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 certainlyextend beyond the question of whether breast implants are safe,important though that question is. The narrow concern about whetherbreast implants cause autoimmune or connective-tissue diseaseis, in fact, largely settled. Taken altogether, the studies havefailed to find an association, although they are not large enoughto rule out some small effect. The 95% confidence interval ofthe 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 developingconnective-tissue disease increased from 1% to only 2% (or, putanother way, her chances of remaining free of connective-tissuedisease dropped from 99% to 98%)--not a large chance to take.From a public health perspective, of course, a doubling of riskmay matter, and it certainly would from the perspective of scientistsinterested in the pathogenesis of disease. Unfortunately, thesethree different perspectives--individual, public health, and pathogenetic--areoften blurred when we think about risks, causing unwarranted alarmfor individuals.

The broader effects of the controversy are far from settled. Concernabout groundless mass litigation threatens the medical-deviceindustry, as well as patients dependent on it. Silicone is a componentof a great variety of medical devices, some of them vital, includingshunts, catheters, pacemakers, and artificial heart valves. Already,mass litigation has been launched against manufacturers of penileimplants and the Norplant contraceptive device, both of whichcontain silicone. The principal threat is that suppliers of theraw materials will no longer sell to manufacturers of medicaldevices. Most of the suppliers can well afford to pull out ofthis market, since it accounts for only a trivial part of theirrevenues. Dupont, for example, will no longer supply medical manufacturerswith Dacron polyester, which is used in vascular grafts. In May1994, Senator Joseph Lieberman (D-Conn.), then chairman of theGovernmental Affairs Subcommittee on Regulation and GovernmentInformation, held hearings on the impact of product-liabilitysuits on the availability of medical devices. The father of aboy with hydrocephalus testified of his fear that hydrocephalusshunts, which contain silicone, may become unavailable. Also testifyingwas the president of Meadox Medicals, a manufacturer of vasculargrafts and other devices. She said she had tried to contact 15alternative suppliers of polyester yarn after Dupont announcedit would no longer supply Dacron to her company. None of them,even foreign suppliers, would deal with American manufacturersbecause of the liability risks. Lieberman, arguing for reformof the product-liability system, said, "This is a publichealth time bomb, and the lives of real people are going to belost 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.