History of breast implants and the food and drug administration.
Over the past 30 years, silicone-gel breast implants and their manufacturers have experienced a tumultuous relationship with the FDA and the public, which has changed the modern climate of industry oversight and the field of plastic surgery. We present an account of the events leading up to and resulting from the 1992 FDA moratorium on silicone implants. We highlight the involvement of the manufacturers, the scientific and legal communities, regulators, the plastic surgery community, and others as they strive to come to terms with a fearful public opinion shaped by the influence of the media. Finally, we describe how these past events will help the field of plastic surgery grow and continue to push the bounds of medicine.
Spear
Scott L
SL
Department of Plastic Surgery, Georgetown University Hospital, 1st Floor PHC Building, Washington, DC 20007, USA. spears@gunet.georgetown.edu
Parikh
Pranay M
PM
Goldstein
Jesse A
JA
D001672:Biocompatible Materials / Q000266:history; D018427:Breast Implants / Q000266:history*; D018795:Device Approval / Q000331:legislation & jurisprudence; D005260:Female; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D020034:Silicone Gels / Q000266:history; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history*
D001672:Biocompatible Materials; D020034:Silicone Gels