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Biological Responses to Metal Implants

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Biological Responses to Metal Implants Biological Responses to Metal Implants U.S. Food and Drug Administration Center for Devices and Radiological Health Office of Product Evaluation and Quality Office of Science Engineering and Laboratories September 2019 i | Page www.fda.gov TABLE OF CONTENTS 1 Introduction ...................................................................................................................................... 1 2 Background: Definitions, History, and Landscape ............................................................................ 3 3 Metals in Human Physiology and Pathology ..................................................................................... 5 3.1 Introduction .................................................................................................................................. 5 3.2 Essential Trace Metal Elements .................................................................................................... 6 3.3 Non-Essential Metals .................................................................................................................... 7 4 Current Nonclinical Pre-market Evaluation of Metal Implants ......................................................... 9 4.1 Introduction .................................................................................................................................. 9 4.2 Biocompatibility .......................................................................................................................... 10 4.2.1 Sensitization ........................................................................................................................ 10 4.2.2 Implantation ........................................................................................................................ 12 4.2.3 Inflammatory Response ...................................................................................................... 12 4.2.4 Genotoxicity and Carcinogenicity ....................................................................................... 13 4.2.5 Systemic Toxicity ................................................................................................................. 14 4.3 CDRH’s Immunotoxicity Guidance .............................................................................................. 16 5 Corrosion and Metal Ion Release .................................................................................................... 17 5.1 Introduction ................................................................................................................................ 17 5.2 Corrosion Susceptibility .............................................................................................................. 19 5.2.1 Physiological Environment .................................................................................................. 19 5.2.2 Mechanical Interactions ...................................................................................................... 20 5.2.3 Active Devices ..................................................................................................................... 20 5.2.4 Processing ........................................................................................................................... 22 5.3 In Vitro Corrosion Testing ........................................................................................................... 22 5.3.1 General Corrosion ............................................................................................................... 22 5.3.2 General Corrosion - Active Implants ................................................................................... 23 5.3.3 Pitting Corrosion ................................................................................................................. 24 5.3.4 Crevice Corrosion ................................................................................................................ 25 5.3.5 Fretting ................................................................................................................................ 25 5.3.6 Galvanic Corrosion .............................................................................................................. 25 5.4 In Vivo Corrosion ......................................................................................................................... 26 i | Page www.fda.gov 5.4.1 Corrosion in Cardiovascular Devices ................................................................................... 27 5.4.2 Corrosion in Orthopedic Devices ........................................................................................ 27 5.4.3 Corrosion in Active Devices ................................................................................................. 28 5.4.4 Correlation to In Vitro Testing ............................................................................................. 28 6 Subclinical Response to Metal Implants ......................................................................................... 31 6.1. Introduction ................................................................................................................................ 31 6.1 Wound Healing ........................................................................................................................... 32 6.1.1 Foreign Body Response (FBR) ............................................................................................. 33 6.2. Innate Immune Responses To Metal Implants ........................................................................... 34 6.2.1. Innate Immune Recognition of Metals ............................................................................... 34 6.2.2. Innate Cellular Responses to Metals ................................................................................... 35 6.3. Adaptive Immune Responses to Metal Implants ........................................................................ 37 6.4. Tissue and Organ Localization of Inflammatory Responses to Metal Implants .......................... 39 6.4.1. Orthopedic Devices ............................................................................................................. 39 6.4.2. Neurologic Devices .............................................................................................................. 40 6.4.3. Cardiovascular Devices ....................................................................................................... 41 6.4.4. Oral and Dental Implants .................................................................................................... 42 6.4.5. Urogenital Devices .............................................................................................................. 43 6.5. Conclusions, Summary, Inflammatory Regulation Underlying Clinical Outcomes ..................... 43 7 Clinical Response to Metal Implants ............................................................................................... 45 7.1 Introduction ................................................................................................................................ 46 7.2 Terminology Pertaining to Potential Clinical, Imaging, and Morphological Manifestations of Metal Implant-Related Adverse Outcomes ............................................................................................ 46 7.2.1 Systemic ARMDs ................................................................................................................. 48 7.2.2 Elevated Metal Ion Levels ................................................................................................... 48 7.2.3 Different Manifestations of Systemic Hypersensitivity and Inflammation ......................... 49 7.3 Sex-Related Issues in Clinical Responses to Metal Implants ....................................................... 51 7.4 Clinical Observations and Investigations of Systemic Responses to Metal Implants ................. 51 7.4.1 Cardiotoxicity ...................................................................................................................... 51 7.4.2 Neurotoxicity ....................................................................................................................... 52 7.4.3 Thyroid toxicity ................................................................................................................... 52 7.4.4 Cancer ................................................................................................................................. 52 7.5 Specific Device Areas .................................................................................................................. 54 ii | Page www.fda.gov 7.5.1 Orthopedic devices ............................................................................................................. 54 7.5.2 Cardiac and Endovascular Implants .................................................................................... 57 7.5.3 Dental and Oral/Maxillofacial Devices ................................................................................ 60 7.5.4 Neurological Devices ........................................................................................................... 62 7.5.5 Gastroenterological Devices ............................................................................................... 63 7.5.6 Gynecological devices ........................................................................................................
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