Informed Consent?
Plastic Surgeons Had
Warnings on Safety
Of Silicone Implants
---
But Absent Formal Study,
Many Ignored Reports
In Journals and Elsewhere
---
Manufacturer's Concerns
By Joan E. Rigdon03/12/1992
The Wall Street Journal
PAGE A1
(Copyright (c) 1992, Dow Jones & Co., Inc.)
Frank Vasey, Melvin Silverstein and James Rudy suffered the same
professional humiliation: When they warned plastic surgeons about
possible problems with silicone breast implants, their warnings were
rejected and they were condemned.After Dr. Vasey, a Florida rheumatologist, published a paper last year
suggesting that implants might trigger autoimmune disorders, some local
plastic surgeons held a press conference in Tampa and blasted him for
"filling up {medical} journals with garbage."Dr. Silverstein, an oncologist, said his findings were ridiculed when he
told a group of plastic surgeons in 1986 that silicone implants make
mammograms almost impossible to read. And Mr. Rudy, an engineer
who was president of a former silicone implant maker called
Heyer-Schulte Corp., says doctors told him he had his "head up his
behind" after he urged them back in 1976 to tell patients of "possible and
known problems and complications" of his own company's product.
Shortly afterward, he resigned; he now runs a laundry.While the silicone-implant debate has focused on whether manufacturers
hid suspected risks from the public, there is evidence that over the past
two decades, plastic surgeons themselves saw and ignored red flags in
this lucrative branch of their specialty. Critics say many plastic surgeons
failed to alert women to possible health risks reported by several sources,
including professional journals, manufacturers and some of their own
patients.Some evidently continue to do so. This newspaper sent a reporter to four
randomly chosen plastic-surgery offices in New York City, presenting
herself as a candidate for implant surgery. The surgeons didn't
recommend silicone-gel implants, on which the FDA has imposed a
moratorium. But all four recommended saline implants, which are
essentially silicone bags filled with saline solution. None mentioned Food
and Drug Administration warnings that saline implants with silicone
exteriors may interfere with mammograms and may pose an increased
risk of cancer and autoimmune disorders.Critics say that the American Society of Plastic and Reconstructive
Surgeons has emphasized promotion of breast implants over investigation
of their safety. The ASPRS is collecting millions of dollars from its
members to lobby to keep the devices on the market."The ASPRS operated like a commercial enterprise rather than a collegial
medical society," says Jane Sprague Zones, a medical sociologist at the
University of California at San Francisco and a board member of the
National Women's Health Network. Ms. Zones served as the consumer
representative on the FDA advisory panel that recently recommended
restricting use of silicone implants to breast cancer patients and medical
experiments.Doctors are quick to point out that they couldn't inform patients of risks
they didn't know about, such as Dow Corning Corp. researchers'
previously secret fears that implants could leak or burst, sending silicone
through the body with unknown consequences.But Dow Corning wasn't the only entity studying implants. Dozens of case
studies published in medical journals over the past two decades describe
a litany of problems that may be associated with silicone-gel implants,
including skin rashes, swollen breasts, hardened breasts, severe joint
pain, chronic fatigue and debilitating immune disorders. Even
manufacturers' product literature warned of some possible ill effects of
silicone implants, but many patients say these warnings were never
passed along to them.Plastic surgeons point out that it still isn't known what health risks, if any,
are associated with silicone gel implants. They say that if reports of risks
were downplayed, hat's because the reports weren't scientifically
documented. And if they neglected to tell patients of risks outlined in
product literature, that's because "there's a feeling a lot of things in
{product literature} may overly alarm patients," says Norman Cole,
president of the ASPRS.Silicone-gel breast-implant surgery can bring a surgeon anywhere from
$1,000 to $7,500 for a few hours' work. Some plastic surgeons say
privately that this was a powerful temptation to dismiss anecdotal reports
of problems.Anecdotal evidence of trouble surfaced regularly in the medical literature.
In 1979, for instance, the Annals of Plastic Surgery published a report by
Barry Uretsky, a Pittsburgh cardiologist, describing how one patient
suffered fevers, sweats, swollen joints and enlarged kidneys within days
of getting silicone-gel implants. She almost died, the report said, but
recovered seven weeks after her implants were removed. In 1986, the
Journal of Plastic and Reconstructive Surgery published a paper by
Steven R. Weiner, a rheumatologist at the University of California, Los
Angeles, documenting cases of three silicone-implant patients who had
joint pain, including one who lost partial use of an arm.That same year Dr. Silverstein, an oncologist at the Breast Center in Van
Nuys, Calif., presented his group's findings that implants can interfere with
mammograms to a meeting of plastic surgeons in Los Angeles. Dr.
Silverstein recalls: "They said `that's ridiculous. Go back to the laboratory
and study it again. You're going to chase all the patients out of our
offices.'" He did go back to the laboratory, and has repeatedly come to
the same conclusion, which is now gaining acceptance among plastic
surgeons.Mr. Rudy, the former president of Heyer-Schulte Corp., says he became
alarmed about the safety of his own company's silicone implants after
surgeons returned 140 ruptured implants, asking for replacements, in a
13-month period ending in June 1976. In August 1976, he wrote the
surgeons a letter asking for more information on how the implants had
broken and how long they were implanted before breaking. The letter
warned that "currently available mammary prostheses are not perfect" and
that "doctors and patients should expect that some patients will exhibit
some adverse response to silicone implants." Attached was a
bibliography of medical-journal articles.But his customers didn't want to make safety an issue, Mr. Rudy
contends. "Plastic surgeons were willing to discuss problems by pulling
you aside and saying `between us girls,'" he says. "But they didn't want to
openly criticize. They felt any problem that occurred might hurt their own
business."Undoubtedly, many women have researched silicone implants, calculated
the risk-to-reward ratio and decided to go ahead with surgery. For
others the desire for larger breasts may outweigh the risks. "I definitely let
people know about very real complications, but they tend to be so
single-minded of purpose that they sort of hear it with one ear," says
Robert S. Hoffman, a psychiatrist at the Breast Center. Recently, he says,
he tried to discourage a physically fit 22-year-old who worked out
constantly and wanted breast implants because her mother made fun of
her bra size. "I felt there were a lot of things to work on" psychologically,
Dr. Hoffman says. "But she rationalized {the need for surgery} 700
ways."Many women agree that they sought implants to improve their figures and
self-esteem, but wish they had been told of the risks before lying down on
the operating table. Lisa VanSyoc, a Phoenix entrepreneur who got
silicone implants covered with polyurethane in 1990, says she got them
because she "hated looking at that 12-year-old body on a 28-year-old
woman."At the office of Phoenix plastic surgeon James E. Cessna, Ms. VanSyoc
says, she was shown a video featuring women talking about how bigger
breasts had improved their self-esteem. Then, she says, a doctor's aide
gave a short speech on the surgery, dismissed worries that implants might
be associated with rheumatoid arthritis and quickly flipped through a
binder of pictures of women with implants. "I felt like I was on a
conveyor belt," Ms. VanSyoc says.Dr. Cessna declines to discuss her case, citing doctor-patient
confidentiality, but says he and his staff spend two hours with each patient
informing her of risks such as implant rupture, silicone spreading, loss of
nipple sensation and dependency on steroids, which are used to treat
inflamed breasts.Ms. VanSyoc chose another Phoenix doctor, John A. Ward, who
inserted polyurethane-coated silicone implants. She says Dr. Ward
performed the operation without reviewing product literature listing risks,
including infections, muscle pain, swelling, "neural changes," possible
dislodging of the implant, rupture and silicone leakage with "unknown"
long-term health effects. The surgical consent form Ms. VanSyoc signed
mentioned "a possibility of implant breakage or leakage requiring implant
removal or replacement" and stated that "rarely, silicone migration to
adjacent tissues occurs." It didn't mention the possibility that her implants
might dislodge, which they later did.Ms. VanSyoc also says her doctor downplayed risks that she might
temporarily or permanently lose feeling in parts of her breasts. "Now you
could poke me with a knife and I'd stand there and stare at you," she
says. Dr. Ward declines to comment, citing doctor-patient confidentiality.Some women say doctors brushed them aside when they raised questions
about implants. Sonia Woodall, a Lexington, Ky., real-estate developer
whose implants ruptured, says she went back to the doctor who put them
in and complained of symptoms including chronic fatigue, joint pain and
the loss of her monthly period. The surgeon, Dr. John Bostwick III of
Emory University School of Medicine in Atlanta, "told me I was
menopausal and that I should go home and quit reading" about suspected
complications of silicone, she says.Ms. Woodall's husband, Jerry, was in the room at the time and confirms
his wife's recollection. Mr. Woodall says that at the time, he agreed with
the doctor. Ms. Woodall says she was so angry she left the room without
speaking to either the doctor or her husband, and she adds that her
period resumed six weeks after she had her implants removed by another
doctor. Dr. Bostwick declines to comment, citing doctor-patient
confidentiality.With silicone-implant safety now a hotly debated issue, the American
Society of Plastic and Reconstructive Surgeons is sticking to its guns. Dr.
Cole, its president, says, "There are no long-term proven ill effects from
implants that we know of." The society has imposed a special levy on its
members to raise a war chest of $3.9 million over the next three years; so
far, it plans to spend about one-eighth of that on research and the rest on
lobbying.This response has enraged some plastic surgeons, who fear that
responding to health concerns with an expensive lobbying campaign
demeans the profession. "The energy that went into raising money was
absolutely ridiculous," says one ASPRS member, who declines to be
named. "I don't believe in fighting. I believe in getting data. Let's get some
data for these poor souls."Says Dr. Cole, "We felt that we had not had any platform before. It
seemed like it was time for plastic surgeons and patients to tell the other
side."Aggressive lobbying is nothing new for the ASPRS. In a 1982 petition to
the FDA, the late H. William Potterfield, then president of the society,
defined a disease to fit his colleagues' cure. Referring to "the female
breast that does not achieve normal or adequate development," he wrote
that "there is a substantial and enlarging body of medical information and
opinion . . . to the effect that these deformities are really a disease which
in most patients result in feelings of inadequacy, lack of self-confidence,
distortion of body image and a total lack of well being due to a lack of
self-perceived femininity." The ASPRS repudiates that view today.
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