Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.
Department of Surgery, Division of Plastic and Reconstructive Surgery, Massachusetts General Hospital, Boston, MA.
Ann Surg. 2023 Jul 1;278(1):e203-e208. doi: 10.1097/SLA.0000000000005574. Epub 2022 Jul 15.
BACKGROUND/OBJECTIVE: Implant-based breast reconstruction is a common plastic surgery procedure with well-documented clinical outcomes. Despite this, the natural history and timing of key complication endpoints are not well described. The goal of this study is to determine when patients are most likely to experience specific adverse events after implant-based reconstruction.
Retrospective consecutive series of patients who received mastectomy and implant-based reconstruction over a 6-year period were included. Complications and unfavorable outcomes including hematoma, seroma, wound infection, skin flap necrosis, capsular contracture, implant rippling, and implant loss were identified. A time-to-event analysis was performed and Cox regression models identified patient and treatment characteristics associated with each outcome.
Of 1473 patients and 2434 total reconstructed breasts, 785 complications/unfavorable outcomes were identified. The 12-month cumulative incidence of hematoma was 1.4%, seroma: 4.3%, infection: 3.2%, skin flap necrosis: 3.9%, capsular contracture: 5.7%, implant rippling: 7.1%, and implant loss: 3.9%. In the analysis, 332/785 (42.3%) complications occurred within 60 days of surgery; 94% of hematomas, 85% of skin necrosis events, and 75% of seromas occurred during this period. Half of all infections and implant losses also occurred within 60 days. Of the remaining complications, 94% of capsular contractures and 93% of implant rippling occurred >60 days from surgery.
Complications following mastectomy and implant-based reconstruction exhibit a discrete temporal distribution. These data represent the first comprehensive study of the timing of adverse events following implant-based reconstruction. These findings are immediately useful to guide postoperative care, follow-up, and clinical trial design.
背景/目的：基于植入物的乳房重建是一种常见的整形手术，其临床结果有充分的记录。尽管如此，关键并发症终点的自然史和时间仍未得到很好的描述。本研究的目的是确定患者在基于植入物的重建后最有可能经历特定不良事件的时间。
回顾性连续系列在 6 年内接受乳房切除术和基于植入物重建的患者。确定并发症和不良结局，包括血肿、血清肿、伤口感染、皮瓣坏死、包膜挛缩、植入物波纹和植入物丢失。进行时间事件分析，并使用 Cox 回归模型确定与每种结局相关的患者和治疗特征。
在 1473 名患者和 2434 个重建乳房中，发现 785 例并发症/不良结局。血肿的 12 个月累积发生率为 1.4%，血清肿：4.3%，感染：3.2%，皮瓣坏死：3.9%，包膜挛缩：5.7%，植入物波纹：7.1%，植入物丢失：3.9%。在分析中，332/785（42.3%）并发症发生在手术 60 天内；94%的血肿、85%的皮瓣坏死事件和 75%的血清肿发生在此期间。一半的感染和植入物丢失也发生在 60 天内。其余并发症中，94%的包膜挛缩和 93%的植入物波纹发生在手术后>60 天。
乳房切除术和基于植入物的重建后的并发症呈现出明显的时间分布。这些数据代表了对植入物重建后不良事件时间的首次全面研究。这些发现立即有助于指导术后护理、随访和临床试验设计。
