Synthetic Science
http://www.alternet.org/story.html?StoryID=17933
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)