Bioevaluation of plasma polymerized films in skeletal muscle.

Plasma polymerized ethylene (PPE), styrene (PPS), and chlorotrifluoroethylene (PPCTFE) were synthesized by exposing the monomeric gases to an inductively coupled radio frequency "glow-discharge" field. The polymer films were deposited on poly(dimethyl) siloxane (medical grade Silastic), which was then surgically implanted in rat paravertebral muscle for periods up to 84 weeks. The biocompatibility of the plasma deposited films and uncoated Silastic was evaluated by qualitative (graded inflammatory cell response) and quantitative (connnective tissue capsule thickness) techniques as a function of time. The morphological features of the connective tissue capsule and the plasma polymerized films were examined by SEM after 75 weeks of implantation. Results showed that the acute inflammatory cell migration around PPS and PPCTFE was at a maximum in 2 weeks, decaying to control levels in 4 to 8 weeks. The PPE response was judged as less than the control response up to 4 weeks. After 8 weeks no qualitative difference could be detected between the plasma polymerized films and Silastic. On the other hand, a quantifiable change in fibrous capsule response as a function of time and material was noted until 24 weeks. From these data we conclude that these types of films do not elicit an untoward foreign body reaction at a skeletal muscle implant site in rats.