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Expanded Polytetrafluoroethylene (Gore-Tex Soft-Tissue Patch) in Facial Augmentation

Expanded Polytetrafluoroethylene (Gore-Tex Soft-Tissue Patch) in Facial Augmentation Abstract Background: Expanded polytetrafluoroethylene (EPTFE) (Gore-Tex soft-tissue patch) has received favorable clinical reports for use in facial augmentation procedures. We evaluated the EPTFE soft-tissue patch in short-term (3week), intermediate-term (6-month), and long-term (12month) animal models. Methods: Nine pathogen-free male and female New Zealand white rabbits weighing 2 to 4 kg were used. After implantation of the EPTFE soft-tissue patch, the animals were carefully observed on a daily basis for signs of wound infection, seroma, or hematoma formation. The stability of the implant was evaluated and graded after the animals were killed. Tissue specimens, including skin, implant, and underlying bone, were removed en bloc. These blocks were sectioned and stained for histologic evaluation. A portion of these blocks were used for scanning electron microscopy. Results: The material increased in stability over time and showed minimal inflammatory cell response and only a delicate fibrous capsule, even in long-term implants. Ultrastructural analysis demonstrated close apposition of the material to tissue, suggesting good interface bioactivity. Conclusions: The EPTFE soft-tissue patch appears to be safe and reliable material for augmentation, demonstrating high biocompatibility, low tissue reactivity, and increasing stability over time.(Arch Otolaryngol Head Neck Surg. 1993;119:1008-1014) References 1. Maas CS, Merwin GE, Wilson J, Frey MD, Maves MD. Comparison of biomaterials for facial bone augmentation . Arch Otolaryngol Head Neck Surg. 1990; 116:551-556.Crossref 2. Brown BL, Neel HB, Kern EB. Implants of Supramid, Proplast, Plasti-pore, and Silastic . Arch Otolaryngol Head Neck Surg. 1979;105:605-609.Crossref 3. Kornblut AD, Stark TW, Vap JG, deFries HO. The role of autografts, homografts, heterografts, and alloplastic implants in reconstructive head and neck surgery . Arch Otolaryngol Head Neck Surg. 1982;15:147-160. 4. Rees TD, Jobe RP, Ballantyne DL. Inorganic implants . In: Converse JM, ed. Reconstructive Plastic Surgery: General Principles . Philadelphia, Pa: WB Saunders Co; 1977;1:392-412. 5. Davis PK, Jones SM. The complication of silastic implants . Br J Plast Surg. 1971;24:405-411.Crossref 6. Homsy CA. Implant stabilization: chemical and biochemical considerations . Otolaryngol Clin North Am. 1973;4:295-304. 7. Sauer BW, Weinstein AM, Klawitter JJ, Hulbert SF, Leonard RB, Bagwell JG. The role of porous polymeric materials in prosthesis attachment . Biomed Mater Res Symp. 1974;8:145-153.Crossref 8. Homsy CA, Anderson MS. Functional stabilization of soft tissue and bone prosthesis with a porous low modulus materials system . In: Williams DF, ed. Biocompatibility of Clinical Implant Materials . Tunbridge Wells, England: Sector Publishing Ltd; 1976;90:931. 9. Merritt K, Shafer JW, Brown SA. Implant site infection rates with porous and dense materials . J Biomed Mater Res. 1979;13:101-108.Crossref 10. Kirchel SF, Klawitter JJ, Erlich RF. The role of implant porosity on the development of infection . Surg Gynecol Obstet. 1977;144:58-62. 11. Griffiths MV. Biomaterials in reconstructive head and neck surgery . Clin Otolaryngol. 1979;4:363-376.Crossref 12. Adams JS. Grafts and implants in nasal and chin augmentation: rational approach to materials selection . Otolaryngol Clin North Am. 1987;20:913-930. 13. Binder WJ, Kamer FM, Parkes ML. Mentoplasty: a clinical analysis of alloplastic implants . Laryngoscope . 1981;91:383-391.Crossref 14. Freeman BS. Proplast, a porous implant for contour restoration . Br J Plast Surg. 1976;29:158-164.Crossref 15. Pacheo ML, Kamer FM, Mervin ML. Proplast chin augmentation . Laryngoscope . 1976;86:1829-1835.Crossref 16. Rubin LR, Bromberg BE, Walden EH. Long-term human reaction of synthetic plastics . Surg Gynecol Obstet. 1971;132:603-608. 17. Spector M, Flemming WR, Kreutner A. Bone growth into porous high-density polyethylene . J Biomed Mater Res. 1976;10:595-603.Crossref 18. Beekhuis GJ. Augmentation mentoplasty using polyamide mesh . Arch Otolaryngol Head Neck Surg. 1980;106:642-644.Crossref 19. Stucker FJ, Hirokawa RH, Bryarly RC. Technical aspects of facial contouring using polyamide mesh . Otolaryngol Clin North Am. 1982;15:123-131. 20. McCollough EG, Weil C. Augmentation of facial defects using Mersilene mesh implants . Otolaryngol Head Neck Surg. 1979;87:515-561. 21. Beekhuis GJ. Mersilene mesh to augment the nasal bridge . Am J Cosmet Surg. 1986;3:48-53. 22. Beekhuis GJ. Augmentation mentoplasty with polyamide mesh: update . Arch Otolaryngol Head Neck Surg. 1984;110:364-367.Crossref 23. Soyer T, Lempier M, Cooper P, Norton L, Eiseman B. A new venous prosthesis . Surgery . 1972;72:864-872. 24. Florian A, Cohn LH, Dammin GJ, Collins JJ Jr. Small vessel replacement with Gore-Tex (expanded polytetrafluoroethylene) . Arch Surg. 1976;111:267-270.Crossref 25. McAuley CE. Seven year follow-up of expanded polytetrafluoroethylene in femoropopliteal bypass grafts . Ann Surg. 1984;199:57-60.Crossref 26. Jenkins SD, Klamer TW, Parteka JJ, Condon RE. A comparison of prosthetic materials used to repair abdominal wall defects . Surgery . 1983;94:392-398. 27. Bauer JJ, Salky BA, Gelernt IM, Kriel I. Repair of large abdominal wall defects with expanded polytetrafluoroethylene (PTFE) . Ann Surg. 1987;206:765-769.Crossref 28. Neel HB. Implants of Gore-Tex . Arch Otolaryngol Head Neck Surg. 1983;109: 427-433.Crossref 29. Berman M, Pearce WJ, Tinnin M. The use of Gore-Tex E-PTFE bonded to silicone rubber as an alloplastic implant material . Laryngoscope . 1986;96:480-483.Crossref 30. Rothstein SG, Jacobs JB. The use of Gore-Tex implants in nasal augmentation operations . Ear Nose Throat J. 1989;68( (suppl) ):40-45. 31. Waldman RS. Gore-Tex for augmentation of the nasal dorsum: preliminary report . Ann Plast Surg. 1991;26:520-525.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Otolaryngology - Head & Neck Surgery American Medical Association

Expanded Polytetrafluoroethylene (Gore-Tex Soft-Tissue Patch) in Facial Augmentation

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Publisher
American Medical Association
Copyright
Copyright © 1993 American Medical Association. All Rights Reserved.
ISSN
0886-4470
eISSN
1538-361X
DOI
10.1001/archotol.1993.01880210098013
Publisher site
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Abstract

Abstract Background: Expanded polytetrafluoroethylene (EPTFE) (Gore-Tex soft-tissue patch) has received favorable clinical reports for use in facial augmentation procedures. We evaluated the EPTFE soft-tissue patch in short-term (3week), intermediate-term (6-month), and long-term (12month) animal models. Methods: Nine pathogen-free male and female New Zealand white rabbits weighing 2 to 4 kg were used. After implantation of the EPTFE soft-tissue patch, the animals were carefully observed on a daily basis for signs of wound infection, seroma, or hematoma formation. The stability of the implant was evaluated and graded after the animals were killed. Tissue specimens, including skin, implant, and underlying bone, were removed en bloc. These blocks were sectioned and stained for histologic evaluation. A portion of these blocks were used for scanning electron microscopy. Results: The material increased in stability over time and showed minimal inflammatory cell response and only a delicate fibrous capsule, even in long-term implants. Ultrastructural analysis demonstrated close apposition of the material to tissue, suggesting good interface bioactivity. Conclusions: The EPTFE soft-tissue patch appears to be safe and reliable material for augmentation, demonstrating high biocompatibility, low tissue reactivity, and increasing stability over time.(Arch Otolaryngol Head Neck Surg. 1993;119:1008-1014) References 1. Maas CS, Merwin GE, Wilson J, Frey MD, Maves MD. Comparison of biomaterials for facial bone augmentation . Arch Otolaryngol Head Neck Surg. 1990; 116:551-556.Crossref 2. Brown BL, Neel HB, Kern EB. Implants of Supramid, Proplast, Plasti-pore, and Silastic . Arch Otolaryngol Head Neck Surg. 1979;105:605-609.Crossref 3. Kornblut AD, Stark TW, Vap JG, deFries HO. The role of autografts, homografts, heterografts, and alloplastic implants in reconstructive head and neck surgery . Arch Otolaryngol Head Neck Surg. 1982;15:147-160. 4. Rees TD, Jobe RP, Ballantyne DL. Inorganic implants . In: Converse JM, ed. Reconstructive Plastic Surgery: General Principles . Philadelphia, Pa: WB Saunders Co; 1977;1:392-412. 5. Davis PK, Jones SM. The complication of silastic implants . Br J Plast Surg. 1971;24:405-411.Crossref 6. Homsy CA. Implant stabilization: chemical and biochemical considerations . Otolaryngol Clin North Am. 1973;4:295-304. 7. Sauer BW, Weinstein AM, Klawitter JJ, Hulbert SF, Leonard RB, Bagwell JG. The role of porous polymeric materials in prosthesis attachment . Biomed Mater Res Symp. 1974;8:145-153.Crossref 8. Homsy CA, Anderson MS. Functional stabilization of soft tissue and bone prosthesis with a porous low modulus materials system . In: Williams DF, ed. Biocompatibility of Clinical Implant Materials . Tunbridge Wells, England: Sector Publishing Ltd; 1976;90:931. 9. Merritt K, Shafer JW, Brown SA. Implant site infection rates with porous and dense materials . J Biomed Mater Res. 1979;13:101-108.Crossref 10. Kirchel SF, Klawitter JJ, Erlich RF. The role of implant porosity on the development of infection . Surg Gynecol Obstet. 1977;144:58-62. 11. Griffiths MV. Biomaterials in reconstructive head and neck surgery . Clin Otolaryngol. 1979;4:363-376.Crossref 12. Adams JS. Grafts and implants in nasal and chin augmentation: rational approach to materials selection . Otolaryngol Clin North Am. 1987;20:913-930. 13. Binder WJ, Kamer FM, Parkes ML. Mentoplasty: a clinical analysis of alloplastic implants . Laryngoscope . 1981;91:383-391.Crossref 14. Freeman BS. Proplast, a porous implant for contour restoration . Br J Plast Surg. 1976;29:158-164.Crossref 15. Pacheo ML, Kamer FM, Mervin ML. Proplast chin augmentation . Laryngoscope . 1976;86:1829-1835.Crossref 16. Rubin LR, Bromberg BE, Walden EH. Long-term human reaction of synthetic plastics . Surg Gynecol Obstet. 1971;132:603-608. 17. Spector M, Flemming WR, Kreutner A. Bone growth into porous high-density polyethylene . J Biomed Mater Res. 1976;10:595-603.Crossref 18. Beekhuis GJ. Augmentation mentoplasty using polyamide mesh . Arch Otolaryngol Head Neck Surg. 1980;106:642-644.Crossref 19. Stucker FJ, Hirokawa RH, Bryarly RC. Technical aspects of facial contouring using polyamide mesh . Otolaryngol Clin North Am. 1982;15:123-131. 20. McCollough EG, Weil C. Augmentation of facial defects using Mersilene mesh implants . Otolaryngol Head Neck Surg. 1979;87:515-561. 21. Beekhuis GJ. Mersilene mesh to augment the nasal bridge . Am J Cosmet Surg. 1986;3:48-53. 22. Beekhuis GJ. Augmentation mentoplasty with polyamide mesh: update . Arch Otolaryngol Head Neck Surg. 1984;110:364-367.Crossref 23. Soyer T, Lempier M, Cooper P, Norton L, Eiseman B. A new venous prosthesis . Surgery . 1972;72:864-872. 24. Florian A, Cohn LH, Dammin GJ, Collins JJ Jr. Small vessel replacement with Gore-Tex (expanded polytetrafluoroethylene) . Arch Surg. 1976;111:267-270.Crossref 25. McAuley CE. Seven year follow-up of expanded polytetrafluoroethylene in femoropopliteal bypass grafts . Ann Surg. 1984;199:57-60.Crossref 26. Jenkins SD, Klamer TW, Parteka JJ, Condon RE. A comparison of prosthetic materials used to repair abdominal wall defects . Surgery . 1983;94:392-398. 27. Bauer JJ, Salky BA, Gelernt IM, Kriel I. Repair of large abdominal wall defects with expanded polytetrafluoroethylene (PTFE) . Ann Surg. 1987;206:765-769.Crossref 28. Neel HB. Implants of Gore-Tex . Arch Otolaryngol Head Neck Surg. 1983;109: 427-433.Crossref 29. Berman M, Pearce WJ, Tinnin M. The use of Gore-Tex E-PTFE bonded to silicone rubber as an alloplastic implant material . Laryngoscope . 1986;96:480-483.Crossref 30. Rothstein SG, Jacobs JB. The use of Gore-Tex implants in nasal augmentation operations . Ear Nose Throat J. 1989;68( (suppl) ):40-45. 31. Waldman RS. Gore-Tex for augmentation of the nasal dorsum: preliminary report . Ann Plast Surg. 1991;26:520-525.Crossref

Journal

Archives of Otolaryngology - Head & Neck SurgeryAmerican Medical Association

Published: Sep 1, 1993

References