The Enemy Within

In 1992, at the height of the panic over silicone breast implants, some women were so alarmed that they tried to remove their own implants with razor blades. Six years later, a panel of independent experts has confirmed what careful observers have been noting all along: There is no convincing evidence that the implants cause serious illness.

Meanwhile, however, the implants have been effectively banned. The leading manufacturer has been driven into bankruptcy, and the remaining companies face thousands of lawsuits, because a $4.2 billion settlement fund established in 1993 only whetted the appetites of plaintiffs' attorneys.

These lawyers are not suing because of the well-established local problems, such as inflammation and hardening of the breast, experienced by some women with implants. Rather, they claim that silicone leaking from the implants triggers an immune system response that causes a wide variety of complaints, including connective tissue disorders such as lupus, scleroderma, and rheumatoid arthritis.

Two years ago, the judge coordinating the federal breast implant cases charged a panel of four experts with assessing the scientific basis for such claims. This month, after hearing three rounds of testimony and reviewing hundreds of research documents submitted by both sides in the litigation, the panel issued a report that dismayed the trial lawyers but heartened defenders of the scientific method.

"There is no evidence that silicone breast implants precipitate novel immune responses or induce systemic inflammation," the report concludes. Furthermore, "Women with silicone breast implants do not display a silicone-induced systemic abnormality in the types or functions of the cells of the immune system."

In studies looking at the incidence of illnesses allegedly caused by implants, "No association was evident between breast implants and any of the individual connective tissue diseases, all definite connective diseases combined, or other autoimmune/rheumatic conditions." The panel notes that many of the complaints from women with implants "are common in the general population," and "no distinctive features relating to silicone breast implants could be identified."

The report highlights the shoddiness of the approach favored by litigants and activists who blame implants for just about any symptom reported by a woman who has them. According to The New York Times, a leading lawyer/activist/implant recipient complained that the panel "had focused too closely on scientific studies and had not paid enough attention to the experiences of individual women."

That may sound like a plea for compassion and sensitivity, but scientifically it's nonsense. Anecdotes cannot prove a cause-and-effect relationship, since a certain percentage of women with implants are bound to suffer from any condition that affects women in general.

Given the weakness of the evidence, it's amazing that the foes of silicone implants succeeded in destroying the industry. They had help from a credulous press and an overbearing Food and Drug Administration.

Following the lead of a sensational 1990 story on Face to Face with Connie Chung that claimed to offer "shocking information" about a product that "could be poisoning" women, the news media took the accounts offered by plaintiffs and their lawyers at face value. Instead of calming the fears stirred up by this scaremongering, FDA Commissioner David Kessler intensified the hysteria by pulling silicone breast implants off the market in 1992.

At the time, the FDA estimated that 2 million American women had received implants (some following mastectomies, most to enhance their natural appearance), and surveys indicated that the vast majority were pleased with the product. Despite nearly three decades of use with little evidence of substantial hazards, Kessler said the implants had to go because the manufacturers had not proven their safety.

As New England Journal of Medicine Executive Editor Marcia Angell notes in Science on Trial, her account of the controversy, "Kessler seemed to be saying that the benefits were trivial, at least when implants were used for cosmetic purposes, and that therefore the FDA would tolerate almost no risks."

Kessler scoffed at the notion that women should be allowed to make that judgment for themselves. "If members of our society were empowered to make their own decisions about the entire range of products for which the FDA has responsibility," he said, "then the whole rationale for the agency would cease to exist."

Like a true bureaucrat, Kessler considered the idea of reducing his own power patently absurd. But the prospect that he thought was an argument stopper is really just the beginning of debate.