Background: Since the 1960s, silicone implants have been successfully used for breast augmentation and reconstruction. However, safety issues regarding the use of silicone have led to a moratorium by the US Food and Drug Administration between 1992 and 2006.
Design: To date, although the moratorium has been removed and women overwhelmingly prefer silicone over saline implants, local and systemic adverse effects still remain a concern.
Results: Silicone-elicited inflammatory fibro-proliferative response and capsular contracture is irrefutable. Studies on silicone breast implants have not supported a relationship to carcinogenesis, whereas that to autoimmunity mainly to nondefined autoimmune phenomena seems very plausible. These silicone-related autoimmune adverse events termed 'siliconosis' are probably limited to a small minority of implanted patients.
Conclusions: Risk factors, such as characteristic environmental exposure and/or genetic predisposition, still require further elucidation. Similarly to antibacterial agents, texturized implants and Zafirlukast that were found to be beneficial in inhibiting fibro-proliferative response and capsular contracture, elucidating autoimmune-related risk factors might subsequently enable physicians to accurately predict long-term health status of silicone implant recipients.
© 2010 The Authors. European Journal of Clinical Investigation © 2010 Stichting European Society for Clinical Investigation Journal Foundation.