期刊
INTERNATIONAL UROGYNECOLOGY JOURNAL
卷 23, 期 -, 页码 S15-S26出版社
SPRINGER LONDON LTD
DOI: 10.1007/s00192-012-1678-2
关键词
Graft; Mesh; Vaginal prolapse; Pelvic organ prolapse; Safety; Market; Implantable material; New product; Biological property; Prospective randomized trial
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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