Schnur P L, Weinzweig J, Harris J B, Moyer T P, Petty P M, Nixon D, McConnell J P
Division of Plastic and Reconstructive Surgery, Mayo Clinic, Scottsdale, Ariz., USA.
Plast Reconstr Surg. 1996 Oct;98(5):798-803. doi: 10.1097/00006534-199610000-00007.
The ubiquitousness of silicon is well known. Recent work has demonstrated measurable baseline levels of silicon in nonaugmented cadavers, subsequent to numerous reports of significant elevations of such levels within patients with silicone breast implants and even more reports alleging a causal relation between silicone gel prostheses and connective-tissue diseases. Despite the lack of scientifically substantiated data that such a relation exists, the calamitous silicone breast implant controversy has ensued. Saline-filled breast implants are constructed with a silicone elastomer envelope that remains in direct contact with periprosthetic capsular tissue following implantation. Although there is no evidence to link saline implants with any disorders, it is important to know if saline breast implants contribute any silicon to human body baseline silicon levels. The present study measured tissue silicon levels in 28 breasts of 16 patients with saline-filled implants to determine if the silicone envelope of these prostheses can contribute to the elevation of such levels. These data were compared with data from 116 breasts of 65 patients with silicone gel-filled prostheses as well as breast tissue from 17 patients (controls) who had never been exposed to either type of implant. Samples of breast tissue and periprosthetic capsular tissue were obtained from patients with both intact and ruptured implants. Silicon levels of breast tissue specimens from patients with saline-filled implants were within the range of the controls if the implants were intact. Silicon levels in periprosthetic capsular tissue from patients with intact saline-filled implants were significantly higher than controls (p < 0.02); however, they were still 100-fold less than capsular tissue levels from patients with intact gel-filled implants. Silicon levels measured in both types of tissue were significantly elevated in patients with silicone gel-filled implants compared with controls (p < 0.01). In the case of ruptured gel implants, breast tissue demonstrated higher silicon levels than did similar specimens from patients with intact implants (p < 0.054); periprosthetic capsular tissue levels also were elevated, although the differences were not statistically significant (p = 0.54). These findings are independent of the implant brand or length of exposure to the particular prosthesis. The finding of elevated levels of silicon in both breast and periprosthetic capsular tissue in patients with silicone gel-filled implants in no way implies or substantiates any claim of a causal relationship between silicone and any reported illnesses.
硅的普遍存在是众所周知的。最近的研究表明,在未植入假体的尸体中可检测到硅的基线水平,此前有大量报告称硅胶乳房植入患者体内的硅水平显著升高,甚至有更多报告声称硅胶假体与结缔组织疾病之间存在因果关系。尽管缺乏科学证实的数据表明存在这种关系,但灾难性的硅胶乳房植入物争议仍在继续。盐水填充乳房植入物由硅胶弹性体包膜构成,植入后该包膜与假体周围的包膜组织直接接触。虽然没有证据表明盐水植入物与任何疾病有关,但了解盐水乳房植入物是否会使人体硅基线水平升高很重要。本研究测量了16例盐水填充植入物患者的28个乳房中的组织硅水平,以确定这些假体的硅胶包膜是否会导致此类水平升高。这些数据与65例硅胶填充假体患者的116个乳房的数据以及17例从未接触过任何一种植入物的患者(对照组)的乳房组织数据进行了比较。从植入物完整和破裂的患者中获取乳房组织和假体周围包膜组织样本。如果盐水填充植入物完整,其患者乳房组织标本的硅水平在对照组范围内。完整的盐水填充植入物患者的假体周围包膜组织中的硅水平显著高于对照组(p < 0.02);然而,它们仍比完整的硅胶填充植入物患者的包膜组织水平低100倍。与对照组相比,硅胶填充植入物患者的两种组织中测量的硅水平均显著升高(p < 0.01)。对于破裂的硅胶植入物,乳房组织显示出比完整植入物患者的类似标本更高的硅水平(p < 0.054);假体周围包膜组织水平也有所升高,尽管差异无统计学意义(p = 0.54)。这些发现与植入物品牌或接触特定假体的时间长短无关。硅胶填充植入物患者的乳房和假体周围包膜组织中硅水平升高的发现绝不意味着或证实硅胶与任何报道疾病之间存在因果关系的任何说法。