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与使用植入物的盆腔器官脱垂手术相关的不良事件。

Adverse events associated with pelvic organ prolapse surgeries that use implants.

机构信息

Departments of Obstetrics and Gynecology, Kaiser Permanente, Downey, San Diego, and Roseville, California, and Honolulu, Hawaii; and the Division of Epidemiology, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.

出版信息

Obstet Gynecol. 2013 Dec;122(6):1239-45. doi: 10.1097/AOG.0000000000000008.

DOI:10.1097/AOG.0000000000000008
PMID:24201675
Abstract

OBJECTIVE

To estimate the rate of vaginal implant exposure associated with biologic grafts and permanent mesh used for pelvic organ prolapse (POP) surgery, to describe treatments used for these complications, and to estimate response rates to these treatments. The secondary aims were to describe the operative and perioperative complications.

METHODS

This was a retrospective analysis of female members of Kaiser Permanente Southern and Northern California and Hawaii who underwent POP surgeries with biologic grafts and permanent mesh between September 2008 and May 2010. Inpatient and outpatient electronic medical records were reviewed for postoperative adverse events.

RESULTS

During the 21-month period, 1,282 women, mean age of 62 years (±10 standard deviation), median parity of 3 (interquartile range 2-4), and median body mass index of 28 (interquartile range 24-30) underwent prolapse repairs with 1,484 implants with a mean follow-up time of 358 days (±276 standard deviation). Vaginal exposures occurred more often with permanent mesh (53/847 [6%]) than biologic grafts (10/637 [1.6%]) (P<.001). Resolution of vaginal exposure after the first treatment occurred in 24 of 63 (38%), whereas 39 of 63 (62%) required multiple treatments. Surgical excision was performed in 20 of 63 (32%) exposures. Permanent mesh exposures were more likely to require surgical excision (20/53 [38%]) than biologic graft exposures (zero of 10) (P=.02).

CONCLUSION

Vaginal exposure occurred more frequently with permanent mesh than biologic graft, may require multiple treatments, and occasionally require surgical excision.

LEVEL OF EVIDENCE

: II.

摘要

目的

估计与盆腔器官脱垂(POP)手术中使用的生物移植物和永久性网片相关的阴道植入物暴露率,描述这些并发症的治疗方法,并估计这些治疗方法的反应率。次要目的是描述手术和围手术期并发症。

方法

这是对 2008 年 9 月至 2010 年 5 月期间在 Kaiser Permanente 南加州和北加州和夏威夷接受生物移植物和永久性网片 POP 手术的女性成员进行的回顾性分析。对住院和门诊电子病历进行了术后不良事件回顾。

结果

在 21 个月期间,1282 名年龄平均为 62 岁(±10 标准差)、中位产次为 3(四分位间距 2-4)、中位体重指数为 28(四分位间距 24-30)的女性接受了脱垂修复手术,共使用了 1484 个植入物,平均随访时间为 358 天(±276 标准差)。永久性网片(53/847[6%])的阴道暴露发生率高于生物移植物(10/637[1.6%])(P<.001)。63 例阴道暴露患者中,有 24 例(38%)在首次治疗后得到缓解,而 39 例(62%)需要多次治疗。20 例(32%)暴露患者进行了手术切除。永久性网片暴露更可能需要手术切除(20/53[38%]),而生物移植物暴露则不需要(0/10)(P=.02)。

结论

与生物移植物相比,永久性网片的阴道暴露更常见,可能需要多次治疗,偶尔需要手术切除。

证据水平

II 级。

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