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The information contained in this website is intended for International Health Care Professionals. Patients, please refer to your physician for information.

References

  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. Adams Jr, W. P., Baxter, R., Glicksman, C., Mast, B. A., Tantillo, M., & Van Natta, B. W. (2018). “The Use of Poly-4-Hydroxybutyrate (P4HB) Scaold in the Ptotic Breast:a Multicenter Clinical Study.” Aesthetic Surgery Journal, 38(5), 502-518.
  5. 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.
  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. “Surgical Mesh Electronic IFU.” TIGR Surgical. http://novusscientific.com.
  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. 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.
  12. Guo, Kai & Martin, David. “Poly-4-hydroxybutyrate (P4HB) in Biomedical Applications and Tissue Engineering.” 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. 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.
  21. “Mesh Electronic IFU.” Strattice Surgical. https://allergan-web-cdn prod.azureedge.net
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