Laboratory studies in breast implant patients: ANA positivity, gammaglobulin levels, and other autoantibodies.

Silicone polymers when used in augmentation prosthesis in breast surgery have been associated in the medical literature with various systemic clinical manifestations and abnormal laboratory testing suggestive of an atypical autoimmune disease. The most frequently cited abnormal test result is the antinuclear antibody. The literature regarding this test is reviewed in general, and then specific previous studies analyzed. The present study then compares the rate of positive antinuclear antibody tests in a case series of 3380 breast implant recipients with historical normal controls, and finds a six-fold increase in relative risk of a positive test. Analysis of the data show that this increased tendency is at least partially a function of duration of implant exposure to a significant degree (p < 0.001), and the same data shows it is not patient age related. Possible explanations of this phenomenon are discussed, including animal studies suggesting that silicone serves as an adjuvant, and therefore might have an effect on immune tolerance in the subject population.