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【Plast Reconstr Surg】曼托对硅记忆胶乳房假体的核
Bruce Cunningham, M.D.,M.Sc.
Background: In 2005, convincing safety and efficacy data were presented, resulting
in the approval of Mentor MemoryGel Implants, with conditions.
Methods: 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.
Results: 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.
Conclusion: 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.
(Plast. Reconstr. Surg. 120 (Suppl. 1): 19S, 2007.) 认领此文献 The Mentor Core Study on Silicone MemoryGel Breast Implants
曼托关于硅凝胶乳房假体的核心研究
Background: In 2005, convincing safety and efficacy data were presented, resulting in the approval of Mentor MemoryGel Implants, with conditions
背景：2005年，令人信服的、安全有效的数据的提出使曼托的硅凝胶假体得到了批准。
Methods: 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
方法：本次曼托硅凝胶核心研究采用多种新的方法。选入的近10年1007个病例被分为4组：其中551例是首次隆乳术患者，146例是隆乳修复术患者，251例首次乳房重建患者，59例乳房重建修复的病人。我们将比较术前术后状态、实验仪器以及身体检查来评估患者的病史、病人的舒适度、生活的质量和身体的形态，用相关的组织疾病诊断、风湿病症状、胸廓尺寸改变的大小来确定手术的功效。
Results: 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
结果：安全评估包括并发症比率和重新手术的比率，第3年的结果是由美国FDA专家小组发布的。结果显示：从某种程度上说，在术后三年发生任何并发症（包括再次手术）的危险几率对于首次隆乳术的病人是36.6%，对于隆胸修复的病人是51.1%，对于首次乳房重建的病人是49.4%，对于重建修复的病人是47.5%。经MRI诊断可疑假体破裂的比列在首次隆胸组是0.5%，在隆胸修复组是7.7%，首次乳房重建组为0.9%，重建修复组为0%。只有2个假体而且在一个患者的手术中发现是破裂的，在假体一处患者中，有4.7%是首次隆乳术，12.3%是隆乳修复术，其中病人的选择以及严重的包膜挛缩是主要原因。
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作者:admin@医学,生命科学 2011-08-31 17:15
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