Contemporary Biomaterials: Material and Host Response, Clinical Applications, New Technology, and Legal Aspects

Front Matter......Page 1
Preface......Page 3
Contributors......Page 6
Contents......Page 11
Section I The Status of Biomaterials......Page 28
1. Introduction......Page 29
2. Biomaterials: Magnitude of the Need......Page 32
3. Introduction of Biomaterials into Contemporary Medical Practice......Page 37
Section II Properties, Structure, and Performance of Biomaterials......Page 46
4. Predicting Performance of Materials: Introductory Comments and Critique......Page 47
5. Influence of Physico-Chemical Properties on Material Response: Morphology, Structure, and Interaction......Page 54
6. Mechanical Properties of Biomaterials: Relationship to Clinical Applications......Page 73
7. Metallurgical Observations of Biomaterials......Page 93
8. Surface Phenomena Associated with the in Vivo Behavior of Biomaterials......Page 119
Section III Host Response to Biomaterials......Page 154
9. Host Response: Biological Performance of Biomaterials in the Human Body......Page 155
10. Animal Models for Predicting Clinical Performance of Biomaterials for Cardiovascular Use......Page 159
11. Primary Toxicological Testing as a Means of Safe-Guarding the Patient......Page 207
12. Evaluation of the Blood Compatibility of Synthetic Polymers: Consensus and Significance......Page 220
13. Interrelationship between Biomaterials Behavior and the Living Organism......Page 232
14. Safety and Risk: Limits of Predictability for Biomaterials......Page 238
15. Historical and Future Perspectives of Biocompatibility Testing......Page 246
Section IV Clinical Experience with Biomaterials......Page 258
16. Clinical Benefits and Needs Attributed to Biomaterials......Page 259
17. Clinical Experience with Biomaterials in Oral and Maxillofacial Surgery......Page 281
18. Clinical Experience with Biomaterials for Orthopedic Applications......Page 345
19. Clinical Experience with Biomaterials for Reconstruction and Augmentation......Page 359
20. Clinical Experience with Biomaterials for Cardio-Vascular Applications: Current Assessment......Page 415
Section V New Biomaterials Technology......Page 470
21. Emerging Technologies in Biomaterials......Page 471
22. Present and Potential Biomedical Applications of Composite Materials Technology......Page 480
23. Calcium Phosphate Ceramics: Their Current Status......Page 504
24. Use of Porous Biomaterials for Tissue Ingrowth......Page 520
25. Inject Able Collagen for Soft Tissue Augmentation......Page 555
26. Biomaterials for Blood Purification Therapies......Page 564
27. Macromolecular Delivery Systems for Therapeutic Applications of Controlled Drug Release......Page 587
Section VI Economic, Regulatory, and Legal Aspects of New Biomaterials......Page 602
28. The Introduction and Use of New Biomaterials-A Summary......Page 603
29. Voluntary Standards for Biomaterials: Their Contribution to the Quality of Clinical Care......Page 606
30. Quality Control and Good Manufacturing Practices for Biomaterials......Page 629
31. The Cost Dilemma: The High Cost and Low Volume of Biomaterials......Page 634
32. FDA Regulations and Policy Regarding New Biomaterials......Page 653
33. Legal Aspects of Introducing New Biomaterials......Page 672
Appendix: National Institutes of Health Consensus Development Conference Statement on Clinical Applications of Biomaterials......Page 678
Index......Page 693