Metal-on-metal hip prostheses have been in use clinical since 1960s, and their safety and efficacy has never been reviewed adequately. The current reports of metal-on-metal hip implants’ failure have led to health concernsits. Literature review has been showing diverse changes. Clinical studies have been conducted to ascertain the usefulness of the technology in regard to its safety and efficacy. Ordinarily, metal-on-metal total hip implants are believed to release toxic substances in the patient’s body, causing significant health concerns of the technology.
Therefore, this paper will provide a critical review on the evidence for the safety and efficacy of metal-on-metal hip prostheses, primarily with regard to its insufficiency.
Inhaltsverzeichnis (Table of Contents)
- Abstract
- Introduction
- Materials and Design
- Device Composition
- Clinical Safety and Efficacy
- Conclusion
Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)
This paper critically examines the evidence for the safety and efficacy of metal-on-metal hip prostheses, focusing on the insufficiency of the evidence provided by regulatory agencies. It highlights the potential risks associated with these implants, specifically the release of toxic substances into the patient's body.
- Safety and efficacy of metal-on-metal hip prostheses
- Role of regulatory agencies in technology assessment
- Insufficient evidence base for device approval
- Potential health risks associated with metal-on-metal implants
- Ethical considerations in device clearance and marketing
Zusammenfassung der Kapitel (Chapter Summaries)
- Abstract: Briefly outlines the concerns surrounding the safety and efficacy of metal-on-metal hip implants, highlighting the lack of adequate review and the rising reports of failures.
- Introduction: Discusses the history of metal-on-metal hip prostheses and the increasing concerns regarding their safety and efficacy. It emphasizes the potential release of toxic substances into the body and the need for a critical review of the evidence.
- Materials and Design: Describes the specific materials used in the analysis, including the Cormet Hip Resurfacing System and Birmingham Hip Resurfacing System, and the analytical method (Cox regression model).
- Clinical Safety and Efficacy: Analyzes the literature and argues that FDA's approval of metal-on-metal hip implants was based on insufficient evidence, highlighting instances of negligence in their evaluation and clearance processes. It also presents testimonies from surgeons who have witnessed high failure rates and the potential dangers of these devices.
Schlüsselwörter (Keywords)
Metal-on-metal hip prostheses, safety and efficacy, regulatory agencies, insufficient evidence, toxic substances, health risks, FDA, technology assessment, ethical considerations.
- Citar trabajo
- Patrick Kimuyu (Autor), 2017, The Evidence for the Safety and Efficacy of Metal-On-Metal Hip Prostheses, Múnich, GRIN Verlag, https://www.grin.com/document/381238
