Malata C M, Varma S, Scott M, Liston J C, Sharpe D T
Department of Plastic Surgery, St. Luke's Hospital, Bradford, West Yorkshire, UK.
Med Prog Technol. 1994;20(3-4):251-60.
Of the potential health risks of silicone breast implants it is the concern about implant durability, life span and the possible association with connective tissue disease which has attracted most attention. A prospective study addressing these factors was therefore undertaken over an 11 month period. 51 patients presenting with significant capsular contracture, suspected prosthesis rupture or unrelieved implant-induced anxiety underwent revisional breast surgery after biochemical, haematological and immunological screening. Of these 51 patients (83 breasts), 14 (19 breasts) had ruptured implants (23% incidence). These were all smooth prostheses belonging to a cohort manufactured more than 10 years ago; their mean in situ duration being 12 years vs. 5.5 years for the intact group (p = 0.0024; Kruskal-Wallis one-way ANOVA). There were no systemic complications from implant rupture and the mean blood silicon level was normal. One patient with pre-existing pernicious anaemia had elevated autoantibodies. The mean ESR in the ruptured implant group was 6 mm/hour. It is concluded that rupture of breast implants is not as uncommon as hitherto thought and is strongly correlated with their in situ duration. In this study implant gel leakage was not associated with serious systemic effects.
在硅胶乳房植入物的潜在健康风险中，对植入物耐久性、寿命以及与结缔组织疾病可能存在的关联的担忧引起了最多关注。因此，在11个月的时间里进行了一项针对这些因素的前瞻性研究。51例出现明显包膜挛缩、疑似假体破裂或植入物引起的焦虑未缓解的患者，在进行生化、血液学和免疫学筛查后接受了乳房修复手术。在这51例患者（83个乳房）中，14例（19个乳房）出现了植入物破裂（发生率为23%）。这些都是属于10多年前生产的一批光滑假体；它们的平均在位时间为12年，而完整组为5.5年（p = 0.0024；Kruskal-Wallis单因素方差分析）。植入物破裂没有引起全身并发症，平均血液硅水平正常。1例原有恶性贫血的患者自身抗体升高。破裂植入物组的平均血沉为6毫米/小时。结论是，乳房植入物破裂并不像迄今认为的那样罕见，并且与它们的在位时间密切相关。在本研究中，植入物凝胶渗漏与严重的全身影响无关。
