Santanelli di Pompeo Fabio, Clemens Mark W, Paolini Guido, Firmani Guido, Panagiotakos Demosthenes, Sorotos Michail
Aesthet Surg J. 2023 Dec 14;44(1):NP32-NP40. doi: 10.1093/asj/sjad279.
Although textured implants represent fewer than 10% of implants used in the United States, the country reports the highest incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The aim of this study was to perform a systematic literature review on US-based epidemiology to update knowledge on BIA-ALCL in the United States.
Publications on US BIA-ALCL epidemiology were searched between September 2022 and March 2023 on MEDLINE (National Institutes of Health; Bethesda, MD), Embase (Elsevier, Amsterdam, the Netherlands), Web of Science (Clarivate, London, UK), and SCOPUS (Elsevier, Amsterdam, the Netherlands). The US numerator was obtained by averaging the FDA MAUDE database and the PSF PROFILE registry, while the denominator was estimated from chest X-rays, and included female transgender individuals. Prevalence and risk were assessed accordingly, but the incidence rate (IR) could not be updated due to the lack of available follow-up data.
Out of 987 identified manuscripts, 10 were included. The US prevalence of BIA-ALCL in the literature ranged from 1:300 to 1:500,000 and the IR from 4.5 per 10,000 to 31.1 per 100 million persons per year. A mean value of 453.5 BIA-ALCL cases was calculated. From a denominator of 4,264,618 individuals, which includes all breast implant surfaces, we calculated 414,521 individuals with textured implants, indicating a textured prevalence of 109.4 cases per 100,000 individuals and a risk of 1:913.
BIA-ALCL IR, prevalence, and risk has increased when calculated exclusively for patients with textured devices. Although US macrotextured implants were recalled by the FDA, these findings may influence the surveillance of existing patients and the use of macrotextured implants in other parts of the world where they remain widespread.
尽管在美国使用的乳房植入物中，表面有纹理的植入物占比不到10%，但该国报告的乳房植入物相关间变性大细胞淋巴瘤（BIA-ALCL）发病率却是最高的。
本研究旨在对美国的流行病学进行系统的文献综述，以更新关于美国BIA-ALCL的知识。
于2022年9月至2023年3月在MEDLINE（美国国立卫生研究院；马里兰州贝塞斯达）、Embase（爱思唯尔，荷兰阿姆斯特丹）、Web of Science（科睿唯安，英国伦敦）和SCOPUS（爱思唯尔，荷兰阿姆斯特丹）上搜索有关美国BIA-ALCL流行病学的出版物。美国的分子数据通过平均食品药品监督管理局（FDA）不良事件报告系统（MAUDE）数据库和整形手术质量基金会（PSF）PROFILE登记处的数据获得，而分母则根据胸部X光片估算，包括女性 transgender个体。据此评估患病率和风险，但由于缺乏可用的随访数据，发病率（IR）无法更新。
在987篇已识别的手稿中，纳入了10篇。文献中美国BIA-ALCL的患病率在1:300至1:500,000之间，发病率在每年每10,000人4.5例至每1亿人31.1例之间。计算得出BIA-ALCL病例的平均值为453.5例。在包括所有乳房植入物表面的4,264,618人的分母中，我们计算出有414,521人使用了表面有纹理的植入物，表明每100,000人中有109.4例表面有纹理的植入物相关病例，风险为1:913。
仅针对使用表面有纹理的器械的患者计算时，BIA-ALCL的发病率、患病率和风险有所增加。尽管美国的大纹理植入物已被FDA召回，但这些发现可能会影响对现有患者的监测以及大纹理植入物在世界其他仍广泛使用地区的使用。
