THE SILICONE-BREAST-IMPLANT CONTROVERSY Table of Contents Executive Summary Statement of Purpose of the Paper Background Overview of the Problem (Business + Public Policy Implications) ÷ The Role of Regulation in Public Policy ÷ The Impact of Tort Law on Public Policy ÷ The Role of Scientific Evidence in Public Policy ÷ Can Scientific Questions Be Answered in the Courtroom? ÷ The Impact of Profit Motive in Public Policy Making ÷ The Role of the Media in Public Policy Response of Industry to Government Intervention Solutions Conclusion Endnotes Bibliography Exhibits [new page] Executive Summary Beginning in the mid-60's, silicone breast implants, originally considered the perfect substance to enlarge breasts, increasingly became the object of occasional--and then frequent--lawsuits alleging damage to women's health. Leakage of the silicone outer envelopes, it was alleged, caused the body to treat the silicone as a foreign and threatening invader, producing exaggerated immune-resistant reactions, lesions, hardening of the breasts, and even heart attacks and strokes.
Breast implant: saline solution filled breast impl...
Breast augmentation: Late-generation models of sil...
English: Bilateral Breast Augementation, Silicone,...However, despite this slowly-growing body of evidence, the FDA did not regulate breast implants throughout the 1970's and early 80s. Between 1979 and 1992 when they were finally outlawed, silicone breast implant surgery was performed on 100,000 to 150,00 American women per year, earning roughly $500 million for surgeons and manufacturers. Major manufacturers included Dow Corning, Bristol-Myers Squibb, Baxter International, Bioplasty, Mentor Corporation, and McGhan Medical Corporation. In 1992, the FDA banned silicone breast implants. Today's implants are usually filled with salt water (referred to as "saline implants").
A number of business and public policy questions arise when considering the silicone-breast-implant controversy. These include: (#1) the role of regulation in public policy, (#2) the impact of tort law on public policy, (#3) the role of scientific evidence in public policy, (#4) the possibility of answering scientific questions in a...