Immunology of Injectable Collagen in Human Subjects

Abstract

Associated with the use of Zyderm Collagen Implant (ZCI) for soft tissue augmentation, the rate of localized hypersensitivity reactions to the initial test injection of ZCI range from 3.0–3.5% in the literature, and subsequent reactions to treatment have reportedly ranged from 1.1–5.0%. The inflammatory symptoms to the Collagen Test Implant occur within 72 hours in 2% of those injected, indicating a preexisting sensitivity to bovine collagen in this healthy population. Most adverse treatment reactions follow the first treatment and after injection of <5 ml of collagen. Furthermore, antibodies against collagen in sera of subjects reporting localized symptoms of hypersensitivity at test or treatment sites are specific for bovine interstitial collagens and show no cross-reactivity with human collagens. Thus, immunologic reaction to ZCI results in antibovine collagen antibodies and localized inflammatory symptoms in those few subjects who experience hypersensitivity to test or treatment. Glutaraldehyde cross-linked Zyplast Implant (ZI), has demonstrated a lower incidence of hypersensitivity reactions than ZCI. In examining patients tested with ZI or treated for intradermal and subdermal indications, we have experienced only 7 hypersensitivity reactions at test sites of ZI, out of 803 tested subjects, and only 3 reactions among 498 treated patients. Therefore, ZI appears to induce a lower incidence of hypersensitivity reactions than ZCI in man.