the side
effects: difficulty controlling bowels and damage to the nerves to the
rectum."
A point of contention in Mullen's suit is whether the pull-through
constituted experimentation. Defense lawyers say it was not.
In the 1992 journal article, the Nezhats said the surgery had not been done
before and that "as with all new procedures, there are no data to establish
its safety."
That is a description of research, or experimental, surgery, medical
ethicists said.University of Pennsylvania bioethicist Jon Merz said the
pull-through was experimental because the Nezhats could have used simpler
procedures and because Mullen's life did not depend on being subjected to
an untested procedure.
The Nezhats should have had such a procedure reviewed in advance by a
hospital or peer-review board, said George Agich, a bioethicist at the
Cleveland Clinic Foundation.
When Mullen sued the Nezhats in 1993, she demanded that the rectal
pull-through operation be purged from the medical literature. "I just
didn't want to see anybody else go through this," she said.
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You can consult the site:
http://www.phillynews.com/inquirer/2000/Mar/13/magazine/NEZ13.htm
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Paul-André Latulippe
St Christophe d'Arthabaska
Québec, Canada
pa.latulippe@sympatico.ca
