Aesthet Surg J. 2010 Sep;30(5):693-701. doi: 10.1177/1090820X10381880.
BACKGROUND: Form-stable silicone gel breast implants represent the fifth generation of silicone gel augmentation devices. Additional crosslinking between the silicone molecules allows these implants to retain their shape, especially in the vertical position. OBJECTIVE: The authors evaluate the efficacy of Silimed form-stable silicone gel breast implants. METHODS: A total of 355 patients (708 implants) were enrolled prospectively over a 60-month period. Data were collected on patient demographics, implant factors, complications, and revisions. Chi-square analysis and Fisher's exact test were implemented to compare groups with respect to differences in complication and revision rates. RESULTS: The overall tissue-related complication rate was 8.2% per patient, or 4.1% per breast. The overall implant-related cosmetic complication rate was 2.5% per patient, or 1.3% per implant. The overall implant-related complication rate, which was represented by the capsular contracture (CC) rate, was 1.4% per patient and 0.7% per implant. There were no complications in any of the reconstruction patients. There were no deep vein thromboses, pulmonary emboli, myocardial infarctions, or deaths among the patients in this study. In addition, there were no instances of flap necrosis, hematoma, or loss of implant integrity. The overall complication rate was 9.6% per patient, or 4.8% per implant. The overall tissue-related revision rate was 5.4% per patient, with the most common tissue-related reason for revision being unacceptable scarring. The overall implant-related cosmetic revision rate was 7.6% per patient, with the most common reason for revision in this category being size change. The overall implant-related revision rate was 1.1% per patient and was solely due to CC. CONCLUSIONS: This study demonstrates that form-stable silicone gel breast implants are safe and have a complication profile similar to other models of silicone breast implants, with a lower CC rate and a decreased incidence of wrinkling compared to fourth-generation silicone gel implants (as well as other published studies of fifth-generation implants).
背景：形态稳定型硅胶凝胶乳房植入物代表了第五代硅胶凝胶增强装置。硅胶分子之间的额外交联允许这些植入物保持其形状，尤其是在垂直位置。
目的：作者评估 Silimed 形态稳定型硅胶凝胶乳房植入物的疗效。
方法：在 60 个月的时间内，前瞻性纳入了 355 名患者（708 个植入物）。收集患者人口统计学数据、植入物因素、并发症和翻修数据。采用卡方分析和 Fisher 确切检验比较各组间并发症和翻修率的差异。
结果：总的组织相关并发症发生率为每名患者 8.2%，或每侧乳房 4.1%。总的植入物相关美容并发症发生率为每名患者 2.5%，或每侧乳房 1.3%。总的植入物相关并发症发生率，即包膜挛缩（CC）发生率，为每名患者 1.4%，每侧乳房 0.7%。重建患者无一例发生并发症。本研究中无深静脉血栓形成、肺栓塞、心肌梗死或死亡病例。此外，无皮瓣坏死、血肿或植入物完整性丧失。总的并发症发生率为每名患者 9.6%，或每侧乳房 4.8%。总的组织相关翻修率为每名患者 5.4%，最常见的组织相关翻修原因是不可接受的瘢痕。总的植入物相关美容翻修率为每名患者 7.6%，该类别中最常见的翻修原因是大小变化。总的植入物相关翻修率为每名患者 1.1%，仅因 CC 导致。
结论：本研究表明，形态稳定型硅胶凝胶乳房植入物是安全的，其并发症谱与其他类型的硅胶乳房植入物相似，包膜挛缩率较低，与第四代硅胶凝胶植入物（以及其他已发表的第五代植入物研究）相比，皱纹发生率降低。
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