Robert Craig Clark, McKay D Reese, Philopatir Attalla, Justin M Camacho, Milan M Hirpara, Michael R Delong, Chris M Reid
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引用次数: 0
Abstract
Background: Mesh implants are frequently employed in alloplastic breast reconstruction. Notably, no mesh to date has FDA approval for this indication. Several synthetic meshes have been introduced with heterogeneous properties and outcomes.
Objectives: This study aims to systematically review synthetic mesh use in alloplastic breast reconstruction, describe rates of short-term complications, and analyze these outcomes in reports comparing synthetic and biologic meshes. The authors hypothesized data from comparative and noncomparative studies would show no significant differences between synthetic and biological meshes.
Methods: The authors conducted a systematic literature review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Thirty-one studies reporting the use of synthetic mesh and clinical outcomes were included. Eight studies directly comparing synthetic mesh and biological mesh were meta-analyzed for relative risk (RR). Nineteen noncomparative studies were analyzed for meta-rates. Outcomes, including seroma, infection, reoperation, and explant, were assessed on a per-breast basis. Resultant models were challenged for sensitivity and bias.
Results: Meta-analysis of comparative studies demonstrated no difference in the risk of infection with synthetic mesh (RR = 0.53; 95% CI [0.26-1.10]), but a reduced risk of reoperation (RR = 0.54; 95% CI [0.33-0.89]) or explant (RR = 0.43; 95% CI [0.21-0.87]). Meta-analysis of noncomparative studies demonstrated rates of seroma = 3%; 95% CI [1%-6%], infection = 4%; 95% CI [3%-6%], reoperation = 10%; 95% CI [7%-13%], and explant = 3%; 95% CI [2%-5%]).
Conclusions: Studies comparing synthetic and biologic meshes demonstrated noninferiority of synthetic in all outcomes assessed. Noncomparative studies demonstrated rates of seroma, infection, reoperation, and explant similar to literature values for biological mesh.
背景：网状植入物经常用于异体乳房重建。值得注意的是，迄今为止还没有一种网状植入物获得美国食品及药物管理局（FDA）批准用于这一适应症。目前已推出的几种合成网状物具有不同的特性和效果：本研究旨在系统回顾合成网片在异体乳房重建中的应用，描述短期并发症的发生率，并在比较合成网片和生物网片的报告中分析这些结果。作者假设来自比较性和非比较性研究的数据将显示合成网片和生物网片之间没有显著差异：作者按照《系统综述和元分析首选报告项目》指南进行了系统文献综述。共纳入了 31 项报告合成网和临床结果的研究。对 8 项直接比较合成网片和生物网片的研究进行了相对风险 (RR) 的元分析。对 19 项非对比研究进行了元比率分析。结果包括血清肿、感染、再次手术和切除，以每个乳房为基础进行评估。对结果模型的敏感性和偏倚性进行了质疑：比较研究的 Meta 分析表明，合成网片的感染风险没有差异（RR = 0.53；95% CI [0.26-1.10]），但再次手术（RR = 0.54；95% CI [0.33-0.89]）或切除（RR = 0.43；95% CI [0.21-0.87]）的风险降低。非对比研究的 Meta 分析表明，血清肿发生率 = 3%；95% CI [1%-6%]，感染发生率 = 4%；95% CI [3%-6%]，再次手术发生率 = 10%；95% CI [7%-13%]，切除术发生率 = 3%；95% CI [2%-5%]）：结论：比较合成网片和生物网片的研究表明，合成网片在所有评估结果中均无劣势。非比较性研究表明，血清肿、感染、再次手术和切除的发生率与生物网片的文献值相似：
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