Contemporary Biomaterials by John W. Boretos

By John W. Boretos

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Given these definitions we can return to the question of magnitude of need. Where have we gone in the use of medical devices and the use of biomaterials that are crucial to they way they function? As early as 1562 a gold prosthesis was used to close a defect in a cleft palate. Since then we have come a long way. The Pharmaceutical Manufacturers Association (PMA) has provided the information for Table 1. We note that the FDA estimates that there are some 2,600 different medical devices. However, the FDA estimate includes 2,000 devices that are for in vitro diagnosis and should not be included by our extended definition of prosthesis.

In the face of these considerations, the possibilities of development of biomaterials with predictable biocompatibility in the hands of a large number of practicing physicians and surgeons, with widely disparate operational techniques, may be very dismal indeed. The preceding comments are not intended as a discouragement for further intensive research toward the development of improved biomaterials, but rather to emphasize the specific areas of research that are likely to be the most fruitful (for example, research into the interfacial chemistry of biomaterialliving cell boundaries), and to warn against overoptimistic expectations for a rapid solution to these unsolved problems.

Rather, we are limited not by the materials but by our understanding of the deficiencies of the ones we have and how we might combine the best properties of many to improve the long-term efficacy and safety of the materials and the devices for our patients. Thus, it is my belief that the avenue for the future is to return to first principles through Federally sponsored programs which promote a strong alliance between engineer and physician-surgeon to attempt to understand on fundamental rather than empirical bases the major areas that I have outlined.

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