Bengtson Bradley P, Van Natta Bruce W, Murphy Diane K, Slicton Araceli, Maxwell G Patrick
Grand Rapids, Mich.; Indianapolis, Ind.; Santa Barbara, Calif.; and Nashville, Tenn. From Plastic Surgery Associates and Medical Education Research Center; the Perkins Van Natta Center for Cosmetic Surgery and Medical Skincare; Allergan, Inc.; and the Department of Plastic Surgery, Vanderbilt University School of Medicine.
Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):40S-48S. doi: 10.1097/01.prs.0000286666.29101.11.
In February of 2001, Allergan (formerly Inamed) began an Investigational Device Exemption study of a shaped breast implant: the Style 410 highly cohesive silicone-filled breast implant.
Forty-eight plastic surgeons across the United States performed implantation on 941 subjects enrolled in a 10-year study. This prospective, nonrandomized study provided 3-year follow-up data, clinical outcomes, and satisfaction rates from this cohort of 492 primary augmentation, 225 breast reconstruction, and 224 breast revision subjects. Complications were reported and compared with those from current standard gel and saline implant studies.
With greater than 85 percent follow-up compliance at 3 years, complication rates were low among augmentation subjects, with implant malposition being the most common (2.6 percent) and all other complications occurring in less than 2 percent of subjects. In the revision-augmentation group, the most common complications were capsular contracture (4.8 percent) and implant malposition (4.7 percent), with all other complications occurring in less than 4 percent. Asymmetry (8.7 percent) and capsular contracture (5.9 percent) were the only complications that occurred in more than 5 percent of reconstruction subjects. The overall risk of rupture across all cohorts was 1.0 percent by subject and 0.8 percent by implant. Subject satisfaction with implants was 98 percent for augmentation and 90 percent or higher for all other cohorts.
The Style 410 highly cohesive silicone implant has low complication rates and high satisfaction rates through 3 years after implantation. These results are significant in introducing more evidence-based medicine that will allow plastic surgeons and patients to make better informed decisions regarding implant options.
2001年2月，艾尔建公司（前身为英纳美公司）开始了一项关于一种塑形乳房植入物的研究性器械豁免研究：410型高凝聚性硅胶填充乳房植入物。
美国48位整形外科医生对941名参与一项为期10年研究的受试者进行了植入手术。这项前瞻性、非随机研究提供了来自492名初次隆乳、225名乳房重建和224名乳房修复受试者这一队列的3年随访数据、临床结果和满意率。报告了并发症情况，并与当前标准凝胶和盐水植入物研究的并发症进行了比较。
在3年时随访依从性超过85%，隆乳受试者的并发症发生率较低，植入物位置异常最为常见（2.6%），所有其他并发症发生率低于2%。在修复隆乳组中，最常见的并发症是包膜挛缩（4.8%）和植入物位置异常（4.7%），所有其他并发症发生率低于4%。不对称（8.7%）和包膜挛缩（5.9%）是仅有的在超过5%的重建受试者中出现的并发症。所有队列中植入物破裂的总体风险，按受试者计算为1.0%，按植入物计算为0.8%。受试者对植入物的满意率，隆乳者为98%，所有其他队列均为90%或更高。
410型高凝聚性硅胶植入物在植入后3年内并发症发生率低，满意率高。这些结果对于引入更多循证医学具有重要意义，这将使整形外科医生和患者能够在植入物选择方面做出更明智的决定。
