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.
