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Tutoplast-Processed Allografts (Cadaveric Pericardium & Fascia)

Tutoplast is a proprietary multi-step tissue-sterilization and preservation method (originally Biodynamics International / Tutogen Medical, later Mentor Corporation, then Coloplast / RTI Surgical / Surgalign) for cadaveric human allograft tissues — primarily pericardium and fascia lata. The process renders donor tissue acellular, room-temperature-stable, and gamma-sterilized while preserving collagen architecture and tensile properties. Urologic applications span Peyronie's-disease plaque incision and grafting (PIG), complex penile-prosthesis corporoplasty, pubovaginal slings for SUI, sacrocolpopexy for POP, and venous reconstruction.[1][2][3]

For the autologous counterpart see Autologous Fascia Lata. For bovine pericardium products (Peri-Guard, Veritas, Xenform — sometimes manufactured with Tutoplast-derived processing such as Tutopatch / Tutomesh) see Bovine-Derived Grafts. For human acellular dermis (AlloDerm / FlexHD family) see Human Acellular Dermal Matrix.

Material Science & Processing​

The Tutoplast process is a nonaldehyde multi-step sterilization sequence designed to inactivate viruses, bacteria, and prions while preserving the extracellular matrix:[4][5][6]

  1. Osmotic treatment — alternating hypertonic / hypotonic baths lyse and clear donor cells while sparing the ECM.
  2. Oxidative treatment — hydrogen peroxide inactivates residual pathogens.
  3. Alkaline treatment — sodium hydroxide; validated against TSE / vCJD risk.
  4. Solvent dehydration — acetone extracts lipids, reduces antigenicity, and produces a dry tissue with long room-temperature shelf life.
  5. Double-sterile packaging + terminal gamma irradiation at 17.8–25 kGy for SAL 10⁻⁶.

The result is an acellular, solvent-dehydrated, gamma-irradiated allograft rehydrated in saline 1–2 minutes before use, with no donor cells, DNA, or HLA antigens by histology — meeting AATB and FDA HCT/P standards.[1][4] Mechanical testing confirms tensile strength comparable to native tissue, with rehydrated grafts handling and suturing like autologous fascia or pericardium.[5][6] The acetone-dehydration step distinguishes Tutoplast from freeze-dried or solvent-detergent allografts (eg AlloDerm); the trade-off is excellent shelf stability against limited host-cell remodeling — the graft acts as a biologic scaffold for fibrous incorporation rather than a regeneration template.[2] Rat-model tunical-substitution work confirms acceptable biocompatibility for Peyronie's grafting.[7]

Tutoplast Pericardium — Peyronie's Disease​

Tutoplast pericardium has the longest off-the-shelf track record of any cadaveric graft for Peyronie's plaque incision / partial excision and grafting.[8][9]

Key series:

StudynFollow-upOutcomes
Hellstrom & Reddy 2000[1]11Mean 14 mo100% curvature resolution; no rejection / infection
Egydio 2002[10]336–24 moStraightening 91%; preserved erections 88%; geometric incision technique anchored on this graft
Hatzichristou 2002[11]28Mean 21 moStraightening 79%; satisfaction 75%
Levine & Estrada 2003[12]40Mean 22 mo98% straightening; 95% coitus; 70% full unaided erections; 30% required PDE5i for de novo ED; no graft-related AEs
Usta 2004[13]40Mean 30 moCorrection 87.5%; de novo ED 17.5%
Egydio 2008[14]100Mean 47 moStraightening 95%; preserved erection 89%; durable at 4 yr
Taylor & Levine 2008[15]81Mean 58 mo (range 6–185)Long-term Levine series; 91% reported curvature resolution / functional improvement at survey; durable beyond 5 yr
Pathak 2020[16]2812 moStraightening 86%; mean curvature 65° → 7°; 21% de novo ED

Direct head-to-head — Tutoplast pericardium vs dermal vs SIS (Kovac & Brock 2007):[17]

GraftStraighteningLength preservationRigidity preservation
Tutoplast pericardium100%23%39%
Dermal graft60%——
Stratasis (porcine SIS)77%54%77%

The Kovac data highlight Tutoplast pericardium's superior straightening but inferior length / rigidity preservation — a consequence of the graft's relative non-elasticity and propensity to perigraft fibrosis.

Comparative context — Natsos 2024 systematic review and meta-analysis of grafts for Peyronie's:[18]

  • Buccal mucosa graft (BMG) — highest straightening rate, lowest de novo ED.
  • TachoSil collagen fleece — best overall when preoperative curvature severity is weighted in.
  • Tutoplast cadaveric pericardium — durable straightening but higher incidence of postoperative ED than BMG or saphenous vein.

Proposed ED mechanisms with Tutoplast pericardium: cavernosal venous leak from the non-elastic graft, perigraft fibrosis with veno-occlusive dysfunction, and patient-selection bias toward severe curvatures requiring large grafts.[13][16][17][18]

A related modified Horton-Devine series compared dermal and cadaveric pericardial grafts directly, with comparable straightening outcomes but distinct ED profiles.[19]

Tutoplast Pericardium — Complex Penile-Prosthesis Corporoplasty​

Tutoplast pericardium has been used as a corporoplasty patch during IPP / MPP implantation in cases of:[20][21][22]

  • Severe corporal fibrosis (post-priapism, post-infection, post-explant).
  • Prosthesis erosion with tunical-body damage.
  • Deficient or perforated corporal tissue.
  • Concurrent Peyronie's disease with plaque incision at the same operation.

Palese & Burnett 2001 described the technique using Tutoplast pericardium for corporoplasty during complex IPP surgery, noting lower infection risk, easy handling, no donor-site morbidity, and adequate tensile strength to withstand intracorporeal pressures compared with synthetic alternatives.[20]

Farrell 2019 compared pericardium allografts (PA, including Tutoplast / Coloplast pericardium) with hemostatic patches (TachoSil, Evarrest, Nu-Knit) for complex Peyronie's with simultaneous prosthesis placement and plaque incision. At median 34.6 mo for PA:[23]

  • Residual curvature > 20° in only 13.3%.
  • 93.3% engaged in penetrative intercourse.
  • No prosthesis herniation through the tunical defect.
  • No graft-attributable complications.
  • Operative time significantly longer with PA (166 vs 122 min, p = 0.01).

In Martínez-Salamanca's review of prosthesis surgery in corporal fibrosis, off-the-shelf allograft pericardium remains a workhorse for tunical defects encountered during difficult dilation or salvage cases.[21][22]

Tutoplast Fascia Lata — Pubovaginal Sling (SUI)​

Tutoplast fascia lata, marketed as Suspend® Tutoplast Fascia Lata (Mentor Corp), was widely used as an allograft PVS alternative to autologous rectus fascia or autologous fascia lata, eliminating the donor-site incision.[24][25][26][27]

Short-Term Outcomes (≤ 2 yr)​

Studyn / designFollow-upResult
Wright 1998[24]59 allograft vs 33 autograftMean 11.5 moEqually high success; no infection / erosion; shorter OR time and LOS with allograft
Flynn 2002[25]63 allograft vs 71 autograft≥ 2 yrCure 71% vs 77% (p = 0.42); recurrent SUI 13% vs 10% (p = 0.58); significantly less postoperative pain with allograft
Amundsen 2000[26]104 freeze-dried allograft fascia lata, single-bankShort-termAcceptable early continence outcomes
Almeida 2004[27]Cadaveric allograft PVSShort-termReduced OR time and LOS vs autograft

Long-Term Outcomes — The Durability Signal​

StudyComparisonFinding
McBride 2005[28]32 Suspend Tutoplast vs 39 autologous fascia lata, ≥ 2 yrUrodynamic SUI recurred in 41.7% of Tutoplast pts vs 0% autograft (p = 0.007); subjective QoL was similar
Howden 2006[29]Autologous rectus fascia vs cadaveric fasciaCadaveric: regular leakage 39.6% vs 28.3% (p = 0.04); reoperation for SUI 12.7% vs 3.3% (p = 0.003); 3–4× higher failure per women-year
FitzGerald 2000[30]Freeze-dried cadaveric fascia20% graft disintegration on re-exploration; 37% objective failure at 12 mo
Brown 2000[31]Cadaveric fasciaHigh failure at 12 mo prompted abandonment in some centers
Soergel 2001[32]Tutoplast solvent-dehydratedLower disintegration than freeze-dried; outcomes closer to autologous

The McBride and Howden data are the critical durability signal: cadaveric fascia lata slings — including the solvent-dehydrated Tutoplast preparation — show substantially worse long-term continence outcomes than autologous fascia, likely from progressive graft degradation and resorption. Most centers have since reverted to autologous fascia (rectus or fascia lata) or synthetic mid-urethral mesh for SUI surgery.[29][33][34]

Tutoplast Fascia Lata — Peyronie's Disease​

Kalsi 2006 reported the largest dedicated Tutoplast-fascia-lata Peyronie's series — n = 14, plaque-incision-and-grafting:[35]

  • Complete straightening 11/14 (79%).
  • Patient satisfaction 13/14 (93%).
  • De novo ED in 1 patient (7%).
  • 4 patients reported penile shortening > 1 cm.
  • No graft retraction, infection, or rejection.

The de novo ED rate (7%) is lower than the Tutoplast pericardium pooled estimate (17–30%) in the same era — though small numbers limit conclusions and the comparison is not randomized.

Pelvic Organ Prolapse — Sacrocolpopexy​

Tutoplast fascia lata has been evaluated as an alternative to polypropylene mesh for abdominal / laparoscopic sacrocolpopexy in vaginal-vault prolapse.[36][37]

Loffeld 2009 — 19 Tutoplast vs 20 Prolene mesh, mean 45-mo follow-up:[36]

  • Risk of reintervention for recurrent prolapse 2.9× higher with Tutoplast (RR 2.9, 95% CI 0.9–9.5).
  • Prolene group significantly more satisfied with operative result.

Cochrane review (Maher 2016) of apical-prolapse surgery includes Culligan 2005 (polypropylene vs Tutoplast cadaveric fascia lata for sacrocolpopexy); biologic-graft evidence for vaginal-prolapse repair remains limited and is no longer central to the contemporary algorithm.[37] ACOG and AUGS positioning: biologic grafts for vaginal POP repair show similar outcomes to native-tissue repair without the durability advantage of synthetic mesh; most studied biologic grafts (including Tutoplast fascia lata for POP) are no longer commercially available.[38]

Venous Reconstruction​

A small case series (Coleman 2014, n = 7) used bovine pericardium (a Tutoplast-related but distinct xenogeneic product) for complex urologic venous reconstruction — IVC patching, iliac venous patching, left renal vein replacement, renal autotransplantation. No venous thrombosis at mean 14.8 mo.[39] Human-tissue Tutoplast pericardium has not been systematically studied in venous reconstruction. See Bovine-Derived Grafts for the broader bovine-pericardium venous-reconstruction discussion.

Indications & Positioning​

When Tutoplast-processed grafts make sense:

  • Patient declines an autologous donor-site incision (cosmetic concern, prior abdominal surgery, BMI).
  • Re-do Peyronie's grafting where autologous tissue is exhausted.
  • Long graft requirement (eg circumferential or bilateral plaque) where autologous yield is insufficient.
  • Complex IPP corporoplasty for fibrotic / perforated / eroded corpora.
  • Off-the-shelf availability needed (no preoperative harvest planning).

When to choose otherwise:

  • BMG remains the contemporary graft of choice for Peyronie's where straightening and ED-preservation are jointly prioritized.[18]
  • Autologous rectus fascia remains the gold-standard PVS material for female SUI; cadaveric slings (including Tutoplast) are not first-line based on McBride and Howden long-term data.[28][29][33]
  • For male SUI / continence devices, synthetic slings (AdVance) and the AMS 800 AUS are the modern mainstays; cadaveric fascia has no current male-SUI role.
  • For abdominal sacrocolpopexy, polypropylene mesh remains the standard based on Loffeld and contemporary registries.[36][37]

Advantages​

  • No donor-site morbidity — eliminates the second surgical incision for autologous harvest.[1][24][35]
  • Off-the-shelf availability — room-temperature storage, long shelf life, no special preparation beyond saline rehydration.
  • Reduced operative time — shorter procedures vs autologous-harvest cases.[24][25]
  • Low immunogenicity — processing removes cellular components; HLA-negative scaffold.
  • Adequate tensile strength — withstands intracorporeal pressures in penile surgery.[20]
  • Pliability — pericardium conforms well to irregular tunical defects.[1][19]

Limitations​

  • Long-term graft degradation — most significant concern for load-bearing applications (PVS, sacrocolpopexy).[28][29][36]
  • Higher de novo ED in Peyronie's grafting vs BMG and TachoSil.[17][18]
  • Inferior length and rigidity preservation vs Stratasis (SIS) in head-to-head Peyronie's data.[17]
  • Cost — commercially processed allograft is more expensive than autologous tissue (partly offset by shorter OR).[27]
  • Commercial availability has narrowed — multiple Tutoplast-branded products discontinued or off-market during the Mentor → Coloplast / RTI → Surgalign corporate transitions; PVS and POP indications largely abandoned.

Safety & Regulatory Status​

  • Disease transmission: no confirmed cases of viral or prion transmission attributable to Tutoplast processing in any indication; AATB tissue-banking standards apply.[4][5][6]
  • Immunogenicity: clinical antigenic reactions are exceedingly rare; preserved collagen scaffold integrates as a fibrous template.
  • Manufacturer history: Biodynamics → Tutogen → Mentor → Coloplast → RTI Biologics → RTI Surgical → Surgalign Holdings (2020); product availability has varied by region.

Current Status​

  • SUI slings: largely replaced by autologous fascia or synthetic mid-urethral slings; cadaveric Tutoplast fascia lata not first-line.[29][33][34]
  • Prolapse repair: synthetic mesh for abdominal sacrocolpopexy or native-tissue repair preferred; Tutoplast cadaveric fascia lata not routine.[36][37]
  • Peyronie's disease: Tutoplast pericardium remains a viable off-the-shelf option for plaque incision and grafting, though TachoSil, BMG, and porcine SIS are increasingly preferred. Pericardium allografts continue to play a role in complex Peyronie's with simultaneous prosthesis placement.[18][23]
  • Complex IPP corporoplasty: Tutoplast pericardium remains an accepted scaffold for tunical defects encountered during difficult dilation, prior-erosion salvage, or fibrotic corpora.[20][21][22]

Comparative Summary​

PropertyTutoplast PericardiumTutoplast Fascia LataAutologous Fascia LataBMG (Peyronie's)
Donor siteNoneNoneThighCheek
Shelf storageRoom tempRoom tempn/an/a
OR time savedYesYesNo (additional 30–45 min)No (additional 30 min)
Peyronie's straightening79–100%~ 79% (small series)Comparable~ 90%+
De novo ED (Peyronie's)17–30%~ 7%LowerLowest
Sling durability (female SUI)n/aPoor long-term (USI recurrence 41.7%)Excellentn/a
Sacrocolpopexy durabilityn/aInferior to Prolene (2.9× reintervention)n/an/a
Complex IPP corporoplastyEstablished off-the-shelf optionLimited dataPossiblen/a

References​

1. Hellstrom WJ, Reddy S. "Application of pericardial graft in the surgical management of Peyronie's disease." J Urol. 2000;163(5):1445–7.

2. Lemer ML, Chaikin DC, Blaivas JG. "Tissue strength analysis of autologous and cadaveric allografts for the pubovaginal sling." Neurourol Urodyn. 1999;18(5):497–503. doi:10.1002/(sici)1520-6777(1999)18:5<497::aid-nau12>3.0.co;2-1

3. Khoshnoodi P, Wesson MC, Albo M. "Cadaveric tissue and tissue processing." Curr Urol Rep. 2008;9(5):362–9. doi:10.1007/s11934-008-0064-6

4. Moore MA, McIlroy BK, Phillips RE. "Nonaldehyde sterilization of biologic tissue for use in implantable medical devices." ASAIO J. 1997;43(1):23–30.

5. Vangsness CT, Wagner PP, Moore TM, Roberts MR. "Overview of safety issues concerning the preparation and processing of soft-tissue allografts." Arthroscopy. 2006;22(12):1351–8. doi:10.1016/j.arthro.2006.10.009

6. Grieb TA, Forng RY, Bogdansky S, et al. "High-dose gamma irradiation for soft tissue allografts: high margin of safety with biomechanical integrity." J Orthop Res. 2006;24(5):1011–8. doi:10.1002/jor.20079

7. Leungwattanakij S, Bivalacqua TJ, Caulfield JJ, Hellstrom WJ. "Evaluation of cadaveric pericardium in the rat for the surgical treatment of Peyronie's disease." Urology. 2000;56(6):1075–80. doi:10.1016/s0090-4295(00)00820-7

8. Egydio PH. "Surgical treatment of Peyronie's disease: choosing the best approach to improve patient satisfaction." Asian J Androl. 2008;10(1):158–66. doi:10.1111/j.1745-7262.2008.00374.x

9. Levine LA, Burnett AL. "Standard operating procedures for Peyronie's disease." J Sex Med. 2013;10(1):230–44. doi:10.1111/j.1743-6109.2012.03003.x

10. Egydio PH, Lucon AM, Arap S. "A single relaxing incision to correct different types of penile curvature: surgical technique based on geometrical principles." BJU Int. 2002;90(9):945–7. doi:10.1046/j.1464-410x.2002.03056.x

11. Hatzichristou DG, Hatzimouratidis K, Apostolidis A, Tzortzis V, Bekos A, Ioannidis E. "Corporoplasty using Tutoplast human pericardium allograft for the surgical correction of Peyronie's disease." J Urol. 2002;167(2 Pt 1):673–7. doi:10.1016/S0022-5347(01)69121-9

12. Levine LA, Estrada CR. "Human cadaveric pericardial graft for the surgical correction of Peyronie's disease." J Urol. 2003;170(6 Pt 1):2359–62. doi:10.1097/01.ju.0000091102.10849.95

13. Usta MF, Bivalacqua TJ, Sanabria J, Koksal IT, Moparty K, Hellstrom WJ. "Patient and partner satisfaction and long-term results after surgical treatment for Peyronie's disease." Urology. 2003;62(1):105–9. doi:10.1016/s0090-4295(03)00244-9

14. Egydio PH, Sansalone S. "Penile extender device and choice of grafts in Peyronie's disease." Transl Androl Urol. 2013;2(1):14–7. doi:10.3978/j.issn.2223-4683.2013.01.06

15. Taylor FL, Levine LA. "Surgical correction of Peyronie's disease via tunica albuginea plication or partial plaque excision with pericardial graft: long-term follow up." J Sex Med. 2008;5(9):2221–8. doi:10.1111/j.1743-6109.2008.00941.x

16. Pathak RA, Broderick GA. "Peyronie's disease: a review of management." Transl Androl Urol. 2020;9(Suppl 2):S252–61.

17. Kovac JR, Brock GB. "Surgical outcomes and patient satisfaction after dermal, pericardial, and small intestinal submucosal grafting for Peyronie's disease." J Sex Med. 2007;4(5):1500–8. doi:10.1111/j.1743-6109.2007.00453.x

18. Natsos AN, Tatanis V, Kontogiannis S, et al. "Grafts in Peyronie's surgery without the use of prostheses: a systematic review and meta-analysis." Asian J Androl. 2024;26(3):250–9. doi:10.4103/aja202358

19. Chun JL, McGregor A, Krishnan R, Carson CC. "A comparison of dermal and cadaveric pericardial grafts in the modified Horton-Devine procedure for Peyronie's disease." J Urol. 2001;166(1):185–8.

20. Palese MA, Burnett AL. "Corporoplasty using pericardium allograft (Tutoplast) with complex penile prosthesis surgery." Urology. 2001;58(6):1049–52. doi:10.1016/s0090-4295(01)01410-8

21. Martínez-Salamanca JI, Mueller A, Moncada I, Carballido J, Mulhall JP. "Penile prosthesis surgery in patients with corporal fibrosis: a state of the art review." J Sex Med. 2011;8(7):1880–9. doi:10.1111/j.1743-6109.2011.02281.x

22. Lee Z, Shen J, Wessells H. "Complex penile surgery: plication, grafting, and implants." Urol Clin North Am. 2022;49(3):419–35. doi:10.1016/j.ucl.2022.04.006

23. Farrell MR, Abdelsayed GA, Ziegelmann MJ, Levine LA. "A comparison of hemostatic patches versus pericardium allograft for the treatment of complex Peyronie's disease with penile prosthesis and plaque incision." Urology. 2019;129:113–8. doi:10.1016/j.urology.2019.03.008

24. Wright EJ, Iselin CE, Carr LK, Webster GD. "Pubovaginal sling using cadaveric allograft fascia for the treatment of intrinsic sphincter deficiency." J Urol. 1998;160(3 Pt 1):759–62. doi:10.1016/S0022-5347(01)62779-4

25. Flynn BJ, Yap WT. "Pubovaginal sling using allograft fascia lata versus autograft fascia for all types of stress urinary incontinence: 2-year minimum followup." J Urol. 2002;167(2 Pt 1):608–12. doi:10.1016/S0022-5347(01)69095-5

26. Amundsen CL, Visco AG, Ruiz H, Webster GD. "Outcome in 104 pubovaginal slings using freeze-dried allograft fascia lata from a single tissue bank." Urology. 2000;56(6 Suppl 1):2–8. doi:10.1016/s0090-4295(00)00673-7

27. Almeida SH, Gregório E, Grando JP, et al. "Pubovaginal sling using cadaveric allograft fascia for the treatment of female urinary incontinence." Transplant Proc. 2004;36(4):995–6. doi:10.1016/j.transproceed.2004.03.058

28. McBride AW, Ellerkmann RM, Bent AE, Melick CF. "Comparison of long-term outcomes of autologous fascia lata slings with Suspend Tutoplast fascia lata allograft slings for stress incontinence." Am J Obstet Gynecol. 2005;192(5):1677–81. doi:10.1016/j.ajog.2005.01.078

29. Howden NS, Zyczynski HM, Moalli PA, et al. "Comparison of autologous rectus fascia and cadaveric fascia in pubovaginal sling continence outcomes." Am J Obstet Gynecol. 2006;194(5):1444–9. doi:10.1016/j.ajog.2006.01.058

30. FitzGerald MP, Mollenhauer J, Brubaker L. "The fate of rectus fascia suburethral slings." Am J Obstet Gynecol. 2000;183(4):964–6. doi:10.1067/mob.2000.106857

31. Brown SL, Govier FE. "Cadaveric versus autologous fascia lata for the pubovaginal sling: surgical outcome and patient satisfaction." J Urol. 2000;164(5):1633–7. doi:10.1016/S0022-5347(05)67043-4

32. Soergel TM, Shott S, Heit M. "Poor surgical outcomes after fascia lata allograft slings." Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(4):247–53. doi:10.1007/s001920170047

33. Wu JM. "Stress incontinence in women." N Engl J Med. 2021;384(25):2428–36. doi:10.1056/NEJMcp1914037

34. Chen YA, Jean-Michel M. "Resurgence of autologous fascial slings in a challenging climate for sling surgery: a 20-year review of comparative data." Obstet Gynecol Surv. 2022;77(11):696–706. doi:10.1097/OGX.0000000000001072

35. Kalsi JS, Christopher N, Ralph DJ, Minhas S. "Plaque incision and fascia lata grafting in the surgical management of Peyronie's disease." BJU Int. 2006;98(1):110–4. doi:10.1111/j.1464-410X.2006.06251.x

36. Loffeld CJ, Thijs S, Mol BW, Bongers MY, Roovers JP. "Laparoscopic sacrocolpopexy: a comparison of Prolene and Tutoplast mesh." Acta Obstet Gynecol Scand. 2009;88(7):826–30. doi:10.1080/00016340902883158

37. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. "Surgery for women with apical vaginal prolapse." Cochrane Database Syst Rev. 2016;10:CD012376. doi:10.1002/14651858.CD012376

38. Committee on Practice Bulletins—Gynecology and American Urogynecologic Society. "Pelvic organ prolapse: ACOG Practice Bulletin, Number 214." Obstet Gynecol. 2019;134(5):e126–42. doi:10.1097/AOG.0000000000003519

39. Coleman S, Kerr H, Krishnamurthi V, et al. "The use of bovine pericardium for complex urologic venous reconstruction." Urology. 2014;83(2):495–7. doi:10.1016/j.urology.2013.10.011