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.

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