Biomaterials, Medical Devices and Tissue Engineering

Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from months (class I device) to in excess of ten years (class III device). The use of polymers, metals, ceramics and composite materials in the formulation of medical devices dates back centuries to when plant and animal skins were used for the amelioration of pathological conditions that resulted from mechanical, chemical or pathogenic trauma to tissues and organs. This text presents a detailed review of the current use of materials for the replacement of a range of body tissues, providing an analysis of the short and long term evaluation of each material. After an opening chapter investigating the scope and potential market for medical implants, each subsequent chapter focuses on a separate area of tissue replacement and discusses in depth materials currently used clinically as well as new materials now under development. Would dressings and skin replacement are reviewed followed by replacement skeletal tissues, biomaterials used in ophthalmology, cardiovascular implants, facial implants, dental implants and breast implants. The two primary pathways used to gain market approval in the USA, 510(k) and PMA, are also desceibed. Each of these tissue replacements are analyzed in terms of physico-chemical requirements and biocompatability assessment and the advantages and disadvantages of each material are summarized. The book is aimed at the reader who has an understanding of the basic concepts of polymers, metals and ceramics as well as biocompatability assessessment and will be of interest to all those in university biomaterials and biomechanics departments or medical schools, orthopaedic surgeons, industrial researchers and implant manufacturers.