BMJ:隆胸需谨慎!乳房植入物被证实与罕见癌症有关

2019-07-28 杜贝贝 生物探索

7月24日,制药公司Allergan宣布,受美国食品药品监督管理局(FDA)要求在全球范围内召回其Biocell纹理乳房植入物。其召回原因在于:这种乳房假体可能与一种被称为间变性大细胞淋巴瘤(BIA-ALCL)的罕见癌症有关。

7月24日,制药公司Allergan宣布,受美国食品药品监督管理局(FDA)要求在全球范围内召回其Biocell纹理乳房植入物。其召回原因在于:这种乳房假体可能与一种被称为间变性大细胞淋巴瘤(BIA-ALCL)的罕见癌症有关。

据FDA发布的调查数据显示,目前全世界已有573人因乳房假体植入而患有该疾病并已致33例死亡。其中481例的病因明显归于Allergan公司的Biocell隆胸假体,并有12例死亡与此相关。FDA设备和放射健康中心主任Jeffrey Shuren博士表示:“正是这些丰富的死亡数据才让我们作出召回的决定。”

间变性大细胞淋巴瘤

隆胸手术的风险一直都是整形手术关注的重点,早在1997年便有报告首次表明了乳房植入物与疾病之间存在联系。自2011年来FDA一直在关注乳房植入物与癌症之间的联系,在本次召回报告中他们所公告的便是:乳房植入物与间变性大细胞淋巴瘤(BIA-ALCL)相关。

Cederna,美国整形外科基金会的前任总裁介绍到:“间变性大细胞淋巴瘤(BIA-ALCL),并不是乳腺癌,而是一种罕见的、可治疗的T细胞淋巴瘤。它通常发生在隆胸手术植入、因乳房癌而切除乳房后的假体植入等手术后,表现为乳房植入物周围的液体肿胀。尽管该癌症是可治疗的,但如果不及时发现的话,它也会发生增殖和转移来威胁病人生命。”

纹理表面是罪魁祸首

一般来说,乳房植入假体分为无纹理光面和纹理表面两种,之所以设计纹理表面,是因为可以防止假体随意滑动。但也正是因为纹理的不光滑性,往往与植入部位周围的组织进行摩擦从而引起炎症,进而发展组织积液与肿胀,在不及时处理的情况下可能导致BIA-ALCL这种罕见癌症的发生。

美国休斯顿安德森癌症中心的整形外科医生Mark Clemens博士一直在对淋巴瘤进行相关研究并怀疑造成BIA-ALCL的罪魁祸首可能与植入假体的纹理表面有关。在多年调查之后,FDA承认了这一相关性。



乳房植入物与BIA-ALCL的形成过程

其实,市面上存在纹理表面的乳房植入假体商品有很多,但这次FDA仅仅只要求了Allergan公司召回其纹理表面的乳房假体,其原因在于,据FDA的数据分析得出,与同样拥有纹理表面的乳房假体生产商相比,使用Allergan纹理表面的乳房假体所导致患BIA-ALCL的风险几率竟大高出6倍之多。

癌变几率很小

纵观美国整个乳房假体市场,绝大多数乳房假体产品都是无纹理光面的,而纹理表面的乳房假体仅仅只占市场的10%。更值得一提的是,Allergan公司的纹理表面乳房假体仅占该市场的比重还不足5%。

FDA首席副局长Amy Abernethy也表示,这种疾病的总体发病率似乎相对较低,如果植入该乳房假体的消费者并没有发生任何不适,建议不用将此植入假体取出。若出现不适症状,最好与相关医师进行沟通,了解相关情况后再做出处理。

结语

正如美国研究乳房植入物的国家健康研究中心主任Diana Zuckerman所说的:“当女性决定在乳房切除术或隆胸术后进行乳房植入以进行重建时,不应该将生命置于淋巴瘤的危险之中。”

所以,爱美有风险,隆胸需谨慎。

原始出处:

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    2020-06-14 gaoxiaoe
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    2019-07-30 syscxl
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    2019-07-30 jiyangfei

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