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【Plast Reconstr Surg】曼托对硅记忆胶乳房假体外形
Bruce Cunningham, M.D.,M.Sc.
Background: Two-year safety and efficacy data were presented to the Canadian
Therapeutic Products Directorate Scientific Advisory Panel, in Ottawa, Ontario,
Canada.
Methods: The 955 women enrolled in the 10-year, multicenter, Mentor MemoryGel
study were distributed into four cohorts: 572 augmentation patients, 123 revisionaugmentation
patients, 191 reconstruction patients, and 69 revision-reconstruction
patients. The surgeons in the study received an intensive clinical educational
program in addition to the protocol.
Results: Mentor’s 2-year study results indicate that the risk of any complication
or reoperation at some point through 2 years after implant surgery is 24.5
percent for primary augmentation patients, 30.2 percent for revision-augmentation
patients, 42.9 percent for primary reconstruction patients, and 41.8
percent for revision-reconstruction patients. The rupture rates reported from
the magnetic resonance imaging cohort were 0 percent for all groups. Patients
reoperated on at least one time were as follows: 9.4 percent for primary augmentation,
12.8 percent for revision-augmentation, 27.3 percent for primary
reconstruction, and 19.4 percent for revision-reconstruction. Also, 2.4 percent
of primary augmentation patients, 7.3 percent of revision-augmentation patients,
8.9 percent of primary, and 11.6 percent of reconstruction patients had
their implants removed, with patient choice and capsular contracture being the
most common reasons.
Conclusions: The data from the Mentor CPG Gel Study resulted in approval of
these implants for general use on October 20, 2006. The educational program
resulted in improved clinical outcomes and probably should be required for all
surgeons using the devices.
(Plast. Reconstr. Surg. 120 (Suppl. 1): 33S, 2007.) 认领此文献 The Mentor Study on Contour Profile Gel Silicone MemoryGel Breast Implants
曼托对记忆胶乳房假体外形轮廓的研究
Background: Two-year safety and efficacy data were presented to the Canadian Therapeutic Products Directorate Scientific Advisory Panel, in Ottawa, Ontario, Canada
背景：位于温太华的加拿大医疗产品董事会科学顾问小组报道了记忆胶假体两年有效性与安全性的相关数据
Methods: The 955 women enrolled in the 10-year, multicenter, Mentor MemoryGel study were distributed into four cohorts: 572 augmentation patients, 123 revisionaugmentation patients, 191 reconstruction patients, and 69 revision-reconstruction patients. The surgeons in the study received an intensive clinical educational program in addition to the protocol
方法：曼托对记忆胶假体的研究是选择不同地区的955名妇女为研究对象，对她们随访了10年， 并分为14组：572名隆胸患者，123名隆胸修复患者，191名乳房重建患者，69名重建修复患者。参与该研究的外科医生都接受过临床和实验的集中培训。
Results: Mentor’s 2-year study results indicate that the risk of any complication or reoperation at some point through 2 years after implant surgery is 24.5 percent for primary augmentation patients, 30.2 percent for revision-augmentation patients, 42.9 percent for primary reconstruction patients, and 41.8 percent for revision-reconstruction patients. The rupture rates reported from the magnetic resonance imaging cohort were 0 percent for all groups. Patients reoperated on at least one time were as follows: 9.4 percent for primary augmentation, 12.8 percent for revision-augmentation, 27.3 percent for primary reconstruction, and 19.4 percent for revision-reconstruction. Also, 2.4 percent of primary augmentation patients, 7.3 percent of revision-augmentation patients, 8.9 percent of primary, and 11.6 percent of reconstruction patients had their implants removed, with patient choice and capsular contracture being the most common reasons
结果：曼托两年的研究结果认为，假体植入2年后出现并发症或再次手术的风险：第一次隆胸患者为24.5%，隆胸修复患者30.2%，第一次乳房重建者42.9%，乳房重建修复者41.8%。MRI显示没有发生假体破裂。9.4%初次隆胸患者，12.8%隆胸修复患者，27.3%初次乳房重建者，19.4%需重建修复者，需要再次手术。而且，2.4%初次隆胸患者，7.3%隆胸修复者，8.9%初次乳房重建者，11.6%重建修复者，因为个人原因和发生包膜挛缩已将假体取出。
Conclusions: The data from the Mentor CPG Gel Study resulted in approval of these implants for general use on October 20, 2006. The educational program resulted in improved clinical outcomes and probably should be required for all surgeons using the devices
结论：2006年10月20日，根据研究结果，曼托认为记忆胶假体可以广泛应用。由于对外科医生进行教育培训，可以提高该假体的临床应用效果，因此这也成为外科医生在应用假体前所学习的内容。 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-06-22 05:15
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