Parham Christopher S, Hanson Summer E, Butler Charles E, Calobrace M Bradley, Hollrah Raylene, Macgregor Terri, Clemens Mark W
Department of Surgery, Division of Plastic Surgery, Pennsylvania State University, College of Medicine, Hershey, PA, USA.
Department of Plastic Surgery, MD Anderson Cancer Center, University of Texas, Houston, TX, USA.
Gland Surg. 2021 Jan;10(1):417-429. doi: 10.21037/gs.2020.03.06.
The United States Food and Drug Administration (FDA) recently recognized the necessity for improved patient education and public awareness of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is an uncommon T-cell lymphoma that can arise years after placement of a textured breast implant or tissue expander. Patients and providers would greatly benefit from a broader awareness of BIA-ALCL and how it presents with both common and rare symptoms. Disease awareness can be improved with specific steps moving forward. This includes improved counseling about annual recommendations from the FDA, standard of care guidelines, current estimates of disease prevalence, and manufacturer-specific risk for developing the malignancy. Informed consent for implant-based breast surgery should include a discussion of BIA-ALCL, symptoms, inherent risks and alternatives. Consideration should be given for reasonable efforts to retroactively contact patients with textured implants to inform them of recent regulatory actions as well as the risk of developing the disease and the signs and symptoms to watch for. Where risk can be reduced, all steps should be taken to ensure patient safety. In keeping with our commitment to patient safety, the strategies moving forward for implant-based breast surgery should be marked by patient awareness, physician vigilance, and defined by evidence-based diagnosis and treatment.
美国食品药品监督管理局(FDA)最近认识到加强患者教育以及提高公众对乳房植入物相关间变性大细胞淋巴瘤(BIA-ALCL)认识的必要性。BIA-ALCL是一种罕见的T细胞淋巴瘤,可在植入有纹理的乳房植入物或组织扩张器数年之后出现。患者和医疗服务提供者若能更广泛地了解BIA-ALCL及其常见和罕见症状的表现,将大有裨益。通过采取具体措施可以提高对该疾病的认识。这包括加强关于FDA年度建议、护理标准指南、当前疾病患病率估计以及特定制造商发生恶性肿瘤风险的咨询。基于植入物的乳房手术的知情同意应包括对BIA-ALCL、症状、固有风险和替代方案的讨论。应考虑做出合理努力,追溯联系使用有纹理植入物的患者,告知他们最近的监管行动以及患病风险和需要留意的体征和症状。在可以降低风险的地方,应采取一切措施确保患者安全。为履行我们对患者安全的承诺,基于植入物的乳房手术未来的策略应以患者意识、医生警惕性为特点,并以循证诊断和治疗为准则。