Stevens W Grant, Pacella Salvatore J, Gear Andrew J L, Freeman Mark E, McWhorter Celeste, Tenenbaum Marissa J, Stoker David A
Aesthet Surg J. 2008 Nov-Dec;28(6):642-7. doi: 10.1016/j.asj.2008.09.008.
Since the introduction of fourth- and fifth-generation silicone gel implants, manufacturers have conducted several prospective, multicenter trials to examine their safety and efficacy. However, these studies were not standardized with regard to surgeon skill, pocket placement, operative technique, adjunct therapies, or postoperative management.
The purpose of this study was to examine the surgical outcomes of a single surgeon (WGS) in a consecutive series of breast augmentation cases using a fourth-generation cohesive silicone MemoryGel breast implant (Mentor, Santa Barbara, CA).
A retrospective chart review was conducted to identify all patients who underwent silicone breast augmentation within the Mentor Adjunct Silicone MemoryGel breast implant by a single surgeon (WGS) within a single free-standing outpatient surgical center over a 13-year period (1992 to 2006). For each patient, demographic information, comorbidities, and surgical information (implant size and concomitant surgery) were recorded. In addition, outcomes were analyzed to identify complications and the need for surgical revision.
A total of 1012 fourth-generation, textured, cohesive silicone gel implants were placed in 511 patients during the 13-year study period. The overall complication rate per implant was 5.5% (n=56 implants in 43 patients). The most common complication was capsular contracture (n=26; 2.6 %) followed by abnormal scarring (n=11; 1.1%). The overall revision rates per patient and per implant were 8.0% (n = 41 patients) and 6.8% (n = 69 implants), respectively. The average time interval between initial implantation and revision was 18.5 months (range, 2 weeks to 26 months). The most common indication for surgical revision was patient desire for implant size change (n=15 patients) followed by Baker class III or IV capsular contracture (n=13 patients). The presence of previous surgery for capsular contracture was not statistically correlated to the need for revision (P= .326). Age (P= .568), previous history of breast surgery (P= .704), and history of smoking (P= .138) were also not statistically correlated to revision. Placement of the implant in the subglandular position (n=30 implants), however, was statistically correlated with need for revision (P< .01).
Mentor fourth-generation cohesive silicone gel implants possess a complication and revision profile that is superior to earlier-generation silicone gel implants. Implantation with MemoryGel implants, when standardized with regard to surgeon and operative technique, can have significantly reduced complication and revision rates compared to the Mentor Core Data.
自第四代和第五代硅胶植入物问世以来，制造商已开展多项前瞻性多中心试验以检验其安全性和有效性。然而，这些研究在外科医生技术、植入腔隙位置、手术技术、辅助治疗或术后管理方面并未标准化。
本研究的目的是考察一位外科医生（WGS）在连续一系列使用第四代粘性硅胶记忆凝胶乳房植入物（美国加州圣巴巴拉市曼托公司生产）的隆胸病例中的手术效果。
进行一项回顾性病历审查，以确定在13年期间（1992年至2006年）于一家独立的门诊手术中心由同一位外科医生（WGS）使用曼托辅助硅胶记忆凝胶乳房植入物进行硅胶隆胸的所有患者。记录每位患者的人口统计学信息、合并症和手术信息（植入物大小及同期手术）。此外，分析结果以确定并发症情况及手术修复的必要性。
在13年的研究期间，共511例患者植入了1012枚第四代、带纹理的粘性硅胶凝胶植入物。每枚植入物的总体并发症发生率为5.5%（43例患者中的56枚植入物）。最常见的并发症是包膜挛缩（26例；2.6%），其次是异常瘢痕形成（11例；1.1%）。每位患者和每枚植入物的总体修复率分别为8.0%（41例患者）和6.8%（69枚植入物）。初次植入与修复之间的平均时间间隔为18.5个月（范围为2周至26个月）。手术修复最常见的指征是患者希望改变植入物大小（15例患者），其次是贝克III级或IV级包膜挛缩（13例患者）。既往有包膜挛缩手术史与修复需求无统计学相关性（P = 0.326）。年龄（P = 0.568）、既往乳房手术史（P = 0.704）和吸烟史（P = 0.138）与修复也无统计学相关性。然而，植入物置于乳腺下位置（30枚植入物）与修复需求有统计学相关性（P < 0.01）。
曼托第四代粘性硅胶凝胶植入物的并发症和修复情况优于早期的硅胶凝胶植入物。与曼托核心数据相比，当在外科医生和手术技术方面实现标准化时，使用记忆凝胶植入物可显著降低并发症和修复率。
