McLaughlin Joseph K, Lipworth Loren, Murphy Diane K, Walker Patricia S
International Epidemiology Institute, Rockville, MD 20850, USA.
Ann Plast Surg. 2007 Nov;59(5):569-80. doi: 10.1097/SAP.0b013e318066f0bd.
Few implantable medical devices have been studied for their safety more extensively than silicone gel-filled breast implants. We summarize the epidemiologic evidence on the safety of breast implants, most of which is drawn from large cohort studies with long-term follow-up. The topics addressed in this report include cancer, breast cancer detection, connective tissue disease, suicide, offspring effects, neurologic disease, implant rupture, and local perioperative complications and additional surgery. We conclude that the weight of the epidemiologic evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurologic disease. Women with breast implants do not present with more advanced stages of breast cancer or suffer impaired survival after breast cancer diagnosis. The only study to examine an actual incidence rate of breast implant rupture reported rupture-free survival of 98% at 5 years and 83%-85% at 10 years for newer "third-generation" implants. Future studies are needed to determine whether the consistently observed excess of suicide among women with implants reflects underlying psychiatric illness prior to breast augmentation surgery or other factors.
很少有可植入式医疗设备像硅胶填充乳房植入物那样，在安全性方面得到如此广泛的研究。我们总结了关于乳房植入物安全性的流行病学证据，其中大部分来自长期随访的大型队列研究。本报告涉及的主题包括癌症、乳腺癌检测、结缔组织病、自杀、对后代的影响、神经系统疾病、植入物破裂以及局部围手术期并发症和额外手术。我们得出结论，流行病学证据的分量并不支持乳房植入物与乳腺癌或任何其他类型癌症、明确或非典型结缔组织病、对后代的不良影响或神经系统疾病之间存在因果关系。植入乳房植入物的女性在乳腺癌诊断时不会出现更晚期的阶段，也不会在乳腺癌诊断后生存受损。唯一一项研究实际乳房植入物破裂发生率的研究报告称，新型“第三代”植入物在5年时无破裂生存率为98%，在10年时为83%-85%。未来需要进行研究，以确定在植入物女性中持续观察到的自杀率过高是否反映了隆胸手术前的潜在精神疾病或其他因素。
