Before she received breast implants in 1985, recalls Linda Wilson, her doctor offered words of reassurance. “He said that they would reduce the risk of breast cancer and that I would never have a problem, ” said the 44-year-old Vancouver office manager. Instead, Wilson said, her first set of implants, which were encased in a polyurethane foam shell, began to disintegrate within weeks and had to be removed. Eventually, she received silicone-gel implants—but not before undergoing eight operations and enduring five prolonged stays in hospital recovering from infections and other complications. In 1989, Wilson added, she sued two doctors who had operated on her, but a B.C. Supreme Court judge rejected her claims after a nine-day trial. Said Wilson-. “All of this has left my breasts extremely disfigured and just a mess. ”
In 1969, after several years spent raising her family, Phyllis Rittenhouse decided to return to work. She was 40 years old and, looking in the mirror, she did not like what she saw. “I said, ‘Face it, Phyllis, you can use some help,’ ” recalled Rittenhouse, owner of a Toronto business that provides post-operative care for plastic-surgery patients. “I had breast-fed three children and my breasts were starting to droop. ’’Rittenhouse had an implant operation that, she says, rejuvenated her sagging bosom and boosted her self-esteem. Three years ago, at 60, she had the implants removed in order to have another operation aimed at lifting her breasts. She says that the original implants had never caused her any pain or discomfort, and that they were in perfect condition after 20 years in her body. Said Rittenhouse-. “I never regretted my operation for a minute. ”
Wilson and Rittenhouse are among the more than one million North American women who have had synthetic devices implanted in their breasts. They also stand at opposite ends of a debate now raging among recipients, doctors and government regulators over the safety of the implants. Dozens of American women, and a handful of Canadian recipients, are now suing Michigan-based Dow Corning Corp., a leading manufacturer of silicone-gel implants, on the grounds that they suffered health problems or personal injury due to the devices. In early January, the Canadian and American governments imposed temporary, voluntary moratoriums on the use of silicone implants, and both will decide by the end of April whether to lift the ban or make it permanent. Meanwhile, most plastic surgeons continue to defend the benefits of implants. “I’ve done more than 500 of these operations over the past 20 years,” said Toronto physician John Taylor, vice-president of the Canadian Society for Aesthetic Plastic Surgery, “and I believe this is a good operation.”
Surgeons have been performing breast implant procedures for almost 30 years, and during that time an estimated 150,000 Canadian women have received the devices, 80 per cent of them for cosmetic reasons. Many patients, doctors say, come to them complaining that their small breasts are sapping their selfesteem; some, they say, have spent their entire adult lives avoiding beaches (page 44). In major entertainment centres like Hollywood and Las Vegas—arguably the twin capitals of North America’s breast-obsessed society—implants and other forms of cosmetic surgery have become commonplace—and often vital to career advancement. Said Beverly Hills, Calif., surgeon George Semel: “One of the exciting things about plastic surgery in Los Angeles is that it is becoming an integral part of society, just like going to the dentist or the barber.”
Doubts: The debate over the safety of silicone-gel implants flared last December when officials with the U.S. Federal Court in San Francisco disclosed information listing internal corporate documents from Dow Coming. The documents, which had been submitted to the court while the firm was fighting a lawsuit, revealed that some Dow Coming employees had doubts about corporate studies purporting to show that silicone-gel implants were safe (page 42). Based on that information, Dr. David Kessler, commissioner of the U.S. Food and Drug Administration, imposed a moratorium on silicone-gel implants on Jan. 6. Kessler also convened a 10-member advisory panel, which heard evidence from dozens of experts in Washington from Feb. 18 to 21. The panel supported the FDA moratorium, suggesting that the implants be used only on women requiring reconstructive surgery, or in tightly controlled clinical tests.
Since then, the FDA has received thousands of calls and letters from nervous implant recipients. In mid-February, the agency even set up a toll-free hotline to handle inquiries. And many women now maintain that a wide variety of ailments are directly or indirectly linked to implants. One of the most common conditions is a hardening of the breasts as the body forms scar tissue around the implant to protect itself from a foreign object. Implants can rupture, which allows the silicone gel to begin migrating through the body, critics say. Some doctors and recipients also contend that the implants may cause cancers and a variety of autoimmune diseases such as rheumatoid arthritis, scleroderma—a tightening and hardening of the skin—and lupus erythematosus, which leads to rashes and chronic pain in the joints.
Despite the controversy, some women are still determined to have breast implants, and there are doctors willing to accommodate them. “I don’t like implants, but I like to see my patients happy,” said Elizabeth Hall-Findlay, a Banff, Alta., plastic surgeon. “And I am not concerned with cancer and autoimmune reactions.” Hall-Findlay said that silicone is an inert substance that does not react with human tissue. She also noted that it is a component of numerous other medical devices, such as pacemakers, that can be placed permanently in a patient’s body. She added: “If silicone were so bad, there would be an epidemic of autoimmune disease in response.”
An implant operation costs from $3,000 to $5,000 in Canada and, when performed for cosmetic reasons, is not covered by provincial health-care plans. According to most surgeons, it is a fairly simple procedure. Taylor said that patients are usually given a sedative to help them relax before receiving a general anesthetic. The operation takes about two hours, and most patients are sent home several hours after the surgery is finished. Incisions for inserting the implants can be made in the crease beneath the breast, in the area of the nipple or under the armpit. Taylor said that most patients have a clear idea how big they want to be, and most can be accommodated. But in some cases, a woman’s skin is abnormally tight, which prevents her from achieving her preferred breast size through an implant.
Mary Smith, a 36-year-old Mississauga, Ont., woman, ignored the safety controversy and went ahead with an implant operation last week. Smith, who has an eight-year-old daughter and works at an aircraft factory, said that she has been unhappy with her small breasts for years—and even more so since they began to shrink after she gave birth and had three miscarriages. She added that for her, the benefits of a fuller bosom outweighed any potential risks. “I wanted to feel better about myself,” said Smith. “I wore big, loose clothing to hide the way I looked. I could go shopping and try on 10 or 12 outfits and walk out with nothing because they didn’t fit right.”
But other women say that implants have left them miserable. Norma Laflèche, a 58-yearold Montreal housewife, said that she received her first set of implants in 1981 after having numerous cysts removed from her breasts. Laflèche said that within five months of the operation, she was experiencing excruciating pain and had to have the implants removed. She had two more pairs implanted and removed, she said, and is now on her fourth set. She is scheduled to have them taken out within the next couple of weeks and will not have another set implanted. Said Laflèche: “It’s been seven operations in 10 years. I could have worked during those years but I was always at the doctor’s, always at the hospital, always in pain, always on pills, always tired.”
Lawsuits: A handful of disgruntled Canadian implant recipients have begun to sue their doctors and the manufacturers for damages. Vancouver lawyer Mark Steven, who represented Wilson in her 1989 trial, said that he is preparing three lawsuits against New York City-based Bristol Myers Squibb Co., which manufactured polyurethane-coated Même implants through a subsidiary company called g Surgitek. He is also representing four other Z women who are suing Dow Coming for damS ages allegedly caused by ruptured implants, g So far, only one Canadian woman has sucZ cessfully sued an implant manufacturer. In 5 May, 1990, a B.C. Supreme Court justice in I Vancouver awarded Susan Hollis, who was 30 I at the time, $95,000 for pain, suffering and lost a wages caused by a ruptured Dow Coming implant. Derek Mullan, a Vancouver lawyer who represented Dow Coming, said that the device was implanted in October, 1983, at Kelowna General Hospital and removed 18 months later after the woman complained of breast pain. Mullan said that the case is still before the courts because Dow Coming has appealed the decision.
American judges and juries, meanwhile, have made multimillion-dollar damage awards to three implant recipients over the past year, although manufacturers are now appealing each decision. In December, 1991, a federal district court jury in San Francisco granted 48-year-old Mariann Hopkins of nearby Sonoma County $8.6 million in damages, the largest of the three awards. The jury ruled that the woman developed connective cell disease when one of her Dow Corning implants ruptured. As well, the jury found that the company had misrepresented its studies, which purported to demonstrate the safety of the device. The huge awards, combined with the FDA’s Jan. 6 moratorium, have unleashed a flood of American lawsuits against the manufacturers; some lawyers put the number at 1,000, but they acknowledge that nobody has an exact count.
Survey: Despite those developments, most plastic surgeons who perform the operations insist on the safety of implants. Norman Cole, a Louisville, Ky., surgeon and president of the Chicago-based American Society of Plastic and Reconstructive Surgeons, said that the society’s figures show that only one per cent of silicone-gel implants rupture. And less than 10 per cent of implant patients, he added, experience hardening of the breasts. Late last year, the society hired an independent research firm to conduct a nationwide survey of implant recipients. According to the society, of the 592 women surveyed—who had lived with implants for an average of eight years—93 per cent were satisfied customers.
Wallace Goodstein, a Beverly Hills plastic surgeon, said that he has performed the procedure between 400 and 500 times over the past decade, and only about 10 patients have suffered complications requiring secondary surgery. Goodstein said that he has become so confident about the safety and effectiveness of implant surgery that he performed the operation on his own wife, Judy, a flight attendant, in 1984. “I’m not in practice purely to make my house payments,” said Goodstein. “I want to make a positive impact in people’s lives.”
Toronto surgeon Taylor said that the longterm success of the procedure depends on careful screening of potential patients. As Taylor explains it, he tries to ensure that each patient is emotionally and psychologically stable. He also said that he will not accept a patient who wants an implant to please a husband or boyfriend. Taylor claimed that of his more than 500 implant patients over the past two decades, 10 to 20 per cent have later complained that their breasts were too firm.
Still, for those women who remain apprehensive about artificial implants, there is a far more complex method of reconstructing or enhancing breasts that involves transplanting abdominal muscle and fat to the breast cavity. Most patients spend about five days in hospital recovering. Michael Drever, an Etobicoke, Ont., surgeon, said that he has used the procedure on more than 800 women since 1975. About two-thirds of them, he said, are having reconstruction following mastectomies; the others, who simply want larger breasts, must cover the $7,000 - to - $10,000 cost themselves.
Although many plastic surgeons argue that artificial breast implant devices are durable and reliable, some scientists contend that they have discovered serious structural weaknesses. Pierre Blais, a physical chemist who worked for 13 years as a senior scientific adviser with Health and Welfare Canada, resigned in December, 1989, after a dispute over departmental approval of Surgitek’s Même implant. According to Blais, the outer layer of the shell was made from industrial-quality materials similar to upholstery foam—and frequently deteriorated after it had been implanted. The device was one of the most popular breast implants during the late 1980s because it was heavily promoted by the manufacturer. But the company voluntarily removed the product from the market last April after an FDA study showing that the shell could break down in the body was leaked to The New York Times. Said Blais: “That device injured an enormous number of people.”
Blais concedes that silicone-gel implants are better than the Même, but he insists that there are still problems. He said that the shells frequently contain defects, and that the gel can seep through the walls even if there are no cracks or ruptures. Robert Guidoin, scientific director of the Quebec Bio-Materials Institute in Quebec City, has drawn similar conclusions after examining 350 silicone-gel implants that were removed from women. Particles from fat cells are capable of penetrating the shell of an implant, he said, and a minute amount of silicone gel can escape. Concluded Guidoin: “Usually after several years in a woman’s body, an implant is very much damaged because of the penetration of fat particles.”
In order to resolve the controversy over the safety of breast implants, the federal health department has appointed a four-member independent advisory committee. Cornelia Baines, a University of Toronto epidemiologist and head of the committee, acknowledges that she and her three colleagues are faced with a complex and perhaps thankless job. She said that many Canadian women who have had implants are now plagued by doubts. But for women who still want the operation, the moratorium on the use of silicone-gel devices has created anger and exasperation. At a time when good looks and good health are not necessarily synonymous, it may take more than a federal committee to calm the raging medical maelstrom over beauty and the breast.
BY D’ARCY JENISH, THERESA FITZGERALD, JAMES DEACON, JOHN HOWSE