This article will consider the regulatory policies of the FDA in protecting the health of the nation's women, particularly its handling of silicone gel breast implants and its policing of the leading implant manufacturer, Dow Corning Corporation. While this article recognizes the various difficult problems which the FDA must address in protecting consumers from unsafe food, drugs, and medical devices, it also recognizes the need for reform. This article will describe what resulted from the tragedies of diethylstilbestrol (DES) and the Dalkon Shield. With these failures in mind, this article will examine present FDA policies, describe social forces outside of the agency which affect women's health as well as regulatory decisions, and propose reforms that will enhance the effectiveness of protections for the women of this country.
Reforms in Medical Device Regulation: An Examination of the Silicone Gel Breast Implant Debacle, 23 Golden Gate U. L. Rev.