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Transvaginal Mesh Kits-How 'Serious' Are the Complications and Are They Reversible?

机译:阴道网状套件-并发症有多“严重”且可逆?

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To review the merit of the U.S. Food and Drug Administration-issued warnings on the use of transvaginal mesh in women with pelvic organ prolapse because of escalating complications. On institutional review board approval, we reviewed the data from 2 tertiary institutions managing complications of transvaginal mesh. The data recorded included mesh type, details of surgical removal, and patient-reported clinical outcomes. From 2006 to March 2011, 58 women were evaluated. Their mean age was 54-6 years (range 32-80), with a mean follow-up of 13 months (range 6-67). The mean interval to mesh excision surgery from the original prolapse surgery was 21 months (range 2-60). Of the 58 women, 35 (60%) had undergone concurrent midurethral sling surgery with the transvaginal mesh surgery. Also, 21 of the 58 patients (36%) had undergone initial mesh removal attempts before their referral to either tertiary institution. Most women presented with multiple complaints, with mesh extrusion the most frequently reported, (n = 43 [74%]). Of the 58 women, 17 (29%) required re-excision of residual mesh, 13 once and 4 twice. Five women developed recurrent symptomatic pelvic organ prolapse (7%). The residual rate of dyspareunia and pelvic pain was 14% and 22%, respectively. Fourteen women (24%) were treated successfully, with complete resolution of all presenting symptoms. As outlined in the Food and Drug Administration notifications, patients should be forewarned that some transvaginal mesh complications are life altering and might not always be surgically correctable.
机译:回顾美国食品和药物管理局发布的关于因并发症升级而导致盆腔器官脱垂的妇女使用阴道网的警告的优点。经机构审查委员会批准,我们审查了来自2家处理经阴道网状并发症的大专院校的数据。记录的数据包括网格类型,手术切除的详细信息以及患者报告的临床结果。从2006年到2011年3月,对58位女性进行了评估。他们的平均年龄为54-6岁(范围为32-80),平均随访时间为13个月(范围为6-67)。从最初的脱垂手术到网状切除手术的平均间隔为21个月(范围2-60)。在58名妇女中,有35名(60%)接受了经阴道网状手术同时进行的尿道中段吊带术。另外,在58名患者中,有21名(36%)在转诊至任何一家大专院校之前进行了初次网状切除尝试。大多数妇女表现出多种抱怨,最常报告网状组织挤压术(n = 43 [74%])。在58名女性中,有17名(29%)需要再次切除残留的网片,其中13次需要再次切除,4次需要再次切除。五名妇女出现复发性症状性盆腔器官脱垂(7%)。痛经的残留率和骨盆痛分别为14%和22%。成功治疗了十四名妇女(占24%),所有症状均得到完全缓解。正如美国食品药品监督管理局(FDA)通知中概述的那样,应预先警告患者,某些经阴道网状并发症会改变生活,并且可能并不总是可以通过手术矫正。

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