Höfner K, Hampel C, Kirschner-Hermanns R, Alloussi S H, Bauer R M, Bross S, Bschleipfer T, Goepel M, Haferkamp A, Hüsch T, Kaufmann A, Kiss G, Kranz J, Oelke M, Pannek J, Reitz A, Rutkowski M, Schäfer W, Schulte-Baukloh H, Schumacher S, Seif C, Schultz-Lampel D
Urologische Klinik, Evangelisches Krankenhaus Oberhausen, Virchowstr. 20, 46047, Oberhausen, Deutschland.
Urologische Abteilung, Marien-Hospital Erwitte, Erwitte, Deutschland.
Urologe A. 2020 Jan;59(1):65-71. doi: 10.1007/s00120-019-01074-y.
Due to a safety alert issued by the US Food and Drug Administration (FDA) in 2011 for transvaginal mesh implants to treat female prolapse as a result of numerous reports of complications such as infection, chronic pain, dyspareunia, vaginal erosion, shrinkage and erosion into other organs nearly all industrial products have been withdrawn from the market in the meantime. The United Kingdom, Australia, and New Zealand extended warnings and prohibitions even on the implantation of midurethral slings (TVT, TOT). In view of these current international controversies regarding the use of implanted materials for the treatment of stress incontinence and prolapse and the lack of clear guidelines for the use of biomaterials, the opinion of the Working Group on Urological Functional Diagnostics and Female Urology should provide clarity. The Opinion is based on the SCENIHR Report of the "European Commission's Scientific Committee on Emerging and Newly Identified Health Risks", the "Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence" and in compliance with relevant EAU and national guidelines and the opinion of the Association for Urogynaecology and Plastic Pelvic Floor Reconstruction (AGUB eV). In addition, recommendations are given for the future handling of implants of slings and meshes for the treatment of stress incontinence and prolapse from a urologic viewpoint.
由于美国食品药品监督管理局（FDA）于2011年发布了关于经阴道网状植入物治疗女性盆腔器官脱垂的安全警报，原因是有大量关于感染、慢性疼痛、性交困难、阴道糜烂、萎缩以及侵蚀至其他器官等并发症的报告，在此期间几乎所有工业产品都已退出市场。英国、澳大利亚和新西兰甚至扩大了对中段尿道吊带（TVT、TOT）植入的警告和禁令。鉴于目前在使用植入材料治疗压力性尿失禁和盆腔器官脱垂方面存在的国际争议，以及缺乏生物材料使用的明确指南，泌尿外科功能诊断与女性泌尿外科工作组的意见应能提供清晰的指导。该意见基于“欧盟新兴和新确定健康风险科学委员会”的SCENIHR报告、“欧洲泌尿外科协会和欧洲妇科泌尿协会关于使用植入材料治疗盆腔器官脱垂和压力性尿失禁的共识声明”，并符合相关的欧洲泌尿外科协会和国家指南以及妇科泌尿与盆底重建协会（AGUB eV）的意见。此外，从泌尿外科的角度对未来治疗压力性尿失禁和盆腔器官脱垂的吊带和网状植入物的处理给出了建议。
