Zdrowie i gospodarka · 01/05/2014

FDA Proposes New Requirements for Surgical Mesh Used in Transvaginal Pelvic Organ Prolapse Repair

The US Food and Drug Administration (FDA) is issuing a proposed rule requiring the submission of a premarket approval application for surgical mesh devices used in transvaginal pelvic organ prolapse repair, if they are reclassified from class II to class III, in an effort to reduce the risk of complications and improve public safety.