In vitro and in vivo biocompatibility evaluation of a polyalkylimide hydrogel for soft tissue augmentation

J Biomed Mater Res B Appl Biomater. 2005 Feb 15;72(2):230-8. doi: 10.1002/jbm.b.30157.

Abstract

Injectable fillers are commonly used in Plastic and Reconstructive Surgery to correct serious and slight aesthetic defects due to their low invasiveness and an easy implant technique procedure. Synthetic hydrogels are proposed as filler materials for their similarity with soft tissue and to avoid many disadvantages of naturally derived materials such as short persistence, allergenicity, and immunogenicity. Our studies are focused on the biocompatibility evaluation of a polyacrylic hydrogel containing alkylimide-amide groups and pyrogen free water (96%) (Bio-Alcamid by means of the in vitro cytotoxicity and mutagenicity assays and the in vivo skin irritation, sensitization test, and subcutaneous implant. All tests conducted on Bio-Alcamid showed no toxicity. It is a substance easy to inject and remove; it does not migrate, and its safety allows it to be a suitable filler for the correction of slight and also very serious aesthetic defects.

MeSH terms

  • 3T3 Cells
  • Acrylic Resins / administration & dosage
  • Acrylic Resins / chemistry
  • Acrylic Resins / pharmacology
  • Animals
  • Biocompatible Materials / administration & dosage
  • Biocompatible Materials / chemistry
  • Biocompatible Materials / pharmacology*
  • Cell Survival
  • Guinea Pigs
  • Hydrogels / administration & dosage
  • Hydrogels / chemistry
  • Hydrogels / pharmacology*
  • Implants, Experimental / adverse effects
  • Implants, Experimental / microbiology
  • Implants, Experimental / standards
  • Materials Testing*
  • Mice
  • Mutagenicity Tests
  • Patch Tests
  • Plastic Surgery Procedures / methods*
  • Plastic Surgery Procedures / standards
  • Prostheses and Implants / standards*
  • Rabbits

Substances

  • Acrylic Resins
  • Bio-Alcamid
  • Biocompatible Materials
  • Hydrogels