Evaluation of expanded polytetrafluoroethylene as a soft-tissue filling substance: an analysis of design-related implant behavior using the porcine skin model

Soft-tissue augmentation using the synthetic nonfluid biomaterial expanded polytetrafluoroethylene (ePTFE) has been supported by number of recent reports citing the favorable characteristics of biocompatibility, soft and natural feel, ease of use, and permanent augmentation. Concern has been expressed about this application for ePTFE material because of the proximity of the implants to the skin surface and potential problems with infection and extrusion. We evaluated the behavior of a series of specific ePTFE implant designs using a long-term subcutaneous augmentation model. By using a porcine model, 466 implants of ePTFE in the form of strips, rolls, or tubes were placed using a percutaneous insertion device subcutaneously over the dorsum and face. The animals were divided into three study groups by length of implantation (3 weeks, control; 6 months, intermediate term; and 12 months, long-term) and en-bloc tissue specimens, including skin, implants, and underlying soft tissue, were harvested for gross and histologic examination. Implants were removed at the earliest sign of infection, exposure, or extrusion and the difficulty of removal was ascertained and recorded. These data reveal that ePTFE material elicits acceptable levels of tissue activity with low extrusion rates over the short and long term supporting its use for soft-tissue augmentation. The data show a clear difference, however, in the host response and behavior of the implants for this application based on shape or design. A statistically significant difference in the low, but measurable, extrusion rates was observed amongst these implant designs. ePTFE tubes showed greater stability and predictable augmentation over other implant designs for soft-tissue augmentation and seem to represent a substantial improvement for this application.