Dow Corning Breast Implants: An Ethical Case Analysis
Dow Corning, along with several other companies, began to sell small plastic bags filled with silicone gel to serve as breast implants in 1963. The silicone gel inside the bags was believed to be a safe, biologically inert substance unlikely to do any harm to a woman receiving an implant. Rapidly, breast implants became an important and popular form of cosmetic surgery, though about 20 percent of all implants were performed on women recovering from a mastectomy (Velasquez, 2002).
In bringing its silicone gel breast implants to market, Dow Corning had conducted only a limited two-year series of animal studies to evaluate the potential toxicity or other ill effects of the implant. Further, because they were classified as a medical device, the implants were not regulated by the Food and Drug Administration (FDA) until 1976 when the United States Congress passed legislation incorporating this and other medical devices into the purview of the FDA.
Though Dow Corning developed new implants that were believed to be improved, they also had an independent laboratory conduct relatively rapid animal tests on the new models. In 1975, a seven-day test employing rabbits as subjects revealed that the rabbits experienced mild to moderate acute inflammatory reactions to the implants (Velasquez, 2002).
Other tests using a limited sample of monkeys also conducted in 1975 found some migration of the silicone gel into the animals' bodies, but researchers felt that because the gel was biologically inert, any such migration would be harmless. However, in 1976, Dow Corning began to receive complaints from physicians who had used the silicone breast implants and who had observed severe inflammatory reactions in their patients and indications that the silicone was migrating in patients' bodies. Some researchers at Dow Corning called for an in-depth study of the gel, plastic envel...