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"FDA ends ban on silicone breast implants"



"The government on Friday rescinded a 14-year ban on silicone gel implants for cosmetic breast enhancement, a decision praised by some for providing women with a better product but criticized by others who still question their safety. ... After rigorous review, the [Food and Drug Administration] can offer a 'reasonable assurance' that silicone implants are 'safe and effective,' said Donna-Bea Tillman, director of the FDA Office of Device Evaluation." (Ricardo Alonso-Zaldivar and Daniel Costello, Los Angeles Times, Nov. 18). Silicone breast implants, available to consumers in most other countries, were driven from the market after a campaign of speculation and misinformation by trial lawyers and allied "consumer" groups, particularly Dr. Sidney Wolfe's Public Citizen Health Research Group. The campaign resulted in billions in legal settlements over nonexistent autoimmune effects from the devices, none of which had to be repaid even after more careful scientific studies dispelled the early alarms. Chapter 4 of my book The Rule of Lawyers, which tells the story of the silicone litigation episode in detail, isn't online. The New York Sun has an editorial drawing some of the appropriate conclusions ("Now They Tell Us", Nov. 20)(cross-posted from Overlawyered).

 

 


Isaac Gorodetski
Project Manager,
Center for Legal Policy at the
Manhattan Institute
igorodetski@manhattan-institute.org

Katherine Lazarski
Press Officer,
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.