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International Urogynecology Journal

, Volume 23, Supplement 1, pp 15–26 | Cite as

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
  • Mark Slack
  • Donald Ostergard
  • Mauro Cervigni
  • Jan DeprestEmail author
IUGA Grafts Roundtable 2010

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.

Keywords

Graft Mesh Vaginal prolapse Pelvic organ prolapse Safety Market Implantable material New product Biological property Prospective randomized trial 

Notes

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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Copyright information

© The International Urogynecological Association 2012

Authors and Affiliations

  • Mark Slack
    • 1
  • Donald Ostergard
    • 2
  • Mauro Cervigni
    • 3
  • Jan Deprest
    • 4
    • 5
    Email author
  1. 1.Department of Obstetrics and Gynaecology, Addenbrooke’s HospitalUniversity of Cambridge Teaching Hospitals TrustCambridgeUK
  2. 2.Division of Urogynecology, Department of Obstetrics, Gynecology and Women’s Health, School of MedicineUniversity of LouisvilleLouisvilleUSA
  3. 3.Department of UrogynecologySan Carlo-IDI HospitalRomeItaly
  4. 4.Department of Development and Regeneration, Faculty of Medicine, Pelvic Floor UnitUniversity Hospitals Leuven, Katholieke Universiteit LeuvenLeuvenBelgium
  5. 5.Verloskunde en GynaecologieUniversitaire Ziekenhuizen LeuvenLeuvenBelgium

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