Evaluation of artecoll polymethylmethacrylate implant for soft-tissue augmentation: biocompatibility and chemical characterization.

Artecoll polymethylmethacrylate implant (Artecoll) is a combination of polymethylmethacrylate beads suspended in 3.5% atelocollagen and has been designed for use in soft-tissue augmentation applications. The biocompatibility and immunogenicity of Artecoll were evaluated to assess the safety of this product for use in the dermis. To characterize the collagen component, chemical analysis was performed including trypsin sensitivity, differential scanning calorimetry, and pepsin content. Particle size analysis was also performed on the polymethylmethacrylate beads. The ability of this material to elicit an immunologic response was measured in a sensitized and nonsensitized guinea pig intradermal model. In these studies, 24 guinea pigs were injected intradermally with either Artecoll or Zyderm, a bovine collagen product for soft-tissue augmentation. Six sites were evaluated for each material at 3, 7, and 28 days after injection. In the sensitized model, 60 guinea pigs were divided into five groups, and each group received a sensitizing dose (in conjunction with Freund's adjuvant) of Zyderm, Artecoll, or a nonsensitizing dose of the same materials. The fifth group served as a nontreatment control. After the animals were sensitized, they were challenged with intradermal injections of various antigens to evaluate delayed type hypersensitivity reactions. Chemical characterization indicated polymethylmethacrylate beads of varying sizes, including many less than 35 microns, and a vehicle of extensively denatured and impure collagen. In vivo evaluations indicated that Artecoll elicited an immune response in guinea pigs, including delayed type hypersensitivity and antibody reactions. Histological assessment demonstrated particle phagocytosis and transepidermal elimination. Following immunization with Artecoll, guinea pigs were also found to be sensitized to pepsin, an impurity found in the collagen carrier. The biocompatibility of this material was compared with that of bovine dermal collagen (Zyderm collagen implant), which is widely used and accepted as biocompatible. The results of this evaluation indicate that Artecoll polymethylmethacrylate implant has the potential to elicit an immune response in humans, and polymethylmethacrylate beads are susceptible to phagocytosis and elimination.