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Serum proteins and paraproteins in women with silicone implants and connective tissue disease: a case-control study.

Csako G, Costello R, Shamim EA, O'hanlon TP, Tran A, Clauw DJ, Williams HJ, Miller FW

ABSTRACT: Prior studies have suggested abnormalities of serum proteins, including paraproteins, in women with silicone implants but did not control for the presence of connective-tissue disease (CTD). This retrospective case-control study, performed in tertiary-care academic centers, assessed possible alterations of serum proteins, including paraproteins, in such a population. Seventy-four women with silicone implants who subsequently developed CTD and 74 age- and CTD-matched women without silicone implants were assessed in the primary study; other groups were used for additional comparisons. Routine serum protein determinations and high-sensitivity protein electrophoresis and immunofixation electrophoresis were performed for detection of paraproteins. Women with silicone implants, either with or without CTD, had significantly lower serum total protein and alpha-1, alpha-2, beta, and gamma globulins, and IgG levels compared to those without silicone implants. There was no significant difference, however, in the frequency of paraproteinemia between women with silicone implants and CTD (9.5%) and age- and CTD-matched women without silicone implants (5.4%) (OR 1.82 [95% CI 0.51 to 6.45]). Paraprotein isotypes were similar in the two groups and the clinical characteristics of the 13 women with paraproteinemia were comparable to an independent population of 10 women with silicone breast implants, CTD and previously diagnosed monoclonal gammopathies. In summary, this first comprehensive study of serum proteins in women with silicone implants and CTD found no substantially increased risk of monoclonal gammopathy. Women with silicone implants, however, had unexpectedly low serum globulin and immunoglobulin levels, with or without the subsequent development of CTD. The causes and clinical implications of these findings require further investigation.

Published 18 September 2007 in Arthritis Res Ther, 9(5): R95.
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