Study of the main histopathological characteristics of a cadaveric fascia lata allomaterial in an in vivo experiment

Objective. The fascia lata allomaterial (FLA) has been successfully used in ophthalmology, dentistry, thoracic surgery, neurosurgery, and other fields. However, data on its application in breast reconstruction are extremely limited.

Purpose of a study: to conduct a randomized controlled experimental investigation of the histological and biomechanical characteristics of cadaveric fascia lata allomaterial (alloplant®) compared to other allomaterials used in breast reconstruction.

Material and Methods. The study involved 30 white outbred rats, randomly divided into 3 groups (10 animals each): xenograft, synthetic mesh, and FLA. On days 1, 3, 7, 10, and 14 post-surgery, the implants were removed en bloc for histological analysis, focusing on neovascularization, fibrosis, inflammatory response, and collagen fiber organization. Additionally, the thickness of the inflammatory infiltrate and the lysis surface area were assessed.

Results. In the FLA group, inflammatory cells infiltrated the matrix surface more actively at both the beginning and end of the experiment compared to the other groups (p < 0.05). The most active resorption occurred in the synthetic mesh group, while the lowest lysis rate, particularly in the second week, was observed in the xenograft group. The FLA showed superior fibrosis (p < 0.05), inflammatory infiltrate (p < 0.05), and collagen organization (p < 0.05) compared to the synthetic mesh.

Conclusion. The cadaveric fascia lata allograft in a rat model demonstrated slower biodegradation compared to a synthetic mesh, with no statistically significant difference from the xenograft group.

1. Lansen L.A., Macadam S.A. The use of AlloDerm in postmastectomy alloplastic breast reconstruction: part I. A systematic review. Plastic and Reconstructive Surgery. 2011 Jun 1;127(6):2232-2244.

2. Balayssac D., Poinas A.C., Pereira B., Pezet D. Use of permacol in parietal and general surgery: a bibliographic review. Surgical Innovation. 2013 Apr;20(2):176-182.

3. Darehzereshki A., Goldfarb M., Zehetner J., Moazzez A., Lipham J.C., Mason R.J., Katkhouda N. Biologic versus nonbiologic mesh in ventral hernia repair: a systematic review and meta-analysis. World Journal of Surgery. 2014;38:40-50.

4. See C.W., Kim T., Zhu D. Hernia mesh and hernia repair: a review. Engineered Regeneration. 2020 Jan 1;1:19-33.

5. Baichorov E.A., Zikiryakhodzhaev A.D., Ismagilov A.Kh., Vanesyan A.S. Sravnitel'nyy analiz kachestva zhizni, svyazannogo so zdorov'yem patsiyentov s rakom molochnoy zhelezy, posle odnomomentnoy prepektoral'noy rekonstruktsii [Comparative analysis of health-related quality of life in patients with breast cancer after immediate prepectoral breast reconstruction] Plasticheskaya khirurgiya i esteticheskaya meditsina – Plastic Surgery and Aesthetic Medicine, 2022;2:25-32 (in Russ.) https://doi.org/10.17116/plast.hirurgia202202125.

6. Ismagilov A.Kh., Pushkarev A.V., Galeev M.G., Vanesyan A.S. Primeneniye atsellyulyarnyh dermal'nykh matrits v rekonstruktsii molochnoy zhelezy [Acellular dermal matrices in breast reconstruction]. Plasticheskaya khirurgiya i esteticheskaya meditsina – Plastic Surgery and Aesthetic Medicine. 2023;3:139–144. (In Russ.). https://doi.org/10.17116/plast.hirurgia2023031139

7. Murphy D., O’Donnell J.P., Ryan É.J., O’Neill B.L., Boland M.R., Lowery A.J., Kerin M.J., McInerney N.M. Immediate breast cancer reconstruction with or without dermal matrix or synthetic mesh support: a review and network meta-analysis. Plastic and Reconstructive Surgery. 2023 Apr 1;151(4):563e-574e.

8. Makarewicz N., Perrault D., Sharma A., Shaheen M., Kim J., Calderon C., Sweeney B., Nazerali R. Comparing the Outcomes and Complication Rates of Biologic vs Synthetic Meshes in Implant-Based Breast Reconstruction: A Systematic Review. Annals of Plastic Surgery. 2023 May 1;90(5):516-527.

9. AbdulAl M., Zaernia A., Sefat F. Biomaterials for breast reconstruction: Promises, advances, and challenges. Journal of Tissue Engineering and Regenerative Medicine. 2020 Nov;14(11):1549-1569.

10. Abhari R.E., Izett-Kay M.L., Morris H.L., Cartwright R., Snelling S.J. Host-biomaterial interactions in mesh complications after pelvic floor reconstructive surgery. Nature Reviews Urology. 2021 Dec;18(12):725-738.

11. Kelangi S.S., Theocharidis G., Veves A., Austen W.G., Sheridan R., Goverman J., Bei M. On skin substitutes for wound healing: Current products, limitations, and future perspectives. Technology. 2020 Mar 26;8(01n02): 8-14.

12. Patel S., Ziai K., Lighthall J.G., Walen S.G.. Biologics and acellular dermal matrices in head and neck reconstruction: a comprehensive review. American Journal of Otolaryngology. 2022 Jan 1;43(1):103233.

13. Gierek M., Łabuś W., Kitala D., Lorek A., Ochała-Gierek G., Zagórska K.M., Waniczek D., Szyluk K., Niemiec P. Human acellular dermal matrix in reconstructive surgery – a review. Biomedicines. 2022 Nov 9;10(11):2870.

14. Pushkarev A.V. Primeneniye alloimplantata na osnove shirokoy fastsii bedra cheloveka pri odnomomentnyh rekonstruktsiyah s ispol'zovaniyem silikonovogo endoproteza u bol'nyh rakom molochnoy zhelezy: Patent № RU 2809428, MPK A61B17/00 ot 11.12.2023 [Fascia lata allograft implementation in the implant-based immediate breast reconstruction in breast cancer patients. Patent No. RU 2809428, MPK A61B17/00, date: 11.12.2023] (in Russ.).

15. FSR2011/12012 [Online]. (Date of accept: 24 August 2024). Available at: https://nevacert.ru/reestry/medreestr/fsr-2011-12012-8251 (in Russ.).

16. Aleksandrova B.L., Ratmirova Sh.O. Sravnitel'naya harakteristika allotransplantatov dlya skleroplastiki, izgotovlennyh raznymi metodami [Comparative analysis of allografts with different modes of fabrication for scleroplaty]. Vestnik Orenburgskogo gosudarstvennogo universiteta – Vesntik of the Orenburg State University 2012;12(148):23-25. (in Russ.)

17. Vorobyоv K.A., Bozhkova S.A., Tikhilov R.M., Cherny A.Zh. Sovremennyye sposoby obrabotki i sterilizatsii allogennyh kostnyh tkaney (obzor literatury) [Current methods of processing and sterilization of bone allografts (review of literature)]. Travmatologiya i ortopediya Rossii – Traumatology and Orthopedics of Russia. 2017;23(3):134-147. doi: 10.21823/2311-2905-2017-23-3-134-147.

18. Ermoshchenkova M.V., Chissov V.I., Usov A.V., Sukhotko A.S., Tukmakov A.Yu., Baichorov E.A., Zikiryahodjaev A.D. Primeneniye biologicheskih i sinteticheskih materialov pri rekonstruktivno-plasticheskih operatsiyah u bol'nyh rakom molochnoy zhelezy [Biological and synthetic mesh use in reconstructive surgery in patients with breast cancer]. Issledovaniya i praktika v meditsine – Research’n Practical Medicine Journal. 2017;4(1):23-32. (in Russ.) doi: 10.17709/2409-2231-2017-4-1-3

19. OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects | OECD Guidelines for the Testing of Chemicals | OECD iLibrary [Online]. [Referred on 24 Aug 2024]. Available at: https://www.oecdilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788

20. Directive, EUs. “63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.” Off. J. Eur. Union 276, 2010; 33-79.

21. Taube A.A., Sharafieva A.A., Shigarova L.V., Flisyuk E.V., Moskvin A.V. Rossiyskiye ispytatel'nye tsentry: aspekty razrabotki sistem menedzhmenta kachestva dlya vnedreniya printsipov nadlezhashchey laboratornoy praktiki [Russian testing centers: aspects of developing quality management systems for implementing the principles of good laboratory practice]. Voprosy obespecheniya kachestva lekarstvennykh sredstv – Journal of Pharmaceuticals Quality Assurance Issue. 2021; 2(32): 54-61 (in Russ.). https://www.doi.org/10.34907/JPQAI.2021.53.38.004

22. Kalin M., Kuru S., Kismet K., Barlas A.M., Akgun Y.A., et al. The Effectiveness of Porcine Dermal Collagen (Permacol® ) on Wound Healing in the Rat Model. Indian J Surg. 2015; 77(S2): 407-11.

23. FSZ 2009/05039 | Surgical Implant Permacol | Regist of medical devices 2024 [Online]. [referred on 24 Aug 2024]. Available at: https://reestrinform.ru/reestr-meditcinskikh-izdeliy/reg_number-%D0%A4%D0%A1% D0%97_2009/05039.html?ysclid=m048wc3c67311861850 (In Russ.).

24. Dieterich M., Reimer T., Dieterich H., Stubert J., Gerber B. A short-term follow-up of implant based breast reconstruction using a titanium-coated polypropylene mesh (TiLoop® Bra). European Journal of Surgical Oncology. 2012;38(12):1225-1230.

25. Farr N.T.H., Klosterhalfen B., Noé G.K. Characterization in respect to degradation of titanium-coated polypropylene surgical mesh explanted from humans. Journal of Biomedical Materials Research Part B: Applied Biomaterials. 2023;111(5):1142-1152.

26. Rolph R., Farhadi J. The use of meshes and matrices in breast reconstruction. British Journal of Hospital Medicine. 2018 Aug 2;79(8):454-459.