Publication: FDA's Role in the Silicone Breast Implant Story
Open/View Files
Date
1997
Authors
Published Version
Published Version
Journal Title
Journal ISSN
Volume Title
Publisher
The Harvard community has made this article openly available. Please share how this access benefits you.
Citation
FDA's Role in the Silicone Breast Implant Story (1997 Third Year Paper)
Research Data
Abstract
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.
Description
Other Available Sources
Keywords
Food and Drug Law, FDA,, silicone breast implants
Terms of Use
This article is made available under the terms and conditions applicable to Other Posted Material (LAA), as set forth at Terms of Service