USE OF ANTIPOLYMER ANTIBODY-ASSAY IN RECIPIENTS OF SILICONE BREAST IMPLANTS

Background Local complications (encapsulation, rashes, rupture, and le akage) can occur after placement of silicone-gel-containing breast imp lants (SBI). Whether SBI exposure results in systemic manifestations i n some recipients is controversial. We have carried out a blinded stud y to assess whether there is any difference between SBI recipients and non-exposed controls in the proportions positive for serum antibodies directed against polymeric substances. Methods We recruited female SB I recipients (including those without symptoms) who presented to a sin gle rheumatology clinic, A physician global assessment was used to cla ssify SBI recipients who did not meet criteria for specific autoimmune diseases according to the severity of local and systemic signs and sy mptoms. Controls were recruited from among clinic staff and their acqu aintances. Results of the antipolymer antibody (APA) assay were compar ed with those of an assay for antinuclear antibodies (ANA) and with th e severity of the signs and symptoms. Findings Positive APA results we re found in one (3%) of 34 SBI recipients with limited symptoms, two ( 8%) of 26 with mild symptoms, seven (44%) of 16 with moderate symptoms , and 13 (68%) of 19 with advanced symptoms. Four (17%) of 23 healthy non-SBI-exposed controls and two (10%) of 20 non-exposed women with cl assic autoimmune diseases were positive for APA. Thus, women with mode rate or advanced symptoms were significantly more likely than those wi th limited or mild symptoms, or nonexposed controls to have APA (p<0.0 01). The proportion with positive ANA results was higher for women wit h classic autoimmune diseases 14 (70%) of 20 than for any SBI-exposed subgroup (0-33%). Interpretation The APA assay can objectively contrib ute to distinguishing between SBI recipients with limited or mild sign s and symptoms, SBI recipients with more severe manifestations, and pa tients with specific autoimmune diseases. Further studies will be need ed to define the signs and symptoms associated with exposure to SBI.