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SILICONE BREAST IMPLANT RECIPIENTS WITH RHEUMATIC DISEASE SYMPTOMS

This article was originally published in The Gray Sheet

Executive Summary

SILICONE BREAST IMPLANT RECIPIENTS WITH RHEUMATIC DISEASE SYMPTOMS: most patients in a study published in the June 15 Annals of Internal Medicine appeared not to have "serious connective tissue disease," Alan Bridges, MD, University of Wisconsin, Madison, et al. report. The majority of the 156 women in the study did not have "serological findings consistent with serious connective tissue disease such as scleroderma or systemic lupus erythematosus," the study authors report. The study population consisted of women with silicone breast implants who had been referred between October 1990 and March 1992 to three rheumatologists for evaluation of rheumatic symptoms. There also were two control groups: 12 patients with implants and no rheumatic symptoms and 174 women with fibromyalgia without silicone implants. Based on the nature of their symptoms, the patients were divided into three groups: joint and muscle pain; joint swelling; and connective tissue disease. Four of the 95 patients in the joint and muscle pain group had elevated IgG levels, and two patients had elevated levels of IgM. One patient had an IgA deficiency. The mean immunoglobulin (IgG, IgM, IgA) levels for the group "were in the normal range," the authors report. In addition, comparison of the three immunoglobulin levels for the joint and muscle pain group with control patients "showed no statistical differences (P > 0.2 for all comparisons)." All of the patients had normal levels of complement. Nine of the women in the group had elevated levels of rheumatoid factor (> 60 IU/mL); six had elevated levels of C- reactive protein (> 1 IU/mL). The mean levels for rheumatoid factor and C-reactive protein "were within the normal range," the authors report. In addition, "the proportion of patients with joint and muscle pain and abnormal levels of immunoglobulin, ANA, rheumatoid factor and C-reactive protein did not differ from controls (P > 9.2 for all comparisons)." All of the patients had normal levels of complement. Three of the 32 women in the joint swelling group had an elevated rheumatoid factor level (67, 105 and 247 IU/mL); five patients had elevated C-reactive protein levels; and two patients had elevated IgM levels. All of the patients had normal levels of complement. Bridges et al. report that "the mean values of the immunoglobulin, rheumatoid factor, and C-reactive protein levels were within the normal range" for the group, and "the proportion of patients with joint swelling and abnormal levels of immunoglobulin, ANA, rheumatoid factor and C-reactive protein did not differ from controls (P > 0.15 for all comparisons)." Of the 29 patients in the connective tissue disease group, eight had abnormal immunoglobulin levels: one women had IgA deficiency and seven had elevated immunoglobulin levels (IgG-4, IgM-2, IgA-1). The authors note that "although the mean immunoglobulin levels were within the normal range, the IgM level was significantly higher in the connective tissue disease group compared to the control group of patients with fibromyalgia (P = 0.04)." In addition, the "proportion of patients with abnormal immunoglobulin levels was significantly higher in the connective tissue disease group compared with the groups with joint pain and joint swelling and with controls (P = 0.05)." Five of the patients in the connective tissue disease group had elevated rheumatoid factor levels, and one patient had an elevated C-reactive protein level. "The proportion of patients with abnormal rheumatoid factor and C-reactive protein levels did not differ from controls (P > 0.2)," the authors note. Although the study showed that most women with silicone implants and rheumatic disease symptoms had normal immunologic test results, "some women had findings that were unusual even for patients referred to rheumatologists," according to the study. Bridges et al. note that 10 (6.4%) of the study patients had autoantibodies to BB' polypeptide, "a distinctly unusual autoantibody response characteristically found only in patients with connective tissue disease." The authors note that the study did not evaluate the epidemiologic relationship between silicone exposure and rheumatic disease, and that the study population does not reflect the general population of silicone breast implant recipients. "Therefore, the degree of risk for development of rheumatic disease cannot be ascertained from this study." However, they add: "Our observations support the possibility that atypical autoimmune illness may be associated with silicone exposure in a small number of women." This issue needs to be addressed in a "large prospective controlled study," they conclude.

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