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Difficulties in showing the biologic activity of silicones in vitro have contributed to the controversy over effects of silicone mammary implants in vivo. We adapted a standard lymphocyte stimulation test to detect evidence of cellular immunity in patients with silicone gel implants. Initially, lymphocytes were harvested from 70 implant patients, 76 normal controls without implants or symptoms, and 18 patients with classic rheumatic disorders and without a history of silicone implants. The harvested lymphocytes were stimulated with PWM, PHA, Con A, and pharmaceutical grade colloidal silicon dioxide (silica). Implant patients showed increased SI compared to controls and those with rheumatic disorders. The mean SI of implant patients was 195.0 +/- 19.3, 18-fold that of normal controls (< 0.0001). Patients with rheumatic disease showed the same SI as controls (P = 0.3577). A follow-up study included 220 normal controls without implants, 942 silicone gel implant patients with demonstrable rheumatic symptoms, and 34 implant patients without symptoms at the time of the study. The average SI for the 220 normal controls was 10.0 +/- 0.41. Among the symptomatic implant women, 860 (91.3%) had SI significantly above those of the normal controls. Of these, 171 (18.2%) had SI between 25 and 50, 316 (33.5%) had SI between 50 and 100, and 373 (39.6%) had SI over 100. The data presented confirms that silicone implant patients respond immunologically to the silicon dioxide contained in mammary prostheses.

Preliminary criteria for the classification of systemic lupus erythematosus (SLE) were applied to patients with early diagnosed SLE and rheumatoid arthritis (RA) who are participants in a prospective community study of arthritis of recent onset. Sensitivity of the criteria was 88 % , and specificity against RA was 97.5 ye. Sensitivity increased to 92 % without loss of specificity when high titer antinuclear antibody (ANA) was used as an alternative criteria manifestation to LE cells. These results show the efficacy of the proposed criteria for early diagnosed patients, and support the inclusion of high titer ANA in the SLE criteria.Recently published preliminary criteria for the classification of systemic lupus erythematosus (SLE) (1) were applied to 25 patients with a clinical diagnosis of SLE, and to 40 patients with a clinical diagnosis