Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Nova Medical School, Lisbon, Portugal.
Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
Breast. 2019 Apr;44:90-93. doi: 10.1016/j.breast.2019.01.011. Epub 2019 Jan 26.
During the last two decades the number of breast implants used in aesthetic, oncologic and risk reducing surgery has increased substantially mainly due to the improvement and confirmed safety of these devices. Since identification of the first case of anaplastic large cell lymphoma associated with a breast implant (BIA-ALCL) 20 years ago, there has been an increase in the number of reports of this very rare disease, demonstrating a clear association with breast implants. Whilst the majority of cases are localised and cured by implant removal and full capsulectomy, a small percentage require chemotherapy and the mortality rate is very low. The evidence linking BIA-ALCL to implant surface texturing, as the majority of cases were diagnosed in patients with textured implants, has raised concerns about the long term safety of these devices resulting in patient and regulatory authority concerns globally. We hereby present the current published knowledge about the link between BIA-ALCL and implant surface texture and a review of current regulatory and professional body advice across Europe, which may enable a better understanding of this rare disease, how to manage and ultimately prevent it. We conclude by giving EUSOMA recommendation, towards the unnecessary change in attitudes towards implant based surgery, according to the most recent available published evidence as long as patients are properly informed about the risk of BIA-ALCL.
在过去的二十年中,由于这些设备的改进和安全性得到证实,用于美容、肿瘤学和降低风险手术的乳房植入物数量大幅增加。自 20 年前首例与乳房植入物相关的间变性大细胞淋巴瘤(BIA-ALCL)被发现以来,这种非常罕见的疾病报告数量有所增加,明确显示与乳房植入物有关。虽然大多数病例通过取出植入物和完整的囊切除术即可局部治愈,但一小部分病例需要化疗,死亡率非常低。将 BIA-ALCL 与植入物表面纹理联系起来的证据,因为大多数病例是在接受纹理植入物的患者中诊断出的,这引起了人们对这些设备长期安全性的担忧,从而导致全球患者和监管机构的关注。在此,我们介绍了目前关于 BIA-ALCL 与植入物表面纹理之间联系的已发表知识,并回顾了欧洲当前的监管和专业机构建议,这可能有助于更好地了解这种罕见疾病,以及如何管理和最终预防它。我们的结论是,根据最新的可用发表证据,在患者充分了解 BIA-ALCL 风险的情况下,向基于植入物的手术的不必要态度转变提出 EUSOMA 建议。
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