Soft Tissue Response to Polytetrafluoroethylene and Silicone Rubber in Humans: Morphological and Immunohistochemical Observations

Abstract

The objective of this study was by morphological and immunohistochemical means to investigate the cellular tissue response to the alloplastic materials polytetrafluoroethylene (PTFE polymer), and soft and hard silicone rubber over time. In seven healthy volunteers implants made of Proplast-Teflon, and soft and hard silicone were inserted subcutaneously in unloaded areas in the iliac crest region. After 1, 2, 4, 12, and 26 weeks, respectively, the implants with surrounding soft tissue were removed en bloc for histological and immunohistochemical examination using a panel of antibodies to various leukocyte markers. The tissue reaction to the various alloplastic materials varied greatly with the focus on macrophage and giant cell reactions and eventual formation of a peri-implant fibrous capsule. The most extensive changes developed next to porous Proplast, both with respect to degree of changes and endurance of tissue reaction. Less intense reactions were seen, in decreasing order, to soft silicone, Teflon, and hard silicone. The study gave no clues to a toxic, allergic, or traditional immunological pathogenesis of the tissue reaction induced by the test materials.

Triple histology of an extracted polytef (gore-tex) implant

“…Our findings are consistent with selected previously documented histologic features, including fibrous tissue interfacing with normal soft tissue, and the changes in skin thickness. However, in contradistinction to one previous report [5], we observed no calcifications, inflammation or foreign body giant cells. In addition, we did observe a partial peri-implant fibrous capsule.…”

Evaluation of Surgically Retrieved Temporomandibular Joint Alloplastic Implants: Pilot Study

“…Silastic® was introduced to the medical community in 1968 as an interpositional material for the reconstruction of arthritic or severely damaged joints in the hand after experimental evidence showed its biocompatibility. 42 Researchers 37,42,51 demonstrated that different forms of Silastic® implants became surrounded by a fibrous capsule. It was thought that solid silicone fulfilled many of the requirements of an ideal implant material even though occasional intracellular particles of silicone elastomer were observed inside tissue macrophages.…”

Safety Assessment of Polyfluorinated Polymers as Used in Cosmetics

“…The cellular tissue response to subcutaneously implanted PTFE (laminated to aluminum oxide; 5 × 10 mm 2 implant blocks) was evaluated using 7 healthy volunteers. 46 PTFE was implanted s.c. in the iliac crest region. After 1, 2, 4, 12, and 26 wk, respectively, the implants with surrounding soft tissue were removed for histological and immunohistochemical examination using a panel of antibodies to various leukocyte markers.…”