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There is no such thing as a biocompatible material.

David F Williams1

  • 1Wake Forest Institute of Regenerative Medicine, Winston-Salem, NC, USA; Christiaan Barnard Department of Cardiothoracic Surgery, University of Cape Town, South Africa; Tsinghua University, Beijing, China; Shanghai Jiao Tong University, Shanghai, China; Biomedical Materials, Taipei Medical University, Taiwan; University of Liverpool, UK; Editor-in-Chief, Biomaterials.

Biomaterials
|September 30, 2014
PubMed
Summary

Biocompatibility is not an inherent material property but a system characteristic. Using "intrinsically biocompatible system" accurately describes biomaterial-host interactions, avoiding assumptions of universal material suitability.

Keywords:
BiocompatibilityHost responseImmunityInflammationPathwaysToxicity

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Area of Science:

  • Biomaterials Science
  • Translational Medicine
  • Regulatory Science

Background:

  • The term 'biocompatible' is frequently used to describe a material property in biomaterials science.
  • This characterization has significant implications for selecting biomaterials and understanding their performance.
  • Current usage often oversimplifies the complex interactions between materials and biological systems.

Purpose of the Study:

  • To critically evaluate the scientific rationale behind the term 'biocompatible'.
  • To propose a more precise terminology for describing the interaction between biomaterials and biological hosts.
  • To address the potential risks associated with the assumption of universal biocompatibility.

Main Methods:

  • This paper presents a conceptual analysis and linguistic argument.
  • It reviews the scientific literature and clinical performance data related to biomaterial interactions.
  • The discussion focuses on the systemic nature of biocompatibility.

Main Results:

  • Biocompatibility is a property of the entire system (material + host), not an intrinsic material property.
  • The term 'biocompatible material' is scientifically inaccurate and potentially misleading.
  • Clinical performance in one context does not guarantee performance in another.

Conclusions:

  • The phrase 'intrinsically biocompatible system' is recommended for scientific, regulatory, and legal contexts.
  • This precise terminology enhances the scientific rationale for biomaterial selection and performance assessment.
  • Adopting accurate language is crucial for patient safety and effective biomaterial development.