Science guides FDA decision

? A decade ago, the Food and Drug Administration issued a ban on silicone breast implants. Last week, after two days of public testimony, a special advisory panel of the FDA voted to lift the ban and restore silicone implants to the market. The FDA is expected to endorse the panel’s decision. What happened?

There are a number of explanations, but the most important is that, in 1992, the FDA commissioner was David Kessler, now dean of the Yale medical school, a physician with strong political inclinations. Today, the commissioner is Mark McClellan, whose faith in science appears stronger than the grip of popular opinion. Eleven years ago, Kessler was heavily influenced by the public-relations campaign, undertaken by the trial bar and heavily promoted by Ralph Nader’s Public Citizen Health Research Group, to persuade women that silicone breast implants were poisoning them.

Now, however, it appears that scientists, and not trial lawyers, are judging the issue. And while some argue that there may yet be uncertainty about the long-term effects of silicone implants, there is plentiful evidence that — apart from acknowledged dangers, such as leakage, which applies to any substance — silicone implants are demonstrably safe. Women who underwent the procedure 30 years ago are still alive and healthy and, so far as anyone knows, perfectly satisfied with the results.

So why did David Kessler concede to the trial bar? Because in the late 1980s and early ’90s, some patients came forth to ascribe their health problems to their silicone breast implants. It was impossible, at the time, to find any connection between their medical problems and their implants, but such minor considerations would hardly deter the personal-injury bar. Lawyers sued the manufacturers and distributors of implants. Parading their suffering customers before friendly juries, they reaped millions of dollars in class-action settlements — very little of which, needless to say, trickled down to their clients — and drove A.H. Robins and Dow Corning, which dealt in silicone products, into bankruptcy.

All of this was made possible by David Kessler’s decision to ban silicone implants, victimize the firms that had made up a perfectly legitimate business and scare thousands of women into needless procedures to remove their implants. The commissioner of the FDA in effect made a scientific decision that was not only influenced by lawyers with financial stakes in the game, but also taken in the face of all present and subsequent scientific evidence.

I do not mean to suggest, of course, that the women who exhibited these symptoms had invented them — although, I suspect, more than a few cases were psychosomatic. But it is difficult to reconcile two salient facts with public apprehensions about the dangers of silicone.

First, over a dozen years, a series of exhaustive investigations by disinterested investigators, published in such venues as The New England Journal of Medicine, have failed to discover any connection between cancer or diseases of the immune system and silicone breast implants.

Second, there is the statistical factor. In any given concentration of hundreds of thousands of people, it is inevitable that some will develop various illnesses — indeed, all will develop one syndrome or another. The fact that certain women have silicone breast implants may be of interest, but it hardly follows that the implants have made them sick.

So, in the end, we are left with the estimated 200,000 women in America who seek breast augmentation or reconstructive procedures every year.

A dozen years ago, on the basis of spectral evidence, they were frightened away from silicone implants or, in many instances, prompted to undergo surgery to remove existing implants — all for no valid scientific reason. The FDA, in its wisdom, chose to cause needless anguish and penalize businesses because the trial bar was not above exploiting fear, the media were too compliant to investigate claims and the FDA commissioner ignored science in favor of politics.


Philip Terzian is the associate editor of the Providence Journal.