INTRODUCTIONThe recent withdrawal of specific silicone, polyurethane, polyester, fluorinated hydrocarbon polymers, and other polymers from the market for use in implantable medical devices has created the potential for a crisis in biomaterials availability. The cost of testing, qualification, regulatory compliance, and product liability insurance to manufacturers of basic materials used in medical devices has steadily increased over the past decade. Recently, litigation directed at these parties has carried with it large financial penalties and adverse As a result, many surgical implants that depend upon these materials for their construction may be at risk. To complicate the situation further, invaluable biomaterials experience amassed over decades in a wide variety of applications could also be lost. Nevertheless, a search for materials that are "not substantially different" is underway to find replacements that can match the physical, chemical, and biological characteristics of those that are being withdrawn so that old and new medical devices that have a history of acceptability using these materials will be available when needed.
BACKGROUND
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