Cunningham Bruce
Minneapolis, Minn. From the Department of Plastic and Reconstructive Surgery, University of Minnesota.
Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):19S-29S. doi: 10.1097/01.prs.0000286574.88752.04.
In 2005, convincing safety and efficacy data were presented, resulting in the approval of Mentor MemoryGel Implants, with conditions.
The 1007 women enrolled in the 10-year, multicenter, Mentor Core MemoryGel Study were distributed into four cohorts: 551 primary augmentation patients, 146 revision-augmentation patients, 251 primary reconstruction patients, and 59 revision-reconstruction patients. Preoperatively and postoperatively, study instruments and physical examinations were administered to assess medical history, patient satisfaction, quality of life and body image, connective tissue disease diagnosis, rheumatology symptoms, and chest size change to determine the efficacy of surgery.
Safety assessments included complication rates and rates of reoperation. Results at 3 years were reported at the U.S. Food and Drug Administration panel. Results indicate that the risk of any complication (including reoperation) at some point through 3 years after implant surgery is 36.6 percent for primary patients, 50.1 percent for revision-augmentation patients, 49.4 percent for primary reconstruction patients, and 47.5 percent for revision-reconstruction patients. Suspected rupture rates reported from the magnetic resonance imaging cohort were 0.5 percent for primary augmentation, 7.7 percent for revision-augmentation, 0.9 percent for primary reconstruction, and 0 percent for revision-reconstruction. Only two implants, in a single patient, were found surgically to be ruptured. There were 4.7 percent primary and 12.3 percent revision-augmentation patients who had their implants removed, with patient choice and severe capsular contracture being the most common reasons.
The data demonstrated safety and efficacy of the devices, but also indicate that a focus must be placed on better education and technique to improve clinical outcomes in the future.
2005年，有令人信服的安全性和有效性数据公布，由此Mentor MemoryGel乳房植入体有条件获批。
1007名女性参与了为期10年的多中心Mentor Core MemoryGel研究，被分为四个队列：551名初次隆乳患者、146名修复隆乳患者、251名初次乳房重建患者和59名修复乳房重建患者。术前和术后，使用研究工具并进行体格检查，以评估病史、患者满意度、生活质量和身体形象、结缔组织病诊断、风湿症状以及胸部尺寸变化，从而确定手术效果。
安全性评估包括并发症发生率和再次手术率。美国食品药品监督管理局专家小组报告了3年时的结果。结果表明，植入手术后3年内，初次手术患者发生任何并发症（包括再次手术）的风险为36.6%，修复隆乳患者为50.1%，初次乳房重建患者为49.4%，修复乳房重建患者为47.5%。磁共振成像队列报告的疑似破裂率，初次隆乳为0.5%，修复隆乳为7.7%，初次乳房重建为0.9%，修复乳房重建为0%。仅在一名患者身上发现有两个植入体通过手术证实发生破裂。有4.7%的初次手术患者和12.3%的修复隆乳患者取出了植入体，最常见的原因是患者自主选择和严重的包膜挛缩。
数据证明了该装置的安全性和有效性，但也表明未来必须更加注重更好的教育和技术，以改善临床结果。
