Ig. Trumpy et al., SOFT-TISSUE RESPONSE TO POLYTETRAFLUOROETHYLENE AND SILICONE-RUBBER IN HUMANS - MORPHOLOGICAL AND IMMUNOHISTOCHEMICAL OBSERVATIONS, Scandinavian journal of plastic and reconstructive surgery and hand surgery, 31(4), 1997, pp. 295-301
The objective of this study was by morphological and immunohistochemic
al means to investigate the cellular tissue response to the alloplasti
c materials polytetrafluoroethylene (PTFE polymer), and soft and hard
silicone rubber over time. In seven healthy volunteers implants made o
f Proplast-Teflon(R), and soft and hard silicone were inserted subcuta
neously in unloaded areas in the iliac crest region. After 1, 2, 4, 12
, and 26 weeks, respectively, the implants with surrounding soft tissu
e were removed en bloc for histological and immunohistochemical examin
ation using a panel of antibodies to various leukocyte markers. The ti
ssue reaction to the various alloplastic materials varied greatly with
the focus on macrophage and giant cell reactions and eventual formati
on of a peri-implant fibrous capsule. The most extensive changes devel
oped next to porous Proplast, both with respect to degree of changes a
nd endurance of tissue reaction. Less intense reactions were seen, in
decreasing order, to soft silicone, Teflon, and hard silicone. The stu
dy gave no clues to a toxic, allergic, or traditional immunological pa
thogenesis of the tissue reaction induced by the test materials.