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A standardized description of graft-containing meshes and recommended steps before the introduction of medical devices for prolapse surgery

Consensus of the 2nd IUGA Grafts Roundtable: Optimizing Safety and Appropriateness of Graft Use in Transvaginal Pelvic Reconstructive Surgery

  • IUGA Grafts Roundtable 2010
  • Published:
International Urogynecology Journal Aims and scope Submit manuscript

Abstract

Over the past decade, a huge number of new implants and ancillary devices have been introduced to the market. Most of these have become clinically available with little or no clinical data or research. This is a less-than-ideal situation, and this subgroup of the ad hoc IUGA roundtable conference wants to open the discussion to change this, by proposing a pragmatic minimum clearance track for new products being introduced to the market. It consists of an accurate and more standardized product description, data on the biological properties gathered in animal experiments, anatomical cadaveric studies, and upfront clinical studies followed by a compulsory registry on the first 1,000 patients implanted. Ideally, manufacturers should support well-designed prospective (randomized) clinical trials that can support the claimed benefits of the new product.

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Conflicts of interest

Mark Slack is a consultant for Johnson and Johnson and Boston Scientific. Jan Deprest is or was a paid speaker and consultant for Ethicon, AMS, and Bard and has received research grants from Ethicon, FEG Textiltechnik, AMS, and Bard. Mauro Cervigni was a consultant for Johnson and Johnson, Bard, and Medtronic. Donald Ostergard was a consultant for AMS.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Addenbrooke’s Hospital, University of Cambridge Teaching Hospitals Trust, Cambridge, UK

    Mark Slack

  2. Division of Urogynecology, Department of Obstetrics, Gynecology and Women’s Health, School of Medicine, University of Louisville, Louisville, KY, USA

    Donald Ostergard

  3. Department of Urogynecology, San Carlo-IDI Hospital, Rome, RM, Italy

    Mauro Cervigni

  4. Department of Development and Regeneration, Faculty of Medicine, Pelvic Floor Unit, University Hospitals Leuven, Katholieke Universiteit Leuven, Leuven, Belgium

    Jan Deprest

  5. Verloskunde en Gynaecologie, Universitaire Ziekenhuizen Leuven, 3000, Leuven, Belgium

    Jan Deprest

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  1. Mark Slack
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  2. Donald Ostergard
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  3. Mauro Cervigni
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  4. Jan Deprest
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Corresponding author

Correspondence to Jan Deprest.

Additional information

Data were presented at the 2nd IUGA Grafts Roundtable June 2010.

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Slack, M., Ostergard, D., Cervigni, M. et al. A standardized description of graft-containing meshes and recommended steps before the introduction of medical devices for prolapse surgery. Int Urogynecol J 23 (Suppl 1), 15–26 (2012). https://doi.org/10.1007/s00192-012-1678-2

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  • DOI: https://doi.org/10.1007/s00192-012-1678-2

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