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 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.
Castleman, Michael, Implanted evidence: the medical establishment has misread the data. Breast implants are still dirty.(oft-cited 1994 Mayo Clinic study cited by implant industry supporters is flawed)(Well Being)(Column. Vol. 23, Mother Jones, 01-11-1998, pp 25(2).