ABSTRACT
Silicone gel breast implants were first introduced into the American market in the early 1960s as substitutes for earlier, less satisfactory devices, such as wax, fabric, directly injected silicone, synthetic sponges or saline-filled implants. By the 1970s, silicone gel breast implant (SGBI) were in wide use for cosmetic breast augmentation as well as for breast reconstruction following cancer surgery. After 1976, SGBIs were subject to review by advisory panels to the Food and Drug Administration (FDA), the regulatory agency whose task it was to decide whether to demand additional testing or to leave the devices on the market. By all indications, FDA exercised its review power lackadaisically and without serious conviction throughout the 1980s. Players in the SGBI expertise game have diverged not only with respect to their framing of the central issues in the case but also in their representations of the standards governing admissibility.
