Introduction: Position of medical devices has increased for last 30 years in otorhinolaryngology. Legal directive of use, main indications and perspectives are presented.
Results and discussion: Biomaterials are medical devices planned for tissue reconstruction or substitution. The approval labelling are planned in Europe by the European Community certification (marquage CE) and overseen by a postmarket medical device safety (matériovigilance), that are completely independent from the Food and Drug Administration certification. Indications of biomaterials are likely competitive to those of autografts; their advantage is to limit the morbidity due to autograft harvesting. Benefits are aesthetics, functional or complementary. Main indications are presented in otology, rhinology, face traumatology, laryngology, anti-aging surgery, implants and epithesis. Research fields are scanned (increased therapeutic properties, drug delivery systems, tissue engineering...).
Conclusion: Biomaterials are increasingly implanted in ENT surgery. The surgical success of their use require a strict legal label and well-defined indications.