| Ilena Rose 2004-10-29, 7:16 pm |
| http://www.motherjones.com/news/out.../wellbeing.html
Implanted Evidence
The medical establishment has misread the data. Breast implants are
still dirty.
By Michael Castleman
January/February 1998 Issue
Junk science—the term has been bandied about a lot lately, especially
in defense of silicone gel breast implants. But if you look beyond the
headlines and sound bites, it's quite clear that implant
apologists—notably Marcia Angell, executive editor of the prestigious
New England Journal of Medicine—are guilty of the very sin they accuse
implant critics of: junk science.
Recall that in several high-profile lawsuits, women have won
multimillion-dollar damage awards from implant makers by persuading
juries that the gelatinous devices cause debilitating arthritis-like
conditions, known as connective tissue diseases, and that implant
maker Dow Corning Corp. fraudulently marketed the products despite
prior knowledge of potential side effects from the devices. In 1992,
safety concerns led the Food and Drug Administration to set severe
restrictions on the use of silicone gel implants. The media ran
stories sympathetic to implant plaintiffs, and in 1994, Dow Corning
offered to establish a $4.2 billion fund to compensate women who could
demonstrate harm from the devices. The implant debacle looked like a
clear victory for tens of thousands of female Davids over a corporate
Goliath.
Then suddenly, the media pendulum swung the other way, depicting
implants and their makers as the unfortunate victims of greedy women
and attack-dog lawyers. A 1994 study published in the NEJM by
researchers at the Mayo Clinic compared the medical records of 1,498
women without implants residing in Olmsted County, Minnesota, where
Mayo is located, with those of 749 age-matched women who'd received
implants at the clinic from 1964 through 1991. The researchers found
"no association between breast implants and the connective tissue
diseases that were studied."
In an accompanying editorial, Angell praised the study as
meticulous—"well-designed…the best data we have." She subsequently
became the chief apologist for implants. Her 1996 book, Science on
Trial, portrays Dow Corning as a near-innocent raped by scurrilous
plaintiffs and lawyers. And just a few months ago, she reiterated her
implant defense: "We can say with reasonable confidence…that any link
between implants and a variety of systemic diseases and symptoms is
very small, if it exists at all."
The impact has been significant: In current settlement discussions,
Dow Corning (now in Chapter 11 bankruptcy) is offering $2.4
billion—$1.8 billion less than the 1994 offer.
But the study Angell touts as "the best data we have" is a case of
junk science. In epidemiology, the larger the number of people
studied, the more reliable the results. The Mayo group of 749 implant
recipients sounds large, but the connective tissue diseases linked to
implants are rather rare. To detect them with any reliability would
require a much larger group than the Mayo sample. In the words of the
Mayo researchers themselves: "We had limited power to detect an
increased risk of rare connective tissue diseases." They calculated
that to detect any significant increase in risk would require a sample
of "62,000 women with implants and 124,000 without them"—83 times more
implant recipients than they studied.
In addition, the Mayo researchers paid attention only to classic
symptoms of connective tissue diseases (rheumatic conditions
associated with lupus, rheumatoid arthritis, and scleroderma) and
ignored unusual symptoms that other {publish-page-break}
studies have linked to silicone gel exposure. Other studies
vindicating implants have similar flaws, according to an exhaustive
1996 FDA review published in the Annals of Internal Medicine, which
concluded that "no implant study has ruled out…increased risk of
connective tissue disease."
Why would the NEJM and other journals publish flawed research? Some
may suggest darkly that pressure from the drug and medical device
industries—heavy funders of medical research and the major advertisers
in medical journals—played a role. Perhaps. But in all likelihood,
there's a simpler answer: Gathering truly definitive data based on a
huge sample of women with implants is financially and logistically
impossible. Researchers submit fair-to-poor data because that's the
best they can do. The journals bury the researchers' own
qualifications deep in the report, and these qualifications rarely
make it into the mainstream press. The press, it seems, believes that
when it comes to hot-button medical issues, any study is better than
none, even if the results are misleading. Bad data can be the "best"
data if that's all that's available.
Despite the clear flaws in the studies she cites, Angell insists that
any apparent connection between implants and connective-tissue
diseases is coincidental. "Remember, about 1 percent of women have
implants, and another 1 percent have some form of connective tissue
disease. Therefore, about 10,000 adult women in this country have
both—just by coincidence," she wrote in April 1996.
She would be making a good point—if only 10,000 women claimed
connective tissue symptoms from implants. But more than 300,000 women
have filed claims against implant makers—at least 50,000 of which
involve symptoms of connective tissue disease. And since the early
1960s, when implants were first introduced, dozens of medical journal
reports have documented strange connective tissue symptoms in women
with the devices. If these reports are to be believed, connective
tissue problems affect well over the 10,000 women who might develop
them by chance.
Recently, Harvard researchers surveyed 395,000 women in their ongoing
Women's Health Cohort Study, 10,830 of whom had received breast
implants from 1962 to 1991. This is by far the largest implant study
to date, though it falls well short of the 62,000 recipients the Mayo
researchers calculated would be necessary to answer the
connective-tissue-disease question once and for all. This study has
its flaws—notably that it relies on self-reported cases—but the sample
is still 14 times larger than the Mayo's and more able to show a link
to connective tissue diseases. And it did—revealing a 24 percent
increase in the incidence of lupus, scleroderma, rheumatoid arthritis,
etc., among the women who had implants. This increase is small by
statistical standards, but the real figure could be higher because,
like the other researchers, this group looked only for the classic
illnesses, not the atypical connective tissue symptoms many women with
implants have reported.
Meanwhile, the attention given to connective tissue diseases has
obscured from public discussion the other serious—and
indisputable—problems caused by implants. They are clearly prone to
rupture, in some cases sending gobs of silicone gel coursing around
women's bodies. Dow Corning claimed its implants would "last a
lifetime." But according to the 1996 FDA review, one-third to one-half
of implants rupture or leak silicone gel within 10 years; after 10
years, the number increases to between 64 and 96 percent.
Even if they don't fall apart, implants often cause painful hardening
of the tissue around the device (capsular contraction) and other local
problems, including breast infection, chronic breast pain, and
destruction of nipple tissue. Last March, the Mayo Clinic team
released a report showing that its 749 implant recipients "frequently
experienced local complications," chief among them capsular
contraction, with 24 percent of the women requiring additional surgery
to replace ruptured implants and correct other problems. There are no
medical disputes surrounding these complications—and thus no media
attention.
And while implants have never been linked to breast cancer, they
interfere with mammography, limiting cancer detection. According to
the FDA review, implants obscure 25 to 35 percent of breast tissue.
Don't believe the implant apologists. Silicone gel breast implants are
dirty.
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