Atlanta, Ga.; and Medellin, Colombia From the Division of Plastic and Reconstructive Surgery, Emory University; private practice; and Paces Plastic Surgery.
Plast Reconstr Surg. 2011 Mar;127(3):1300-1310. doi: 10.1097/PRS.0b013e318205f41b.
BACKGROUND: This study evaluated patients who underwent primary breast surgery within a single group practice from 1994 to 2009. Reoperations were divided by reoperation reason into total reoperations and implant-specific reoperations. The authors hypothesized that the implant-specific reoperation rate will provide the most accurate measurement of complications caused by the breast implant device. METHODS: A total of 812 patients received the same brand of breast implant for primary breast augmentation or augmentation/mastopexy. Safety and efficacy data were recorded and complication rates were calculated. Statistics were applied using Kaplan-Meier estimated cumulative incidence calculations. RESULTS: This study included 482 patients with saline and 330 patients with silicone implants. The most common complications included capsular contracture, rippling, rupture, infection, and hematoma. A total of 8.2 percent of patients developed Baker grade III/IV capsular contracture by 6 years. The raw incidence of rippling was 7.1 percent, and the rate was significantly increased in underweight patients with subglandular saline implants (p = 0.045). The rate of total reoperation at 1 year was 14.2 percent. While a significantly increased rate of total reoperation was seen for silicone compared with saline implants (p < 0.01), no difference was seen in the rate of implant-specific reoperation for saline compared to silicone implants (p = 0.582). CONCLUSIONS: The use of total reoperation rates as an indication of complications of breast implants can lead to both an overestimation of implant-related complications and the inaccurate conclusion that silicone implants result in higher complication rates than saline implants. The implant-specific reoperation rate may provide a more accurate incidence of implant complications than the total reoperation rate, which includes reoperations for factors unrelated to the implant.
背景:本研究评估了 1994 年至 2009 年间在单一医疗集团中接受原发性乳房手术的患者。再手术按再手术原因分为全乳房手术和植入物特异性再手术。作者假设,植入物特异性再手术率将提供对乳房植入物装置引起的并发症最准确的测量。
方法:共有 812 名患者接受了同一种品牌的乳房植入物进行原发性乳房增大或增大/乳房成形术。记录了安全性和疗效数据,并计算了并发症发生率。使用 Kaplan-Meier 估计累积发生率计算进行了统计学分析。
结果:本研究包括 482 名盐水袋患者和 330 名硅胶患者。最常见的并发症包括包膜挛缩、波纹、破裂、感染和血肿。6 年内,共有 8.2%的患者出现贝克 3/4 级包膜挛缩。波纹的原始发生率为 7.1%,在皮下植入盐水袋的体重不足患者中显著增加(p = 0.045)。术后 1 年总再手术率为 14.2%。硅胶组总再手术率明显高于盐水组(p < 0.01),但盐水组和硅胶组之间植入物特异性再手术率无差异(p = 0.582)。
结论:将总再手术率作为乳房植入物并发症的指标可能导致对植入物相关并发症的高估,以及错误地得出硅胶植入物比盐水植入物导致更高并发症发生率的结论。植入物特异性再手术率可能比总再手术率更准确地反映植入物并发症的发生率,后者包括与植入物无关的再手术。
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