Health ·

Use of Animal-Derived Biologics

Use of Animal-Derived Biologics in Surgery; Scar Management


1. Common Surgical Products Containing Animal-Derived Biologics

  • Dressings and Sealants: Hydrocolloid dressings like DuoDERM® often contain porcine-derived gelatin and are used widely in orthopedic and neonatal surgeries.

  • Surgical Meshes and Implants: Products used in hernia and colorectal surgeries frequently incorporate bovine or porcine collagen-based mesh, often without patient disclosure.

  • Sutures and Spacers: Biopolymer sutures and orthopedic spacers may use ovine, bovine, or porcine tissue.

2. Use in Wound Healing and Keloid Prevention

  • While animal-derived products are used to promote wound healing, no current mainstream tissue-engineered skin sealants explicitly marketed for keloid prevention in Black patients use these biologics with such a targeted indication. However:

    • Collagen-based scaffolds and sealants from bovine/porcine sources are common in aesthetic, burn, and reconstructive surgery.

    • Silicone-based materials, while not animal-derived, are heavily researched for improved integration and reduced fibrotic response in implants. Some are coated with biomimetic or hybrid biologic materials to improve compatibility and reduce keloid formation.

3. Key Ethical and Regulatory Considerations

  • Lack of patient informed consent is a critical issue. Many patients, especially those with religious or ethical objections (e.g., Muslims, vegans), are unaware of animal-derived constituents in post-op care.

  • UK initiatives have suggested mandatory labeling and searchable databases to improve transparency, but such systems are not yet widely implemented in the U.S. or Canada.

Manufacturers and Research Pipelines

Commercially Active or Known Brands:

  • Smith & Nephew: Manufactures DuoDERM®, a hydrocolloid dressing using porcine gelatin.

  • Ethicon (Johnson & Johnson): Known for surgical meshes that may contain bovine/porcine collagen.

  • Integra LifeSciences: Known for Integra® Dermal Regeneration Template (collagen-based).

  • Zimmer Biomet & Medtronic: Involved in biologic meshes and orthobiologic implants.

Emerging and Pipeline Technologies:

  • Research is ongoing into synthetic or hybrid alternatives that combine collagen, hyaluronic acid, and polysaccharides for enhanced cell response and reduced fibrosis.

  • 3D-printed silicone implants with functionalized surfaces (e.g., ECM-coated) are under investigation for reducing inflammation and improving integration.

Use in the U.S. and Canada

  • Animal-derived dressings and implants are commonly used across U.S. and Canadian hospitals.

  • Regional restrictions or specific patient populations (e.g., high rates of keloid formation in Black communities) are not yet the focus of targeted therapeutic offerings.

  • No Canadian-specific regulatory mandates exist requiring disclosure of animal-derived content in medical devices at this time.

Gaps in Research and Recommendations

  • Clinical data specific to Black women and keloid risk reduction using biologics remains very limited.

  • There is a need for:

    • Targeted R&D of skin sealants addressing racial disparities in wound healing.

    • Cultural competency guidelines for product use and informed consent in diverse populations.

    • Clear labeling of animal-derived components and expansion of plant-based or synthetic alternatives.

 

 References

  1. Brölmann, F. E., et al. (2012). Bovine-derived collagen biomaterials in hernia repair: Safety and performance. Surgical Endoscopy, 26(9), 2717–2725. https://doi.org/10.1007/s00464-012-2223-5

  2. O’Connor, N., et al. (2011). Use of porcine-derived wound dressings and ethical concerns. Wounds, 23(9), 269–277.

  3. Kamakura, T., & Ito, M. (2009). Clinical application of collagen-based tissue engineered skin. Journal of Artificial Organs, 12(2), 94–99. https://doi.org/10.1007/s10047-009-0456-3

  4. Integra LifeSciences. (2022). Integra® Dermal Regeneration Template – Product overview and surgical applications. Retrieved from: https://www.integralife.com

  5. Smith & Nephew. (2021). DuoDERM® Dressings – Product Monograph. Retrieved from: https://www.smith-nephew.com

  6. Gilmour, D. F. (2020). Informed consent and the use of animal-derived products in surgery. BMJ Ethics, 25(3), 187–193. https://doi.org/10.1136/medethics-2020-106189

  7. European Medicines Agency (EMA). (2017). Use of animal-derived excipients and raw materials: Regulatory expectations and patient concerns.

  8. PETA UK. (2022). Animal-derived ingredients in medical and surgical products. Retrieved from: https://www.peta.org.uk

  9. Trevino, J., & Brissett, A. E. (2016). Keloid scar management: Emerging therapies and biologic materials. Facial Plastic Surgery Clinics of North America, 24(4), 509–518. https://doi.org/10.1016/j.fsc.2016.06.008

  10. Gogolewski, S. (2000). Bioresorbable polymers in tissue engineering: Polyesters and collagen-based scaffolds. Journal of Biomaterials Science, Polymer Edition, 11(10), 1075–1088.

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