Definitions of Biomaterials for the Twenty-First Century

Xingdong Zhang, David Williams

• Publisher: Elsevier
• Year: 2019
• Print ISBN: 9780128182918
• eBook ISBN: 9780128182925
• Topic: Technology & Engineering
• Subtopic: Biotechnology in Medicine
• Index: Technology & Engineering

Definitions of Biomaterials for the Twenty-First Century is a review of key, critical biomaterial terms and definitions endorsed by the International Union of Societies for Biomaterials Science and Engineering. The topics and definitions discussed include those in general biomaterials and applications, biocompatibility, implantable and interventional devices, drug delivery systems, regenerative medicine and emerging biomaterials. The book reviews the discussion of these terms by leaders in the global biomaterials community and summarizes the agreed upon definitions.- Provides readers with the official definitions of critical biomaterials terms endorsed by the International Union of Societies for Biomaterials Science and Engineering- Includes the combined contributions from more than 50 global leaders in the biomaterials community- Updates terms based on the latest advances in clinical and scientific understanding and expanded scope of biomaterials science

IV

Biocompatibility and immune responses to biomaterials

Discussed in Session II and Final General Session

• Session II Plenary Presentation: James Anderson
• Session II Moderato: Andrés García
• Session II Reporter: Serena Best
• Final Session Moderator: David Williams
• Final Session Reporters: Carl Simon, Helen Lu, Serena Best

A Biocompatibility

(a) Possible Definitions of “Biocompatibility” Included in Final Program

The ability of a material to perform with an appropriate host response in a specific application

(b) James Anderson; Perspectives on “Biocompatibility” and Suggested Definition

James Anderson

Let us begin with the first definition, “biocompatibility,” which is found on page 13 of your booklet. This definition has served us well since Chester. This definition is internationally used. It is used by regulatory agencies. It will continue to be used by regulatory agencies. It will be continued to be used by colleagues working in the field of biomaterials. And no suggestion of change is made.

(c) Edited Discussion of “Biocompatibility”

Andrés García

Any discussions? Okay, if not, we are going to take the first vote, are we ready?

(d) Final Definition and Voting for “Biocompatibility”

Biocompatibility

• The ability of a material to perform with an appropriate host response in a specific application

  Voting Yes	46
  Voting No	1
  Abstain	0
  Total Votes	47
  Number voting Yes or No	47
  Percentage Yes Votes	97.9%

• The definition achieved Consensus, having more than 75% Yes votes, with absolute number greater than 30.

B Inflammation

Editor’s Note: A wide-ranging discussion took place in Session II around the broad subject of inflammation, with many comments, not surprisingly, involving the mechanisms and phenomena of immunity, hypersensitivity, and fibrosis. The most relevant comments from contributors are included in those sections judged to be most appropriate. In Session II, the resulting vote was inconclusive; a further discussion took place during the Final General Summary Session, and a further vote was taken. These two discussions are included here in Part One and Part Two respectively.

(a) Possible Definitions of “Inflammation” Included in Final Program

1. 1. The immediate response by blood cells to injury/implantation/injection; initially acute inflammation (polymorphonuclear leukocytes) followed by chronic inflammation (monocytes, lymphocytes) with early resolution leading to the formation of granulation tissue surrounding the implant with subsequent fibrous capsule (fibrosis) formation and the foreign body reaction at the biomaterial/tissue interface
2. 2. A localized tissue reaction, involving both cellular and humoral components, in response to infection, irritation or injury

(b) James Anderson; Perspectives on “Inflammation” and Suggested Definition

James Anderson

So innate immunity is inflammation, and what is inflammation? Inflammation is this series of events as it applies to biomaterials. It starts with acute inflammation; the continuum moves into chronic inflammation and into the formation of granulation tissue surrounding the implant and then subsequent fibrous capsule formation. And the foreign body reaction, consisting of macrophages and foreign body giant cells is seen at the biomaterial/tissue interface. This is acute inflammation, which is generally accepted in the biomaterials community.

(c) Edited Discussion of “Inflammation”

PART ONE: Discussion in Session II

Rena Bizios	I love all these definitions and they are very thorough and very up to the point. We need one definition for immunomodulation, because it has become a buzzword and no one knows what it means, especially the students. Going back to your definition of inflammation, and since we are focusing it on materials, should we put the foreign body reaction first before the encapsulation? In terms of the sequence of events. You know better than that, but I always think that foreign body reaction proceeds, or should proceed. Correct me if I am wrong.
James Anderson	I do not understand what your issue is.
Rena Bizios	You have presented the order of events that take place. And first we have the neutrophils and monocytes, macrophages. Then the granulation tissue formation and then as far as materials, interaction with materials, do the foreign body reaction events that precede the fibrous encapsulation formation. Therefore the order of appearance should be the subsequent foreign body reaction then fibrous capsule formation.
James Anderson	As we know, but is not included in this meeting, there is the classic Vroman effect, which involves protein adsorption to surfaces. And it to this surface that monocytes then adhere.
Andrés García	Another question is whether you should reverse the order of fibrosis and foreign body reaction.
James Anderson	I have no problem with that.
Helen Lu	Jim, I have a question about macrophages. You know there is a lot of literature on this, and people are working on studies where you differenti...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• Attendees at Chengdu Definitions in Biomaterials Conference 2019
• Acknowledgments
• I. Introduction
• II. Biomaterials and biomedical materials
• III. Biomaterial types
• IV. Biocompatibility and immune responses to biomaterials
• V. Biodegradation phenomena
• VI. Regenerative medicine
• VII. Biomaterial-based devices
• VIII. Biomaterial-based delivery systems
• IX. Biomaterial-based biotechnology
• X. Commentary and summary
• Annex A. Provisional list of terms to be discussed and examples of possible definitions
• Annex B. The Chengdu Declaration
• Index