Slings operations work very differently from mesh sheet implantations and should not be banned

P. Petros
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Abstract

The persistent media campaign against mesh products in the United Kingdom (UK) successfully resulted in the banning earlier this year of all mesh slings and mesh kits by the UK government. Unlike the Food and Drug Administration (FDA) where suppliers of mesh kits were put on notice to provide the data to justify their continued sale, the UK government instituted the Cumberlage report, and acted on its recommendations. As the co-inventor of the now discontinued midurethral sling (MUS), the subject of this editorial, I fully endorse the recommendations for thorough premarket testing on any implantable device, for that is exactly the course which the late Ulf Ulmsten and I followed with the MUS. I also endorse the ban against mesh sheets which did not follow the exhaustive testing of the MUS. The Cumberlage report, unfortunately, is not based or robust scientific data. It consisted of opinions mainly from non-experts, including a journalist. It does not take into consideration the vast 10-year clinical and scientific background of the MUS. Apparently not considered were well reasoned scientific opinions from expert committees from almost every learned body, which generally concluded that the benefits of slings far outweighed their complications and, even years ago, that mesh sheet surgery required more proof. ABSTRACT
吊索操作与网片植入非常不同,不应被禁止
今年早些时候,英国政府成功地禁止了所有网状吊索和网状套件。与美国食品药品监督管理局(FDA)不同的是,英国政府制定了坎伯拉格报告,并根据其建议采取了行动。作为现已停产的中尿道吊带(MUS)的共同发明人,也就是这篇社论的主题,我完全赞同对任何植入式设备进行彻底的上市前测试的建议,因为这正是已故的乌尔夫·乌尔姆斯滕和我使用中尿道吊带所遵循的过程。我也支持对未经过MUS详尽测试的网片的禁令。不幸的是,坎伯拉奇的报告没有依据,也没有可靠的科学数据。它主要由非专家的意见组成,其中包括一名记者。它没有考虑到MUS庞大的10年临床和科学背景。显然,几乎所有有学问的机构的专家委员会都没有考虑到合理的科学意见,他们普遍认为吊带的好处远远超过并发症,甚至在几年前,网片手术还需要更多的证据。摘要
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