Biocompatibility and tissue interactions of a new filler material for medical use.
Filler materials for medical use present limits, such as the induction of chronic inflammation and fibrosis. In the search for synthetic materials with improved biocompatible properties, a new polyacrylamide hydrogel, Aquamid (Contura SA, Montreux, Switzerland), has been investigated in preclinical systems. In cell cultures (endothelial cells and fibroblast), no or only transient biological effects were associated with 10% Aquamid exposure. The Aquamid-host interactions were examined in mice (10 mice per group) implanted subcutaneously or in the mammary fat pad with a very large volume (1.5 ml) of the material. Blood analysis, performed after 15 and 94 days (five mice per time for each group) to detect acute or late manifestations of toxicity, did not reveal relevant abnormalities in either group of Aquamid-bearing mice compared with control mice, except for a transient thrombocytopenia and a mild leukocytosis. Histological analysis of the pellet showed the presence of a thin, poorly vascularized cyst wall in implants. Only mild mesenchymal reparative and inflammatory processes were observed, even at longer observation times (more than 400 days). No alterations in any organ were detected. Despite the large volume implanted (approximately 5 percent of mouse body weight), the Aquamid pellet maintained its original size and shape without spreading or sticking to surrounding tissues. In conclusion, the study indicated a good tolerability of the new biopolymer in preclinical systems. The clinical utility of this new compound, if confirmed by clinical randomized trials showing its atoxic properties, could be in the field of aesthetic plastic surgery as a filler material for body contouring and in reconstructive surgery and above all in cancer patients to restore surgical defects.
Zarini
Elena
E
Istituto Nazionale per lo Studio e la Cura dei Tumori and the Universita Statale degli Studi di Milano, Milan, Italy.
Supino
Rosanna
R
Pratesi
Graziella
G
Laccabue
Diletta
D
Tortoreto
Monica
M
Scanziani
Eugenio
E
Ghisleni
Gabriele
G
Paltrinieri
Saverio
S
Tunesi
Gianfranco
G
Nava
Maurizio
M
D000180:Acrylic Resins / Q000008:administration & dosage / Q000009:adverse effects*; D000818:Animals; D002417:Cattle; D002455:Cell Division / Q000187:drug effects; D002460:Cell Line; D002470:Cell Survival / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005549:Foreign-Body Reaction / Q000209:etiology / Q000473:pathology; D006801:Humans; D020100:Hydrogels / Q000008:administration & dosage / Q000009:adverse effects*; D066298:In Vitro Techniques; D007279:Injections, Subcutaneous; D007958:Leukocyte Count; D008422:Materials Testing; D051379:Mice; D010976:Platelet Count; D015361:Rhytidoplasty; D040521:Subcutaneous Tissue / Q000473:pathology
D000180:Acrylic Resins; C486838:Aquamid; D020100:Hydrogels