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International Urogynecology Journal

Erschienen in:

01.04.2012 | IUGA Grafts Roundtable 2010

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

verfasst von: Mark Slack, Donald Ostergard, Mauro Cervigni, Jan Deprest

Erschienen in: International Urogynecology Journal | Sonderheft 1/2012

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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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Titel: 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
verfasst von: Mark Slack
Donald Ostergard
Mauro Cervigni
Jan Deprest
Publikationsdatum: 01.04.2012
Verlag: Springer-Verlag
Erschienen in: International Urogynecology Journal / Ausgabe Sonderheft 1/2012
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-012-1678-2

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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

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Weitere Artikel der Sonderheft 1/2012

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

Credentialing for transvaginal mesh placement—a case for “added qualification” in competency

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