title: 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.
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.
authors.affiliation: Department of Obstetrics and Gynaecology, Addenbrooke's Hospital, University of Cambridge Teaching Hospitals Trust, Cambridge, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Slack
authors.forename: Donald
authors.initials: D
authors.lastname: Ostergard
authors.forename: Mauro
authors.initials: M
authors.lastname: Cervigni
authors.forename: Jan
authors.initials: J
authors.lastname: Deprest
mesh_terms: D000818:Animals; D002102:Cadaver; D005260:Female; D006801:Humans; D023421:Models, Animal; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011817:Rabbits; D019651:Plastic Surgery Procedures / Q000009:adverse effects / Q000379:methods*; D012042:Registries; D012756:Sheep; D013526:Surgical Mesh / Q000009:adverse effects* / Q000592:standards*