SELF-REPORTED SIGNS AND SYMPTOMS IN BREAST IMPLANT PATIENTS WITH NOVEL ANTIBODIES TO SILICONE SURFACE-ASSOCIATED ANTIGENS [ANTI-SSAA(X)]

In research animals, the immune adjuvant activity of silicone in elici ting antibodies to associated protein antigens is now well established , In humans, the immune adjuvant activity of silicone remains controve rsial, Clusters of data from various research groups are beginning to define the boundary conditions for future large epidemiological studie s, In that spirit, this manuscript reports pilot clinical data from a serological study conducted 3 years ago and reported previously in thi s journal, Sera from a self-selected symptomatic population of patient s with breast implants were assayed for elevated concentrations of ant ibodies showing binding avidity to silicone surface associated antigen s [anti-SSAA(x)]. In that study of 249 patients, two distinct statisti cally significant subgroups were identified on the basis of the serolo gical assay alone: patients without any elevated anti-SSAA(x) (negativ e) and patients with elevated anti-SSAA(x) (positive) (p < 0.001), In this study, a clinical survey returned by 226 of those patients was co rrelated with the previously acquired serological findings, The 11 mos t common clinical complaints reported by the 199 anti-SSAA(x) negative patients and by the 27 anti-SSAA(x) positive were compared and their frequencies analyzed, The 199 anti-SSAA(x) negative patients, as a gro up, showed a lower frequency of a variety of signs and symptoms compar ed to the 27 anti-SSAA(x) positive patients, Statistically significant differences were seen in three of the symptoms: fever, foot pain, and sleep disturbance (p < 0.05), In addition, the syndrome of fever in t he absence of local chest pain was a significantly associated with ant i-SSAA(x) positivity Cp < 0.001). (C) 1995 John Wiley and Sons, Inc.