Urology – BioSure Fascia Lata
Discover how advanced biologic materials can elevate clinical outcomes. This section helps you make informed choices with confidence, highlighting the science behind materials that deliver reliable results. Compare autologous and allograft sources to see how each one supports healing and explore the difference between decellularization and sterilization techniques that ensure safety while preserving regenerative potential.
BioSure Fascia Lata is restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue by a qualified healthcare professional (i.e., physician). This includes supplemental support and reinforcement of soft tissue and grafting for horizontal and vertical soft tissue augmentation of thickness and length. The implant is provided sterile and requires rehydration prior to use.
BioSure Fascia Lata Is Compliant with the Requirements Establishes by the FDA For Human Tissue Product: CFR 21 1270 and CFR 21 1271
Natural Integration
The use of biological material has significantly improved graft integration with host tissue.
Minimal Inflammation
It has also minimized subsequent inflammatory host response after implantation.
Material Options
There are two subcategories: Autograft and Allograft Material.
Surgical Cases
Autologous vs. Allograft Tissues
Autografts
Allografts
Pros
- Risk of rejection is minimal.
- Easy acceptance of the graft at the host site.
Cons
- Donor-site morbidity.
- Post-operative pain of several months.
- Cosmetic concerns regarding scar formation.
- More complex anesthesia and surgery time.
Pros
- Risk of rejection is minimal compared to synthetic material.
- No donor-site morbidity.
- No discomfort associated with harvesting the autograft.
- Less surgery time, no double surgeries.
Cons
- Processing and sterilization conditions to reduce risk of rejection.
- Mechanical properties are slightly lower.
Comparison of Allograft Materials
Dermal
Fascia Lata
Pros
- Highly dense due to collagen fibers and bundles. This results in acceptable tensile strength and mechanical properties.
- Dermal allografts have good flexibility. However, studies have shown that tensile strength and mechanical properties significantly reduce over time, failing to provide long-term support to the pelvic organs.
Cons
- Compared to other allografts materials, dermal allografts are almost non-porous due to the high density of collagen fibers. This does not always allow for an optimum host cell integration.
- Poor tissue union.
Pros
- Fascia lata is more porous than dermal tissue, which allows for good tissue integration and good tissue union.
- Fascia lata has shown the highest and most optimal tensile strength with:
- Fascia lata: 217 N
- Human Dermis: 122 N
- Others: 42 N
- Long-term stability with its mechanical properties. All from allograft tissue.
Cons
- It is not as flexible as dermal allografts.
Why Does Fascia Lata Tissue Outperform Dermal Tissue?
- Biomechanical Advantages
- Fascia lata is a collagen-rich strap designed to resist tensile load.
- Unlike dermis, it does not rely heavily on elastin networks for strength.
- Even after processing, fascia lata maintains its mechanical integrity, providing long-term durability under chronic pelvic loads.
- Dermis Limitations
- Dermis contains both collagen and an elastic fiber network. However, human studies show that elastin deteriorates with age: fibers fragment, shorten, and fibroblasts produce less tropoelastin.
- Tissue banks commonly source dermis from older donors, meaning grafts arrive with a pre-degraded elastin structure.
- Processing methods—solvent dehydration, detergents, and gamma irradiation—further compromise collagen ultrastructure and elasticity.
- Clinically, dermal matrices perform well for reinforcement or coverage, but struggle under constant tension, leading to stretch, laxity, and recurrence over time.
- Clinical Evidence
- Fascia lata slings used in stress urinary incontinence demonstrate long-term continence and low complication rates.
- Dermis grafts used in pelvic organ prolapse show safety and patient-reported improvement, but objective measures reveal laxity accumulation with time.
- Processing Matters
Decellularization and Sterilization Technique
BioSure Fascia Lata is a lyophilized sheet processed with the highest quality, and aseptic control standards to ensure minimal or no debris, thus removing organic material (lipids, blood) rendering any microorganisms inactive or nonexistent.
BioSure Fascia Lata
- Longer shelf life for the graft.
- Better cell adhesion and, therefore, tissue integration once implanted in the host.
- Preservation of tissue tensile strength since scCO2 does not modify the structure of the tissue
Step 1: Decellularization
Step 2: Sterilization
Step 3: Outcome
Better dehydration of the tissue for longer shelf life of the graft.
Decellularization and sterilization through scCO2 allows an optimal removal of donor DNA material without altering the surface of the fibers and structure of the tissue.
❌ Other Allografts
- Suboptimal tissue integration since cell adhesion has been compromised due to the erosion of fibers.
- Reduced tensile strength due to breakage and unnatural crosslinking of collagen fibers.
Step 1: Decellularization
Step 2: Sterilization
Step 3: Outcome
Acceptable dehydration through use of solvents.
Sterilization through gamma-irradiation induces significant changes in the structure of the material which may have an important impact in their performance during clinical use.
BioSure Use in Fistula Repairs
Supercritical CO₂ vs. Gamma-Irradiation
Supercritical CO₂ is an advanced sterilization method that offers a gentle yet effective alternative for tissue processing. While gamma-irradiation has a detrimental effect on the mechanical properties of tissue, supercritical CO₂ provides sterilization without significantly compromising structural integrity. Studies comparing supercritical CO₂ and gamma-irradiation-treated samples highlight the advantages of this innovative approach in preserving both safety and performance.
Benefits of scCO₂ in Allograft’s Clinical Performance
Sterilizing allograft material with scCO2 has shown significant advantages over other more conventional sterilization techniques (i.e., gamma irradiation, steam sterilization, EtO, etc.):
- Effective sterilization capable of reaching SAL 10-6.
- Does not decrease the tensile strength of the graft.
- The technique does not react with the tissue, hence no additional crosslinking of collagen fibers (no increased rigidity of the tissue).
scCO₂
- Good penetration in tissues.
- Tensile strength remains the same even after sterilization.
Gamma-Irradiation
- Induces significant changes in the structure of the graft, compromising its performance during clinical use.
- Strong impact on mechanical properties, reducing the tensile strength of the graft.
- Generate free hydroxyl radicals increasing the risk of carcinogenic effects in patient’s lives.
Case Studies
Processing Differences (scCO₂ vs Gamma)
- Schmid R, et al. Supercritical CO₂ sterilization preserves biomechanical properties of tendon allografts compared with gamma irradiation. J Orthop Res. 2017.
- Oberringer M, et al. Supercritical carbon dioxide–based decellularization and sterilization of dense connective tissues. Biomed Mater. 2018.
Dermis and Elastin Aging
- Mithieux SM, Weiss AS. Design of an elastin-layered dermal regeneration template. Biomaterials. 2017.
- Lynch B, et al. A mechanistic view on the aging human skin through ex vivo mechanical and microstructural characterization.
Acta Biomater. 2022.
Processing and Its Effects on Dermis
- Priddy LB, et al. Effect of gamma irradiation dose on biomechanical properties of acellular dermal matrix. J Biomed Mater Res. 2017.
- Dewey MJ, et al. Decellularization methods of dermal tissues affect mechanical and biological properties. Acta Biomater. 2020.
Resources
Browse these abstracts for a quick insight into the ideas, research, and innovations shaping the field.
Each summary highlights the essentials, making it easy to discover what matters most before diving deeper.
Effects of Supercritical Fluid CO₂ and 25 kGy Gamma Irradiation on the Initial Mechanical Properties and Histological Appearance of Tendon Allograft.
This study compares two sterilization methods—supercritical CO₂ and gamma irradiation—on tendon allografts. Findings show that gamma irradiation weakens tendon structure and mechanical strength, while supercritical CO₂ preserves biomechanical properties and tissue integrity, suggesting it as a safer alternative for graft preparation.
Autologous, Cadaveric, and Synthetic Materials Used in Sling Surgery: Comparative Biomechanical Analysis.
This study compares the biomechanical strength of autologous, cadaveric, and synthetic materials used in sling surgery. Results show cadaveric allografts had the highest tensile strength in full-strip slings, while synthetics performed best in patch suture slings. Autografts and allografts were significantly weaker as patch slings. Material type and sling construction both influenced performance, with implications for surgical outcomes and recurrence risk.
Ordering Information
Placing an order with us is designed to be simple and efficient. Our team works closely with you to ensure accurate product selection, timely delivery, and compliance with all regulatory requirements. Clear communication and dedicated support make the ordering process seamless — so you can focus on providing the best care for your patients. To begin your order, please reach out to us through our Contact Page.
Code | Description | Size |
BE6002FD | BioSure Fascia Lata | 2 x 10 cm |
BE6010FD | BioSure Fascia Lata | 7 x 10 cm |
Product Brochures
Explore our comprehensive product brochures to learn more about the features, clinical applications, and handling instructions for each offering. Whether you are seeking solutions for bone regeneration, soft tissue repair, or aesthetic enhancement, our brochures provide detailed information to help guide your selection and optimize patient care. Click below to view or download the latest brochures and discover how xCyte BioTech can support your clinical practice.
Packaging and Storage
Our allograft products are carefully packaged to protect sterility, preserve quality, and ensure confidence at the point of use. Designed for reliability from storage to the operating room, each product arrives ready for seamless integration into your surgical workflow.
Explore full packaging details, storage guidelines, and handling information on our Packaging & Storage page.
