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Implanted Evidence

The medical establishment has misread the data. Breast implants are still dirty.

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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