"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 thirties 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 non-refundable down payment already made, a thirty-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 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 this February, after an advisory panel recommended that the ban be reinvestigated, the FDA 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 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 billon. Aware that its long-term viability was in question, the company launched one of the most effective PR campaigns in history steered by DC-based 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 multi-million 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 Mayo. 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 7-12 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 and one admitted under oath that he knew that Dow Corning had donated $7 million to Brigham & Women's Hospital, a participant in the study.
Nor was this the only time the saintly NEJM had been surprised in bed with corporations. In 1996, the Journal ran an editorial claiming 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, banned by the FDA in 1997. In November, 1997 it 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 with ties to corporations invariably acted as shills.
The implant studies follow this pattern: The two Mayo clinic studies were partially funded by the American Society of Plastic and Reconstructive Surgeon and indirectly by manufacturers, and other studies by Emory University and Michigan were 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 themselves 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 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 45-59 percent increased risk of rheumatoid arthritis, 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 1940's 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 twenty years, this cover-up by the parent company resulted in punitive damages of $14.2 million for the company's role in the poisoning that resulted in brain lesions and permanent disability for plaintiff Charlotte Mahlum in 1995.
In 2001, when the National Cancer Institute presented its study of 13,500 women who had implants for at least 8 years, the most thorough to date, 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 2-3 times higher rates of brain cancer, 3 times higher rates of lung cancer, and 4-5 times higher rates of suicide. Another NCI study found a 21% overall increased risk of cancer for women with implants adding cervical cancer, leukemia, stomach, and vulvar cancer to the other risks which include 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, Arthritis & Rheumatism, and The Archives of Pathology and Laboratory Medicine, physicians have voiced their strong concerns.
Yet in the public arena, exactly the opposite view has been prevailing thanks to Dow's stunning success in deploying "astro-turf" lobbying by groups like Y-Me, which in the past have received donations by Dow and Bristol Myers Squibb, and the reassuring "Nicole" pro-implant website that popped up ubiquitously when women tried to research implants and also funded partially by plastic surgeons. Like the surgeons' websites -- which rarely present any sharply negative images and portrayed the whole operation in slick, glossy pictures -- it was 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 capsular contraction as a "minor problem" though contracture, a serious problem in 20% of cases, can even in milder forms make the breast hard as a football. In extreme cases, pain is so severe as to demand immediate surgery.
Like Fumento, Citizens Against Law Suit 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 but the truth is product liability and medical malpractice cases amounted to only 2% and 4.4% 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 90's the age of junk science and lumped implants in with alar and dioxins as a scare tactic of the anti-business flat-earth society left, airbrushed Dow into a martyr. By 1995 when it 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 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, for four out of the nine voting members were themselves plastic surgeons.
In this context, the FDA's February 8 reversal reinstating the silicone ban is a welcome decision, but 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 thirty percent chance of deflation in the first ten years, a much higher rate than silicone.
Dr. Diana Zuckerman of the National Center for Policy Research for Women & Families (www.center4policy.org), 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 3 percent to 7 percent each. And these are only the results at five years 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% 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 or 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 10-20 years in length for a sizeable population, all such conclusions are likely to be premature. Right now, implanted women are simply guinea pigs. Both types of implants need much more study before being used in women.
Dow's strategy has only succeeded because it has managed to appropriate the language of self-empowerment and present the ban as an assault on women's autonomy whereas plastic surgeons have been systemically undermining women's autonomy by pushing 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 choice were being empowered, surgeons would also spend more time offering alternatives such as lift surgery or suction cups, which have had some success. But both 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 off the sale of each implant. 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 as a commodity open to the consumer's rational choice like any other forgets that surgeons are not vendors like car salesmen but trustees of their patient's 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.