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. Rigdon

                   03/12/1992
                   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.
 

                    -30-
 

                      Back to Joan's clips