Tinkler J, Gott D, Ludgate S
Department of Health Medical Devices Directorate, London.
Health Trends. 1994;26(1):25-6.
Following concern over a suggested link between the implantation of silicone gel and connective tissue disease, the Medical Devices Directorate (MDD) of the Department of Health reviewed all available data for submission to a specially convened Expert Advisory Group. Animal studies indicated that silicones are unlikely to stimulate a specific antibody response or cell-mediated immunity, that they have no adverse effect on resistance to infection, and produce minimal effects in the presence of potent adjuvants but can act as adjuvants themselves. The connective tissue disease most commonly claimed to be associated with breast implants is scleroderma. Although one series of patients showed a significantly higher prevalence of this disease than expected, there is no clear indication that the incidence of scleroderma in women with breast implants is any higher than in the general population.
在对硅胶植入物与结缔组织疾病之间可能存在的联系表示担忧之后，卫生部医疗器械局（MDD）审查了所有可用数据，以便提交给一个专门召集的专家咨询小组。动物研究表明，硅酮不太可能刺激特异性抗体反应或细胞介导的免疫反应，它们对抗感染能力没有不良影响，在存在强效佐剂的情况下产生的影响极小，但自身也可作为佐剂。最常声称与乳房植入物相关的结缔组织疾病是硬皮病。尽管有一组患者显示这种疾病的患病率明显高于预期，但没有明确迹象表明植入乳房假体的女性中硬皮病的发病率高于一般人群。
