A hardcopy version of this case, with supporting teaching materials, may be ordered in the Spring, 1997 from the Darden Case Bibliography.
June, 1975:
Dow Corning Corporation (DCC) Chemist Kim Anderson [1] examined the situation. Some of her co-workers had expressed concern about the new, more fluid silicone gel for the breast implant. (A breast implant is a silicone sac filled with silicone gel that simulates natural breast tissue.) They worried that the new gel, with its thinner consistency and additional swelling agent, might be more likely to diffuse the swelling agent through the breast implant wall than the standard gel which had been used for ten years. Such an occurrence might lead to movement of the silicone in the woman's body. Although silicone was considered chemically inert, and therefore safe for use in the human body, such movement was undesirable.
Still, Anderson went over the new formulation in her mind. The new implant gel used a different ratio of basically the same ingredients as the old gel, materials already safety-tested and used in the human body. Moreover, since the new gel was a different formulation of these ingredients, Dow Corning conducted more testing on it, along with some other experimental gels. The corporation completed a two-week study focused on the reaction of rats and monkeys to the injected silicone gel [2], and a similar three-month rabbit study [3]. The rabbit study found some localized reaction to the gels in the animals, but attributed it to the "trauma of implantation," [4] not the gel itself. Anderson looked over some results of the other study including the statement : "None of the new gel formulations appear to be more susceptible to systemic migration than the standard formulation, which has been implanted with apparent safety in humans for the previous . . . [ten] . . . years" [5]. Anderson's Product Management Group (PMG) leader had asked for her recommendation on going forward with production by four o'clock today. It was now two o'clock. What should she do?