Dow Corning Breast Implants

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 g

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ng said, however, the issue of whether or not companies manufacturing breast implants and the physicians and institutions performing the surgery acted in good faith still must be addressed. Buck (1992) noted that many of the breast augmentation procedures and products û including Dow Corning's silicone gel implants û were brought to the market and made available with only limited preliminary testing and research on their potential for doing harm. Just as the women seeking breast augmentation acted freely in making a choice to undergo surgery, so did the for-profit manufacturers and fee-for-service physicians and medical institutions also act freely. Pollitt (1992) argued that when the FDA began to take a serious look at the safety of silicone gel breast implants, it did so only after a number of lawsuits had been filed against Dow Corning in which it was alleged that the company had failed to take into account the toxic potential of their products. Until litigation occurred, the FDA was content to characterize silicone gel breast implants as "medical devices," ignoring their potential for harm. In other words, from the perspective of the FDA in the early years, a silicone gel implant was the virtual equivalent of a metal ca
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Approximate Pages = 18 (250 words per page)

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