Clark Robert Craig, Reese McKay D, Attalla Philopatir, Camacho Justin M, Hirpara Milan M, Delong Michael R, Reid Chris M
Aesthet Surg J Open Forum. 2024 Aug 21;6:ojae066. doi: 10.1093/asjof/ojae066. eCollection 2024.
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.
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.
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.
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%]).
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.
网片植入物常用于异体乳房重建。值得注意的是,迄今为止尚无网片获得美国食品药品监督管理局(FDA)针对该适应症的批准。几种合成网片已被引入,其特性和效果各异。
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无显著差异。
作者按照系统评价和荟萃分析的首选报告项目(PRISMA)指南进行了系统的文献综述。纳入了31项报告合成网片使用情况和临床结果的研究。对8项直接比较合成网片和生物网片的研究进行荟萃分析以计算相对风险(RR)。对19项非比较性研究进行荟萃分析以计算荟萃率。对包括血清肿、感染、再次手术和取出植入物在内的结果按每侧乳房进行评估。对所得模型进行敏感性和偏倚检验。
比较性研究的荟萃分析表明,使用合成网片时感染风险无差异(RR = 0.53;95%可信区间[0.26 - 1.10]),但再次手术风险降低(RR = 0.54;95%可信区间[0.33 - 0.89])或取出植入物风险降低(RR = 0.43;95%可信区间[0.21 - 0.87])。非比较性研究的荟萃分析表明血清肿发生率 = 3%;95%可信区间[1% - 6%],感染发生率 = 4%;95%可信区间[3% - 6%],再次手术发生率 = 10%;95%可信区间[7% - 13%],取出植入物发生率 = 3%;95%可信区间[2% - 5%])。
比较合成网片和生物网片的研究表明,在所有评估结果中合成网片并不逊色。非比较性研究表明血清肿、感染、再次手术和取出植入物的发生率与生物网片的文献值相似。