P005: Surgisis Implants in the Treatment of Deep Nasolabial Folds

Abstract

Objectives: To relate our experience using an acellular, soft tissue matrix derived from porcine small intestinal submucosa (Surgisis; Cook Biotech Inc, West Lafayette, Ind.) for effacement of deep nasolabial folds. Methods: A prospective, uncontrolled study examining the results of nasolabial fold effacement using Surgisis implants was undertaken during a 12-month period. Patients seeking treatment of deep nasolabial folds underwent implantation of Surgisis under local anesthesia. Patient satisfaction, procedure tolerability and complications were determined by questioning at 1, 3 and 12 months post-operatively. Results: Thirteen patients underwent nasolabial fold implantation bilaterally and completed post-operative follow-up. No banding, extrusion, shrinkage of the implant, or unnatural sensations were reported post-operatively. No significant complications were encountered At one month, the average patient satisfaction score was 6.9/10. Satisfaction scores decreased to 5.9 at 3 months and 5.1 at 12 months. Conclusions: This study demonstrates technical ease, early safety and moderately successful short-term treatment of deep nasolabial folds with Surgisis implantation. The long-term benefits of Surgisis implantation in effacement of the nasolabial folds requires further investigation. All thirteen patients tolerated bilateral Surgisis implantation for the treatment of deep nasolabial folds under local anesthesia. Three patients graded the intraoperative pain as a 7 on a 10 point scale despite local anesthesia. However, no procedure was terminated due to pain or technical difficulty. The average intraoperative pain score was 4.2. All patients returned to pre-operative functioning on post-operative day one. Pre-, intraand post-operative photography was used in all cases (figures 2-5). At 1 month post-operatively, the average satisfaction score was 6.9 with a range of 3 to 9. Three month questioning revealed an average satisfaction score of 5.9 (range 3 to 8). At 12 months, patient satisfaction decreased to an average of 5.1 (range 1 to 8). Early dissatisfaction with the procedure was due to failure to efface the nasolabial fold. Dissatisfaction occurring at 3 and 12 months was mostly due to a gradual deepening of the crease with time. No banding, extrusion or shrinkage of the implant was identified or reported. Implants were neither noticeable, nor palpable. Entry and exit sites healed without incident with the exception of transient erythema at one insertion site in one patient. This was treated successfully with an oral antibiotic. Six patients reported mild swelling which resolved by post-operative day one. All patients denied allergic reactions and bleeding or hematoma formation. One patient reported mild bruising which had resolved by the first post-operative visit. All patients denied changes in sensation or interference in facial function. Results