Re: Controversy follows influential surgeons
From: Jim Connerth (babydoc@apex.net)
Wed Mar 15 18:04:29 2000
Sove(?sp)pullthru ,is,I believe,an old accepted procedure-done for rectal prolapse
and megacolon;is it unusual for path to occasionaly show little or no endo,when we
see it??
Paul-André Latulippe wrote:
> This is the second part of the "The Inquirer" newspaper's report.
>
> Do anybody have a complete knowledge of the "pull-through" procedure??
>
> *******************
>
> Surgical technique blamed in lawsuit
>
> 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.
>
> ***************************
>
> You can consult the site:
>
> http://www.phillynews.com/inquirer/2000/Mar/13/magazine/NEZ13.htm
>
> **************************
>
> Paul-André Latulippe
> St Christophe d'Arthabaska
> Québec, Canada
>
> pa.latulippe@sympatico.ca
