BIA-ALCL资源
通过数字和它们的含义

马克·克莱门斯，医学博士

2020年8月20日，美国总统奥巴马将与美国总统奥巴马会面.S. Food and Drug Administration (FDA) released a safety communication updating the current understanding of BIA-ALCL, the number of known worldwide cases and calling for a voluntary Class I device recall of higher-risk devices. 许多成员对有关BIA-ALCL的许多数据表示困惑. The purpose of this document is to discuss and bring clarity to some of the figures surrounding this rare disease.

733

The recent BIA-ALCL update reported that the FDA has been made aware of 733 medical device reports (MDRs) for BIA-ALCL cases worldwide related to breast implants. This is in comparison previous FDA reports of 573 unique and pathologically confirmed cases in July 2019, 2019年3月660份医疗器械报告(mdr), 2018年3月为414份mdr, 2017年3月有359份mdr, 2016年1月为258份，2011年1月为64份. 当制造商被列出时，FDA报告90.世界上4%的病例与植入Allergan有关，7.3%导师植入物，1.5% Sientra种植体，0.9%的其他制造商. 重要的是, the FDA does not recommend the prophylactic explantation of implants without the diagnosis of BIA-ALCL. Prophylactic procedures such as implant exchange or capsulectomy have not been shown to mitigate future risk of disease.

4.5%

FDA最近更新的733份报告包括28份(5.3%)平滑植入报告. 这类似于去年更新的26 (4.5%)光滑的植入物, 2018年有30人(7%), 2017年有28人(8%), 2016年为11% (4%). 非常重要的, 28例为光滑种植体, 10人有未知的植入史, 8人有植入纹理的历史, 9号患者之前有过植入物，但质地未知, 1例有平滑植入的病史. 记住这些MDR报告, FDA“不能确认报告的植入历史是否完整。.” There were no reports of cases associated with tissue expanders but there is one tissue expander report to the 配置文件 registry. 到目前为止, no purely clinical history of purely smooth-surface devices and BIA-ALCL has ever been confirmed in any series, 有详细历史记录的注册或病例报告. FDA证实，BIA-ALCL主要与纹理表面植入物有关.

36

FDA报告了全世界36例独特的死亡病例. 而血清肿是所有BIA-ALCL病例中最常见的表现(53%), a capsular mass was the most common presentation among the deaths (39%) likely indicating more advanced and invasive disease.

166

166例经证实的美国病例已报告给"个人资料档案"登记处. The 配置文件 registry is a joint collaboration between the FDA and ASPS/PSF to prospectively track BIA-ALCL patients. Based upon a global network of international plastic surgery societies sharing tracking of cases, ASPS现在知道全世界有885个独特的病例.

1:355-86,029

目前公布的BIA-ALCL的终生风险估计为1:355-1:86,029基于不同制造商类型的纹理植入物的可变风险. 据《十大网赌排行榜》2017年报道，纹理植入物的总体风险为1:30,000年重要的是, this was an average number across both Allergan and Mentor textured implants which were demonstrated to have a 6:1 ratio. BIA-ALCL cases from the Allergan prospective CA/CARE trial have been reported to demonstrate a risk of 1:2,207与爱力根生物细胞. 今年, 澳大利亚和新西兰的研究人员报告的比例为1:3,爱力根生物细胞的风险是345分和1:86,029风险与曼拓Siltex. Worldwide clusters of disease have been reported and importantly represent heightened disease awareness and excellent long-term surveillance at these centers. Unfortunately a growing narrative exists of misattributing clusters to “lapses in surgical technique” and “poor institutional hygiene” without any supportive data, 是什么在约束外科医生，阻碍病例的报告. 到目前为止, no operative strategy has been shown to decrease or affect the future risk of BIA-ALCL.

1,400

每年有1400名患者被诊断为ALCL. ALCL is a family of diseases from the very aggressive systemic ALCL to the indolent lymphoproliferative disorder primary cutaneous ALCL. 这是2016年第一次, the World Health Organization added BIA-ALCL as a provisionally recognized lymphoma to the family of existing ALCL. It is important to differentiate BIA-ALCL from primary lymphoma of the breast which is predominantly a B-cell lymphoma with an incidence of approximately 1:4 million. ALK+ disease and B cell pathology should be concerning for primary lymphoma of the breast rather than BIA-ALCL.

<5%

在美国，每年大约有55万例隆胸手术.S. 在这些植入物中，大约有7万个有纹理的乳房植入物，相当于12个.截至2017年，市场占有率为7%. In March 2019, the FDA reported that this market share may have recently decreased to less than 5%.

93%

在3年的随访中，93%的患者无病, 如果治疗得当，哪种预后最好. The National Comprehensive Cancer Network defines optimal treatment which is total capsulectomy and implant removal for most patients with disease confined to the capsule (35 percent of patients) or a resectable mass (40 percent of patients). Advanced disease with lymph node metastasis (14 percent of patients) or organ metastasis (1 percent of patients) may require further treatment with chemotherapy using either CHOP anthracycline based-protocol and/or targeted immune therapy with brentuximab vedotin. Radiation therapy is only reserved for local unresectable disease such as into the chest wall and mediastinum. 晚期癌症是癌症的最后阶段, and these patients substantiate the World Health Organization classification of BIA-ALCL as a lymphoma and not benign or lymphoproliferative.

30

For a suspected patient with a delayed seroma (>1 year), 至少抽吸50ml液体，送去做CD30免疫组化, 细胞学和流式细胞术. CD30 is the main diagnostic test that must be performed on the seroma fluid as routine pathology or H&E染色常误诊.

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