Department of Gynecology, Jeanne de Flandre University Hospital, Lille, France.
Unit of Gynecology and Obstetrics, IRCCS San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy.
Expert Rev Med Devices. 2023 May;20(5):393-400. doi: 10.1080/17434440.2023.2199926. Epub 2023 Apr 9.
In recent decades, concerns about safety of synthetic non-absorbable materials transvaginally implanted emerged. We aim to define the actual role of synthetic non-absorbable transvaginal mesh (TVM) for pelvic organ prolapse (POP) and mid-urethral sling (MUS) for stress urinary incontinence (SUI), in relation with the worldwide legislative evolution.
While in the United Kingdom MUS is not considered the first-line surgical option, other countries adopt MUS as the main procedure. United States, United Kingdom, Australia, New Zealand, France banned or paused TVM use for POP repair. At the same time, Germany, Asian, and South American countries adopt TVM after adequate counseling for selected populations such as women affected by or at high risk of POP relapse and contraindication for other surgical routes.
The worldwide evolution of recommendations determined deep modification of clinical practice, with native tissue repair returning to forefront when the vaginal route is indicated. A more careful evaluation of the safety and efficacy profile of meshes' materials and the assessment of the minimal surgeon's expertise in performing TVM procedures became crucial. A multidisciplinary approach and a high specialization of the hospitals both in performing mesh procedures and in managing complications are mandatory.
近几十年来，人们对经阴道植入的合成不可吸收材料的安全性产生了担忧。我们旨在根据全球立法的演变，确定合成不可吸收经阴道网片（TVM）在治疗盆腔器官脱垂（POP）和治疗压力性尿失禁（SUI）的尿道中段吊带（MUS）中的实际作用。
虽然在英国，MUS 并不是首选的一线手术方法，但其他国家则将 MUS 作为主要手术方法。美国、英国、澳大利亚、新西兰和法国禁止或暂停了 TVM 用于 POP 修复。与此同时，德国、亚洲和南美洲国家在对特定人群（如 POP 复发或其他手术途径禁忌的患者）进行充分咨询后，采用 TVM。
全球推荐意见的演变导致临床实践发生了深刻的改变，当阴道途径适用时，原生组织修复重新成为首选。现在，评估网片材料的安全性和疗效特征，以及评估术者实施 TVM 手术的最低专业水平变得至关重要。多学科方法和医院在实施网片手术和处理并发症方面的高度专业化都是强制性的。
