Altered systemic serologic parameters in patients with silicone mammary implants.

[BACKGROUND] The most common local complication in patients with silicone mammary implants (SMIs) is excessive peri-SMI connective tissue capsule formation and its subsequent contracture. However, considerable controversy remains as to whether these implants also cause systemic side effects. The present study was undertaken to identify possible alterations of serological markers in SMI patients that may herald systemic side effects.

[METHODS] We investigated several systemic serological parameters in 143 individuals, 93 of whom had received SMIs and 50 were controls. The patients were grouped according to the severity of capsular contracture (Baker scores I-IV) and the duration of SMI implants (less than 1 year, between 1 and 5 years, more than 5 years). We also included control groups (female blood donors, nurses with possible professional silicone exposure). Patients with breast cancer and subsequent SMI-reconstruction were excluded from the study since they are generally considered immunocompromised. The following parameters were determined: anti-neutrophil cytoplasmatic autoantibodies (cANCA), anti-nuclear autoantibodies (ANA), anti-cardiolipin antibodies (CL-Ab), rheumatoid factor (RF), complement components (C3, C4), circulating immune complexes (CIC), procollagen III (a marker of active fibrosis), anti-polymer antibodies (APA) and soluble intercellular adhesion molecule-1 (sICAM-1).

[RESULTS] The following parameters were increased in the sera of SMI patients: CIC, procollagen III, APA, sICAM-1.

[CONCLUSIONS] We found a set of parameters in serum that correlate with fibrosis development and the duration of the implants in otherwise healthy SMI carriers. Future studies will clarify whether these serological abnormalities will be useful in predicting clinical disease, and also further assess the sensitivity and specificity of these parameters. Our present recommendation as a result of this study is that SMI patients with persistent abnormal serological parameters should be monitored closely by a clinical team that includes rheumatologists.