Sterilization, toxicity, biocompatibility and clinical applications of polylactic acid/polyglycolic acid copolymers

Biomaterials

Volumn 17, Issue 2, 1996, Pages 93-102

  Athanasiou, Kyriacos A ^a   Niederauer, Gabriele G ^a   Agrawal, C Mauli ^a  

^a UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

Author keywords

Polyglycolic acid; Polylactic acid; Toxicity

Indexed keywords

BIOCOMPATIBILITY; CELLS; COPOLYMERS; IMPLANTS (SURGICAL); MEDICAL APPLICATIONS; ORGANIC ACIDS; ORTHOPEDICS; STERILIZATION (CLEANING); TISSUE; TOXICITY;

CLINICAL APPLICATIONS; POLYGLYCOLIC ACID; POLYLACTIC ACID;

BIOMATERIALS;

COPOLYMER; POLYGLYCOLIC ACID; POLYLACTIC ACID;

ASEPSIS; BIOCOMPATIBILITY; CELL PROLIFERATION; FRACTURE FIXATION; HUMAN; IMPLANTATION; INFLAMMATION; LIGAMENT SURGERY; OSTEOPENIA; PRIORITY JOURNAL; REVIEW; TENDON SURGERY; TOXICITY TESTING;

EID: 0030061447     PISSN: 01429612     EISSN: None     Source Type: Journal    
DOI: 10.1016/0142-9612(96)85754-1     Document Type: Article

References (100)

1. Rozema FR, Bos RRM, Boering G, van Asten JAAM, Nijenhuls AJ, Pennings AJ. The effects of different steam-sterilization programs on material properties of poly(L-lactide). J Appl Biomater 1991; 2: 23-28.
2. Gilding D, Reed AM. Biodegradable polymers for use in surgery - polyglycolic/poly(lactic acid) homo- and copolymers: 1. Polymer 1979; 20: 1459-1464.
3. Vainionpää S, Kilpikari J, Laiho J, Helevirta P, Rokkanen P, Törmälä P. Strength and strength retention in vitro, of absorbable, self-reinforced polyglycolide (PGA) rods for fracture fixation. Biomaterials 1987; 8: 46-48.
4. Laitinen O, Törmälä P, Taurio R et al. Mechanical properties of biodegradable ligament augmentation device of poly(L-lactide) in vitro and in vivo. Biomaterials 1992; 13: 1012-1016.
5. Chu CC, Williams DF. The effect of gamma irradiation on the enzymatic degradation of polyglycolic acid absorbable sutures. J Biomed Mater Res 1983; 17: 1029-1040.
6. Vink P, Pleijsier K. Aeration of ethylene oxide-sterilized polymers. J Biomater 1986; 7: 225-230.
7. Matthews IP, Gibson C, Samuel AH. Enhancement of the kinetics of the aeration of ethylene oxide sterilized polymers using microwave radiation. J Biomed Mater Res 1989; 23: 143-156.
8. Saalman E. Infrared spectroscopic study of polymers exposed to ethylene oxide. J Biomater 1985; 6: 225-230.
9. Verheyen CCPM, de Wijn JR, van Blitterswijk CA, de Groot K. Evaluation of hydroxylapatite/poly(L-lactide) composites: mechanical behavior. J Biomed Mater Bes 1992; 26: 1277-1296.
10. van Sliedregt A, van Blitterswijk CA, Hesseling SC, Grote JJ, deGroot K. The effect of the molecular weight of polylactic acid on in vitro biocompatibility. Adv Biomater 1990; 9: 207-212.
11. van Sliedregt A, Radder AM, deGroot K, van Blitterswijk CA. In vitro biocompatibility testing of polylactides. Part I: proliferation of different cell types. J Mater Sci: Mater Med 1992; 3: 365-370.
12. Mikos AG, Sarakinos G, Leite SM, Vacanti JP, Langer R. Laminated three-dimensional biodegradable foams for use in tissue engineering. Biomaterials 1993; 14: 323-330.
13. Taylor MS, Daniels AU, Andriano KP, Heller J. Six bioabsorbable polymers: in vitro acute toxicity of accumulated degradation products. J Appl Biomater 1994; 5: 151-157.
14. Christel PS, Vert M, Chabot F, Abois Y, Leary JL. Polylactic acid for intramedullary plugging. In: Ducheyne P, ed. Biomaterials and Biomechanics. Amsterdam: Elsevier Science Publishers, 1983.
15. Matsusue Y, Yamamuro T, Oka M, Shikinami Y, Hyon S-H, Ikada Y. In vitro and in vivo studies on bioabsorbable ultra-high-strength poly(L-lactide) rods. J Biomed Mater Res 1992; 26: 1553-1567.
16. Klompmaker J, Jansen HWB, Veth RPH, deGroost JH, Nijenhuis AJ, Pennings AJ. Porous polymer implant for repair of meniscal lesions: a preliminary study in dogs. Biomaterials 1991; 12: 810-816.
17. Suganuma J, Alexander H. Biological response of intramedullary bone to poly-L-lactic acid. J Appl Biomater 1993; 4: 13-27.
18. Verheyen CCPM, deWijn JR, van Blitterswijk CA, Rozing PM, deGroot K. Examination of efferent lymph nodes after 2 years of transcortical implantation of poly(L-lactide) containing plugs: a case report. J Biomed Mater Res 1993; 27: 1115-1118.
19. Nelson JF, Standford HG, Cutright DE. Evaluation and comparisons of biodegradable substances as osteogenic agents. J Oral Surg 1977; 43(6): 836-843.
20. Hollinger JO. Preliminary report on the osteogenic potential of a biodegradable copolymer of polylactide (PLA) and polyglycolide (PGA). J Biomed Mater Res 1983; 17: 71-82.
21. Kleinschmidt J, Marden L, Kent D, Quigley N, Hollinger J. A multiphase system bone implant for regenerating the calvaria. J Plast Reconstr Surg 1993; 91: 581-588.
22. Levy F, Hollinger J, Szachowicz E. Effect of a bioresorbable film on regeneration of cranial bone. J Plast Reconstr Surg 1994; 93: 307-311.
23. von Schroeder HP, Kwan M, Amiel D, Coutts RD. The use of polylactic acid matrix and periosteal grafts for the reconstruction of rabbit knee articular defects. J Biomed Mater Res 1991; 25: 329-339.
24. Athanasiou KA, Schmitz JP, Schenck RC, Clem M, Aufdemorte T, Boyan BD. The use of biodegradable implants for repairing large articular cartilage defects in the rabbit. Trans Orthop Res Soc 1992; 17: 172.
25. Athanasiou KA, Schenck RC, Constantinides G, Sylvia V, Aufdemorte T, Boyan BD. Biodegradable carriers of TGF-β in rabbit osteochondral defects. Trans Orthop Res Soc 1993; 18: 288.
26. Santavirta S, Konttinen YT, Saito T et al. Immune response to polyglycolic acid implants. J Bone Joint Surg 1990; 72-B: 597-600.
27. Hope PG, Williamson DM, Coates CJ, Cole WG. Biodegradable pin fixation of elbow fractures in children. J Bone Joint Surg 1991; 73: 965-968.
28. Böstman OM. Osteolytic changes accompanying degradation of absorbable fracture fixation implants. J Bone Joint Surg 1991; 73-B: 679-682.
29. Böstman OM. Intense granulomatous inflammatory lesions associated with absorbable internal fixation devices made of polyglycolide in ankle fractures. Clin Orthop Related Res 1992; 278: 193-199.
30. Böstman O, Partio E, Hirvensalo E, Rokkanen P. Foreign-body reactions to polyglycolide screws. Acta Orthop Scand 1992; 63: 173-176.
31. Böstman O, Päivärinta U, Partio E, Vasenius J, Manniner M, Rokkanen P. Degradation and tissue replacement of an absorbable polyglycolide screw in the fixation of rabbit femoral osteotomies. J Bone Joint Surg 1992; 74-A(7): 1021-1031.
32. Päivärinta U, Böstman O, Majola A, Toivonen T, Törmälä P, Rokkanen P. Intraosseous cellular resonse to biodegradable fracture fixation screws made of polyglycolide polylactide. Arch Orthop Trauma Surg 1993; 112: 71-74.
33. Böstman O, Mäkelä EA, Södergard J, Hirvensalo E, Törmälä P, Rokkanen R. Absorbable polyglycolide pins in internal fixation of fractures in children. J Ped Orthop 1993; 13: 242-245.
34. Bucholz RW, Henry S, Henley MB. Fixation with bioabsorbable screws for the treatment of fractures of the ankle. J Bone Joint Surg 1994; 76-A: 319-324.
35. Leenslag JW, Pennings AJ, Bos RRM, Rozema FR, Boering G. Resorbable materials of poly(L-lactide): VII. In vivo and in vitro degradation. Biomaterials 1987; 8: 311-314.
36. Galgut P, Pitrola R. Waite I, Doyle C, Smith R. Histological evaluation of biodegradable and non-biodegradable membranes placed transcutaneously in rats. J Clin Periodontol 1991; 18: 581-586.
37. Rozema FR, Bos RRM, Boering G et al. Tissue response to pre-degraded poly(L-lactide). In: Plank H, Dauner M. Renardy M, eds. Degradation Phenomena on Polymeric Biomaterials. New York: Springer, 1992: 123-131.
38. Lam KH, Schakenraad JM, Esselbrugge H. Feijen J, Nieuwenhuis PP. The effect of phagocytosis of poly(L-lactic acid) fragments on cellular morphology and viability. J Biomed Mater Res 1993; 27: 1569-1577.
39. Visscher GE, Robison RL, Maulding HV, Fong JW, Pearson JE, Argentieri GJ. Biodegradation of and tissue reaction to poly(DL-lactide) microcapsules. J Biomed Mater Res 1986; 20: 667-676.
40. Schakenraad JM, Oosterbaan JA, Nieuwenhuis P et al. Biodegradable hollow fibres for the controlled release of drugs. Biomaterials 1988; 9: 116-120.
41. Schakenraad JM, Hardonk MJ, Feijen J, Molenaar I, Nieuwenhuis P. Enzymatic activity toward poly(L-lactic acid) implants. J Biomed Mater Res 1990; 24: 529-545.
42. Schwope AD, Wise DL, Howes IF. Development of polylactic/glycolic acid delivery systems for use in treatment of narcotic addiction. Nat Inst Drug Abuse Res Monogr Ser 1976; January: 13-18.
43. Gibbons DF. Tissue response to resorbable synthetic polymers. In: Plank H, Dauner M, Renardy M. eds. Degradation Phenomena on Polymeric Biomaterials. New York: Springer, 1992: 97-104.
44. Devereux DF, O'Connell SM, Liesch JB, Weinstein M, Robertson FM. Induction of leukocyte activation by meshes surgically implanted in the peritoneal cavity. Am J Surg 1991; 162: 243-246.
45. Devereux DF, O'Connell SM, Spain DA, Robertson FM. Peritoneal leukocyte response following placement of polyglycolide acid intestinal sling in patients with rectal carcinoma. Dis Colon Rectum 1991; 34: 670-674.
46. Horton CE, Adamson JE, Mladick RA, Carraway JH. Vicryl synthetic absorbable sutures. Am Surg 1974: 729-731.
47. Postlethwait RW. Polyglycolic acid surgical suture. Arch Surg 1970; 101: 489-494.
48. Frazza EJ, Schmitt EE. A new absorbable suture. J Biomed Mater Res Symp 1971; 1: 43-58.
49. Racey GL, Wallace WR, Cavalaris J, Marguard JV. Comparison of a polyglycolic-polylactic acid suture to black silk and plain catgut in human oral tissues. J Oral Surg 1978; 36: 766-770.
50. Cutright DE, Hunsuck EE. Tissue reaction to the biodegradable polylactic acid suture. J Oral Surg 1971; 31: 134-139.
51. Kulkarni RK, Moore G, Hegyeli AF, Leonard F. Biodegradable poly(lactic acid) polymers. J Biomed Mater Res 1971; 5: 169-181.
52. Kulkarni RK, Pani KC, Neuman C, Leonard F. Polylactic acid for surgical implants. Arch Surg 1966; 93: 839-843.
53. Cutright DE, Beasley JD, Perez B. Histologic comparison of polylactic: and polyglycolic acid sutures. J Oral Surg 1971; 32: 165-173.
54. Cutright DE, Hunsuck EE, Beasley JD. Fracture reduction using a biodegradable material, polylactic acid. J Oral Surg 1971; 29: 393-397.
55. Rokkanen P, Böstman O, Vainionpää S et al. Biodegradable implants in fracture fixation: early results of treatment of fractures of the ankle. Lancet 1985; 1: 1422-1424.
56. Böstman O, Vainionpää S, Hirvensalo E et al. Biodegradable internal fixation for malleolar fractures. J Bone Joint Surg 1987; 69-B: 615-619.
57. Böstman O, Hirvensalo E, Vainionpää S et al. Ankle fractures treated using biodegradable internal fixation. Clin Orthop Related Res 1989; 238: 195-203.
58. Böstman O, Hirvensalo E, Vainionpää S, Vihtonen K, Törmälä P, Rokkanen P. Degradable polyglycolide rods for the internal fixation of displaced bimalleolar fractures. Int Orthop (SICOT) 1990; 14: 1-8.
59. Hirvensalo E. Fracture fixation with biodegradable rods. Acta Orthop Scand 1989; 60: 601-606.
60. Böstman O, Hirvensalo E, Mäkinen J, Rokkanen P. Foreign-body reactions to fracture fixation implants of biodegradable synthetic polymers. J Bone Joint Surg 1990; 72-B: 592-596.
61. Gerbert J. Effectiveness of absorbable fixation devices in Austin bunionectomies. J Am Pediat Med Assoc 1992; 82: 189-195.
62. Hirvensalo E, Böstman O, Vainionpää S, Törmälä P, Rokkanen P. Biodegradable fixation in intraarticulate fractures of the elbow joint. Acta Orthop Scand Suppl 1988; 227: 78-79.
63. Hoffmann R, Krettek C, Haas N, Tscherne H. Die distale Radiusfraktur. Frakturstabilisierung mit biodegradablen Osteosynthes Stiften (Biofix). Exper Unters Klinische Erfahrungen 1989; 92: 430-434.
64. Casteleyn PP, Handelberg F, Haentjens P. Biodegradable rods versus Kirschner wire fixation of wrist fractures. J Bone Joint Surg 1992; 73-B: 858-861.
65. Böstman O, Mäkelä EA, Törmälä P, Rokkanen R. Transphyseal fracture fixation using biodegradable pins. J Bone Joint Surg 1989; 71-B: 706-707.
66. Bos RRM, Boering G, Rozema FR, Leenslag JW. Resorbable poly(L-lactide) plates and screws for the fixation of zygomatic fractures. J Oral Maxillofac Surg 1987; 45: 751-753.
67. Gerlach KL. Treatment of zygomatic fractures with biodegradable poly(L-lactide) plates and screws. Clinical implant materials. In: Heimke G, Soltesz U, Lee ACJ, eds. Advances in Biomaterials. Amsterdam: Elsevier, 1990: 573-578.
68. Bergsma EJ, Rozema FR, Bos RRM, deBruijn WC. Foreign body reactions to resorbable poly(L-lactide) bone plates and screws used for the fixation of unstable zygomatic fractures. J Oral Maxillofac Surg 1993; 51: 666-670.
69. Böstman O. Current concepts review: absorbable implants for fixation of fractures. J Bone Joint Surg 1991; 73-A: 148-153.
70. Daniels AU, Chang MKO, Andriano KP. Mechanical properties of biodegradable polymers and composites proposed for internal fixation of bone. J Appl Biomater 1990; 1: 57-78.
71. Törmälä P, Vainionpää S, Kilpikari J, Rokkanen P. The effects of fibre reinforcement and gold plating on the flexural and tensile strength of PGA/PLA copolymer materials in vitro. Biomaterials 1987; 8: 42-45.
72. Törmälä P, Vasenius J, Vainiompää S, Pohjonen T, Rokkanen P, Laiho J. Ultra high strength absorbable self-reinforced polyglycolide (SR-PGA) composite rods for internal fixation of bone fractures: in vitro and in vivo study. J Biomed Mater Res 1991; 25: 1-22.
73. Ruuskanen MM, Kallioinen MJ, Kaarela OI, Laiko JA, Törmälä PO, Waris TJ. The role of polyglycolic acid rods in the regeneration of cartilage from perichondrium in rabbits. Scand J Plast Reconstruct Hand Surg 1991; 25: 15-18.
74. Majola A, Vainionpää S, Vihtonen K et al. Absorption, biocompatibility and fixation properties of polylactic acid in bone tissue: an experimental study in rats. Clin Orthop Related Res 1991; 268: 260-269.
75. Athanasiou KA, Singhal AR, Agrawal CM, Boyan BD. In vitro degradation and release characteristics of biodegradable implants containing trypsin inhibitor. Clin Orthop Related Res 1995; 315: 272-281.
76. Mikos AG, Bao Y, Cima LG, Ingber DE, Vacanti JP, Langer R. Preparation of poly(glycolic acid) bonded fiber structures for cell attachment and transplantation. J Biomed Mater Res 1993; 27: 183-189.
77. Freed LE, Marquis JC, Nohria A, Emmanual J, Mikos AG, Langer R. Neocartilage formation in vitro and in vivo using cells cultured on synthetic biodegradable polymers. J Biomed Mater Res 1983; 27: 11-23.
78. Schmitz JP, Hollinger JO. A preliminary study of the osteogenic potential of a biodegradable alloplasticosteoinductive alloimplant. Clin Orthop Related Res 1988; 245-255.
79. Hollinger JO, Schmitz JP. Restoration of bone discontinuities in dogs using a biodegradable implant. J Oral Maxillofac Surg 1987; 45: 594-600.
80. Heckman JD, Boyan BD, Aufdemorte TB, Abbott JT. The use of bone morphogenetic protein in the treatment of non-union in a canine model. J Bone Joint Surg 1991; 74-A: 750-764.
81. Agrawal CM, Best J, Boyan BD, Heckman JD. In vitro protein release characteristics of a bioabsorbable carrier of BMP for fracture non-unions. Trans ORS 1994; 19: 602.
82. Agrawal CM, Best J, Boyan BD, Heckman JD. Protein release kinetics of a biodegradable implant used for delivering BMP to fracture non-unions. The 20th Annual Meeting of the Society for Biomaterials, 1994: 95.
83. Turk AE, Ishida K, Jensen JA, Wollman JS, Miller TA. Enhanced healing of large cranial defects by an osteoinductive protein in rabbits. J Plast Reconstruct Surg 1993; 92(4): 593-600.
84. Kenley R, Marden L, Turek T, Jin L, Ron E, Hollinger JO. Osseous regeneration in the rat calvarium using novel delivery systems for recombinant human bone morphogenetic protein-2 (rhBMP-2). J Biomed Mater Res 1994; 28: 1139-1147.
85. Lee, SC, Shea M, Battle MA et al. Healing of large segmental defects in rat femurs is aided by RhBMP-2 in PLGA matrix. J Biomed Mater Res 1994; 28: 1149-1156.
86. Brady JM, Cutright DE, Miller RA, Battistone GC. Resorption rate, route of elimination, and ultrastructure of the implant site of polylactic acid in the abdominal wall of the rat. J Biomed Mater Res 1973; 7: 155-166.
87. Miller RA, Brady JM, Cutright DE. Degradation rates of oral resorbable imlants (polylactates and polyglycolates): rate modification with changes in PLA/PGA copolymer ratios. J Biomed Mater Res 1977; 11: 711-719.
88. Varma S, Lumb WV, Johnson LW, Ferguson HL. Further studies with polyglycolic acid (Dexon) and other sutures in infected experimental wounds. Am J Vet Res 1981; 4: 571-574.
89. Walter EP, Waldhausen JA, Prophet A, Pierce WS. Primary vascular anastomosis in growing pigs: comparison of polypropylene and polyglycolic acid sutures. J Thoracic Cardiovasc Surg 1981; 81: 921-927.
90. Christel P, Chabot F, Leray JL, Morin C, Vert M. Biodegradable composites for internal fixation. In: Winters GL, Gibbons DF, Plenk H, eds. Biomaterials 1980. John Wiley & Sons, 1982: 271-280.
91. Salthouse TN. Tissue response to sutures. In: Rubin LR, ed. Biomaterials in Reconstructive Surgery. St. Louis: Mosby, 1983: 131-142.
92. Higashi S, Yamamuro T, Nakamura T, Ikada Y, Hyon S-H, Jamshidi K. Polymer-hydroxyapatite composites for biodegradable bone fillers. Biomaterials 1986; 7: 183-187.
93. Leenslag JW, Pennings AJ, Bos RRM, Rozema FR, Boering G. Resorbable materials of poly(L-lactide): VI. Plates and screws for internal fracture fixation. Biomaterials 1987; 8: 70-73.
94. Schakenraad JM, Nieuwenhues P, Molenaar I, Helder J, Dykstra PJ, Feijen J. In vivo and in vitro degradation of glycine/DL-lactic acid copolymers. J Biomed Mater Res 1989; 23: 1271-1288.
95. Cooper ML, Hansbrough JF, Spielvogel RL, Cohen R, Bartel RL, Naughton G. In vivo optimization of a living dermal substitute employing cultured human fibroblasts on a biodegradable polyglycolic acid or polylactin mesh. Biomaterials 1991; 12: 243-248.
96. Böstman O, Päivärinta U, Partio E et al. The tissue-implant interface during degradation of absorbable polyglycolide fracture fixation screws in the rabbit femur. Clin Orthop Related Res 1992; 285: 263-272.
97. Kobayashi H, Shiraki K, Ikada Y. Toxicity test of biodegradable polymers by implantation in rabbit cornea. J Biomed Mater Res 1992; 26: 1463-1476.
98. Robert P, Mauduit J, Frank RM, Vert M. Biocompatibility and resorbability of a polylactic acid membrane for periodontal guided tissue regeneration. Biomaterials 1993; 14: 353-358.
99. Wetter LA, Dinneen MD, Levitt MD, Motson RW. Controlled trial of polyglycolic acid versus catgut and nylon for appendicectomy wound closure. Br J Surg 1991; 78: 985-987.
100. Fraser RK, Cole WG. Osteolysis after biodegradable pin fixation of fractures in children. J Bone Joint Surg 1992; 74-B: 929-930.