Abstract
Introduction and hypothesis
A terminology and standardized classification has yet to be developed for those complications arising directly from the insertion of synthetic (prostheses) and biological (grafts) materials in female pelvic floor surgery.
Methods
This report on the above terminology and classification combines the input of members of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a Joint IUGA/ICS Working Group on Complications Terminology, assisted at intervals by many expert external referees. An extensive process of 11 rounds of internal and external review took place with exhaustive examination of each aspect of the terminology and classification. Decision-making was by collective opinion (consensus).
Results
A terminology and classification of complications related directly to the insertion of prostheses and grafts in female pelvic floor surgery has been developed, with the classification based on category (C), time (T) and site (S) classes and divisions, that should encompass all conceivable scenarios for describing insertion complications and healing abnormalities. The CTS code for each complication, involving three (or four) letters and three numerals, is likely to be very suitable for any surgical audit or registry, particularly one that is procedure-specific. Users of the classification have been assisted by case examples, colour charts and online aids (www.icsoffice.org/complication).
Conclusions
A consensus-based terminology and classification report for prosthess and grafts complications in female pelvic floor surgery has been produced, aimed at being a significant aid to clinical practice and research.
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Acknowledgements
The co-authors acknowledge the support and goodwill of the IUGA and ICS leadership in this second Joint Report from the two societies, following on from the Joint Report on Terminology for Female Pelvic Floor Dysfunction [14]. We thank Mr Dominic Turner and Mr Ashley Brookes from the ICS Office for their assistance and expertise in developing the online aids and the progress towards an ICS-IUGA Registry.
This document has involved 11 rounds of full review by co-authors. Following website publication (Version 8), there have been four rounds of further review. Versions 3 and 10 were subject to live meetings in Cancun (June 2007) and Toronto (August 2010).
The valuable input of Professor Bernard Jacquetin is gratefully acknowledged. The comments of the following reviewers in response to website publication (April to June 2010) are also much appreciated: Dr Angamuthu Arunkalaivanan, Dr Kiran Ashok, Professor Peter Dietz, Dr Nathan Guerette, Professor Don Ostergard and Professor Peter Petros.
Conflicts of interests
BT Haylen: Assistance from Boston Scientific to attend London June 2008 Meeting of the Authors of IUGA-ICS Report on Terminology for Female Pelvic Floor Dysfunction.
RM Freeman: Educational meetings: Astellas and Pfizer. All income from commercial trials and some of the honoraria go to his research fund. Locality lead for the NIHR Peninsula Collaboration for Leadership in Applied Health Research and Care (PenCLAHRC). PROSPECT: A grant holder for this nationally funded trial of prolapse surgery.
SE Swift: No disclosures.
M Cosson: Consultant: Ethicon. Educational sessions: Ethicon, Ipsen. Unconditional grant for fundamental research: Ethicon.
G Willy Davila: Travel expenses or honoraria and consultant: AMS, Novosys. Holds a position of influence in IUGA and NAFC.
J Deprest: Consulting or lecturing: American Medical Systems, Bard, Johnson and Johnson, (Ethicon Gynaecare). His laboratory has received unconditional grants from the same companies, as well as Covidien (formerly Tyco Healthcare).
PL Dwyer: Department research grant from American Medical Systems (AMS).
B Fatton: Consulting or lecturing: Boston Scientific, Astellas and Tena.
E Kocjancic: Consultant: AMS, Coloplast and Bard. Speaker: Astra Zeneca.
J Lee: Travel fellowship awarded by national society; grant sponsored by American Medical Systems.
C Maher: No disclosures.
E Petri: No disclosures.
DE Rizk: No disclosures.
PK Sand: Advisor: Allergan, Astellas, GSK, Coloplast, Ortho, Pfizer, Sanofi, Aventis, Watson. Speaker: Allergan, Astellas, GSK, Ortho, Pfizer, Watson. Investigator: Boston Scientific, Pfizer, Watson, Ortho, Bioform.
GN Schaer: Advisor (in Switzerland): Astellas, Novartis, Pfizer, Gynecare.
R Webb: Travel bursaries: Ethicon, AMS, Pfizer, Astellas. Lecture fees: (departmental) Pfizer, Astellas. Research: Allergan Astellas.
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International Urogynecology Journal, Vol. 22, No. 1, 2011. Copyright 2011. This material is reproduced with permission of Wiley-Liss, Inc., a subsidiary of John Wiley & Sons, Inc., and the International Urogynecological Association.
This document is being published simultaneously in Neurourology and Urodynamics (NAU) and the International Urogynecology Journal (IUJ), the respective journals of the sponsoring organizations, the International Continence Society (ICS) and the International Urogynecological Association (IUGA) in the January 2011 issue of each journal.
Standardization and Terminology Committee (IUGA) - Bernard T. Haylen, Robert M. Freeman, Steven E. Swift, Peter L. Dwyer, Joseph Lee, Eckhard Petri, Diaa E. Rizk, Peter K. Sand, Gabriel N. Schaer
Standardization and Terminology Committee (ICS) - Robert M. Freeman, Ralph J. Webb
Joint IUGA/ICS Working Group on Complications Terminology - Bernard T. Haylen, Robert M. Freeman, Steven E. Swift, Michel Cosson, Chris Maher, G. Willy Davila, Jan Deprest, Peter L. Dwyer, Brigitte Fatton, Ralph J. Webb
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Haylen, B.T., Freeman, R.M., Swift, S.E. et al. An International Urogynecological Association (IUGA) / International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery. Int Urogynecol J 22, 3–15 (2011). https://doi.org/10.1007/s00192-010-1324-9
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DOI: https://doi.org/10.1007/s00192-010-1324-9