Biomaterials for tissue reconstruction and bone substitution of the ear, nose and throat, face and neck.

The role of biomaterials has become more important in the last 30 years in otorhinolaryngology. Legal directives for their use and, more importantly, indications have been specified. Biomaterials are medical devices, designed for tissue substitution or reconstruction. Approval labeling is issued in the form of European Community certification and postmarketing medical device safety in Europe - completely independent from the US FDA's certification. The indications for biomaterials are generally similar to those of autografts. Their main advantage is that they limit the morbidity caused by autograft harvesting. The benefits are aesthetic, functional or both. The main indications are in otology, sinus surgery, cranio-maxillo-facial traumatology, osteosynthesis and orthognatic surgery, skeletal augmentation and anti-aging surgery, facial prosthetic rehabilitation and laryngology. The research fields are extremely varied (e.g., increased therapeutic properties, drug-delivery systems or tissue engineering). Increasingly, biomaterials are implanted and the surgical success of their use is dependent upon strict legal labeling and well-defined indications.