Biocompatibility - A Serious Issue

A product or material designed for human implantation is considered biocompatible only after it has been extensively tested. Two levels of biocompatibility are available and should be ascertained prior to implantation of any restorative material ( including filling materials, bonding agents, lining cement ect... ).

GENERAL BIOCOMPATIBILITY and INDIVIDUAL BIOCOMPATIBILITY

General Biocompatibility is established after a series of biological tests have been performed successfully. A truly generally biocompatible material will show absolutely no reactivity and no cell toxicity in those tests. A " pass " mention without the actual result(s) of the test(s) may mean that the product has met a minimum requirement that has been set by the testing laboratory. This minimum requirement does not insure general biocompatibility. A " pass " without the actual result(s) may well indicate that the product is still reactive and toxic to cells but to a level deemed acceptable by the manufacturer and the testing laboratory. Biological tests have been developed and standardized by ISO and/or ANSI.  At present these tests are not mandatory and most manufacturers will not do them. One way for the consumer to know if the materials to be used in their treatments are generally biocompatible is to ask their health practitioner for tests results of the materials. If these results are not available or only a " pass " mention is offered then a claim of biocompatibility should be viewed with caution.

Individual Biocompatibility is established after successfully testing each product or material against a specific individual. A number of testing techniques are available to health practitioners for individual biocompatibility testing. Discuss this with our staff. Individual biocompatibility testing is important because a product or material that is generally biocompatible may still be a problem for a specific individual. A simple example is food allergies where foods considered very safe can still cause severe allergic reactions in a few individuals. For that reason absolute biocompatibility does not exist. Obviously if a product or material has poor general biocompatibility then it is very likely that it will also have poor individual biocompatibility and vice versa. Some individuals have a high level of tolerance and may tolerate materials with poor or average biocompatibility but using them would offer only a relatively narrow margin of safety as any changes in the individual's health over time could reduce or eliminate his tolerance level. Furthermore the need to tolerate a material with poor or average biocompatibility will still exact a price that the well informed individual may not want to pay.

THE BEST SAFETY MARGIN IS OBTAINED BY SELECTING ONLY MATERIALS THAT HAVE A HIGH LEVEL OF GENERAL BIOCOMPATIBILITY, THEN TESTING THEM FOR INDIVIDUAL BIOCOMPATIBILITY AND USING ONLY THOSE WITH THE BEST RESULTS.

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