12 Bio-Alcamid®
Summary and Key Features
• Bio-Alcamid® is an acrylic acid-derived, synthetic permanent gel used for soft tissue augmentation
• Bio-Alcamid® quickly gained widespread popularity for the correction of large-volume defects
• Short-term infectious complications are probably physician related
• Long-term inflammatory / infectious complications are significant and may be product related
• Long-term dislocation is product related and strongly suggests structural instability over time
• Correct treatment of all complications is very important and the best method is aggressive removal of the product
Introduction
Following further research to improve biocompatibility, of which the company never released any detail, the product was changed again in 2001, the new name being Bio-Alcamid®. This was a non-biodegradable, biocompatible synthetic polymeric transparent gel with a reticulated structure derived from acrylic acid, containing 4% alkyl-amide-imide groups and 96% apyrogenic water (Fig. 12.1). In 2001, Bio-Alcamid® obtained a Conformité Européenne (CE) certificate, the only requirement in Europe for approval of an injectable filler. It was produced in three different forms of increasing density, i.e. lips, face, and body. The indications remained the same as for Formacryl / Bio-Formacryl®, and again no limits were established in terms of injectable volumes per patient. Bio-Alcamid® correction of large-volume deficiencies such as those caused by pectus excavatum, Poland and Parry–Romberg syndromes and HIV drug-induced lipodystrophy quickly became popular. The patients tolerated the injections well and the clinical results seemed very satisfactory. The material was seen as a valid alternative to lipostructure because of the more predictable results that it offered. The reports in the early literature were extremely good (e.g. those by Pacini et al, Protopapa et al, Terenzi et al, and Casavantes).