Biodegradation of polyurethane foam, revisited, in the rat model.

In a prospective, randomized, controlled animal study, we systematically analyzed implanted polyurethane foam to determine the rate of degradation in the rat and to compare it to our previous human data. Sixteen 1-cm2 silicone-backed pieces of polyurethane foam were randomly implanted into dorsal subcutaneous pockets in each of 16 Sprague-Dawley rats. Eight animals had polyurethane implants removed at 3 and 6 months and the remaining 8 animals at 9 and 12 months. Specimens were examined either by histology or by scanning electron microscopy of recovered foam after collagenase digestion of the capsule. Histologically, there was evidence of foam degradation and a multinucleated giant cell inflammatory response surrounding the implants. With the scanning electron microscope, the strut width of the polyurethane foam upon implantation measured 51.4 +/- 1.3 microns (mean+SEM). This progressively decreased to 29.1 +/- 1.3 microns at 3 months, 16.6 +/- 0.6 micron at 6 months, 14.9 +/- 0.5 micron at 9 months, and 13.2 +/- 0.3 micron at 12 months (p < 0.0001). Duration of implantation has a significant impact on polyurethane degradation as measured by scanning electron microscopy in the rat animal model. The rate of degradation in the rat is much faster than in our human study, indicating that the rat studies cannot be used to draw conclusions regarding rate of biodegradation in humans.