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Tutoplast-Processed Allografts

Tutoplast is a tissue-processing method, not a single graft. This page concerns donated human pericardium, fascia lata and dermis. Tissue source, processing and operation matter: outcomes with bovine pericardium, autologous fascia, freeze-dried cadaveric fascia and solvent-dehydrated Tutoplast fascia cannot be combined as if they describe one implant.[1][2][3]

Coloplast currently lists Tutoplast pericardium, Suspend fascia lata and Axis dermis. Its February 2026 Axis/Suspend safety statement includes supplemental suburethral support for SUI and pelvic-floor fascial reinforcement for POP. These are 361 human cell and tissue products restricted to homologous use; availability and this regulatory category do not establish superiority over another operation or material.[1][2]

Related materials: Autologous Fascia Lata, Bovine-Derived Grafts, and Human Acellular Dermal Matrix.

Preparation and safety​

The currently linked Tutoplast pericardium IFU, DOC 5052 R3 dated June 29, 2018, describes solvent dehydration and terminal low-dose gamma irradiation to a sterility assurance level of 10⁻⁶. It does not provide a universal irradiation dose for all Tutoplast products.[3]

For that pericardium product, soak in room-temperature sterile saline for up to 30 minutes to improve handling. Use it under minor to moderate tension, place stitches 2–3 mm from the edge, and select long-lasting material if using absorbable sutures. It is for one patient on one occasion, without resterilization. Inspect packaging, expiration and labeling, and complete the tissue-utilization record for traceability. A two-minute soak advertised for Axis/Suspend is not the preparation instruction for every Tutoplast graft.[2][3]

Processing and donor screening reduce infectious risk but do not eliminate it. The label warns about potential disease transmission, localized immunological reactions, trace processing chemicals, active infection and poor perfusion. Host response determines incorporation. Do not promise a DNA-free implant, zero prion risk, no inflammatory reaction or assured replacement by functional native tissue.[1][2][3]

Peyronie's grafting​

Pericardium is an available option for tunical reconstruction in appropriately selected patients, but current EAU guidance identifies no best graft material. An off-the-shelf graft avoids tissue harvest; it does not remove the operation's risks of erectile dysfunction, sensory change, recurrent curvature or shortening. Baseline erectile function, deformity and the extent of tunical incision or excision must guide counseling.[4]

A useful long-term cohort is Taylor and Levine's 81 men receiving partial plaque excision and Tutoplast pericardial grafting, followed for an average of 58 months. At survey, 91% reported residual curvature below 30°—not necessarily a completely straight penis. Rigidity was unchanged or better in 68%; 79% could have intercourse with or without a PDE5 inhibitor, and 75% were satisfied. Treatment was selected by a clinical algorithm, not randomized against plication or another graft.[5]

For Tutoplast fascia lata, a separate 14-man series reported 11 completely straight penises, one new case of erectile dysfunction and four men reporting shortening greater than 1 cm at a mean 31 months. This cannot establish lower erectile-dysfunction risk than pericardium from a different cohort.[6]

Small retrospective comparisons and pooled single-arm graft series differ in baseline erectile function, curvature, surgical technique and follow-up. They do not justify a ranking of buccal mucosa, TachoSil, SIS and pericardium, or a mechanistic claim that one material causes the observed erectile-function difference. See the Peyronie's Disease surgical atlas.[4][7]

Corporoplasty with a penile prosthesis​

Pericardium can cover selected tunical defects during complex prosthesis surgery. In Farrell 2019, 15 men receiving pericardium were compared retrospectively with 18 receiving hemostatic patches: ten Evarrest, six Nu-Knit and only two TachoSil. Median follow-up was 34.6 months for pericardium versus 6.6 months for patches. Operative time was shorter in the pooled patch group, and no material-attributable complications or prosthesis herniations were reported in either group.[8]

This was not a TachoSil randomized trial, and its small groups with unequal surveillance do not establish equivalent durability or lower infection risk. Defect closure, infection management and prosthesis selection remain operation-specific decisions.

Pubovaginal slings​

Allograft fascia avoids a harvest incision, but continence durability has been inconsistent. Results also depend on the particular tissue-bank preparation; freeze-dried fascia studies are not automatically Tutoplast studies.

In the McBride comparison, 71 women originally received autologous fascia lata (39) or Suspend Tutoplast fascia lata (32), but only 47 underwent objective and/or subjective follow-up after at least two years. Urodynamic stress incontinence was detected in 41.7% of the assessed allograft group versus none in the assessed autograft group; subjective outcomes did not show the same difference. The 41.7% estimate should not be applied to all 32 originally treated women.[9]

A separate 303-woman observational cohort reported more reoperations for SUI with cadaveric than autologous fascia (12.7% versus 3.3%), with a difference persisting after accounting for follow-up duration. This is a broader cadaveric-fascia comparison, not a randomized estimate for every current Suspend product.[10]

The AUA/SUFU surgical options for an index patient include synthetic midurethral sling, autologous fascia pubovaginal sling, Burch colposuspension and bulking agents. Cadaveric graft availability should not be interpreted as guideline endorsement of equivalent long-term continence.[11]

Prolapse support​

Keep abdominal sacrocolpopexy evidence separate from vaginal graft augmentation. The Culligan 2005 randomized study enrolled 100 women with posthysterectomy vault prolapse. Four assigned fascia received polypropylene because of a supply shortage; the published outcome groups followed the received material. Among 89 one-year attendees, objective success was 41/45 with mesh and 30/44 with Suspend fascia. Failure was any postoperative POP-Q stage 2 or greater; failures were anterior or posterior, with no apical point-C failures. Subjective outcomes were not reported in that paper, and the trial was too small to establish comparative safety.[12]

At five years, only 58 women returned, 29 per group. Objective success was 27/29 with mesh and 18/29 with fascia; clinical success using a definition incorporating symptoms was 28/29 and 26/29, respectively, without a statistically significant difference. Attrition and the different outcome definitions matter.[13]

These findings support concern about anatomical durability of that fascia preparation in sacrocolpopexy. They do not prove that all human allografts are ineffective, that synthetic mesh is risk-free, or that the same estimates apply to vaginal prolapse repair. Current Axis/Suspend labeling and individualized procedural evidence should be assessed separately.[2]

References​

  1. Coloplast. Tutoplast Pericardium Allograft: current product listing and brief safety statement. Manufacturer page.
  1. Coloplast. Axis Dermis and Suspend Fascia Lata Tutoplast Processed Allografts. Brief statement PM-11535, February 2026. Manufacturer page.
  1. RTI Surgical / Coloplast. Tutoplast Processed Pericardium: instructions for use, DOC 5052 R3, June 29, 2018; version currently linked by manufacturer. Full IFU.
  1. European Association of Urology. Sexual and Reproductive Health Guidelines, 2026: Penile Curvature, surgical treatment and graft materials. Guideline chapter.
  1. 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
  1. 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
  1. 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
  1. 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
  1. 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
  1. 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
  1. Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline (2023). Journal of Urology. 2023;209:1091–1098. doi:10.1097/JU.0000000000003435.
  1. Culligan PJ, Blackwell L, Goldsmith LJ, et al. A randomized controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy. Obstetrics & Gynecology. 2005;106:29–37. doi:10.1097/01.AOG.0000165824.62167.c1.
  1. Tate SB, Blackwell L, Lorenz DJ, Steptoe MM, Culligan PJ. Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up. International Urogynecology Journal. 2011;22:137–143. doi:10.1007/s00192-010-1249-3.