Autoimmune/inflammatory syndrome (ASIA) induced by biomaterials injection other than silicone medical grade

Systemic autoimmune/granulomatous adverse reactions related to biomaterials other than silicone have rarely been reported.

The aim of this paper is to communicate the cases of autoimmune/inflammatory syndrome induced by adjuvants (ASIA) in a study of Spanish patients suffering from inflammatory disorders related to biomaterial injections other than silicone, principally hyaluronic acid, acrylamides or methacrylate compounds.

The authors performed a retrospective analysis of the clinical, laboratory, histopathology and follow-up of a cohort of 250 cases of patients suffering from inflammatory/autoimmune disorders related to bioimplant injections.

Of these 250 cases, patients with adverse reactions related to silicone injections (n = 65) were excluded. Of the remaining 185, 15 cases (8%) had systemic or distant and multiple complaints that could be categorized as ASIA. In all but four patients, inflammatory features at the implantation site preceded distant or systemic manifestations. Abnormal blood tests were common. Eleven cases (73.3%) with inflammatory localized nodules and panniculitis evolved into a variety of disorders, namely, primary biliary cirrhosis, Sjögren's syndrome, sarcoidosis, human adjuvant disease and inflammatory polyradiculopathy. Four cases presented primarily with systemic autoimmune disorders.

Infrequently, biomaterials other than silicone can provoke local inflammatory adverse reactions that may evolve into systemic autoimmune and/or granulomatous disorders. Whether or not these biomaterials act as an adjuvant, they could be included in the ASIA category.