10 Things to Know About SurgiMend® Collagen Matrix for Soft Tissue Reconstruction

Surgeons often turn to biologic meshes for hernia repair when synthetic meshes are not ideal for a given patient and presentation. SurgiMend® Collagen Matrix for Soft Tissue Reconstruction is a biologic that offers a distinct alternative to synthetic and other collagen products for soft tissue repair and reconstruction. Intrinsically strong, it handles and can be sutured in place like natural tissue.

Here are 10 things you need to know about SurgiMend:

1. It does not elicit a detrimental inflammatory response. That’s because SurgiMend goes through a patented processing method to remove preservatives, denatured proteins, artificial chemical crosslinks, cells, lipids, carbohydrates and other agents that can induce inflammation.^{2, 3, 4, 5}
2. SurgiMend is rapidly revascularized to support tissue building for prolonged reinforcement. ^{5, 6, 7}
3. It is terminally sterilized, safe and consistent. SurgiMend is free of potentially antigenic antibiotics and is terminally sterilized. Derived from well-defined and characterized source tissue with respect to age, SurgiMend has consistent mechanical strength, structure and composition.
4. SurgiMend is derived from fetal and neonatal bovine dermal collagen. It consists of an array of distinct interwoven collagen fibers with ample porosity to allow for rapid cell repopulation and vascularization. While both fetal and adult dermal tissues are predominantly composed of Type I collagen, fetal and neonatal bovine tissue more is rich in Type III collagen (20% to 30%), which is the first type of collagen synthesized during both embryonic development and wound healing.^{8, 9}
5. SurgiMend shows low recurrence rates in complex abdominal wall reconstruction patients up to seven years post implantation as demonstrated in multiple peer reviewed journal articles since 2013.^{10, 11, 12, 13, 14, 15, 16, 17}
6. SurgiMend 3.0 and 4.0 demonstrate four times more tear resistance and greater than double tensile and suture retention strength than StratticeTM ¹⁸ as demonstrated in published bench testing.¹⁶ The biological makeup of bovine dermis, including its inherent collagen fiber architecture, leaves SurgiMend unmatched in available thicknesses and mechanical strength.¹⁹
7. SurgiMend rehydrates in one to three minutes when placed in room temperature saline. Once fully hydrated, the material is pliable and compliant, readily conforming to the surgical site.
8. It can be trimmed to size, wet or dry, and placed in any orientation, with either side facing up.
9. SurgiMend has a macroporous design in 2mm thickness that facilitates fluid drainage.
10. It is available in more than 60 size configurations up to 25cm x 40cm and 1.0-4.0mm thickness to provide surgeons with the flexibility to choose the most appropriate thickness strength and size for each procedure, technique and patient.

References

1. Cornwell K et al. A generative tissue fabricated with SurgiMend has a mesothelial lining limiting adhesion formation in a model of large ventral hernia repair. Presented at the meeting of the American Hernia Society, Orlando, FL, March 2010.
2. Cornwell KG, Zhang F, Lineaweaver W. Bovine fetal collagen reinforcement in a small animal model of hernia with component repair. J Surg Res. 2016;201(2):416-424.
3. Adelman DM, Cornwell KG. Bioprosthetic Versus Synthetic Mesh: Analysis of Tissue Adherence and Revascularization in an Experimental Animal Model. Plast Reconstr Surg Glob Open. 2018;6(5).
4. Rennert RC, Sorkin M, Garg RK, Januszyk M, Gurtner GC. Cellular response to a novel fetal acellular collagen matrix: implications for tissue regeneration. Int J Biomater. 2013;2013:527957.
5. Valentin JE, Badylak JS, McCabe GP, Badylak SF. Extracellular matrix bioscaffolds for orthopaedic applications. A comparative histologic study. J Bone Joint Surg Am. 2006;88(12):2673-2686.Adelman DM, Cornwell KG. Bioprosthetic Versus Synthetic Mesh: Analysis of Tissue Adherence and Revascularization in an Experimental Animal Model. Plast Reconstr Surg Glob Open. 2018;6(5).
6. Rennert RC, Sorkin M, Garg RK, Januszyk M, Gurtner GC. Cellular response to a novel fetal acellular collagen matrix: implications for tissue regeneration. Int J Biomater. 2013;2013:527957.
7. Ramshaw JAM. Distribution of Type III Collagen in Bovine Skin of Various Ages. Connect Tissue Res. 1986;14(4):307-314.
8. Smith LT, Holbrook KA, Madri JA. Collagen types I, III, and V in human embryonic and fetal skin. Am J Anat. 1986;175(4):507-521.
9. Ghali S, Turza KC, Baumann DP, Butler CE. Minimally Invasive Component Separation Results in Fewer Wound-Healing Complications than Open Component Separation for Large Ventral Hernia Repairs. J Am Coll Surg. 2012;214(6):981-989.
10. Lineaweaver W. Improvement of success rates for abdominal component reconstructions using bovine fetal collagen. Ann Plast Surg. 2012;68(5):438-441.
11. Booth JH, Garvey PB, Baumann DP, et al. Primary Fascial Closure with Mesh Reinforcement Is Superior to Bridged Mesh Repair for Abdominal Wall Reconstruction. J Am Coll Surg. 2013;217(6):999-1009.
12. Clemens MW, Selber JC, Liu J, et al. Bovine versus Porcine Acellular Dermal Matrix for Complex Abdominal Wall Reconstruction: Plast Reconstr Surg. 2013;131(1):71-79.
13. Garvey PB, Martinez RA, Baumann DP, Liu J, Butler CE. Outcomes of Abdominal Wall Reconstruction with Acellular Dermal Matrix Are Not Affected by Wound Contamination. J Am Coll Surg. 2014;219(5):853-864.
14. Asaad M, Kapur SK, Baumann DP, Liu J, Butler CE. Acellular Dermal Matrix Provides Durable Long-Term Outcomes in Abdominal Wall Reconstruction: A Study of Patients with Over 60 Months of Follow-up. Ann Surg. 2020;Publish Ahead of Print.
15. Ramshaw JAM. Distribution of Type III Collagen in Bovine Skin of Various Ages. Connect Tissue Res. 1986;14(4):307-314.
16. Data on file, Internal testing PDR 198.
17. Data on file, Internal testing PDR 231.
18. Wells HC, Sizeland KH, Kirby N, Hawley A, Mudie S, Haverkamp RG. Collagen Fibril Structure and Strength in Acellular Dermal Matrix Materials of Bovine, Porcine, and Human Origin. ACS Biomater Sci Eng. 2015;1(10):1026-1038.
19. Adelman DM, Selber JC, Butler CE. Bovine versus Porcine Acellular Dermal Matrix: A Comparison of Mechanical Properties. Plast Reconstr Surg Glob Open. 2014;2(5):e155.

Indications

SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes.

SurgiMend is specifically indicated for:

• Plastic and reconstructive surgery.
• Muscle flap reinforcement.
• Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Warnings and Precautions

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

• Consider the loading environment when selecting the product thickness; thicker product tends to have greater initial strength.
• Fenestrated product will stretch more than non-fenestrated product.
• Meshing of fenestrated product is not recommended.
• Do not expose to chemicals or substances other than sterile, room temperature 0.9% saline.
• Excessive heat can damage collagen. Do not hydrate in 0.9% saline warmed above room temperature.

If, when hydrated, the product shrinks in size, DO NOT use the product as it may be damaged.

• SurgiMend should be used with caution where any pre-existing pathology may limit blood supply and compromise healing.
• Treat any existing infection appropriately in an attempt to eliminate infection. If used in contaminated or infected wounds collagen-based implants can weaken or break down if exposed to bacterial enzymes.
• SurgiMend should be used with caution in surgical locations where the product may be exposed to stomach and/or intestinal contents.

Collagen-based implants can be susceptible to degradation by digestive enzymes and conditions of acidic (low) pH.

• Do not resterilize as this may damage SurgiMend.
• SurgiMend is for single patient use only and is to be implanted surgically.
• SurgiMend has not been evaluated in pregnant women.
• The patient’s medical condition may adversely impact healing of the deficient tissue. These conditions may include, but are not limited to: smoking, diabetes, insufficient blood supply at the implant site, and exposure of the implant site to radiotherapy.
• Do not use product past the date of expiration.
• General risks may include, but are not limited to: infection, allergic reactions, pain, swelling or bruising, foreign body reaction, acute or chronic inflammatory reactions, adhesions, seroma, hematoma, and repair laxity. The patient should be made aware of these risks and others associated with general surgery and the use of anesthesia.

Have you heard about our new guarantee program for soft tissue reconstruction? Learn more here.