PURPOSE: We report a series of postoperative inflammatory reactions of a tension-free pubourethral sling procedure using an 8-ply small intestinal submucosa (SIS) and review the literature regarding inflammatory reactions with this material in genitourinary reconstruction. MATERIALS AND METHODS: Between August 2002 and June 2003, 6 of 10 patients treated for stress urinary incontinence with 8-ply SIS had postoperative inflammatory reactions. Patients underwent a thorough evaluation, including history, physical examination and urodynamic studies, before surgical intervention. RESULTS: All patients presented with induration and erythema at the abdominal incision site(s) and pain 10 to 39 days postoperatively. Pelvic examinations were negative. In 3 patients the inflammatory reaction resolved with minimal or no intervention. Incision and drainage of a sterile abscess were required in 1 patient. Despite 7 days of prophylactic postoperative antibiotics and anti-inflammatory drugs, 2 patients had delayed inflammatory reactions. One patient had resolution with conservative treatment, while the other had an abscess that spontaneously drained. With short-term followup (mean 7 months, range 4 to 10), 8 patients are dry, 1 is improved and 1 is incontinent. CONCLUSIONS: While the results with the 8-ply SIS tension-free sling in the short term are encouraging, the additional morbidity is alarming and caution is warranted. It is essential that patients be made aware of potential risks and possible delayed presentation of morbidity with the use of this material. The human to 8-ply SIS interaction needs further investigation to ensure that long-term safety and efficacy will not be jeopardized. Until then we will continue to use other sling materials.
PURPOSE: We report a series of postoperative inflammatory reactions of a tension-free pubourethral sling procedure using an 8-ply small intestinal submucosa (SIS) and review the literature regarding inflammatory reactions with this material in genitourinary reconstruction. MATERIALS AND METHODS: Between August 2002 and June 2003, 6 of 10 patients treated for stress urinary incontinence with 8-ply SIS had postoperative inflammatory reactions. Patients underwent a thorough evaluation, including history, physical examination and urodynamic studies, before surgical intervention. RESULTS: All patients presented with induration and erythema at the abdominal incision site(s) and pain 10 to 39 days postoperatively. Pelvic examinations were negative. In 3 patients the inflammatory reaction resolved with minimal or no intervention. Incision and drainage of a sterile abscess were required in 1 patient. Despite 7 days of prophylactic postoperative antibiotics and anti-inflammatory drugs, 2 patients had delayed inflammatory reactions. One patient had resolution with conservative treatment, while the other had an abscess that spontaneously drained. With short-term followup (mean 7 months, range 4 to 10), 8 patients are dry, 1 is improved and 1 is incontinent. CONCLUSIONS: While the results with the 8-ply SIS tension-free sling in the short term are encouraging, the additional morbidity is alarming and caution is warranted. It is essential that patients be made aware of potential risks and possible delayed presentation of morbidity with the use of this material. The human to 8-ply SIS interaction needs further investigation to ensure that long-term safety and efficacy will not be jeopardized. Until then we will continue to use other sling materials.
Authors: Fadee G Mondalek; Benjamin J Lawrence; Bradley P Kropp; Brian P Grady; Kar-Ming Fung; Sundar V Madihally; Hsueh-Kung Lin Journal: Biomaterials Date: 2008-03 Impact factor: 12.479
Authors: Alex Gomelsky; Rashel M Haverkorn; Walter J Simoneaux; Seth Bilello; William S Kubricht Journal: Int Urogynecol J Pelvic Floor Dysfunct Date: 2007-03-01