Urology

References noted with a yellow highlight refer to human patients.

Hayn MH, Bellinger MF, Schneck FX. “Small intestine submucosa as a corporal body graft in the repair of severe chordee.” Urology 2009;73:277-279.

Farahat Y, Eltatawy H, Haroun H “The small intestinal submucosa (SIS) as a suburethral sling for correction of stress urinary incontinence: Preliminary experience.” UroToday International Journal 2009;2(3).

Ashley RA, Palmer BW, Schultz AD “Leukocyte inflammatory response in a rat urinary bladder regeneration model using porcine small intestinal submucosa scaffold.” Tissue Engineering 2009 Apr 17. [Epub]

Roth CC, Bell CH, Woodson B “Temporal differentiation and maturation of regenerated rat urothelium.” BJU International 2008 Nov 19. [Epub]

Leslie JA, Cain MP, Kaefer M “Corporeal grafting for severe hypospadias: A single institution experience with 3 techniques.” Journal of Urology 2008;180:1749-1752.

Shukla D, Box GN, Edwards RA “Bone marrow stem cells for urologic tissue engineering.” World Journal of Urology 2008;26:341-349.

Lee EW, Shindel AW, Brandes SB. “Small intestinal submucosa for patch grafting after plaque incision in the treatment of Peyronie's disease.” International Brazilian Journal of Urology 2008;34:191-197.

Han P, Luo JC, Zhi W “[Constructing tissue-engineered urothelial structures in vitro and in vivo].” Sichuan Da Xue Xue Bao Yi Xue Ban 2008;39:481-484, 510.

Frederiksen H, Davidsson T, Gabella G “Nerve distribution in rat urinary bladder after incorporation of acellular matrix graft or subtotal cystectomy.” Scandanavian Journal of Urology and Nephrology 2008;42:205-212.

Baumert H, Hekmati M, Dunia I “Laparoscopy in ureteral engineering: A feasibility study.” European Urology 2008;54:1154-1163.

John TT, Aggarwal N, Singla AK “Intense inflammatory reaction with porcine small intestine submucosa pubovaginal sling or tape for stress urinary incontinence.” Urology 2008;72:1036-1039.

Ayyildiz A, Akgül KT, Huri E “Use of porcine small intestinal submucosa in bladder augmentation in rabbit: long-term histological outcome.” ANZ Journal of Surgery 2008;78:82-86.

Simon J, de Petriconi R, Meilinger M “Optimized haemostasis in nephron-sparing surgery using small-intestine submucosa.” BMC Urology 2008;8:8.

Drewa T. “The artificial conduit for urinary diversion in rats: a preliminary study.” Transplant Proceedings 2007;39:1647-1651.

Knoll LD. “Use of Small intestinal submucosa graft for the surgical management of Peyronie's Disease.” Journal of Urology 2007;178:2474-2478.

Elmore JM, Kirsch AJ, Scherz HC “Small intestinal submucosa for corporeal body grafting in severe hypospadias requiring division of the urethral plate.” Journal of Urology 2007;178:1698-1701.

Braga LH, Pippi Salle JL, Dave S “Outcome analysis of severe chordee correction using tunica vaginalis as a flap in boys with proximal hypospadias.” Journal of Urology 2007;178:1693-1697.

Breyer BN, Brant WO, Garcia MM “Complications of porcine small intestine submucosa graft for Peyronie's disease.” Journal of Urology 2007;177:589-591.

Iijima K, Igawa Y, Imamura T “Transplantation of preserved human amniotic membrane for bladder augmentation in rats.” Tissue Engineering 2007;13:513-524.

Kovac JR, Brock GB. “Surgical outcomes and patient satisfaction after dermal, pericardial, and small intestinal submucosal grafting for Peyronie's Disease.” Journal of Sexual Medicine 2007;4:1500-1508.

Beintker M, Vogt B, Schubert J “[Urethroplasty with tissue matrix : Microsurgical animal experiments with small intestinal submucosa.]” Urologe A. 2007;46:1236-1237.

Palminteri E, Berdondini E, Colombo F “Small intestinal submucosa (SIS) graft urethroplasty: Short-term results.” European Urology 2007;51:1695-1701.

de Almeida SH, Rodrigues MA, Gregório E “Influence of sling material on inflammation and collagen deposit in an animal model.” International Journal of Urology 2007-14:1040-1043.

Wang DS, Anderson DA, Fretz PC “Laparoscopic augmentation cystoplasty: a comparison between native ileum and small intestinal submucosa in the porcine model.” BJU International 2007;99:628-631.

Rolle L, Tamagnone A, Bollito E “[Could plaque excision surgery with sis graft induce a new fibrotic reaction in la Peyronie's disease patients?]” Archivio italiano di urologia, andrologia 2007;79:167-169.

Baumert H, Simon P, Hekmati M “Development of a seeded scaffold in the great omentum: Feasibility of an in vivo bioreactor for bladder tissue engineering.” European Urology 2007;52:884-892.

Baumert H, Mansouri D, Fromont G “Terminal urothelium differentiation of engineered neoureter after in vivo maturation in the 'Omental Bioreactor'.” European Urology 2007;52:1492-1498.

Fiala R, Vidlar A, Vrtal R “Porcine small intestinal submucosa graft for repair of anterior urethral strictures.” European Urology 2007;51:1702-1708.

Knoll LD. “Use of porcine small intestinal submucosal graft in the surgical management of Peyronie's disease.” Current Clinical Urology: Peyronie's Disease: A Guide to Clinical Management. 2006, pp. 209-216.

Donkov II, Bashir A, Elenkov CH “Dorsal onlay augmentation urethroplasty with small intestinal submucosa: Modified Barbagli technique for strictures of the bulbar urethra.” International Journal of Urology 2006;13:1415-1417.

John T, Bandi G, Santucci R. “ Porcine small intestinal submucosa is not an ideal graft material for Peyronie's disease surgery.” Journal of Urology 2006;176:1025-1029.

Leungwattanakij S, Pummangura N, Ratana-Olarn K. “Penile enhancement using a porcine small intestinal submucosa graft in a rat model.” International Journal of Impotence Research 2006;18:39-43.

Huang X, Luo J, Liao Y “[Study on small intestinal submucosa as repair materials in urethral reconstruction].” Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi 2006;20:206-209.

Caione P, Capozza N, Zavaglia D “In vivo bladder regeneration using small intestinal submucosa: experimental study.” Pediatric Surgery International 2006;22:593-599.

Krambeck AE, Dora CD, Sebo TJ “Time-dependent variations in inflammation and scar formation of six different pubovaginal sling materials in the rabbit model.” Urology 2006;67:1105-1110.

Hauser S, Bastian PJ, Fechner G “Small intestine submucosa in urethral stricture repair in a consecutive series.” Urology 2006;68:263-266.

Chung SY, Krivorov NP, Rausei V “Bladder reconstitution with bone marrow derived stem cells seeded on small intestinal submucosa improves morphological and molecular composition.” Journal of Urology 2005;174:353-359.

Alpert SA, Cheng EY, Kaplan WE “Bladder neck fistula after the complete primary repair of exstrophy: a multi-institutional experience.” Journal of Urology 2005;174:1687-1690.

Misseri R, Cain MP, Casale AJ “Small intestinal submucosa bladder neck slings for incontinence associated with neuropathic bladder.” Journal of Urology 2005;174:1680-1682.

Samli M, Singla AK. “Absorbable versus nonabsorbable graft: outcome of bone anchored male sling for post-radical prostatectomy incontinence.” Journal of Urology 2005;173:499-502.

Schultheiss D, Gabouev AI, Cebotari S “Biological vascularized matrix for bladder tissue engineering: matrix preparation, reseeding technique and short-term implantation in a porcine model.” Journal of Urology 2005;173:276-280.

le Roux PJ. “Endoscopic urethroplasty with unseeded small intestinal submucosa collagen matrix grafts: a pilot study.” Journal of Urology 2005;173:140-143.

Sardeli C, Axelsen SM, Bek KM. “Use of porcine small intestinal submucosa in the surgical treatment of recurrent rectocele in a patient with Ehlers-Danlos syndrome type III.” International Urogynecology Journal and Pelvic Floor Dysfunction 2005;16:504-505.

Wunsch L, Ehlers EM, Russlies M. “Matrix testing for urothelial tissue engineering.” European Journal of Pediatric Surgery 2005;15:164-169.

El-Hakim A, Marcovich R, Chiu KY “First prize: Ureteral segmental replacement revisited.” Journal of Endourology 2005;19:1069-1074.

Kogan BA. “Small intestinal submucosa bladder neck slings for incontinence associated with neuropathic bladder.” International Brazilian Journal of Urology 2005;31:614-615.

Cannon TW, Sweeney DD, Conway DA “A tissue-engineered suburethral sling in an animal model of stress urinary incontinence.” BJU International 2005;96:664-669.

Zhang Y, Lin HK, Frimberger D “Growth of bone marrow stromal cells on small intestinal submucosa: an alternative cell source for tissue engineered bladder.” BJU International 2005;96:1120-1125.

Jones JS, Rackley RR, Berglund R “Porcine small intestinal submucosa as a percutaneous mid-urethral sling: 2-year results.” BJU International 2005;96:103-106.

Thiel M, Rodrigues Palma PC, Riccetto CL “A stereological analysis of fibrosis and inflammatory reaction induced by four different synthetic slings.” BJU International 2005;95:833-837.

Rahman NU, Minor TX, Deng D “Combined external urethral bulking and artificial urinary sphincter for urethral atrophy and stress urinary incontinence.” BJU International 2005;95:824-826.

Frimberger D, Morales N, Shamblott M “Human embryoid body-derived stem cells in bladder regeneration using rodent model.” Urology 2005;65:827-832.

Jones JS, Vasavada SP, Abdelmalak JB “Sling may hasten return of continence after radical prostatectomy.” Urology 2005;65:1163-1167.

Lai JY, Chang PY, Lin JN. “Bladder autoaugmentation using various biodegradable scaffolds seeded with autologous smooth muscle cells in a rabbit model.” Journal of Pediatric Surgery 2005;40:1869-1873.

Kalota SJ. “Small intestinal submucosa tension-free sling: Postoperative inflammatory reactions and additional data.” Journal of Urology 2004;172:1349-1350.

Ho KL, Witte MN, Bird ET. “8-ply small intestinal submucosa tension-free sling: spectrum of postoperative inflammation.” Journal of Urology 2004;171:268-271.

Hafez AT, El-Assmy A, El-Hamid MA. “4 layer versus 1 layer small intestinal submucosa for correction of penile chordee: experimental study in a rabbit model.” Journal of Urology 2004;171:2489-2491.

Landman J, Olweny E, Sundaram CP “Laparoscopic mid sagittal hemicystectomy and bladder reconstruction with small intestinal submucosa and reimplantation of ureter into small intestinal submucosa: 1-year followup.” Journal of Urology 2004;171:2450-2455.

Dora CD, Dimarco DS, Zobitz ME “Time dependent variations in biomechanical properties of cadaveric fascia, porcine dermis, porcine small intestine submucosa, polypropylene mesh and autologous fascia in the rabbit model: Implications for sling surgery.” Journal of Urology 2004;171:1970-1973.

El-Assmy A, Hafez AT, El-Sherbiny MT “Use of single layer small intestinal submucosa for long segment ureteral replacement: A pilot study.” Journal of Urology 2004;171:1939-1942.

de Tayrac R, Haab F, Madelenat P “[Distribution of surgical operations for female stress urinary incontinence in parisian public hospitals in 2002-2003]” Progres en Urologie 2004;14:521-524.

Zhang Y, Kropp BP, Lin HK “Bladder regeneration with cell-seeded small intestinal submucosa.” Tissue Engineering 2004;10:181-188.

Kropp BP, Cheng EY, Lin HK “Reliable and reproducible bladder regeneration using unseeded distal small intestinal submucosa.” Journal of Urology 2004;172:1710-1713.

Wiedemann A, Otto M. “Small intestinal submucosa for pubourethral sling suspension for the treatment of stress incontinence first histopathological results in humans.” Journal of Urology 2004;172:215-218.

Faramarzi-Roques R, Malgat M, Desgrandchamps F “Mitochondrial metabolism in the rat during bladder regeneration induced by small intestinal submucosa.” BJU International 2004;94:419-423.

El-Assmy A, El-Hamid MA, Hafez AT. “Urethral replacement: a comparison between small intestinal submucosa grafts and spontaneous regeneration.” BJU International 2004;94:1132-1135.

El-Assmy A, El-Hamid MA, Abo-Elghar ME “Single-layer small intestinal submucosa or tunica vaginalis flap for correcting penile chordee.” BJU International 2004;94:1097-1101.

Campodonico F, Benelli R, Michelazzi A “Bladder cell culture on small intestinal submucosa as bioscaffold: experimental study on engineered urothelial grafts.” European Urology 2004;46:531-537.

Konig JE, Pannek J, Martin W “[Severe postoperative inflammation following implantation of a Stratasis sling]..” Urologe A 2004;43:1541-1543.

Greca FH, Noronha L, Bendhack M “Use of small intestine submucosa as ureteral allograft in pigs.” International Brazilian Journal of Urology 2004;30:327-335.

Nuininga JE, van Moerkerk H, Hanssen A “A rabbit model to tissue engineer the bladder.” Biomaterials 2004;25:1657-1661.

Duchene DA, Jacomides L, Ogan K “Ureteral replacement using small-intestinal submucosa and a collagen inhibitor in a porcine model.” Journal of Endourology 2004;18:507-511.

Mulcahy JJ. “Use of penile implants in the constructed neophallus.” International Journal of Impotence Research 2003;15:S129-S131.

Wilson TS, Lemack GE, Zimmern PE. “Management of intrinsic sphincteric deficiency in women.” Journal of Urology 2003;169:1662-1669.

Ritchey ML, Ribbeck M. “Successful use of tunica vaginalis grafts for treatment of severe penile chordee in children.” Journal of Urology 2003;170:1574-1576.

Soergel TM, Cain MP, Kaefer M “Complications of small intestinal submucosa for corporal body grafting for proximal hypospadias.” Journal of Urology 2003;170:1577-1579.

Weiser AC, Franco I, Herz DB “Single layered small intestinal submucosa in the repair of severe chordee and complicated hypospadias.” Journal of Urology 2003;170:1593-1595.

Gabouev AI, Schultheiss D, Mertsching H “In vitro construction of urinary bladder wall using porcine primary cells reseeded on acellularized bladder matrix and small intestinal submucosa.” International Journal of Artificial Organs 2003;26:935-942.

Metwalli AR, Colvert JR, Kropp BP. “Tissue Engineering in urology: Where are we going?” Current Urology Reports 2003;4:156-163.

Nuininga JE, van Moerkerk H, Hanssen A “Rabbit urethra replacement with a defined biomatrix or small intestinal submucosa.” European Urology 2003;44:266-274.

Mantovani F, Trinchieri A, Castelnuovo C “Reconstructive urethroplasty using porcine acellular matrix.” European Urology 2003;44:600-602.

Rutner AB, Levine SR, Schmaelzle JF. “Processed porcine small intestine submucosa as a graft material for pubovaginal slings: durability and results.” Urology 2003;62:805-809.

Paradiso M, Sedigh O, Milan GL. “[Plaque surgery for Peyronie's disease: heterologous grafts].” Arch Ital Urol Androl 2003;75:116-118.

Colvert JR, Kropp BP, Cheng EY “The use of small intestinal submucosa as an off-the-shelf urethral sling material for pediatric urinary incontinence.” Journal of Urology 2002;168:1872-1876.

Kropp BP, Cheng EY, Pope JC “Use of small intestinal submucosa for corporal body grafting in cases of severe penile curvature.” Journal of Urology 2002;168:1742-1745.

Monga M, Cosgrove D, Zupkas P “Small intestinal submucosa as a tunica albuginea graft material.” Journal of Urology 2002;168:1215-1221.

Rotariu P, Yohannes P, Alexianu M “Reconstruction of rabbit urethra with Surgisis® small intestinal submucosa.” Journal of Endourology 2002;16:617-620.

Yohannes P, Rotariu P, Liatsikos E “Role of acellular collagen matrix (Surgisis® ) in the endoscopic management of ureteropelvic junction obstruction.” Journal of Endourology 2002;16:549-556.

Sofer M, Rowe E, Forder DM “Ureteral segmental replacement using multilayer porcine small-intestinal submucosa.” Journal of Endourology 2002;16:27-31.

Paterson RF, Lifshitz DA, Beck SD “Multilayered small intestinal submucosa is inferior to autologous bowel for laparoscopic bladder augmentation.” Journal of Urology 2002;168:2253-2257.

Gulino G, Falabella R, Gentile G “[Radical surgery in Peyronie's disease. Graft comparison].” Minerva Chirugica 2002;57:383-388.

Knoll LD. “Use of porcine small intestinal submucosal graft in the surgical management of tunical deficiencies with penile prosthetic surgery.” Urology 2002;59:758-761.

Rabah DM, Spiess PE, Begin LR “Tissue reaction of the rabbit urinary bladder to tension-free vaginal tape and porcine small intestinal submucosa.” BJU International 2002;90:601-606.

Shokeir AA. “Bladder regeneration: between the idea and reality.” BJU International 2002;89:186-193.

Mantovani F, Trinchieri A, Mangiarotti B “Reconstructive urethroplasty using porcine acellular matrix: preliminary results.” Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica / Associazione ricerche in uro 2002;74:127-128.

Smith TG, Gettman M, Lindberg G “Ureteral replacement using porcine small intestine submucosa in a porcine model.” Urology 2002;60:931-934.

O'Connor RC, Harding JN, Steinberg GD. “Novel modification of partial nephrectomy technique using porcine small intestine submucosa.” Urology 2002;60:906-909.

O'Connor RC, Holloweel CM, Steinberg GD. “Distal ureteral replacement with tubularized porcine small intestine submucosa.” Urology 2002;60:697x-697xii.

Jaffe JS, Ginsberg PC, Yanoshak SJ “Ureteral segment replacement using a circumferential small-intestinal submucosa xenogenic graft.” Journal of Investigative Surgery 2001;14:259-265.

Liatsikos EN, Dinlenc CZ, Kapoor R “Laparoscopic ureteral reconstruction with small intestinal submucosa.” Journal of Endourology 2001;15:217-220.

Liatsikos EN, Dinlenc CZ, Kapoor R “Ureteral reconstruction: Small intestinal submucosa for the management of strictures and defects of the upper third of the ureter.” Journal of Urology 2001;165:1719-1723.

O'Connor RC, Patel RV, Steinberg GD. “Successful repair of a uretero-neobladder stricture using porcine small intestine submucosa.” Journal of Urology 2001;165:1995.

Kubricht WS 3rd, Williams BJ, Eastham JA “Tensile strength of cadaveric fascia lata compared to small intestinal submucosa using suture pull through analysis.” Journal of Urology 2001;165:486-490.

Grossklaus DJ, Shappell SB, Adams MC “Small intestinal submucosa as a urethral coverage layer.” Journal of Urology 2001;166:636-639.

Palma PC, Dambros M, Riccetto CL “[Pubovaginal sling using the porcine small intestine submucosa for stress urinary incontinence].” Brazilian Journal of Urology 2001;27:483-4888.

Knoll LD. “Use of porcine small intestinal submucosal graft in the surgical management of Peyronie's Disease.” Urology 2001;57:753-757.

Kropp BP, Cheng EY. “Bioengineering organs using small intestinal submucosa scaffolds: in vivo tissue-engineering technology.” Journal of Endourology 2000;14:59-62.

Calvano CJ, Moran ME, Parekh A “Laparoscopic augmentation cystoplasty using the novel biomaterial Surgisis: small-intestinal submucosa.” Journal of Endourology 2000;14:213-217.

Portis AJ, Elbahnasy AM, Shalhav AL “Laparoscopic midsagittal hemicystectomy and replacement of bladder wall with small intestinal submucosa and reimplantation of ureter into graft.” Journal of Endourology 2000;14:203-211.

Roemer FD. “There isn't an ideal smooth-surface material--yet: the history and future of urologic materials.” Journal of Endourology 2000;14:1-4.

Desgrandchamps F. “Biomaterials in functional reconstruction.” Current Opinion in Urology 2000;10:201-206.

Portis AJ, Elbahnasy AM, Shalhav AL “Laparoscopic augmentation cystoplasty with different biodegradable grafts in an animal model.” Journal of Urology 2000;164:1405-1411.

Furness PD, Kolligian ME, Lang SJ “Injectable small intestinal submucosa: preliminary evaluation for use in endoscopic urological surgery.” Journal of Urology 2000;164:1680-1685.

Reddy PP, Barrieras DJ, Wilson G “Regeneration of functional bladder substitutes using large segment acellular matrix allografts in a porcine model.” Journal of Urology 2000;164:936-941.

Landman J, Olweny E, Collyer W “Small intestine submucosa: intrinsic and asastomotic tensile strength of SIS using laser welding, fibrin glue, vascular closure staples, endo-GIA staples and sutures.” Minimally Invasive Therapy & Allied Technology 2000;9:375-378.

Alberti C. “[From the intestinal neobladder to the bioartificial bladder: Remarks on some biological implications].” Minerva Urologie & Nefrologie 2000;52:219-222.

Xie H, Shaffer BS, Wadia Y “Use of reconstructed small intestine submucosa for urinary tract replacement.” ASAIO Journal 2000;46:268-272.

Kim BS, Baez CE, Atala A. “Biomaterials for tissue engineering.” World Journal of Urology 2000;18:2-9.

Cheng EY, Kropp BP. “Urologic tissue engineering with small-intestinal submucosa: potential clinical applications.” World Journal of Urology 2000;18:26-30.

Kropp BP. “Developmental aspects of the contractile smooth muscle component in small intestinal submucosa regenerated urinary bladder.” Advances in Bladder Research 1999;462:129-135.

Magunna, C, Spellmeyer “[Bladder augmentation after radical resection using porcine small intestinal submucosa (SIS): first results of the clinical application as a xenograft in the dog and cat].” Kleintierpraxis 1999;44:809-821.

Shalhav AL, Elbahnasy AM, Bercowsky E “Laparoscopic replacement of urinary tract segments using biodegradable materials in a large-animal model.” Journal of Endourology 1999;13:241-244.

Elbahnasy AM, Shalhav A, Hoenig DM “Bladder wall substitution with synthetic and nonintestinal organic materials.” Journal of Urology 1998;159:628-637.

Kropp BP. “Small-intestinal submucosa for bladder augmentation: a review of preclinical studies.” World Journal of Urology 1998;16:262-267.

Badylak SF, Kropp B, McPherson T “Small intestinal submucosa: A rapidly resorbed bioscaffold for augmentation cystoplasty in a dog model.” Tissue Engineering 1998;4:379-387.

Kropp BP, Ludlow JK, Spicer D “Rabbit urethral regeneration using small intestinal submucosa onlay grafts.” Urology 1998;52:138-142.

Kropp BP, Pope JC. “Small intestinal submucosa: A novel substance for the study of cellular interaction and regeneration in the bladder.” Dialogues in Pediatric Urology 1997;20:1-8.

Pope JC, Davis MM, Smith ER “The ontogeny of canine small intestinal submucosa regenerated bladder.” Journal of Urology 1997;158:1105-1110.

Kropp BP, Rippy MK, Badylak SF “Regenerative urinary bladder augmentation using small intestinal submucosa: urodynamic and histopathologic assessment in long-term canine bladder augmentations.” Journal of Urology 1996;155:2098-2104.

Vaught JD, Kropp BP, Sawyer BD “Detrusor regeneration in the rat using porcine small intestinal submucosal grafts: Functional innervation and receptor expression.” Journal of Urology 1996;155:374-378.

Kropp BP, Sawyer BD, Shannon HE “Characterization of small intestinal submucosa regenerated canine detrusor: Assessment of reinnervation, in vitro compliance and contractility.” Journal of Urology 1996;156:599-607.

Kropp BP, Eppley BL, Prevel CD “Experimental assessment of small intestinal submucosa as a bladder wall substitute.” Urology 1995;46:396-400.

Kropp BP, Badylak S, Thor KB. “Regenerative bladder augmentation: a review of the initial preclinical studies with porcine small intestinal submucosa.” Advances in Experimental Medicine & Biology 1995;385:229-235.

Knapp PM, Lingeman JE, Siegel YI “Biocompatibility of small-intestinal submucosa in urinary tract as augmentation cystoplasty graft and injectable suspension.” Journal of Endourology 1994;8:125-130.

NOTE: Any medical device has the potential for complications. Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions, and instructions for use. Potential complications with use of a biologic graft may include bleeding, infection, abscess, induration, acute or chronic inflammation (initial use of biologic graft materials may be associated with transient, mild, localized inflammation), allergic reaction, visceral adhesions, fistula formation, seroma formation, hematoma, extrusion, recurrence of tissue defect, and delayed or failed incorporation of the device.

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