Noone R B
Department of Surgery, University of Pennsylvania School of Medicine, Philadelphia, USA.
Cancer. 1997 May 1;79(9):1747-56. doi: 10.1002/(sici)1097-0142(19970501)79:9<1747::aid-cncr17>3.0.co;2-y.
The silicone gel breast implant has long been an important method of reconstruction for the mastectomy patient. Because of concerns about possible health implications of the implant, the Food and Drug Administration banned its use for augmentation mammaplasty and limited its use in the mastectomy patient to a research protocol study. This article reviews the recent literature about the possible health hazards of the silicone implant.
In this review of the literature, specific attention was directed toward structural failure of the device as well as the diagnosis of rupture, tissue response to silicone, systemic immunologic response to silicone, the relationship of silicone to connective tissue diseases, and the association of the silicone implant with breast carcinoma in both the augmentation mammaplasty patient and the patient undergoing postmastectomy reconstruction. A total of 88 works were reviewed.
The literature fails to support an association between silicone gel breast implants and systemic diseases. Although implants may cause local symptoms, rupture over time, or be associated with an immunologic reaction, comprehensive epidemiologic studies have concluded that there is no connection between breast implants and the known connective tissue diseases or between the implants and breast carcinoma. There is no increase in the risk of recurrence in mastectomy patients reconstructed with implants and no delay in the detection of recurrences. Recent laboratory studies in animals suggest that silicone may have anticarcinogenic effects.
Silicone gel breast implants may rupture and cause local symptoms, but they have not been demonstrated to be a systemic health hazard for patients who have undergone augmentation mammaplasty or postmastectomy reconstruction.
硅胶乳房植入物长期以来一直是乳房切除患者重要的重建方法。由于担心植入物可能对健康产生影响，美国食品药品监督管理局禁止其用于隆乳术，并将其在乳房切除患者中的使用限制在一项研究方案研究中。本文回顾了近期有关硅胶植入物可能存在的健康危害的文献。
在本次文献综述中，特别关注了该装置的结构故障以及破裂的诊断、组织对硅胶的反应、对硅胶的全身免疫反应、硅胶与结缔组织疾病的关系，以及硅胶植入物与隆乳术患者和乳房切除术后重建患者乳腺癌的关联。共回顾了88篇文献。
文献未能支持硅胶乳房植入物与全身性疾病之间存在关联。尽管植入物可能会引起局部症状、随时间推移发生破裂或与免疫反应相关，但全面的流行病学研究得出结论，乳房植入物与已知的结缔组织疾病之间或植入物与乳腺癌之间没有联系。接受植入物重建的乳房切除患者复发风险没有增加，复发检测也没有延迟。最近在动物身上进行的实验室研究表明，硅胶可能具有抗癌作用。
硅胶乳房植入物可能会破裂并引起局部症状，但对于接受隆乳术或乳房切除术后重建的患者来说，尚未证明它们会对全身健康造成危害。
