Larsen Andreas, Bak Erik Eiler Frydshou, Weltz Tim Kongsmark, Hemmingsen Mathilde Nejrup, Andersen Pia Cajsa Leth, Bredgaard Rikke, Damsgaard Tine Engberg, Elberg Jens Jørgen, Trillingsgaard Jesper, Mielke Louise Vennegaard, Hölmich Lisbet Rosenkrantz, Vester-Glowinski Peter, Ørholt Mathias, Herly Mikkel
Aesthet Surg J. 2025 Apr 16;45(5):470-478. doi: 10.1093/asj/sjaf012.
Capsular contracture is a common complication following breast reconstruction and augmentation, but there is limited evidence for the association between silicone leaking from the implant and capsular contracture.
To determine the association between silicone leaking into the surrounding fibrous capsule and the risk of capsular contracture.
This multicenter cross-sectional study included patients undergoing revisional surgery for any indication following breast reconstruction or augmentation with silicone implants. Silicone in the fibrous capsule was quantified using histopathological analysis, and capsular contracture was diagnosed using the Baker classification. Multivariable logistic regression was used to assess the association between the amount of silicone leakage and the predicted risk of capsular contracture. The association was tested in a sensitivity analysis excluding potential confounders and misclassifications.
Among 657 included patients (1147 breasts), 272 patients (346 breasts) had either unilateral or bilateral capsular contracture. Capsular contracture was significantly associated with the amount of silicone in the fibrous capsule (P < .001), independent from the time of implantation (P < .001). The excess risk of capsular contracture increased rapidly by 12% (95% CI, 5.0-18), going from 0.00 mL (0-32nd percentile) to 0.26 mL (60th percentile) of silicone in the fibrous capsule. The association was confirmed in the sensitivity analysis of 421 patients (654 breasts) with intact implants.
Even small amounts of silicone leakage are associated with a significantly increased risk of capsular contracture. This highlights the importance of using breast implants with low silicone leakage rates, such as highly cohesive implants, to prevent capsular contracture.
包膜挛缩是乳房重建和隆胸术后常见的并发症，但关于植入物硅胶渗漏与包膜挛缩之间关联的证据有限。
确定渗漏到周围纤维包膜中的硅胶与包膜挛缩风险之间的关联。
这项多中心横断面研究纳入了因硅胶植入物进行乳房重建或隆胸术后因任何指征接受翻修手术的患者。使用组织病理学分析对纤维包膜中的硅胶进行定量，并使用贝克分类法诊断包膜挛缩。采用多变量逻辑回归评估硅胶渗漏量与预测的包膜挛缩风险之间的关联。在排除潜在混杂因素和错误分类的敏感性分析中对该关联进行了检验。
在纳入的657例患者（1147个乳房）中，272例患者（346个乳房）出现单侧或双侧包膜挛缩。包膜挛缩与纤维包膜中的硅胶量显著相关（P <.001），独立于植入时间（P <.001）。包膜挛缩的额外风险从纤维包膜中硅胶量为0.00 mL（第0 - 32百分位数）迅速增加12%（95%CI，5.0 - 18）至0.26 mL（第60百分位数）。在421例植入物完整的患者（654个乳房）的敏感性分析中证实了这种关联。
即使少量的硅胶渗漏也与包膜挛缩风险显著增加相关。这凸显了使用硅胶渗漏率低的乳房植入物（如高内聚性植入物）以预防包膜挛缩的重要性。
