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1. Data on file at Tepha.
*2. Preclinical data on file at Tepha; results may not correlate to clinical performance in humans.
3. Engelsman, A. F., van der Mei, H. C., Ploeg, R. J., & Busscher, H. J. “The Phenomenon of Infection with Abdominal Wall Reconstruction.” Biomaterials, vol. 28 no. 14, 2018, pp. 2314-2327.
4. Loh, Q. L., Choong, C.. “Three-dimensional scaffolds for tissue engineering applications: Role of porosity and pore size.” Tissue Engineering Part B: Reviews, vol. 19, no. 6, 2013, pp. 485-502. doi:http://dx.doi.org.portal.lib.fit.edu/10.1089/ten.teb.2012.0437
5. Alloderm Regenerative Tissue Matrix, Lifecell Electronic IFU. https://allergan-web-cdn-prod.azureedge.net/actavis/.
6. Amid, P. K. . “Classification of Biomaterials and Their Related Complications in Abdominal Wall Hernia Surgery.” Hernia, vol. 1, no. 1, 1997, pp. 15-21.
7. Bengtson, B., Baxter, R. A., Clemens, M. W., & Bates, D.C50. “A 12-month Survey of Early Use and Surgeon Satisfaction With a New Highly Purified Silk Matrix: SERI SurgicalScaffold.” Plastic and Reconstructive Surgery Global Open, vol. 2, no. 7, 2014.
8. Corey R Deeken, PhD, et al. “Histologic and Biomechanical Evaluation of Crosslinked and Non-Crosslinked Biologic Meshes in a Porcine Model of Ventral Incisional Hernia Repair.” 23 Mar. 2011. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3782991/
9. Deeken, Corey R., and Brent D. Matthews. “Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-Hydroxybutyrate—PHASIX Mesh) in a Porcine Model of Hernia Repair.” ISRN surgery, 2013.
10. “Wound Closure Manual.” Ethicon, Inc. PDF file. 2005.
11. Gross, John E., et al. “An Evaluation of SERI Surgical Scaffold for Soft-Tissue Support and Repair in an Ovine Model of Two-Stage Breast Reconstruction.” Plastic and Reconstructive Surgery, vol. 134, no. 5, 2014, pp.700e-704e.
12. “Chapter 7: Poly-4-hydroxybutyrate (P4HB) in Biomedical Applications and Tissue Engineering.” Biodegradable Polymers Volume 2, by Kai Guo and David Martin, 2015 NovaScience Publishers, Inc, 2015.
13. Halaweish, Ihab, et al. “Novel In Vitro Model for Assessing Susceptibility of Synthetic Hernia Repair Meshes to Staphylococcus Aureus Infection Using Green Fluorescent Protein-Labeled Bacteria and Modern Imaging Techniques.” Surgical Infections, vol. 11, no. 5, 2010, pp. 449-454.
14. Hjort, H., et al. “Three-Year Results From a Preclinical Implantation Study of a Long-Term Resorbable Surgical Mesh with Time-Dependent Mechanical Characteristics.” Hernia, vol. 16, no. 2, 2012, pp. 191-197.
15. Klinge U, Junge K, Spellerberg B, Piroth C, Klosterhalfen B, Schumpelick V. “Do Multifilament Alloplastic Meshes Increase the Infection Rate? Analysis of the Polymeric Surface, the Bacteria Adherence, and the In Vivo Consequences in a Rat Model.” J Biomed Mater Reserve, vol. 63, no. 6, 2002, pp. 765-71.
16. Martin, D P, et al. “Characterization of Poly-4-Hydroxybutyrate Mesh for Hernia Repair Applications.” Journal of Surgical Research, vol. 184, no. 2, 2013, pp. 766–773.
17. Martin, David P., and Simon F. Williams. “Medical Applications of Poly-4-Hydroxybutyrate: a Strong Flexible Absorbable Biomaterial.” Biochemical Engineering Journal, vol. 16, no. 2, 2003, pp. 97-105.
18. Roth, J. S., et al. “Prospective Evaluation of Poly-4-Hydroxybutyrate Mesh in CDC Class L/High-Risk Ventral and Incisional Hernia Repair: 18-Month Follow-Up.” Surgical Endoscopy, vol. 32 no. 4, 2013, pp. 1929-1936.
19. Scott, J. R., Deeken, C. R., Martindale, R. G., Rosen, M. J. “Evaluation of a Fully Absorbable Poly-4-Hydroxybutyrate/Absorbable Barrier Composite Mesh in a Porcine Model of Ventral Hernia Repair.” Surgical Endoscopy, vol.
30, no. 9, 2016, pp. 3691-3701.
20. “Scaffold Electronic IFU.” SERI Surgical. https://www.allergan.com/.
21. “Mesh Electronic IFU.” Strattice Surgical. https://allergan-web-cdn prod.azureedge.net.
22. “Surgical Mesh Electronic IFU.” TIGR Surgical. http://novusscientific.com.
23. Williams, Simon F., Martin, David P., Moses, Arikha C. “The History of GalaFLEX P4HB Scaffold.” Aesthetic Surgery Journal, 2016, pp. S33–S42.
24. Buell, Joseph F. “Initial Experience With Biologic Polymer Scaffold (Poly-4-Hydroxybuturate) in Complex Abdominal Wall Reconstruction.” Annals of Surgery, vol. 266, no. 1, 1 July 2017, pp. 185–188.
25. Cartmill, Barry T. “How Do Absorbable Sutures Absorb? A Prospective Double-Blind Randomized Clinical Study of Tissue Reaction to Polyglactin 910 Sutures in Human Skin.” Orbit, vol. 33, no. 6, 2014, pp. 437–443.
26. Silva, Gayan S. De. “Lack of Identifiable Biologic Behavior in a Series of Porcine Mesh Explants.” Surgery, vol. 156, no. 1, 2014, pp. 183–189., doi:10.1016/j.surg.2014.03.011.
27. Vera, Martin. “Phases of Wound Healing: The Breakdown.” Wound Source. Accessed on Nov 13, 2020. www.woundsource.com"
28. Ana Cristina de Oliveira Gonzalez, Tila Fortuna Costa. “Wound healing - A literature review.” An Bras Dermatol. 2016;91(5):614-20.
29. SIA. DuraSorb Synthetic Mesh. Brochure Printed 20200512. HYPERLINK "http://www.siahealth.com" www.siahealth.com
30. SIA. DuraSorb Synthetic Mesh. Instructions for Use. SI-LS-0002 Rev 3. HYPERLINK "http://www.siahealth.com" www.siahealth.com
31. Levenson SM, Geever EF, Crowley LV, Oates JF 3rd, Berard CW, Rosen H. The Healing of Rat Skin Wounds. Ann Surg. 1965;161(2):293–308.
32. Shuster S, Black MM, McVitie E. The influence of age and sex on skin thickness, skin collagen and density. Br J Dermatol. 1975;93:639-43.
33. G. Patrick Maxwell, MD et al. "Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study." Aesthetic Surgery Journal. 2015, Vol 35(2) 145–155.
34. W. Grant Stevens, MD, et al. "Ten-year Core Study Data for Sientra’s Food and Drug Administration–Approved Round and Shaped Breast Implants with Cohesive Silicone Gel."Plastic and Reconstructive Surgery. April 2018. Supplement.
35. Hammond, Dennis C. M.D, et al. "Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years." Plastic and Reconstructive Surgery: December 2017 - Volume 140 - Issue 6 - p 1142-1150.
36. Grewal, Navanjun S., and Jack Fisher. “Why Do Patients Seek Revisionary Breast Surgery?” Aesthetic Surgery Journal, vol. 33, no. 2, 2013, pp. 237–244.
37. Paige Teller, Therese K. White. The Physiology of Wound Healing: Injury Through Maturation. Surg Clin N Am 89, 2009. 599–610.