This paper will present the history of FDA's policy regarding silicone breast implants, as well as an analysis of the strengths and weaknesses of these actions. Although FDA Commissioner David Kessler's essential judgment that the implants had not been proven safe was sound, both in evaluating the nature and quality of the scientific evidence available, and in adhering to the Congressional guidelines for the type of proof necessary before a device can be approved for marketing, there were many flaws along the way
