Abstract
The biostability of materials used for long term implantable devices has been taken for granted far too often in the past. It is commonly stated that certain materials are inert, nondegradable or implantable, that is, biostable. Is there really any such thing as a nondegradable, inherently biostable material? Silicone rubber, for example, is a polymer that is generally accepted as biostable. None-the-less, it can absorb lipids and stress crack when used as a heart valve poppet. Silicone rubber finger joints can crack and break. Silicone rubber insulated pacemaker leads can fail because of wear, cold flow and/or calcification. The lives of many people depend upon the resistance of their polyester vascular prostheses to degradation. None-the- less, we have seen examples of fibrous lumps of tissue removed from pacemaker patients containing fragments of the dacron pouch used to keep their pulse generators from migrating. Each of these (and many other) materials has been tested on the bench and has been proven to be stable, resistant to oxidation and other degradation mechanisms. The materials have been implanted in animals for long periods of time and have been proven to be “nondegradable”. In fact, these materials have been used very successfully in many chronically implanted device models. Then why the occasional failure of a device made from a biostable polymer? One answer may be the failure or inability to account for device-material-manufacturing process-tissue interactions as well as individual differences (biologic variance).
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Stokes, K.B., Urbanski, P.W. (1992). The Biodegradation of Nondegradable Polymers. In: Planck, H., Dauner, M., Renardy, M. (eds) Degradation Phenomena on Polymeric Biomaterials. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-77563-5_4
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DOI: https://doi.org/10.1007/978-3-642-77563-5_4
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