The current lack of definitive information concerning the relationship of silicone breast implants and rheumatic disease represents a massive failure of industry, government, and medicine. Although it is estimated that two million women have been implant recipients, it is disconcerting that the exact number is unknown. Unfortunately, these women are frightened by the considerable publicity generated by legislative hearings questioning the safety of silicone implants as a newly responsible government now struggles with developing regulations for devices that have been in use for approximately 30 years.
Manufacturers and many plastic surgeons have taken the position that the long-term clinical use of silicone breast implants without obvious evidence of adverse reactions is, by itself, adequate support for the safety of these prostheses. When concerns regarding the safety of these devices surfaced, investigators were chagrined to find that no controlled long-term studies of women with breast implants were published. The best available