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Synthetic Science The FDA banned silicone breast implants last month. Should saline be next? By Lila Rajiva "It's only salt water," says the surgeon flapping the translucent rubbery disk. "If it bursts, it gets absorbed into your blood. The only problem is capsular contracture, and I've seen that only once and she was someone else's patient." The tired-looking woman in her 30s asks doubtfully if there are any other serious issues. "No," he says breezily, "all you have to think about is how you want to look. I'll take care of the rest." A week before surgery and with the nonrefundable down payment already made, a 30-page consent form filled with technical jargon is handed to her to sign. There is no time to study it in great detail, no explanations given, no videotapes shown of the procedures. "That's just for the lawyers," says the surgeon as she hesitates. "Look, anything can be fatal," he adds. "There are more chances of your driving round the corner and being killed." She signs. Missing from this conversation, a paraphrase of the experience of one of about 300,000 women who undergo breast-augmentation surgery every year in America, was any reference to the findings of the most recent and extensive studies of implants that show that not only silicone but saline implants, widely regarded as safe, are health hazards. Early last month, after an advisory panel recommended that the ban be reinvestigated, the Federal Drug Administration upheld the ban on silicone implants saying that more research was necessary to prove their safety. The original ban went into effect in 1991 following a public storm over implants fuelled partly by a 1990 CNN Face to Face with Connie Chung segment that showed leaking silicone gel poisoning the immune system, causing crippling arthritis, skin lesions and horrific disfigurements. The dangers of saline, which are less documented but equally worrisome, include bacterial contamination and hardening and deflation, leading to more surgery. After the 1991 ban against silicone, 400,000 women pressed damages against manufacturer Dow Corning in a class action suit so extensive that Dow finally agreed to settle for over $4 billion. Aware that its long-term viability was in question, the company launched one of the most effective public-relations campaigns in history steered by the Washington, D.C.-based firm Burson-Marsteller, the world's largest PR firm and the folks responsible for making over both the tobacco industry and Union Carbide. How effective this campaign was can be deduced from the fact that within a few years the evidence against implants was being regarded as the epitome of "junk science." In an interview in February 1996 with Frontline, Marcie Angell, editor of the prestigious New England Journal of Medicine and author of a 1996 book called Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case, claimed that a number of studies proved that there was no scientific link between implants and cancer or autoimmune disease. The implication was that hysterical women instigated by lawyers salivating for multimillion dollar fees were storming the Olympian citadels of medicine with junk claims. However, the research Angell cited to support her contention was actually a better candidate for the term "junk" than what she attacked. It was also more insidious because it carried the imprimatur of prestigious institutions like Harvard and the Mayo Clinic. What casual readers could not know was that the 1994 Harvard study, like the others she cited, was damningly flawed in several ways: * The sample size of 1,183 women was too small to study such rare diseases; included women with very recent implants (even one month); did not include women with ruptured implants; and followed the women for 9.9 years on average. Since most serious diseases that could be caused by silicone exposure would most likely develop several years after a rupture (and ruptures tend to happen after seven to 12 years), the study was almost set up for diseases not to show up. * Astoundingly, none of the women was actually examined in person. The findings were all based on questionnaires and records. * Only classic autoimmune disease symptoms were evaluated whereas silicone poisoning, a new disease, manifests atypical ones. * Finally, two of the authors admitted under threat of perjury that they were paid consultants of implant manufacturers. One admitted under oath that he knew that Dow Corning had donated $7 million to Brigham and Women's Hospital, a participant in the study. Nor was this the only time the saintly New England Journal of Medicine had been surprised in bed with corporations. In 1996 the journal ran an editorial claiming that the benefits of diet drugs outweighed the risks without informing readers that the authors were paid consultants for companies that made or marketed one of those drugs, Redux, subsequently banned by the FDA in 1997. In November 1997, the New England Journal of Medicine let the medical director of W.R. Grace and Co., a known chemical-industry polluter, write a review panning a book linking environmental chemicals to higher rates of cancer. And the journal itself concluded in a 1998 study that authors who have ties to corporations invariably act as shills. The implant studies follow this pattern. The two Mayo Clinic studies were partially funded by the American Society of Plastic and Reconstructive Surgeons and indirectly by manufacturers; the other studies by Emory University and University of Michigan, funded directly by Dow. In fact, Dow's general counsel bluntly stated that no studies were conducted without considering their impact on the implant litigation. Even so, the authors of these studies conceded that the absence of proof of a link was not to be taken as the proof of absence of a link. But that was drowned in the PR sound and fury. Playing into the academic need for publications and conferences, Burson-Marsteller, the aforementioned PR firm, used ghost writers to co-author articles for journals, paid well-known professors to present evidence at meetings subject to none of the peer-review standards of academic conferences and was able to get questionable "positive" evidence front-page attention while negative results were buried inside the papers. When a larger study by Dow showed a 45 percent to 59 percent increased risk of rheumatoid arthritis as a result of silicone breast implants, it was abandoned midstream and never publicized. Also undisclosed were memos that showed that Dow Chemical, the creators of Agent Orange and napalm, had known since the 1940s that liquid silicone could migrate to the brain, lungs and liver and damage the nerves and immune system. Since its subsidiary had been marketing the gel implants as safe for 20 years, this cover-up by the parent company resulted in punitive damages of $14.2 million for the company's role in a poisoning that resulted in brain lesions and permanent disability for plaintiff Charlotte Mahlum in 1995. In 2001, when the National Cancer Institute presented its most thorough study to date, of 13,500 women who had had implants for at least eight years, it was subjected to a media nip-and-tuck operation. Excerpts were speciously highlighted to create the illusion of a vindication of implants, though the actual findings were quite disturbing. True, implants were not linked with most cancers, but both saline and silicone were associated with two to three times higher rates of brain cancer, three times higher rates of lung cancer, and four to five times higher rates of suicide. Another NCI study found a 21 percent overall increased risk of cancer for women with implants adding cervical cancer, leukemia, stomach and vulvar cancer to the other risks, including higher incidence of fibromyalgia. While these studies did not establish a causal link, always an extremely difficult proposition, they are surely alarming enough to warrant a hold on all implant sales. In professional journals such as The Journal of Aesthetic Plastic Surgery, The American Journal of Clinical Pathology, The Journal of the American Medical Association, physicians have voiced their strong concerns. Yet in the public arena, exactly the opposite view has been prevailing. This is thanks to Dow's stunning success in deploying so-called "astroturf" lobbying by phony citizen groups like Y-Me (funded by Dow, Bristol Myers Squibb and Plastic Surgeons Associated) and the reassuring "Nicole" pro-implant website (www.implantinfo.com) which, like surgeons' websites that rarely present any sharply negative images and portray the whole operation in slick, glossy pictures, has been little more than an advertisement to lure unwary consumers. Although they are required to, few doctors show patients the FDA site that presents photos of the serious disfigurements possible. Meanwhile, scholars like Michael Fumento of the conservative Hudson Institute, which receives agribusiness funding, likened the anti-implant evidence to snake oil and dismissed the postsurgical scarring known as capsular contraction a "minor problem" though contracture, a serious problem in 20 percent of cases, can even in mild forms make the breast as hard as a football. In extreme cases, the pain is so severe as to demand immediate surgery. Like Fumento, Citizens Against Lawsuit Abuse, another corporate citizen group (funded by big tobacco, health insurance companies and Dow) and Advancement of Sound Science Coalition (also Dow-funded) beat their synthetic breasts over the scourge of frivolous suits based on fraudulent science. The truth is that product liability and medical malpractice cases amounted to only 2 percent and 4.4 percent, respectively, of civil cases in 1996; the bulk of frivolous suits are in fact pursued by businesses against other businesses. The libertarian Cato Institute, which dubbed the '90s the age of "junk" science and lumped implants in with alar and dioxins as a scare tactic of the anti-business flat-earth society, airbrushed Dow as a martyr. By 1995 when Dow filed bankruptcy, the company had conveniently whittled down the claims against it by more than a billion dollars. As its CEO told shareholders, Dow was actually having its most profitable quarter and the Chapter 11 filing was simply a strategy to get on with business. The extent of Dow's rehabilitation was shown by the fact that saline implants were approved by the FDA in May 2000, followed in a narrow vote by silicone in October, 2003. The decision was a shocking display of the incest between government regulators and the industries they regulate, as four out of the nine voting members were themselves plastic surgeons. In this context, the FDA's Feb. 8 reversal reinstating the silicone ban is a welcome decision, but it doesn't address the question of saline implants. Although they were not studied separately, they were also a part of the Cancer Institute study. Saline has a shelf life and, once sterility is lost, has the potential for contamination by fungus and bacteria that can then cause systemic infections. It also has about a 30 percent chance of deflation in the first 10 years, a much higher rate than silicone. Dr. Diana Zuckerman of the National Center for Policy Research for Women and Families, a critic of the saline implants, points out that once approval is given, manufacturers have no incentive to improve the devices, women gain an unwarranted sense of security and the FDA itself retains little ability to check if its guidelines are being followed. She points out that long-term effects aside, local problems are extensive and severe. For example, one recent manufacturer study itself showed that during the first five years of having saline implants, 45 percent of breast cancer reconstruction patients required additional unplanned surgery, 28 percent had their implants removed, 36 percent had capsular contracture, 18 percent had implants that had moved to the wrong place, 18 percent had breast pain, and 8 percent had implants that leaked or deflated. The rates of 10 other complications such as infections, tissue death and implants poking through the skin ranged from three percent to seven percent each. And these are only the results at five years postsurgery, when most implants have not deteriorated. Deflation and rupture caused by wear and tear, breast trauma, undetected damage or shell weakness are further significant complications; one study found that 70 percent of removed implants 11 to 15 years old were ruptured or leaking. When the filling is silicone gel, the silicone can migrate to other parts of the body, cause reactions and be difficult or impossible to remove while the saline, if contaminated, can cause systemic illness. All this is besides so-called cosmetic complications such as alterations in shape or volume of the breast, mammography interference, chest pain and nipple discharge. Neither the original surgery nor most complications are covered under insurance, so many implanted women end up spending tens of thousands of dollars. Although experts like Dr. Neil Rose of Johns Hopkins University state that typical autoimmune disease is unconnected to implants and just naturally much more widespread in middle-aged women than previously suspected, until controlled studies are conducted of 10 to 20 years in length for a sizeable population, all such conclusions are likely to be premature. Right now, implanted women are simply guinea pigs. Dow's strategy has succeeded in part because it has managed to appropriate the language of self-empowerment and present the ban as an assault on women's autonomy. For their part, plastic surgeons have learned to label quite normal variations in breast size and appearance as deformities in need of surgical correction, using terms like hypomastia for small breasts. If women's choices were being enhanced, surgeons would also spend more time offering alternatives such as lift surgery or suction cups, which have had some success. But both of these are one-time remedies whereas implantation offers the surgeon the potential for repeat surgery, can be performed quickly by a specialist and permits a sizeable profit. In other words, implants are a moneymaking hustle in which, since the risks are still unknown even to the experts, the informed consent of the patient is frankly inoperative. In any case, cosmetic surgery that presents itself simply as a commodity open to the consumer's rational choice forgets that surgeons are not vendors like car salesmen but trustees of their patients' health. And when the science that is supposed to guide them dispassionately in their trusteeship is instead synthesized to manipulate the patient, the contamination of patient trust and the profession of medicine are likely to be as toxic as leaking silicone. [ North Bay | Metroactive Central | Archives ]