CASE 6.1 Breast Implants
In the last few decades, silicone has become a crucial industrial product, playing a role in the manufacture of thousands of products, from lubricants to adhesive labels to Silly Putty. One of its medical uses, how-ever, has been controversial— namely, as the gel used for breast implants. Dow Corning, which was founded in 1943 to produce silicones for commercial purposes, invented mammary prostheses in the 1960s. Since then a million American women have had bags of silicone gel implanted in their breasts. For many of them, silicone implants are part of reconstructive surgery after breast cancer or other operations. However, by 1990 four out of five implants were for the cosmetic augmentation of normal, healthy breasts— a procedure that became increasingly popular in the 1980s as celebrities such as Cher and Jenny Jones spoke openly of their surgically enhanced breasts. Today, however, what used to be a common elective operation is rarely performed. 103 The reason dates from the 1980s, when women with silicone breast implants first began reporting certain patterns of illness. There were stories of ruptured or leaky bags, although the estimates of the propor-tion of women affected ranged from 1– 5 percent to 32 per-cent. And there were allegations that the silicone implants were responsible for various autoimmune disorders— such as rheumatoid arthritis, lupus erythematosus, and sclero-derma— in which the body’s immune system attacks its own connective tissue. Then, in 1991, a jury heard the case of Mariann Hopkins, who claimed that her implants had rup-tured and released silicone gel, causing severe joint and muscle pain, weight loss, and fatigue. On the basis of docu-ments suggesting that Dow Corning knew of the dangers of leaky bags, a San Francisco jury found the company guilty of negligence and fraud and awarded Hopkins $ 7.3 million. When Dow Corning first sold breast implants in 1965, they were subject to no specific government regulations. In 1978 the Food and Drug Administration ( FDA) classified them as “ Class II” devices, meaning that they did not need testing to remain on the market. In 1989, however, as worries about the dangers of silicone implants increased, the FDA reclassi-fied them as “ Class III” devices and in 1991 required all manufacturers to submit safety and effectiveness data. Although some FDA staff members were scathingly critical of the poor and inconclusive documentation submitted by the manufacturers, the FDA’s advisory panel ruled that the implants were not a major threat to health. Based on public need, it voted to keep them on the market. After the Hopkins case, however, David A. Kessler, the FDA’s new chairman, called for a moratorium on breast implants. He asked doctors to stop performing the operation, but he told women who had already had the operation not to have the bags removed. Still, the moratorium terrified the women who had had breast implants, a few of whom tried in desperation to carve them out themselves, and it galvanized a political movement led by women who were upset about having been used, yet again, as guinea pigs for an unsafe medical procedure. For them, it was just one more episode in a long history of the mistreatment of women by a medical, scientific, and industrial establishment that refused to treat them as persons and take their needs seriously. The FDA moratorium also galvanized the legal forces marshaled against the manufacturers of silicone bags. By 1994, some twenty thousand lawsuits had been filed against Dow Corning alone. Entrepreneurial lawyers organized most of these actions into a few large class- action suits so that their pooled legal resources would be more than a match for the manufacturers. Meanwhile, Kessler instructed the FDA’s advisory panel to re- study the breast implant question. Presented with a series of anecdotal reports about diseases that are not rare, the panel complained about the lack of hard scientific data. From the scientific point of view, the problem was how to distinguish coincidence from causation. For example, if connective- tissue disease strikes 1 percent of all women and if 1 million women have implants, then statistically one should expect that 10,000 women will have both implants and connective- tissue disease. So if a woman develops the disease, can it correctly be said that it was caused by her breast implants? Moreover, not only does silicone appear to be chemically inert, but silicone from a ruptured breast implant will remain trapped inside a fibrous capsule of scar tissue. Nevertheless, on the basis of the panel’s recommendation, the FDA ruled that silicone may be used only for reconstruction and that cosmetic breast augmentation must be done only with saline packs. At that point the gulf between science, on the one hand, and the FDA and public opinion, on the other, began to widen further. A Mayo Clinic study published in the prestigious New England Journal of Medicine in June 1994 showed that there was no difference between women with breast implants and other women with respect to incidence of connective- tissue disease; by the summer of 1995 two larger studies had con-firmed the Mayo Clinic’s report. On top of that, the FBI and other investigators exposed several labs that were selling to lawyers and victims fraudulent test results purporting to show the pres-ence of silicone in the blood of women with breast implants. Lawyers and other advocates for the women with implants repudiate those studies, contending that the women have a new disease. To this contention scientists respond that the description of the symptoms of this supposed disease keeps changing. Some say it looks like fibromyalgia, which is included in their studies. Many feminist activist groups dis-trust science; they believe that we should pay less attention to statistics and medical studies and greater attention to the women who have suffered. These women know what their bodies have been through, and they are convinced that their implants are responsible. This reasoning, and the skepticism toward science and statistics that it represents, has swayed jurors. After Dow Corning filed bankruptcy in 1995, which brought to a halt the lawsuits against it, new lawsuits were filed against its parent company, Dow Chemical. The first of these resulted in a $ 14.1 million verdict against the company, despite the lack of scientific evidence. Disregarding the New England Journal of Medicine study, the jurors were convinced that this par-ticular plaintiff’s suffering somehow stemmed from her Dow-manufactured breast implant. A few years later, the women who said their silicone breast implants made them ill agreed to settle their claims against Dow Corning for $ 3.2 billion. The settlement is part of its bankruptcy reorganization plan and is similar to a settlement entered into earlier by 3M, Bristol- Myers Squibb, and other manufacturers of breast implants. Update By now, more than twenty reputable scientific studies have been conducted on implant safety. Three European govern-ments have convened scientific panels. The American College of Rheumatology, the American Academy of Neurology, the Institute of Medicine, and the American Medical Association have all published reviews of the evidence, as has an inde-pendent scientific panel appointed by a federal court. The conclusion is unanimous and unequivocal: There is no evi-dence that breast implants cause disease of any kind. 104 In light of these findings and the recommendations of a federal advisory panel, in 2006 the FDA gave conditional approval to Mentor Corporation’s application to produce sili-cone breast implants, thus effectively ending a thirteen- year ban on the use of silicone for cosmetic breast enhancements.
• What does the breast implant controversy reveal about society’s attitudes toward product safety, about the legal liability of manufacturers, and about the role of regulatory agencies like the FDA in protecting consumers? Is our society too cautious about product safety or not cautious enough?
2. Was the FDA justified in placing a moratorium on silicone breast implants and then halting them altogether for cosmetic purposes?
3. Is the agency too concerned with public opinion? Should it pay greater attention to scientific evidence or to the individual women who have suffered?
4. Was it irresponsible of the manufacturers of breast implants to have marketed them without first conclusively proving they were safe? If you were on the jury, would you have found Dow Corning or its parent company liable for the illnesses suffered by women who have had breast implants?
5. On safety matters, should the FDA or any regulatory agency err on the side of overprotection or underprotection? Has the FDA’s stance on breast implants been fair to women who would like breast augmentation but cannot get it? Some people disapprove of cosmetic augmentation or believe it to be a frivolous operation. Do you think that attitudes like this played a role in the controversy over the safety of breast implants?
6. Some argue that in the case of new drugs or medical pro-cedures in which the dangers are uncertain, consumers should be free to decide for themselves whether they wish to run the health risks associated with these products or services. Assess this argument.
PLACE THIS ORDER OR A SIMILAR ORDER WITH US TODAY AND GET AN AMAZING DISCOUNT 🙂