Long-Term Consequences of the Breast Implant Debate

The full effects of the breast-implant controversy are far-reaching, and will probably not be entirely felt for years. They certainly extend beyond the question of whether breast implants are safe, important though that question is. The narrow concern about whether breast implants cause autoimmune or connective-tissue disease is, in fact, largely settled. Taken altogether, the studies have failed to find an association, although they are not large enough to rule out some small effect. The 95% confidence interval of the Nurses' Health Study, for example, was 0.2 to 2.0. Nevertheless, for an individual woman with implants wondering about her risk, even a doubling of risk would mean that her chances of developing connective-tissue disease increased from 1% to only 2% (or, put another way, her chances of remaining free of connective-tissue disease dropped from 99% to 98%)--not a large chance to take. From a public health perspective, of course, a doubling of risk may matter, and it certainly would from the perspective of scientists interested in the pathogenesis of disease. Unfortunately, these three different perspectives--individual, public health, and pathogenetic--are often blurred when we think about risks, causing unwarranted alarm for individuals.

The broader effects of the controversy are far from settled. Concern about groundless mass litigation threatens the medical-device industry, as well as patients dependent on it. Silicone is a component of a great variety of medical devices, some of them vital, including shunts, catheters, pacemakers, and artificial heart valves. Already, mass litigation has been launched against manufacturers of penile implants and the Norplant contraceptive device, both of which contain silicone. The principal threat is that suppliers of the raw materials will no longer sell to manufacturers of medical devices. Most of the suppliers can well afford to pull out of this market, since it accounts for only a trivial part of their revenues. Dupont, for example, will no longer supply medical manufacturers with Dacron polyester, which is used in vascular grafts. In May 1994, Senator Joseph Lieberman (D-Conn.), then chairman of the Governmental Affairs Subcommittee on Regulation and Government Information, held hearings on the impact of product-liability suits on the availability of medical devices. The father of a boy with hydrocephalus testified of his fear that hydrocephalus shunts, which contain silicone, may become unavailable. Also testifying was the president of Meadox Medicals, a manufacturer of vascular grafts and other devices. She said she had tried to contact 15 alternative suppliers of polyester yarn after Dupont announced it would no longer supply Dacron to her company. None of them, even foreign suppliers, would deal with American manufacturers because of the liability risks. Lieberman, arguing for reform of the product-liability system, said, "This is a public health time bomb, and the lives of real people are going to be lost if it explodes...."

From Shattuck Lecture--Evaluating the Health Risks of Breast Implants: The Interplay of Medical Science, the Law, and Public Opinion, N Engl J Med 334(23):1513-1516, 1996.