Porcine Acellular Collagen Matrix
Porcine acellular matrices are a family of tissue-derived scaffolds, including dermis, small intestinal submucosa (SIS) and urinary bladder matrix (UBM). Tissue source, crosslinking, decellularization and sterilization affect handling and remodeling. Avoiding tissue harvest is a practical advantage, but neither an animal origin nor decellularization establishes durable support, freedom from inflammation or suitability for a particular urinary reconstruction.[1][2]
Products named in the literature include Surgisis and Stratasis (Cook porcine SIS), Pelvicol and PelviSoft (Bard porcine dermis, no longer listed as current), ACell urinary bladder matrix, and InteXen (porcine dermal collagen, historical). Availability changes, so check the current listing before planning a case.
This overview covers material selection and evidence boundaries. See Porcine SIS for that specific material and Decellularized ECM for scaffold research.
Remodeling and product selection
The intended response is host-cell infiltration and replacement of the scaffold. Clinical remodeling can be incomplete or accompanied by fibrosis, inflammation, infection and loss of mechanical support. A pathology series of patients requiring reintervention after xenograft sacrocolpopexy found different degradation patterns for porcine dermis and SIS. Dermal failures showed local degradation with minimal foreign-body reaction, whereas dermal erosions and early SIS infections showed inflammatory infiltrates.[2]
Use the exact product's current instructions for indication, animal-tissue hypersensitivity precautions, preparation and fixation.
Urethral and bladder reconstruction
In rabbits, an onlay of acellular matrix from porcine bladder submucosa showed host-cell infiltration and angiogenesis by 2 weeks, a confluent transitional-cell layer, unorganized muscle bundles at 2 months and organized bundles at 6 months, with no strictures on urethrography.[12] Mantovani reported the first clinical porcine SIS urethroplasty, with satisfactory urodynamic and subjective outcome at 16 months.[13] SIS series in men are summarized on the Porcine SIS page.
The AUA 2023 urethral-stricture guideline states, as Expert Opinion, that surgeons should not perform substitution urethroplasty with allograft, xenograft or synthetic materials except under experimental protocols.[14] The EAU 2026 urethral-stricture guideline gives a weak recommendation to avoid cell-free tissue-engineered grafts with extensive spongiofibrosis, a previous failed urethroplasty or a stricture longer than 4 cm.[3] The guideline favors buccal or lingual mucosa when a graft is needed and available, and strongly advises against tubularized grafts in a single-stage urethroplasty.[3]
Small salvage reports show feasibility, with important co-interventions. A pediatric report included ten fistula repairs and two redo urethroplasties in 12 boys, with the matrix used as a splint over the repair. All were reported free of fistula recurrence at a median 2.5 years, and one child developed a wound infection that needed debridement.[4] In two women with complete loss of the posterior urethra, UBM reconstruction was combined with labial fat-pad transposition and a biologic pubovaginal sling; the graft appeared to convert to urethral mucosa, one woman became fully continent and the other improved significantly.[5]
For bladder augmentation, SIS produced regeneration in rat and canine models, and clinical translation has been inconsistent (see Porcine SIS for the human series).[15] Regenerative scaffolds remain a research field. A 2025 TissueSpan report described animal development and initiation of a first human trial, without reporting human outcomes.[6] The 2025 UROGRAFT study investigated a bladder-matrix/collagen/cellulose composite preclinically.[7]
Stress urinary incontinence
The short-term Pelvicol series reported 85% cured and a further 10% improved at a mean 12 months; longer porcine-dermis comparisons reported lower success than autologous fascia.[16][17][8] The series below use different materials and definitions of success.
| Series | Material and design | Reported outcome |
|---|---|---|
| Barrington 2002 | Pelvicol porcine dermis, 40 women; mean 12 months | Cure 85%, a further 10% improved.[16] |
| Giri 2006 | Cross-linked porcine dermis (51) vs rectus fascia (50), nonrandomized; 36 months or more | Patient-perceived success (cured or improved) in 54% vs 80.4% (p = 0.009), among 94 with complete data. Failures in the porcine group appeared by 24 months. The authors concluded that porcine dermis should not substitute for rectus fascia.[17] |
| Broussard 2013 | Porcine dermis bladder-neck sling, 70 women; mean 62.1 months | SUI cure 42.9% and global cure 11.4%. Thirty of 40 women with recurrence had it within 12 months, and 28.6% had further anti-incontinence surgery.[18] |
SIS sling series (Rutner 2003, Siracusano 2011) are on the Porcine SIS page. The AUA/SUFU 2023 panel notes that efforts to substitute porcine dermis or cadaveric fascia for autologous fascia have shown inferior results.[19]
In the follow-up of a four-centre randomized trial, 162 of 201 women were assessed at a median of ten years. Patient-reported dry-or-improved rates were 58% with Pelvicol, 75.4% with autologous fascia and 73% with TVT; complete dryness was 15.7%, 50.8% and 31.7%, respectively. Complete dryness favored autologous fascia over Pelvicol.[8]
Pelvic organ prolapse
| Setting | Evidence and implication |
|---|---|
| Primary transvaginal anterior/posterior repair | The large multicentre PROSPECT trial found no clinically important symptom or functional-cure advantage from biological xenograft augmentation at six years. About 65% returned six-year questionnaires, and no examination was performed at that time. The 2024 Cochrane review (51 trials overall, including 13 comparing transvaginal biological graft with native tissue) did not detect a difference in awareness of prolapse, repeat surgery for prolapse or recurrence on examination in any compartment; a separate anterior-compartment analysis found less recurrence with graft (RR 0.69, 95% CI 0.54–0.90; 7 trials).[9][21] |
| Laparoscopic sacrocolpopexy | Culligan's single-centre RCT randomized women to PelviSoft crosslinked porcine dermis or polypropylene; 57 and 58 were analyzed at 12 months. Objective cure was 46/57 (80.7%) versus 50/58 (86.2%). No significant difference was detected, but the trial was designed to detect a large, 23-percentage-point difference. Clinical cure (84.2% vs 89.7%) also did not differ. It was not an equivalence or noninferiority trial.[10] In the earlier Deprest series (50 xenograft, of which 29 were porcine dermis, vs 100 polypropylene sacrocolpopexies, mean 33 months), vault failure among the 104/150 available for anatomical evaluation was 21% with xenografts vs 3% with polypropylene, and all six reoperations for prolapse were in the xenograft group.[20] In the pathology series of failures, porcine dermis was usually locally degraded but still recognizable years later, with minimal foreign-body reaction. SIS had been replaced by connective tissue, and erosions and early infections showed inflammatory infiltrates.[2] |
US regulatory scope: the FDA's 2019 stop-sale order for devices intended for transvaginal POP repair included Xenform, a bovine-derived product, as well as synthetic products. The FDA order was limited to transvaginal POP devices, excluding midurethral slings and abdominal sacrocolpopexy mesh.[11]
Practical selection questions
- What exact tissue, product generation and current labeled use are being considered?
- Does the evidence match the operation, route, fixation and required duration of support?
- Is the recipient tissue suitable for incorporation, and what alternatives have better evidence?
- Are the patient-relevant outcome, follow-up losses and potential need for reoperation clear?
For other materials, see Human ADM, Bovine grafts and Polypropylene mesh.
References
1. Davis NF, McGuire BB, Callanan A, et al. Xenogenic extracellular matrices as potential biomaterials for interposition grafting in urological surgery. J Urol. 2010;184:2246–2253. doi:10.1016/j.juro.2010.07.038.
2. Deprest J, Klosterhalfen B, Schreurs A, et al. Clinicopathological study of patients requiring reintervention after sacrocolpopexy with xenogenic acellular collagen grafts. J Urol. 2010;183:2249–2255. doi:10.1016/j.juro.2010.02.008.
3. European Association of Urology. Urethral Strictures: Tissue Transfer. 2026. Guideline chapter.
4. Springer A, Subramaniam R. Preliminary experience with the use of acellular collagen matrix in redo surgery for urethrocutaneous fistula. Urology. 2012;80:1156–1160. doi:10.1016/j.urology.2012.06.058.
5. Ansari S, Karram M. Two cases of female urethral reconstruction with acellular porcine urinary bladder matrix. Int Urogynecol J. 2017;28:1257–1260. doi:10.1007/s00192-016-3262-7.
6. Vythilingam G, Larsson HM, Yeoh WS, et al. Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed. Urology. 2025;196:294–299. doi:10.1016/j.urology.2024.12.016.
7. Pokrywczynska M, Fekner Z, Balcerczyk D, et al. Development of UROGRAFT: a bladder acellular matrix-based composite for advanced cystoplasty. ACS Biomater Sci Eng. 2025. doi:10.1021/acsbiomaterials.5c00700.
8. Khan ZA, Nambiar A, Morley R, et al. Long-term follow-up of a multicentre randomised controlled trial comparing tension-free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women. BJU Int. 2015;115:968–977. doi:10.1111/bju.12851.
9. Reid FM, Aucott L, Glazener CMA, et al. PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse. Int Urogynecol J. 2023;34:67–78. doi:10.1007/s00192-022-05308-0.
10. Culligan PJ, Salamon C, Priestley JL, Shariati A. Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial. Obstet Gynecol. 2013;121:143–151. doi:10.1097/AOG.0b013e31827558dc.
11. US Food and Drug Administration. Urogynecologic Surgical Mesh Implants. Regulatory scope.
12. Chen F, Yoo JJ, Atala A. Acellular collagen matrix as a possible "off the shelf" biomaterial for urethral repair. Urology. 1999;54:407–410. doi:10.1016/s0090-4295(99)00179-x.
13. Mantovani F, Trinchieri A, Castelnuovo C, Romanò AL, Pisani E. Reconstructive urethroplasty using porcine acellular matrix. Eur Urol. 2003;44:600–602. doi:10.1016/s0302-2838(03)00212-4.
14. Wessells H, Angermeier KW, Elliott S, et al. Urethral Stricture Disease: AUA Guideline (published 2016; amended 2023), statement 20.
15. Kropp BP. Small-intestinal submucosa for bladder augmentation: a review of preclinical studies. World J Urol. 1998;16:262–267. doi:10.1007/s003450050064.
16. Barrington JW, Edwards G, Arunkalaivanan AS, Swart M. The use of porcine dermal implant in a minimally invasive pubovaginal sling procedure for genuine stress incontinence. BJU Int. 2002;90:224–227. doi:10.1046/j.1464-410x.2002.02850.x.
17. Giri SK, Hickey JP, Sil D, et al. The long-term results of pubovaginal sling surgery using acellular cross-linked porcine dermis in the treatment of urodynamic stress incontinence. J Urol. 2006;175:1788–1792. doi:10.1016/S0022-5347(05)01023-2.
18. Broussard AP, Reddy TG, Frilot CF, Kubricht WS, Gomelsky A. Long-term follow-up of porcine dermis pubovaginal slings. Int Urogynecol J. 2013;24:583–587. doi:10.1007/s00192-012-1919-4.
19. Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline (2023). J Urol. 2023;209:1091–1098. doi:10.1097/JU.0000000000003435.
20. Deprest J, De Ridder D, Roovers JP, et al. Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts. J Urol. 2009;182:2362–2368. doi:10.1016/j.juro.2009.07.043.
21. Yeung E, Baessler K, Christmann-Schmid C, et al. Transvaginal mesh or grafts or native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2024;3:CD012079. doi:10.1002/14651858.CD012079.pub2.