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Banked cadaveric fascia lata: 3-year follow-up

2004, Transplantation Proceedings

Autologous fascial and synthetic materials have been widely used to repair the stress form of urinary incontinence (SUI) as well as pelvic floor prolapse. The safety and long-term durability of cadaveric fascia lata in orthopedic and ophthalmologic surgery have encouraged urogynecologists to use this material for a sling material. The rationale of placement of a sling from cadaveric fascia lata

Banked Cadaveric Fascia Lata: 3-Year Follow-up S.H.M. Almeida, E.P. Gregório, M.A.F. Rodrigues, J.P.S. Grando, H.A. Moreira, and F.C. Fraga ABSTRACT Autologous fascial and synthetic materials have been widely used to repair the stress form of urinary incontinence (SUI) as well as pelvic floor prolapse. The safety and long-term durability of cadaveric fascia lata in orthopedic and ophthalmologic surgery have encouraged urogynecologists to use this material for a sling material. The rationale of placement of a sling from cadaveric fascia lata is based upon decreasing the complication rates caused by autologous and synthetic materials. However, the high costs of the commercially available tissues in Brazil have limited its use in public health. In our institution we developed a cadaveric fascia lata bank, harvesting the material according to the Brazilian Transplantation Legislation and storing it at ⫺70°C. The safety of the tissue is achieved by 25-kGy irradiation. Since 1999, 30 patients have undergone surgery using material from five donors in repairs for stress urinary incontinence and pelvic floor prolapse at a mean of 34 months’ follow-up (ranging from 30 to 40 months), there was no evidence of rejection. Therefore, we have shown the safety of cadaveric fascia lata harvested and treated as described above in our group of patients. S TRESS URINARY INCONTINENCE (SUI) and pelvic floor prolapse have been frequently repaired using autologous fascia and synthetic materials. Each type of material has drawbacks. Synthetic fascia shows a high incidence of infection and urethral erosion, while the choice of autologous fascia requires longer operating times and higher complication rates as a result of the abdominal incision.1 The safety and long-term durability of cadaveric fascia lata in orthopedic and ophthalmologic surgery has encouraged urogynecologists to choose it as sling material since 1990. This source has advantages over the other materials currently used in Brazil, but the important limitation for its use in public health is the high cost of the commercial lata. Since 1999, we have performed surgical repair of SUI and pelvic floor prolapses using lata from a cadaveric fascia lata bank. The aim of the present study is to describe the organization and methods of a cadaveric fascia lata bank as well as the 3-year results using this material. gamma irradiation (25 kGy) was performed to sterilize the allograft. The strings were used in women for stress urinary incontinence and pelvic floor prolapse repairs. Culture tests for bacteria and fungi were performed after procurement and before transplantation. Intraoperatively, the grafts were soaked in antibiotic solution for 30 minutes. RESULTS Thirty patients underwent fascia lata procedures for stress urinary incontinence and pelvic floor prolapse repairs from five cadaveric donors. At a mean of 34 months’ follow-up (ranging from 30 to 40 months), there have not been any complications, including rejection or wound infection. One patient experienced severe vaginal candidiasis on the 12th day after a pelvic floor prolapse repair, which was successfully managed with topical treatment. Another three patients refused surgery using this tissue because of religious issues. During the follow-up, 66.6% of patients reported improvement or cure with the surgery. MATERIALS AND METHODS CFL harvesting follows the Brazilian Transplantation Legislation. All patients included in this study were informed about the procedure and an individual consent form was signed. The fascia lata was obtained right after retrieval of the solid organs, while the donor was still in the operating room. The technique for retrieval obtained the iliotibial tract, which is the thickest part of the fascia lata. The tissue was frozen at ⫺70°C. Hours before the surgery, © 2004 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 36, 993–994 (2004) From the Department of Surgery, Division of Urology, Londrina State University, Londrina, Paraná, Brazil. This work was supported by resources of the Surgery Department. Address reprint requests to Sı́lvio Henrique Maia de Almeida, Av Bandeirantes 460, Londrina, Paraná, Brasil, Cep 86010-020. E-mail: salmeida@sercomtel.com.br 0041-1345/04/$–see front matter doi:10.1016/j.transproceed.2004.03.055 993 994 DISCUSSION The use of cadaveric fascia lata in urogynecology is aimed at decreasing morbidity and costs to patients, at the same time presenting comparable results with regard to initial continence and urinary retention.2 Nevertheless, despite those advantages, there is no standard procedure for processing and storing fascia lata.3 Musculoskeletal strings are frozen and dehydrated for preservation purposes. Some tissue banks use lyophilization, which allows them to be stored at room temperature. When properly used, all processing techniques are equally effective at maintaining the biomechanical properties of fascia lata.3 The absence of infection in our patients demonstrates that treating the tissue with gamma irradiation is safe; sterilization with ethylene oxide is also possible.4 Perhaps the most important question regarding the use of allograft fascia lata is, the potential for disease transmission. Recently, DNA segments were discovered in two commercial sources of human allografts in the United States, including irradiated cadaveric fascia lata. Nevertheless, whether such DNAs are able to transmit diseases is unknown.5 The only case of HIV transmission from a sero-negative ALMEIDA, GREGÓRIO, RODRIGUES ET AL. donor reported in the literature occurred in 1985. The solid tissue recipients acquired the virus, but the musculoskeletal tissue recipients remained free of infection.6 The risk of acquiring HIV from allotransplants in a properly screened donor is lower than through blood transfusion.4 Although the risks are low, a full explanation should be given to the patients to obtain informed consent. The use of gamma-irradiated cadaveric fascia lata from a tissue bank appears to be safe with regard to rejection and wound infection. The organization to harvest fascia lata from cadaveric donors is effective, representing an option for medical centers that are already working with other allograft tissues. REFERENCES 1. Wright JE, Iselin CE, Carr LK: J Urol 160:759, 1998 2. Lemer ML, Chaikin DC, Blaivas JG: Neurourol and Urod 18:497, 1999 3. Singla AK: Contemp Urology 12:51, 2000 4. Buck BE, Malinin TI, Brown MD: Clin Orthop 240:129, 1989 5. Sadhukhan P, Rackley RR, Bandyopadhyay S, et al: J Urol 161(4 Suppl):79, 1999 (Abstract 396) 6. Simonds RJ, Holmberg SD, Hurwitz RL, et al: N Engl J Med 326:726, 1992