Campanale Antonella, Boldrini Rosaria, Marletta Marcella
Rome, Italy.
From the General Directorate of Medical Devices and Pharmaceutical Services, Medical Device Vigilance System and Inspections, Italian Ministry of Health.
Plast Reconstr Surg. 2018 Jan;141(1):11e-19e. doi: 10.1097/PRS.0000000000003916.
To date, 359 cases of anaplastic large cell lymphoma (ALCL) in women with breast implants (breast implant-associated ALCL [BIA-ALCL]) worldwide have been reported among more than 10 million patients who have received implants, but health care authorities suspect this is a possible underestimation, and the limited number of cases makes it difficult to clarify its cause. The General Directorate of Medical Devices and Pharmaceutical Services of the Italian Ministry of Health has examined and studied the Italian BIA-ALCL cases.
An official document has been diffused to all medical associations, aiming at encouraging all physicians to notify each BIA-ALCL case. A retrospective study has been performed on the notified BIA-ALCL cases collected in the database named Dispovigilance.
Research on Dispovigilance returns a list of 22 BIA-ALCL cases. The mean patient age was 49.6 years (range, 30 to 71 years). The average time to the onset of the symptoms was 6.8 years (range, 1 to 22 years). The average time to diagnosis was 7.8 years (range, 4 to 22 years). The estimated incidence of the Italian BIA-ALCL cases related to 2015 is 2.8 per 100,000 patients.
The pathogenesis of BIA-ALCL remains unknown. The establishment of a national breast implant registry is needed to better understand some aspects of this disease. Future genetic studies on the population affected could clarify why only some patients with implants develop this disease.
迄今为止，在全球超过1000万接受乳房植入物的患者中，已报告了359例患有乳房植入物的女性发生间变性大细胞淋巴瘤（ALCL）（乳房植入物相关ALCL [BIA-ALCL]），但卫生保健当局怀疑这可能是低估，而且病例数量有限使得难以阐明其病因。意大利卫生部医疗器械和药品服务总局已对意大利的BIA-ALCL病例进行了检查和研究。
已向所有医学协会分发了一份官方文件，旨在鼓励所有医生报告每例BIA-ALCL病例。对在名为Dispovigilance的数据库中收集的已报告BIA-ALCL病例进行了回顾性研究。
对Dispovigilance的研究返回了一份22例BIA-ALCL病例的清单。患者的平均年龄为49.6岁（范围为30至71岁）。症状出现的平均时间为6.8年（范围为1至22年）。诊断的平均时间为7.8年（范围为4至22年）。2015年意大利BIA-ALCL病例的估计发病率为每10万名患者2.8例。
BIA-ALCL的发病机制仍然未知。需要建立一个国家乳房植入物登记处，以更好地了解这种疾病的某些方面。未来对受影响人群的基因研究可能会阐明为什么只有一些植入物患者会患上这种疾病。
