硅胶乳房植入失败和额外手术的频率:35项研究的分析,报告了8000多个植入物的检查。

J S Marotta, C W Widenhouse, M B Habal, E P Goldberg
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引用次数: 64

摘要

虽然硅胶乳房植入物(sgbi)会产生许多“局部”并发症(如疼痛、硬纤维囊、毁容、慢性炎症、植入物外壳失效)并需要频繁的手术修复,但迄今为止还没有对临床数据进行大规模队列回顾性定量分析的报道,特别是关于失败率和额外手术的报道。来自35项不同研究的数据,涵盖了8000多个外植的sgbi,现已被分析并在此报告。由于对移植假体进行检查是确定假体外壳完整性的最终方法,因此我们所采用的研究仅报道了种植体持续时间、移植的sgbi总数,以及手术切除后确认外壳破裂或失效(“不完整”)的sgbi数量。数据的指数回归图显示种植体持续时间与外壳损坏百分比直接相关(r2 = 0)。63, r = 0.79)。5年SGBI失败率为30%,10年为50%,17年为70%。初次种植手术后的前5年,失败率为每年6%。三个种植年龄组的方差分析比较(平均种植时间为3。9、10.2和18.9年)显示失败率与种植体持续时间高度显著相关(p < 0.001)。在初次种植体手术后的6年内,33%的种植体出现并发症,需要至少进行一次额外的手术。1993年,美国医学协会科学事务委员会提出的破裂率为4%至6%,当时制造商提出的破裂率为0.2%至1.1%,而5%的破裂率被认为“不是FDA可以接受的安全标准”,而壳牌的破裂率被发现比这高出一个数量级。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Silicone gel breast implant failure and frequency of additional surgeries: analysis of 35 studies reporting examination of more than 8,000 explants.

Although it is well known that silicone gel breast implants (SGBIs) produce many "local" complications (i.e., pain, hard fibrous capsules, disfigurement, chronic inflammation, implant shell failure) and necessitate frequent surgical revisions, no large cohort retrospective quantitative analysis of clinical data has been reported to date, especially for the prevalence of failures and additional surgeries. Data from 35 different studies that encompass more than 8000 explanted SGBIs have now been analyzed and are reported here. Because examination of a prosthesis when explanted is the definitive method for determining shell integrity, the only studies that were used were ones that reported implant duration, the total number of SGBIs explanted, and the number of SGBIs for which shell rupture or failure ("not intact") was confirmed upon surgical removal. An exponential regression plot of data indicated a direct correlation of implant duration with percent shell failure (r2 = 0. 63 and r = 0.79 ). SGBI failure was found to be 30% at 5 years, 50% at 10 years, and 70% at 17 years. The failure rate was 6% per year during the first 5 years following primary implant surgery. ANOVA comparison of three implant age groups (mean implant durations of 3. 9, 10.2, and 18.9 years) indicated a highly significant statistical correlation of percent failure with implant duration (p < 0.001). Complications necessitating at least one additional surgery occurred for 33% of implants within 6 years following primary implant surgery. Shell failure was found to be an order of magnitude greater than the 4 to 6% rupture prevalence suggested by the AMA Council on Scientific Affairs in 1993, the 0.2 to 1.1% cited by manufacturers at that time, and the 5% rupture that was stated to be "not a safety standard that the FDA can accept."

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