Biomechanical effects of e-PTFE implant structure on soft tissue implantation stability: a study in the porcine model

Successful implantation of biocompatible materials depends on physical aspects of its structure. Meshed implants are stable but cannot be easily removed. Nonporous materials are easily removed, but subject to extrusion. We hypothesized that the microporous structure of expanded polytetrafluoroethylene (e-PTFE) would permit limited fibrous ingrowth into the substance of the material, and that tubular implant shape would increase tissue integration while preserving ease of removal. A two-tailed in vivo study was done comparing implant retention, strength of fixation, and removability between tubular and solid-strip e-PTFE implants. Differences in implant retention within tissues were assessed by implanting 396 implants subcutaneously in five swine for observation periods ranging from 3 weeks to 12 months. Strength of implant attachment to host soft tissues was measured at 52 sites by extraction with a tensiometer with forces both parallel and perpendicular to the implant used. Implant porosity was assessed with scanning electron micrography of tubular and solid-strip e-PTFE implants. Measurements of the force and stress tolerances of the implant-tissue interface demonstrated significantly stronger attachment in tubular than strip-shaped implants (P < 0.005). The 11 N (2.75 lb) force sustained by the tubular implant exceeded the 3.4 N (<1 lb) force for the e-PTFE strip by a statistically significant margin on two-tailed Student's t-test (P < 0.005). Even greater forces were tolerated when applied at right angles to the axis of the tubular implant, emulating tissue suspension (21 N, 5.25 lb). The forces and stresses tolerated by both e-PTFE implants far exceeded the fracture stress measured for the implants. Implant extrusion rates were significantly smaller in tubular (0.85%) than in strip-shaped (4.4%) e-PTFE implants (P < 0.05). Standard error of the mean (SEM) demonstrated lesser porosity in tubular than strip implants, suggesting lesser direct tissue attachment. Tubular e-PTFE implant structure facilitates ingrowth of soft tissue through the tube's lumen. This increases the attachment to surrounding soft tissues, increasing fixation strength, decreasing extrusion rate, but still allowing easy removal. These properties may improve clinical applications in facial implantation.