Response to foreign materials includes local tissue reaction,
osteolysis,
implant loosening, and migration to lymph nodes and organs. Bionate
80A human explants show minor wear and slight local tissue reaction,
but we do not know the response at the spinal cord, nerve roots, lymph
nodes, or distant organs. This study aims to figure out reactions
against Bionate 80A when implanted at the spinal epidural space of
24 20-week-old New Zealand white rabbits. In one group of 12 rabbits,
we implanted Bionate 80A on the spinal epidural space, and another
group of 12 rabbits was used as the control group. We studied tissues,
organs, and tissue damage markers on blood biochemistry, urine tests,
and necropsy. The animals’ clinical parameters and weight showed
no statistically significant differences. At 3 months, the basophils
increased slightly in the implant group, platelets decreased in all,
and at 6 months, implanted animals showed slight eosinophilia, but
none of these changes was statistically significant. External, organ,
and spinal tissue examination showed neither toxic reaction, inflammatory
changes, or noticeable differences between groups or survival periods.
Under microscopic examination, the Bionate 80A particles induced a
chronic granulomatous response always outside the
dura mater
, with giant multinucleated cells holding phagocytized particles
and no particle migration to lymph nodes or organs. Thus, it was concluded
that Bionate particles, when implanted in the rabbit lumbar epidural
space, do not generate a significant reaction limited to the surrounding
soft tissues with giant multinucleated cells. In addition, the particles
did not cross the
dura mater
or migrate to lymph
nodes or organs.