Toxicological Aspects of Medical Device Implants

Description

Toxicological Aspects of Medical Device Implants provides comprehensive information on the use of medical implant and devices and the balance between the application of the devices in relation to any potential adverse effects. In order to ensure the safety and effectiveness of medical devices, many international policies, regulations, and standards have been established, and the book also discusses medical devices within this regulatory framework. The book covers a broad range of disease topics and disease-specific implants and an interdisciplinary team of experts brings a wealth of information on implants used in various disease models and associated risk factors. Toxicological Aspects of Medical Device Implants is a comprehensive resource for toxicologists, biomedical engineers, immunologists, medical staff, regulators, and manufacturers working in the field who need to be aware of the potential toxicity and device management of such a wide variety of implants and devices and their health risks. Cover Toxicological Aspects of Medical Device Implants Copyright Contents List of contributors About the editors one Introduction to medical implants 1.1 Introduction to medical implants 1.1.1 What is a medical implant? 1.1.2 History of medical implants 1.1.3 Medical implant types and materials for implants 1.1.4 Implant materials and purpose 1.1.4.1 Implants categories and application 1.1.4.1.1 Physical Sensing and neurology 1.1.4.1.2 Heart and blood vessels 1.1.4.1.3 Orthopaedic 1.1.4.1.4 Electric 1.1.4.1.5 Contraception 1.1.4.1.6 Cosmetic 1.1.4.1.7 Other systems 1.1.5 Medical implants design considerations 1.1.5.1 Design and structure of implantable devices 1.1.5.2 Implantable medical device energy source 1.1.5.3 Data transfer and monitoring 1.1.6 Biological environment/medium 1.1.6.1 Biocompatibility and sterilization 1.1.6.2 Corrosion environment 1.1.6.3 Medical implant device stability 1.1.6.4 Inflammatory response and process 1.1.6.5 Chronic inflammation and mechanical forces 1.1.7 Standards for medical implants Benefits to audience Further reading Sec1 two Dermatology/cosmetics 2.1 Introduction 2.2 Dermal implants 2.3 Body modifications by implants 2.3.1 Subdermal implants 2.3.2 Transdermal implants 2.4 Hair transplant 2.5 MRI as a tool for imaging implants 2.6 Cosmetic surgeon as a career 2.7 Considerations before cosmetic procedures References three Ophthalmology and Otorhinolaryngology 3.1 Ophthalmic implants 3.1.1 Introduction 3.1.2 Implants 3.1.3 Corneal implants 3.1.3.1 Keratoprosthesis 3.1.3.2 Intracorneal ring segments 3.1.4 Orbital implants 3.1.4.1 Anophthalmic implants 3.1.4.2 Hydroxyapatite orbital implant 3.1.5 Extraocular implants (eyeball jewelry) 3.1.6 Intraocular lenses 3.1.6.1 Multifocal IOL 3.1.6.2 Aspheric IOL 3.1.6.3 Anterior chamber IOL 3.1.6.4 Scleral-fixated IOL 3.1.6.5 Phakic IOL 3.1.7 Implants used in the posterior chambers 3.1.7.1 Biodegradable implants 3.1.7.1.1 Biodegradable implants for IOL drug delivery 3.1.7.1.2 Biodegradable implants used in postcataract surgery 3.1.7.1.3 Biodegradable implants used in uveitis 3.1.7.1.4 Advantages and disadvantages of using biodegradable implants 3.1.7.2 Nonbiodegradable implants 3.1.7.2.1 Nonbiodegradable implants for cytomegalovirus retinitis 3.1.7.2.2 Nonbiodegradable implants for uveitis 3.1.7.2.3 Nonbiodegradable implants for diabetic retinopathy 3.1.7.2.4 Advantages and disadvantages of using nonbiodegradable implants 3.1.8 Implants for glaucoma surgery 3.1.8.1 Glaucoma valve implants 3.1.8.2 Implants for nonpenetrating glaucoma surgery 3.1.9 Scleral buckle 3.1.10 Intubation in lacrimal surgery 3.1.11 Glaucoma surgical implants/glaucoma drainage device 3.1.12 Ocular stents 3.1.13 Silicon tubes 3.1.14 Conclusion 3.2 Medical implants in Otorhinolaryngology [Ear, Nose, Throat (ENT)] 3.2.1 Grommets 3.2.2 Epidemiology 3.2.3 Effectiveness based on clinical evidence 3.2.4 Safety 3.2.5 Hearing aid (Cochlear implants) 3.2.5.1 Introduction 3.2.5.2 Safety of cochlear implants and complications 3.2.5.3 Regarding revision implantations 3.2.5.4 Indications of cochlear implant revisions 3.2.5.5 Principles of reporting on device failure 3.2.5.6 Complications 3.2.5.6.1 Bacterial meningitis 3.2.5.6.2 Safety considerations 3.2.5.6.3 Risk management 3.2.6 Conclusion References four Dental 4.1 Introduction 4.2 Diagnostic dental devices 4.2.1 Pulp tester and electrode gel for testing 4.2.2 Dental X-rays and their segments 4.2.3 Intraoral and extraoral source system 4.2.4 X-ray position-indicating device and collimators 4.3 Prosthetic devices 4.3.1 Dental amalgam 4.3.1.1 Biocompatibility and mercury toxicity 4.3.2 Dental materials and cement 4.3.2.1 Zinc oxide eugenol 4.3.2.2 Composites 4.3.3 Metal crowns Lichen planus and other metal allergies 4.3.3.1 Gold foil 4.3.4 Dental casting alloys 4.3.4.1 Causes for alloy-related reactions 4.3.5 Dental implants 4.3.5.1 Endosseous implants 4.3.5.2 Subperiosteal implants 4.3.6 Resin tooth bonding agent 4.3.6.1 Acrylic resins in denture reliners and cushion or pads 4.3.7 Denture adhesives 4.3.8 Gutta-percha 4.3.9 Root canal filling resin 4.3.10 Temporary crown and bridge resin 4.4 Surgical devices 4.4.1 Gas powered jet injectors 4.4.2 Spring-loaded jet injector 4.4.2.1 Splash-back 4.4.2.2 Fluid suck-back 4.4.2.3 Retrograde flow 4.4.3 Dental diamond bur 4.4.4 Dental operating light 4.4.5 Rotary scalers 4.4.6 Bone-cutting instruments 4.4.7 Drill 4.4.8 Burs 4.4.9 Intraoral dental drill 4.5 Therapeutic devices 4.5.1 Teething rings 4.5.2 Orthodontic headgear 4.5.3 Intraoral devices for snoring 4.6 Miscellaneous devices 4.6.1 Dental floss 4.6.2 Endodontic dry heat sterilizer 4.6.3 Glass bead sterilizer 4.6.4 Manual toothbrush 4.7 Conclusion References five Cardiology 5.1 Introduction 5.2 Implanted medical devices in treatment of cardiovascular disease 5.3 Selection of cardiovascular implantable device properties to avoid its toxicological aspects 5.4 Implantable cardiovascular devices and their toxicity 5.4.1 Implantable blood pressure monitors in endovascular repair 5.4.2 Coronary stents 5.4.3 Permanent pacemakers 5.4.4 Leadless pacemakers 5.4.5 Cardiac resynchronization therapy 5.4.6 Leadless cardiac resynchronization therapy 5.5 Implantable cardioverter-defibrillator 5.5.1 Subcutaneous implantable cardioverter-defibrillator 5.5.2 Implantable loop recorders 5.5.3 Left ventricular assist device 5.6 Latest innovative technologies in implantable cardiovascular devices 5.6.1 HeartWare ventricular assist device pump 5.6.2 HeartMate 3 5.6.3 Cardialen 5.6.4 Watchman 5.6.5 Parachute implant 5.7 Tissue-engineered implants in cardiovascular diseases management 5.8 Smart cardiovascular implants and technologies that overcome its toxicological aspects 5.9 Cardiovascular implant-induced toxicity and management methods 5.10 Marketing strategies and regulations to prevent cardiovascular implant-induced toxicity 5.11 Conclusion References six Breasts and birth control 6.1 Introduction 6.2 Breasts implant 6.2.1 Breasts implant technique 6.2.2 Breasts implant rupture 6.2.3 Breasts implant complications 6.2.4 Breasts implant–associated anaplastic large cell lymphoma 6.2.5 Effect of breasts implant on breastfeeding 6.2.6 Capsular contracture 6.3 Birth control implant 6.3.1 The implant as long-acting reversible contraceptives 6.3.2 Subdermal BCI: mode of action and side effects 6.3.3 Effectiveness of BCI 6.3.4 Return to fertility 6.3.5 Acceptability among users 6.4 Conclusion Conflict of interest References seven Gastroenterology 7.1 Introduction 7.2 Commonly used implants in gastrointestinal tract disorders 7.2.1 LINX reflux management system 7.2.2 Adjustable gastric band 7.2.3 Gastric electrical stimulation 7.3 Adverse effects of gastric electrical stimulator 7.4 Adverse effects of magnetic sphincter augmentation 7.5 Adverse effects of endoscopic duodenal–jejunal bypass liner 7.6 Adverse effects of bile duct endoprosthesis 7.7 Adverse effects of long nasointestinal tubes 7.8 Conclusion References eight Obstetrics and gynecology Highlights 8.1 Introduction to medical devices used in obstetrics and gynecology 8.2 Biocompatibility of OB/GYN devices 8.3 Regulatory requirements of the devices 8.3.1 Reclassification of “single-use female condom” into “multiple-use condom” by US-FDA [25] 8.3.1.1 Description of the device and its regulation history 8.3.1.2 Reclassification of the device 8.4 Toxicity of the devices—scientific evidences denoting their hazardous effect 8.4.1 Urogynecologic surgical mesh implants 8.4.2 Contraceptive devices 8.4.3 Intrauterine devices 8.5 Types of OB/GYN devices 8.6 Applications of OB/GYN devices [37] 8.7 Market range of the OB/GYN devices [38] 8.8 Conclusion References nine Urology and nephrology 9.1 Introduction 9.1.1 Urology diseases and incidence 9.1.2 Importance of medical devices and implants 9.1.3 Development of implants 9.1.4 Toxicological testing and its importance 9.2 Ureteral obstruction 9.2.1 Etiology 9.2.2 Pathophysiology of ureteral obstructions 9.2.3 Implants used to treat ureteral obstruction 9.2.4 Complications of ureteral stents used 9.2.4.1 Stent discomfort (irritative bladder symptom) 9.2.4.2 Ureteral peristalsis 9.2.4.3 Stent migration 9.2.4.4 Stent-induced urinary tract infections 9.2.4.5 Stent encrustation 9.2.5 Toxicological evaluation of ureteral stents 9.3 Urinary incontinence 9.3.1 Etiology 9.3.2 Pathophysiology of urinary incontinence 9.3.3 Types of urinary incontinence (Fig. 9.2) 9.3.4 Implants used for urinary incontinence 9.3.5 Complications of implants for the urinary incontinence 9.4 Prostate cancer 9.4.1 Etiology 9.4.2 Pathophysiology of prostate cancer 9.4.3 Implants used in the prostate cancer 9.4.3.1 External beam radiation therapy 9.4.3.2 Internal radiation therapy (brachytherapy) 9.4.4 Complications of implants used 9.4.5 Testing of implants used for prostate cancer 9.5 Erectile dysfunction 9.5.1 Etiology 9.5.2 Pathophysiology of erectile dysfunction 9.5.3 Implants used to treat erectile dysfunction 9.5.4 Complications of penile prosthesis 9.5.5 Toxicological evaluation of penile prosthesis 9.6 Aspects of toxicological evaluation of urological implants 9.6.1 Efficacy or performance testing of urological implants 9.6.2 Toxicity testing of urological implants 9.6.3 Role of pathology in safety evaluation of urology implants 9.7 Future trends in the development of urology and nephrology implants and conclusions References ten Orthopedics 10.1 Introduction 10.2 Factors affecting metal-induced toxicity 10.2.1 Wear 10.2.2 Composition of wear particles 10.2.3 Metal ions shape and chemistry 10.3 Adverse effect of metal ions 10.3.1 Local adverse effect of metal debris 10.3.2 Cell damage due to metal debris 10.3.3 Periprosthetic immune response 10.3.4 Pseudotumor 10.4 Metal ion-associated systemic toxicity 10.5 Immunotoxicity 10.5.1 Immune hyporeactivity or immune suppression 10.6 Patient management 10.7 Conclusion References eleven Neurology and psychiatry Highlights List of abbreviations 11.1 Introduction 11.1.1 Background 11.2 Types of neural implants 11.2.1 Deep brain stimulator 11.2.2 Spinal cord stimulator 11.2.3 Vagus nerve stimulator 11.2.4 Implants for mood disorders 11.2.5 Implants for epilepsy 11.2.6 Neuro surgical implants 11.2.7 Brachytherapy (radiation implants) 11.2.8 Sacral neuromodulation 11.2.9 Median nerve stimulation 11.2.10 Robotic therapy 11.3 Neurophysiology and mechanism of implants 11.3.1 Brain–machine and neural interface 11.3.2 Neural plasticity 11.3.3 Neural prostheses 11.3.4 EcoG systems 11.3.5 Neurorehabilitation and electrical stimulation 11.4 Toxicological effects of neural implants 11.4.1 Side effects of DBS electric implants 11.4.2 Adverse effects of sacral neuromodulation 11.4.3 Blood–brain barrier disruption in intracortical implants 11.4.4 Adverse effects of brachytherapy 11.4.5 Biocompatibility and neurotoxicity of metals used for neural repairs 11.4.6 Diagnosis and treatment of metallosis-induced toxicity 11.4.7 Foreign body response as a cause of implant failure 11.4.8 Astrocytes damage 11.4.9 Acute vascular damage and hemorrhage 11.4.10 Ethical concern of neural implant 11.5 Conclusion and future directions References Further reading Index Back Cover