The Silicone Gel-Filled Breast Implant Controversy: Testing the Bounds of Regulatory Intervention

Abstract

Silicone gel-filled breast implants were first introduced in the United States in the 1960s and immediately gained popularity among women seeking to augment or reconstruct their breasts. However, although the Food and Drug Administration (FDA) had the authority to regulate medical devices since the 1970s, breast implants were largely unregulated until concerns about a link between the devices and connective tissue diseases surfaced in the early 1980s. In the subsequent years, thousands of plaintiffs prevailed against implant manufacturers, leading to the bankruptcy of Dow Corning and a multi-million dollar class settlement. Ultimately, the controversy resulted in a FDA ban on silicone breast implants in 1992 that still survives today. This paper examines the silicone breast implant controversy from the inception of silicone devices to the current regulatory status of breast implants in the United States. Part I describes the early uses of silicone and the introduction of silicone gel-filled breast implants in the United States. Part II examines the regulatory framework for medical devices that ultimately gave the FDA the authority to ban silicone breast implants. Part III depicts the responses to the FDA’s decision from both proponents and opponents of the use of breast implants. Parts IV and V present the scientific research concerning the safety of the devices. Finally, Part VI examines the current developments regarding silicone implants, and Part VII provides some conclusions for the future.