A Comparison of Capsular Contracture Rates after Implant-Based Breast Reconstruction Using ADM Versus Synthetic Mesh

Jennifer Bai, Sarah Ferenz, Megan Fracol, John Y S Kim
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Abstract

Abstract Goals/Purpose Capsular contracture is a local complication in which there is tightening of the capsule around the implant. This complication has been shown to occur in 15-30% of implant-based breast reconstruction patients and often requires revision surgery for correction. Prior investigations have suggested that the use of ADM can reduce the risk for development of capsular contracture, with more recent research suggesting that synthetic mesh may provide the same benefit. Several meta-analyses have attempted to compare ADM and mesh use for the prevention of capsular contracture, but they all emphasize the continued need for clinical investigation with direct comparisons. The goal of this study is to assess our own reconstruction patient population to compare capsular contracture rates between ADM and mesh cohorts, as well as to assess for other potential risks that may increase the rate of capsular contracture in these patients. Methods/Technique A 15-year retrospective review of all implant-based breast reconstructions performed by the senior author was performed. All operations occurred between 2008 and 2023 in a hospital setting. Patient demographics were assessed including age, BMI, implant size, radiation history, location of malposition, and use of either ADM or mesh. Post-operative complications including incidence of capsular contracture were recorded. Patients who had documented capsular contracture prior to scaffold insertion were excluded from the study. Wilcoxon signed rank test, 2-sided t-test, and Fischer’s Exact test were used to compare baseline demographics and capsular contracture rates between the two groups, along with a multivariate logistic regression analysis to control for potential confounders. Results/Complications Fifty-two breasts underwent capsulorraphy, of which 25 (48.1%) used ADM and 27 (51.9%) used mesh. Average age was 50.6 years, average BMI was 27.7, average implant size was 541.8 cc, and eight breasts (15.4%) had been irradiated. Average follow-up time was seven years (mean = 85.4 months, range 22 – 149 months, SD = 35.9). Fourteen (26.9%) capsulorraphies were for inferior malposition, 13 (25.0%) for lateral malposition, and 25 (48.1%) were for inferolateral malposition. Patients in the ADM group had significantly more lateral malposition prior to insertion as compared to the mesh group which had more inferior malposition (p=0.0246). There was no significant difference between the two groups for any other recorded baseline demographic; these demographics included age, BMI, hypertension, diabetes, history of tobacco use, radiation, chemotherapy, implant volume, and implant surface texture. Capsular contracture occurred in 2 ADM breasts (8.0%) and 4 mesh breasts (14.8%) with no significant difference between the two groups (p=0.6695). Five of these capsular contractures had documented Baker grades with three grade II, one grade III, and one grade IV. None of the recorded baseline demographics significantly increased the risk for capsular contracture development. Conclusion ADM and synthetic mesh both function as effective tools for reducing the risk of developing capsular contracture after prosthetic breast reconstruction. The rate of capsular contracture with ADM was only 8.0% and the rate with mesh was only 14.8%. Both rates are lower than the 15-30% incidence that has been found in breast reconstruction patients without mesh. None of the patient demographics were significant risk factors for capsular contracture development, so these are unlikely to be confounders. There was no significant difference in rate of capsular contracture between the two groups, suggesting that ADM and mesh are similarly efficacious at preventing capsular contracture in reconstruction patients.
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使用 ADM 与合成纤维网片进行植入式乳房再造术后膀胱挛缩率的比较
摘要 目标/目的 囊膜挛缩是假体周围囊膜收紧的一种局部并发症。15-30% 的假体乳房再造患者会出现这种并发症,通常需要进行翻修手术进行矫正。之前的研究表明,使用 ADM 可以降低发生包膜挛缩的风险,而最近的研究表明,合成网片也可以提供同样的益处。有几项荟萃分析试图比较 ADM 和网片在预防囊性挛缩方面的作用,但它们都强调临床研究仍需进行直接比较。本研究的目的是评估我们自己的重建患者群体,比较 ADM 和网片组群的囊膜挛缩率,并评估可能增加这些患者囊膜挛缩率的其他潜在风险。方法/技术 对资深作者进行的所有植入物乳房重建手术进行了为期 15 年的回顾性审查。所有手术均在 2008 年至 2023 年期间在医院进行。对患者的人口统计学特征进行了评估,包括年龄、体重指数(BMI)、假体大小、放射史、错位位置以及使用 ADM 或网片的情况。记录了术后并发症,包括囊膜挛缩的发生率。研究排除了在支架植入前有囊膜挛缩记录的患者。采用 Wilcoxon 符号秩检验、双侧 t 检验和费舍尔精确检验比较两组患者的基线人口统计学特征和囊膜挛缩率,并进行多变量逻辑回归分析以控制潜在的混杂因素。结果/并发症 52 例乳房接受了囊膜成形术,其中 25 例(48.1%)使用了 ADM,27 例(51.9%)使用了网片。平均年龄为 50.6 岁,平均体重指数为 27.7,平均植入物大小为 541.8 毫升,8 个乳房(15.4%)接受过放射治疗。平均随访时间为七年(平均 = 85.4 个月,范围为 22 - 149 个月,SD = 35.9)。14例(26.9%)囊状切除术是针对下侧错位,13例(25.0%)是针对外侧错位,25例(48.1%)是针对内外侧错位。与网片组相比,ADM 组患者在植入前外侧错位的比例明显更高,而网片组患者下侧错位的比例更高(P=0.0246)。两组患者在其他记录的基线人口统计学指标方面没有明显差异,这些人口统计学指标包括年龄、体重指数、高血压、糖尿病、吸烟史、放疗、化疗、植入物体积和植入物表面质地。有 2 个 ADM 乳房(8.0%)和 4 个网状乳房(14.8%)发生了包膜挛缩,两组之间无显著差异(P=0.6695)。在这些包膜挛缩中,有 5 例记录了贝克分级,其中 3 例为 II 级,1 例为 III 级,1 例为 IV 级。所记录的基线人口统计学特征均未显著增加囊挛缩发生的风险。结论 ADM 和合成网片都能有效降低假体乳房重建后出现包膜挛缩的风险。使用 ADM 的包膜挛缩率仅为 8.0%,使用网片的包膜挛缩率仅为 14.8%。这两个比率都低于未使用网片的乳房重建患者 15%-30% 的发生率。患者的人口统计学特征都不是包膜挛缩发生的重要风险因素,因此这些因素不太可能是混杂因素。两组患者的囊膜挛缩发生率没有明显差异,这表明 ADM 和网片在预防重建患者囊膜挛缩方面的效果相似。
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