The present study was conducted to determine if 200 patients with sili
cone-gel implants demonstrated elevated levels of autoantibodies, comp
ared with a similar group of 100 age-matched control subjects without
breast implants. These results were then compared with 29 patients who
had demonstrated implant rupture. Differences in the frequency of aut
oantibody levels were determined by the chi-squared test. Differences
in autoantibody titers were determined by Wilcoxon's signed rank test.
Differences were considered significant with p > 0.05. The prevalence
of a positive antinuclear antibody (ANA) test (dilution 1:100) in the
200 patients with breast implants was 26.5% compared with 28% in the
100 control subjects. In 29 patients with implant rupture, only 17.2%
tested ANA positive. These values were not significantly different. In
addition, there were no significant differences between the ANA titer
s of positive patients in each group. In each of the three groups, all
patients who tested ANA positive were analyzed to assess the frequenc
y and titer of other autoantibodies, including anti-DNA, anti-cardioli
pin, anti-SSA, anti-SSB, anti-SM, anti-RNP, and anti-Scl-70. There wer
e no significant differences between the frequency or titer of any of
these autoantibody levels in each of the three groups of patients. The
se studies strengthen the concept that there is no conclusive evidence
that silicone-gel implants are related to the development of connecti
ve tissue disease.