Synthetic Science
By Lila Rajiva, AlterNet February 24, 2004
"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 phony citizen groups like Y-Me, funded by Dow, Bristol
Myers Squibb, and Plastic Surgeons Associated 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 who 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.
~~~~~~~~~
For links and studies, you are welcome to visit:
www.BreastImplantAwareness.org
www.BreastImplantInfo.org (Dr. Zuckerman's site)