Kolasiński Jerzy, Sorotos Michail, Firmani Guido, Panagiotakos Demosthenes, Płonka Justyna, Kolenda Małgorzata, Santanelli di Pompeo Fabio
Aesthet Surg J. 2023 Oct 13;43(11):1258-1268. doi: 10.1093/asj/sjad181.
Epidemiologic studies on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) currently estimate the risk between 1:300 and 1:30,000, assessed mainly in large breast reconstruction populations.
The aim of the study was to assess BIA-ALCL epidemiology in a cohort of patients who have received textured implants for cosmetic indications.
In a prospective cohort observational study, 1501 patients who received a cosmetic breast augmentation between 2006 and 2016 were monitored, recording any implant-related complications, including BIA-ALCL. Cross-checking of clinical, pathology, and external records data identified cases. Prevalence, implant-specific prevalence (I-SP), incidence rate (IR), event-free time (EFT), and the Kaplan-Meier survival estimate were calculated.
All but 2 patients received macrotextured or microtextured devices bilaterally. Mean follow-up was 3.2 years (1 months to 16.4 years). Five BIA-ALCL cases were investigated. Prevalence was 1:300 patients; I-SP was 6.9 cases/1000 individuals/Allergan BIOCELL devices and 1.3 cases/1000 individuals/Mentor Siltex devices; and IR was 1.07 cases/1000 females/year. Mean (SD) EFT was 9.2 years.
When using a denominator based on a cohort of cosmetic patients, BIA-ALCL occurrence is higher than previously reported, particularly with macrotextured devices. Given the similar IRs in reconstructive and cosmetic cohorts, their even distribution could be consequent to underreporting due to poorer follow-up and lower awareness in the latter group. The genetic predisposition in the oncologic cohort reasonably affects the early onset more than the IR. The importance of accurate follow-up is confirmed. Stratification risks analysis can guide surgeons during patient counseling regarding the decision for prophylactic explantation.
目前关于乳房植入物相关间变性大细胞淋巴瘤（BIA-ALCL）的流行病学研究估计其风险在1:300至1:30,000之间，主要是在大型乳房重建人群中评估得出。
本研究旨在评估一组因美容目的接受表面有纹理植入物的患者中BIA-ALCL的流行病学情况。
在一项前瞻性队列观察研究中，对2006年至2016年间接受美容性隆乳手术的1501例患者进行监测，记录任何与植入物相关的并发症，包括BIA-ALCL。通过对临床、病理和外部记录数据进行交叉核对来确定病例。计算患病率、特定植入物患病率（I-SP）、发病率（IR）、无事件时间（EFT）以及Kaplan-Meier生存估计值。
除2例患者外，其余患者均双侧植入了大纹理或微纹理假体。平均随访时间为3.2年（1个月至16.4年）。对5例BIA-ALCL病例进行了调查。患病率为1:300患者；I-SP为每1000人/Allergan BIOCELL假体6.9例以及每1000人/Mentor Siltex假体1.3例；IR为每1000名女性/年1.07例。平均（标准差）EFT为9.2年。
以一组美容患者为分母时，BIA-ALCL的发生率高于先前报道，尤其是使用大纹理假体时。鉴于重建和美容队列中的IR相似，其均匀分布可能是由于后者随访较差和认识不足导致报告不足所致。肿瘤队列中的遗传易感性合理地对早期发病的影响大于对IR的影响。证实了准确随访的重要性。分层风险分析可在患者咨询预防性取出假体的决策过程中指导外科医生。
