Epidemiology of Autoimmune and Immunological Diseases in Association with Silicone Implants: Is There an Excess of Clinical Disease or Antibody Response in Population-based or Other “Controlled” Studies?

Case reports, small case series and media coverage have led to the general perception that patients with silicone breast implants are at increased risk of connective tissue diseases or rheumatologic disorders. Our understanding of rheumatologic disorders would be enhanced if such an association could indeed be confirmed by controlled studies, but the reported associations of autoimmune diseases have been based on case reports which have had one or more of the deficiencies noted in table 1. Such case reports or case series provide no evidence of an excess of the specified rheumatologic diseases among implant subjects compared to expected incidence. Furthermore, case reports or case series have no denominators and cannot provide rates for comparison. Comparisons between exposed and nonexposed can best be done through a historical cohort study or through case-control analyses.