In vitroandin vivobiocompatibility evaluation of a polyalkylimide hydrogel for soft tissue augmentation

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.

A new model for in vitro testing of vitreous substitute candidates

“…Bio-Alcamid® is a translucent hydrogel with high biocompatibility [26,27] used in plastic surgery and in clinical use forms a surrounding collagen capsule giving it a degree of isolation from the surrounding tissue [28]. The synthetic polymer hydrogel PEG is used in different biomedical application, has been tested for intravitreal administration of drugs [24,39] and is FDA approved for use intravitreally.…”

“…To this end we have used the wellestablished retinal explant model to study three polymer hydrogels of different chemical composition that theoretically may be considered as potential vitreous substitutes; 1) Crosslinked hyaluronic acid (Healaflow®), clinically used in glaucoma surgery [22,23]; 2) Poly (ethylene glycol) (PEG), widely used in different biochemical applications [24,25]; and, 3) Polyalkylimide (Bio-Alcamid®), clinically used in reconstructive surgery [26][27][28][29].…”

A new strategy to replace the natural vitreous by a novel capsular artificial vitreous body with pressure-control valve

“…This test was performed by direct contact of silicone rubber elastomer with cultured fibroblast cells as described earlier. 15,16 Mouse fibroblast L929 cell lines were cultured in Dulbecco modified Eagle's medium (DMEM; GIBCO, Grand Island, Ny, USA), with 10% fetal calf serum, penicillin/streptomycin (100/100 U), and gentamycin (100 mg/ml), and incubated in 5% CO 2 at 371C for 24 h. Then, cell cultures were incubated with samples or negative (DMEM) and positive controls (0.1% phenol solution) at the same conditions for 24 h. The viability and cell metabolic activity were tested by the MTT assays. At least three replicates were performed for this test.…”

Pyrogenicity of hyaluronic acid hydrogel crosslinked by divinyl sulfone for soft tissue augmentation

“…Hydrogels as injection augmentation of facial soft tissue have attracted immediate attention due to their regeneration properties of various tissues, mechanical properties, softness, oxygen permeability, similarities the body's own highly hydrated composition and excellent biocompatibilities [1][2][3][4][5][6][7][8]. They demonstrated their efficacy in correcting aesthetic defects such as congenital or hypovolumetries, nasolabial furrows, forehead, glabella wrinkles, cheekbone, chin hypovolumetry and lip augmentation.…”

“…Among natural polymers, such as collagen, gelatin, fibrin, alginic acid, chitosan and hyaluronic acid (HA), crosslink-stabilized HA is highly acknowledged as a naturally derived injectable filler due to its longevity of correction, a reduced risk of immunogenicity and hypersensitivity, and its controllable mechanical and degradation properties [1,7]. HA is a linear polysaccharide formed from disaccharide units containing N-acetyl-Dglucosamine and glucuronic acid [2,8].…”