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Surgical Implants and Other Foreign Bodies
IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 74
IARC Working Group on the Evaluation of Carcinogenic Risks to Humans.
Evaluates the carcinogenic risks to humans of surgical implants and other foreign bodies. Foreign bodies are defined as any exogenous object that has been introduced into the tissues or cavities of the body and is not rapidly absorbed. The evaluation focuses on exposures caused by the presence in the body of a solid metallic or non-metallic object as a result either of surgery or of involuntary penetration, as through a war wound. Medical and dental devises are grouped together as metallic, non-metallic, and mixed materials, which have different profiles of biological activity.
The volume opens with a review of key concepts in the understanding of host-material interactions. Subsequent chapters evaluate human exposure data, evidence from case reports and analytical studies for carcinogenicity in humans and in companion animals, evidence of carcinogenicity of implanted materials from animal experiments, and further background material on mechanisms of degradation and carcinogenicity.
On the basis of this review, three implants were classified as possibly carcinogenic to humans: polymeric implants prepared as thin smooth films, with the exception of poly(glycolic acid) implants; metallic implants prepared as thin smooth films; and implanted foreign bodies of metallic cobalt, metallic nickel and an alloy powder containing 66-67% nickel, 13-16% chromium, and 7% iron. The remaining materials and implants could not be classified on the basis of available data. The evaluation cites evidence suggesting lack of carcinogenicity in humans of breast implants, made of silicone, for female breast carcinoma.
Contents
- NOTE TO THE READER
- LIST OF PARTICIPANTS
- PREAMBLE
- THE MONOGRAPHS
- INTRODUCTION
- 1. Scope of the monograph
- 2. Host–biomaterial interactions as related to carcinogenesis
- 3. General mechanisms of solid-state carcinogenesis
- 4. Pathology of sarcomas, reactive and pseudoneoplastic conditions
- 5. General issues in epidemiological research on implants and cancer
- 1. EXPOSURE DATA
- 2. STUDIES OF CANCER IN HUMANS
- 3. STUDIES OF CANCER IN ANIMALS SEEN IN VETERINARY PRACTICE
- 4. STUDIES OF CANCER IN EXPERIMENTAL ANIMALS
- 5. OTHER DATA RELEVANT TO AN EVALUATION OF CARCINOGENICITY AND ITS MECHANISMS
- 6. SUMMARY OF DATA REPORTED AND EVALUATION
- APPENDIX
- References
- INTRODUCTION
Corrigenda to the IARC Monographs are published online at http://monographs.iarc.fr/ENG/Publications/corrigenda.php.
Corrigenda to Volume 74. (PDF, 37K)
LIBRARY CATALOGUING DATA
This publication represents the views and expert opinions of an IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, which met in Lyon, 23 February–2 March 1999
Lyon, France - 1999
IARC MONOGRAPHS
In 1969, the International Agency for Research on Cancer (IARC) initiated a programme on the evaluation of the carcinogenic risk of chemicals to humans involving the production of critically evaluated monographs on individual chemicals. The programme was subsequently expanded to include evaluations of carcinogenic risks associated with exposures to complex mixtures, life-style factors and biological agents, as well as those in specific occupations.
The objective of the programme is to elaborate and publish in the form of monographs critical reviews of data on carcinogenicity for agents to which humans are known to be exposed and on specific exposure situations; to evaluate these data in terms of human risk with the help of international working groups of experts in chemical carcinogenesis and related fields; and to indicate where additional research efforts are needed.
The lists of IARC evaluations are regularly updated and are available on Internet: http://www.iarc.fr/
This project was supported by Cooperative Agreement 5 UO1 CA33193 awarded by the United States National Cancer Institute, Department of Health and Human Services. Additional support has been provided since 1986 by the European Commission, since 1993 by the United States National Institute of Environmental Health Sciences and since 1995 by the United States Environmental Protection Agency through Cooperative Agreement Assistance CR 824264.
- ©International Agency for Research on Cancer, 1999
- Distributed by IARCPress (Fax: +33 4 72 73 83 02; E-mail: rf.crai@sserp) and by the World Health Organization Distribution and Sales, CH-1211 Geneva 27 (Fax: +41 22 791 4857; E-mail: tni.ohw@snoitacilbup)
- Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention.
- All rights reserved. Application for rights of reproduction or translation, in part or in toto, should be made to the International Agency for Research on Cancer.
IARC Library Cataloguing in Publication Data
Surgical implants and other foreign bodies /
- IARC Working Group on the Evaluation of Carcinogenic Risks to Humans (1999 : Lyon, France)
- (IARC monographs on the evaluation of carcinogenic risks to humans ; 74)
- 1. Foreign bodies – adverse effects 2. Foreign bodies – congresses
- 3. Implants, artificial – adverse effects 4. Implants, artificial – congresses
- I. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
- II. Series
- ISBN 92 832 1274 6 (NLM Classification: W1)
- ISSN 1017-1606
- PRINTED IN FRANCE
- NLM CatalogRelated NLM Catalog Entries
- Review Biomaterial-associated infection, neoplasia, and calcification. Clinicopathologic features and pathophysiologic concepts.[ASAIO Trans. 1987]Review Biomaterial-associated infection, neoplasia, and calcification. Clinicopathologic features and pathophysiologic concepts.Schoen FJ. ASAIO Trans. 1987 Jan-Mar; 33(1):8-18.
- Review [Cutaneous reactions to orthopedic implants].[Ann Dermatol Venereol. 1996]Review [Cutaneous reactions to orthopedic implants].Vigan M, Girardin P, Adessi B, Laurent R. Ann Dermatol Venereol. 1996; 123(10):686-90.
- Acute foreign body reaction to synthetic dural graft.[Am J Med. 2002]Acute foreign body reaction to synthetic dural graft.Safdar A, Kohn LF, Narayan KK. Am J Med. 2002 Oct 15; 113(6):529.
- Evaluation of the carcinogenic risks to humans associated with surgical implants and other foreign bodies - a report of an IARC Monographs Programme Meeting. International Agency for Research on Cancer.[Eur J Cancer. 2000]Evaluation of the carcinogenic risks to humans associated with surgical implants and other foreign bodies - a report of an IARC Monographs Programme Meeting. International Agency for Research on Cancer.McGregor DB, Baan RA, Partensky C, Rice JM, Wilbourn JD. Eur J Cancer. 2000 Feb; 36(3):307-13.
- Review [Infections associated with the use of biomaterials in medicine].[Postepy Hig Med Dosw. 1994]Review [Infections associated with the use of biomaterials in medicine].Rózalska B. Postepy Hig Med Dosw. 1994; 48(2):143-60.
- Surgical Implants and Other Foreign BodiesSurgical Implants and Other Foreign Bodies
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