title: Intense inflammatory reaction with porcine small intestine submucosa pubovaginal sling or tape for stress urinary incontinence.
abstract: OBJECTIVE
  To report on the intense local inflammatory reactions in patients undergoing pubovaginal sling or tape using a small intestinal submucosa graft. A case series of such inflammatory complications is presented.
  
  
  METHODS
  We performed 16 standard pubovaginal sling or tension-free tape procedures for stress urinary incontinence, using the Cook 4-ply Stratasis or 8-ply Stratasis-TF system. The diagnosis had been confirmed by the history, physical examination, and urodynamic study findings.
  
  
  RESULTS
  Of the 16 patients, 5 (31.3%) had intense suprapubic pain after surgery. One patient had induration of the mons pubis that required surgical drainage. Another patient had vaginal inflammation, with expulsion of graft material. Other patients had intense rectus sheath inflammation, as confirmed on computed tomography, that resolved with conservative care.
  
  
  CONCLUSIONS
  Previous case reports of inflammatory complications of small intestinal submucosa were confirmed in 31% of our patients. We have ceased using this product pending additional investigations or reformulation of the graft material.
authors.affiliation: Department of Urology, Detroit Medical Center, Detroit, Michigan, USA.
authors.forename: Tony T
authors.initials: TT
authors.lastname: John
authors.forename: Neelesh
authors.initials: N
authors.lastname: Aggarwal
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Singla
authors.forename: Richard A
authors.initials: RA
authors.lastname: Santucci
mesh_terms: D000328:Adult; D001705:Bioprosthesis / Q000009:adverse effects*; D015331:Cohort Studies; D005260:Female; D005549:Foreign-Body Reaction / Q000175:diagnosis / Q000209:etiology* / Q000628:therapy; D006801:Humans; D008875:Middle Aged; D012189:Retrospective Studies; D053825:Suburethral Slings / Q000009:adverse effects*; D014550:Urinary Incontinence, Stress / Q000601:surgery*