Implanted Evidence

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