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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\u2010amide groups and pyrogen free water (96%) (Bio\u2010Alcamid\u00ae) by means of the<jats:italic>in vitro<\/jats:italic>cytotoxicity and mutagenicity assays and the<jats:italic>in vivo<\/jats:italic>skin irritation, sensitization test, and subcutaneous implant. All tests conducted on Bio\u2010Alcamid\u00ae 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. \u00a9 2004 Wiley Periodicals, Inc. 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