Assessment of the FDA Backgrounder on Platinum in Silicone Breast Implants: Implications for Public Health Policy

Abstract

A recent report by the U.S. Food and Drug Administration reviewed the literature on the subject of platinum in silicone gel–filled breast implants. In this study the author evaluates the FDA report for scientific accuracy and impartiality, and provides relevant discussions on financial conflicts of interest, an Institute of Medicine report, and public health policy. The study suggests that the FDA used discredited scientific practices in compiling its report. Reports by regulatory agencies should be scientifically accurate, with no partiality to industry. The current policy of one-way information flow from the FDA directly to those being informed needs to be revised. Greater importance should be placed on studies in which authors have no financial conflicts of interest.