Small intestinal submucosa for pubourethral sling suspension for the treatment of stress incontinence: first histopathological results in humans.

PURPOSE: Small intestinal submucosa (SIS), a biomatrix of porcine origin, is used in pubourethral sling operations for female urinary stress incontinence, among other urological and surgical indications. To our knowledge we report the first histopathological examination of this biomatrix in human subjects.
MATERIALS AND METHODS: In a series of 15 patients with pubourethral sling procedures using SIS 3 reoperations were necessary because of recurrent urinary stress incontinence at a mean of 12.7 months. Biopsies were taken from the implantation site of the SIS band under the vaginal mucosa. Several immunohistochemical reactions were used to identify any inflammatory reaction.
RESULTS: The biopsies under investigation showed nothing more than focal residues of the SIS implant without any evidence of a specific tissue reaction. There were no changes that might point to a foreign body reaction. There was likewise no evidence of any significant immunological reaction and in particular no evidence of any chronic inflammatory reaction.
CONCLUSIONS: The morphological findings point to outstandingly good biocompatibility of SIS. During healing the material is incorporated into the body without any foreign body or inflammatory reaction. The results of the first histological investigation of SIS in human subjects emphasize the special status of SIS among implant materials.