A CLINICAL-STUDY OF THE RELATIONSHIP BETWEEN SILICONE BREAST IMPLANTSAND CONNECTIVE-TISSUE DISEASE

Objective. This study was a blinded, concurrent assessment of a histor ical cohort derived from a provincial registry (1978 to 1986) of boast implant recipients (cosmetic, not reconstructive) and controls (other cosmetic surgery) to test the hypothesis that connective tissue disea se (CTD) is increased in breast implant recipients. Methods. Women who underwent breast implant or other cosmetic surgery during the interva l from 1978 to 1986 were contacted confidentially by Alberta Health an d asked to participate in the study. Those willing to participate comp leted an extensive questionnaire and supplied a blood sample, subseque nt to which all surgical records were reviewed to confirm implant type (s) or cosmetic surgery(ies). All participants with any suggestion of rheumatic disease were assessed blindly by a rheumatologist for CTD. R esults. One thousand five hundred seventy-six breast implant recipient s were recruited, including 1112 who had received silicone gel-filled implants (>13,500 person yrs exposure). Seven hundred twenty-six contr ols were recruited. Prevalence rates adjusted for sex and age for rheu matoid arthritis, systemic lupus erythematosus, scleroderma. and Sjogr en's syndrome (the principal targeted conditions) were consistent with published reports for Caucasian women, While breast implant recipient s self-reported significantly greater rates of symptoms than controls, post-surgical diagnoses of the principal targeted conditions did not indicate an increased incidence of typical or atypical CTD. Conclusion . The results of the study do not support the hypothesis that silicone gel-filled implants induce or promote CTD.