From the Department of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet.
Amalieklinikken.
Plast Reconstr Surg. 2024 Dec 1;154(6):1159-1171. doi: 10.1097/PRS.0000000000011395. Epub 2024 Mar 12.
Silicone leakage from breast implants is a concern with potential implications for patient health. This study aimed to quantify and model silicone leakage from implants to the breast implant capsule and to investigate whether silicone cohesiveness affected the silicone leakage rate.
Silicone content in the breast implant capsule was quantified histologically by measuring the area of silicone deposits. This was used to model silicone leakage over time based on the time of implantation. The effect of cohesiveness on silicone leakage was investigated across all implant brands with declared cohesiveness and in a subanalysis comparing only Mentor cohesive I implants with cohesive II and III implants.
The study included 493 patients with 872 breasts and a median time of implantation of 13.0 years (range, 0.4 to 51 years). The modeling of silicone leakage from intact implants showed that leakage and the acceleration of the leakage rate were significantly higher in low-cohesive implants than in highly cohesive implants ( P < 0.05). This was confirmed when analyzing only Mentor implants ( P < 0.05) and in the case of implant rupture ( P < 0.01) where low-cohesive implants also leaked significantly more than highly cohesive implants.
The authors' results suggest that highly cohesive implants are superior to low-cohesive implants in preventing silicone leakage. Because of the accelerating rate of silicone leakage especially found in low-cohesive implants, the authors propose that exchange of low-cohesive implants could be discussed with patients 10 to 15 years after implantation to minimize silicone leakage, even in the absence of implant rupture.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
乳房植入物的硅酮泄漏是一个令人关注的问题，可能对患者健康产生潜在影响。本研究旨在定量和建模植入物向乳房植入物胶囊的硅酮泄漏，并研究硅酮的内聚性是否影响硅酮泄漏率。
通过测量硅酮沉积物的面积，组织学上量化乳房植入物胶囊中的硅酮含量。这用于根据植入时间来模拟随时间的硅酮泄漏。研究了所有具有宣称内聚性的植入物品牌以及仅对 Mentor 高内聚性 I 型植入物与中内聚性 II 型和 III 型植入物进行比较的亚分析中，内聚性对硅酮泄漏的影响。
该研究纳入了 493 名患者的 872 只乳房，植入时间中位数为 13.0 年（范围，0.4 至 51 年）。对完整植入物的硅酮泄漏进行建模表明，低内聚性植入物的泄漏和泄漏率加速明显高于高内聚性植入物（P < 0.05）。当仅分析 Mentor 植入物时（P < 0.05）和在植入物破裂的情况下（P < 0.01），低内聚性植入物也明显比高内聚性植入物泄漏更多，这一点得到了证实。
作者的结果表明，高内聚性植入物在防止硅酮泄漏方面优于低内聚性植入物。由于低内聚性植入物中发现的硅酮泄漏加速率特别高，作者建议在植入后 10 至 15 年内与患者讨论更换低内聚性植入物，以尽量减少硅酮泄漏，即使在没有植入物破裂的情况下也是如此。
临床问题/证据水平：治疗性，III 级。
