| Foreword | 5 |
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| Preface | 6 |
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| Contents | 7 |
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| Contributors | 11 |
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| Overview | 15 |
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| APPENDIX | 21 |
| APPENDIX (Continued) | 22 |
| APPENDIX (Continued) | 23 |
| APPENDIX (Continued) | 24 |
| APPENDIX (Continued) | 25 |
| REFERENCES | 26 |
| Assessment of Surveillance Test Performance and Cost | 27 |
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| EPIDEMIOLOGICAL PRINCIPLES FOR EVALUATING DIAGNOSTIC TEST PERFORMANCE IN SCREENING FOR DEVICE MALFUNCTION OR INFECTION Overview | 28 |
| DIAGNOSTIC TEST CHARACTERISTICS Validity | 28 |
| LIKELIHOOD RATIOS | 31 |
| REQUIREMENTS FOR ESTABLISHING A SCREENING PROGRAM | 32 |
| RECEIVER OPERATING CHARACTERISTIC CURVE | 32 |
| THRESHOLDS FOR TREATMENT | 33 |
| THRESHOLDS FOR TESTING | 34 |
| ECONOMIC PRINCIPLES OF FOLLOW-UP EVALUATION Overview of Cost Analysis | 36 |
| SUMMARY | 44 |
| REFERENCES | 44 |
| Costs of Follow-Up After Implantation of Prosthetic Devices | 47 |
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| METHODS | 48 |
| RESULTS | 49 |
| COMMENT | 57 |
| REFERENCES | 59 |
| Factors That Should Shape Clinical Strategies | 60 |
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| ETHICAL AND LEGAL ISSUES | 67 |
| DURATION OF SURVEILLANCE | 68 |
| SECONDARY BENEFITS OF FOLLOW-UP | 68 |
| PRIMARY PREVENTION OF DISEASE | 68 |
| SUMMARY | 71 |
| REFERENCES | 72 |
| A View From the US Food and Drug Administration* | 74 |
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| INTRODUCTION | 74 |
| PREMARKET REVIEW Background | 76 |
| POSTMARKET OVERSIGHT Overview | 86 |
| SPECIAL TOPICS Access to Information | 95 |
| REFERENCES | 98 |
| Societal Issues | 101 |
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| TECHNOLOGY AND SOCIETY | 101 |
| TECHNOLOGY AND HISTORY | 101 |
| COSTS | 102 |
| MANAGED CARE | 103 |
| IMPLANTED TECHNOLOGY | 104 |
| BREAST IMPLANTS Background | 104 |
| THE BJORK-SHILEY CONVEXO-CONCAVE ARTIFICIAL HEART VALVE Background | 108 |
| COCHLEAR IMPLANTS (40)* Background | 118 |
| THE TOTAL ARTIFICIAL HEART Background | 120 |
| SOCIETAL ISSUES IN IMPLANTED MEDICAL DEVICES | 123 |
| PROFESSIONAL AND CONSUMER MODELS OF HEALTH CARE | 124 |
| REFERENCES | 124 |
| Databases for Studying the Epidemiology of Implanted Medical Devices* | 127 |
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| INTRODUCTION | 127 |
| SYSTEMATIC NEW DATA COLLECTION | 128 |
| GATHERING AND SYNTHESIS OF EXISTING PATIENT DATA AND STUDIES | 131 |
| FUTURE OF DATABASES FOR STUDYING THE EPIDEMIOLOGY OF IMPLANTED DEVICES Increasing Technological Sophistication of Patient Data | 139 |
| ACKNOWLEDGMENT | 140 |
| REFERENCES | 140 |
| Tissue Reaction to Prosthetic Materials | 145 |
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| INTRODUCTION | 145 |
| MATERIALS USED IN PROSTHESES | 146 |
| MOLECULAR AND CELLULAR EVENTS OF HOMEOSTASIS | 154 |
| HISTOPATHOLOGY OF EXPLANTED PROSTHESES Dental | 159 |
| FUTURE TRENDS IN PROSTHETIC DESIGN | 165 |
| REFERENCES | 165 |
| Prevention of Infection in Prosthetic Devices | 171 |
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| INTRODUCTION | 171 |
| GENERAL PRINCIPLES OF INFECTION PREVENTION IN PROSTHETIC DEVICES Preoperative Measures | 173 |
| INDIVIDUAL CHARACTERISTICS OF THE MOST COMMONLY USED PROSTHETIC DEVICES Breast Implants | 176 |
| SUMMARY | 190<
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