Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

项目摘要/摘要 每八名女性中就有一名会在一生中患上乳腺癌，导致身体和心理上的双重疾病。 侵入性治疗造成的创伤和与乳房切除相关的痛苦。乳房重建术 乳房切除术后已成为许多女性恢复心理健康的关键程序， 植入体重建是最常见的方法。近10万名患者接受重建 在美国每年都有植入物。 外科网状装置，特别是脱细胞真皮基质，现在被大多数人在标签外使用 进行乳房假体再造的整形外科医生。在过去的十年里，外科医生们 主张从肌肉下重建过渡(将植入物放置在胸肌下) 到胸前(放置在胸肌上方)，通常认为网眼对于这一过程是必要的。 外科网片还没有被FDA批准用于这两个解剖位置的乳房重建。这些 网状设备，类似于阴道网状设备，被认为是三级医疗设备，FDA最近优先考虑 在2019年的一次小组会议上对这些产品的评估。 还没有成功地进行I级随机试验来确定实际风险和益处 网状装置在乳房重建中的应用。尽管现有的数据主要是回溯性的， 关于肌肉下重建的观察性、多项小规模研究和荟萃分析发现 使用外科网片的并发症发生率对患者满意度没有好处。实践趋势有 偏离这一结论，很大程度上与现有研究质量不高有关。随着外科医生的转型 对于前胸骨平面，网眼制造商得出结论，不可能进行I级研究 由于在没有网片的情况下进行胸前重建的外科医生很少 援助。尽管如此，一些整形外科医生质疑这一假设，并支持 随机研究，特别是因为在先前的研究中，网眼与更高的并发症有关 亚肌肉平面，是医疗系统的昂贵负担(每个乳房高达20,000美元 取决于产品)。现在，严格评估这些植入的网状装置是关键和可行的。 这些药物正在标签外用于脆弱的乳腺癌患者。这项研究首次提出了 网片辅助二期胸前假体乳房再造的随机多中心试验 在主要制造商之间。重要的是，这将是第一次包括没有 获得MESH，并将遵守FDA的规定，包括批准的调查设备豁免。 目标是证明这种研究的可行性，并为评估产生高水平的数据 对这些产品的安全性和有效性进行评估，以利于妇女的公共健康。

Project Summary/Abstract One in eight women will develop breast cancer in her lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Nearly 100,000 patients undergo reconstruction with implants every year in the United States. Surgical mesh devices, particularly acellular dermal matrices, are now used off-label by most reconstructive surgeons performing prosthetic breast reconstruction. In the past decade, surgeons have advocated a transition from submuscular reconstruction (placement of the implant under the pectoralis muscle) to pre-pectoral (placement above the pectoralis) and often consider mesh to be necessary for this procedure. Surgical mesh has not been approved by the FDA for breast reconstruction for either anatomic location. These mesh devices, similar to vaginal mesh, are considered Class III medical devices and FDA recently prioritized the evaluation of these products during a panel meeting in 2019. No Level I randomized trial has been successfully performed to determine the actual risks and benefits of mesh devices in breast reconstruction. Although the existing data are primarily retrospective and observational, multiple small studies and meta-analyses on submuscular reconstructions have found increased complication rates with the use of surgical mesh and no benefit in patient satisfaction. Practice trends have deviated from this conclusion, largely related to the low quality of the existing studies. As surgeons transition to the pre-pectoral plane, mesh manufacturers have concluded that it is impossible to perform a Level I study due to a perceived paucity of surgeons who would perform pre-pectoral reconstruction without their mesh assistance. Nonetheless, several plastic surgeons have questioned this assumption and are supportive of a randomized study, especially because mesh has been associated with higher complications in prior studies in the submuscular plane, and is an expensive burden on the healthcare system (up to 20,000 dollars per breast depending on the product). It is now critical and feasible to rigorously evaluate these implanted mesh devices that are being used, off-label, in vulnerable breast cancer patients. This study proposes the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. Importantly, it will be the first study to include a control cohort that does not receive mesh and will comply with FDA regulations including an approved Investigational Device Exemption. The goals are to demonstrate feasibility of such a study and to generate high level data toward the evaluation of safety and effectiveness of these products for the benefit of women’s public health.