Current Knowledge on Breast Implant-Associated Anaplastic Large Cell Lymphoma: Evidence from Italian Ministry of Health Registry Data.

Autor: Campanale A; Directorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy. a.campanale@sanita.it., Ventimiglia M; Directorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy., Alfò M; Department of Statistical Sciences, Sapienza University of Rome, Rome, Italy., Cipriani M; Department of Statistical Sciences, Sapienza University of Rome, Rome, Italy., Minella D; Directorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy., Lispi L; Directorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy., Iachino A; Directorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy.
Jazyk: angličtina
Zdroj: Aesthetic plastic surgery [Aesthetic Plast Surg] 2024 Oct 14. Date of Electronic Publication: 2024 Oct 14.
DOI: 10.1007/s00266-024-04426-y
Abstrakt: Background: Accurate estimation of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) incidence is crucial for assessing breast-implant-associated risk. However, the size of the implanted population worldwide is unknown, making it challenging to appropriately estimate this figure. This study aims to provide a new reliable and reproducible method to estimate the breast-implanted-population (BIP), reporting a reliable annual BIA-ALCL incidence estimate. Moreover, we discuss all activities performed over the past decade in collecting complete histories, managing, and monitoring outcomes of each Italian case.
Methods: Data from the National Breast Implant Registry and from manufacturers have been used to define a new formula to estimate the BIP at risk of developing a breast-implant-related event. From the BIA-ALCL registry, complete information on Italian cases has been collected and analysed. Overall survival is estimated by the Kaplan-Meier curve.
Results: From 2010 to June 2024, 111 BIA-ALCL cases were recorded in Italy. The estimated incidence rate showed an upward trend, ranging from 2.68 to 6.35 cases per 100,000 patient-years. Thanks to newly promoted disease awareness, most patients had a complete response to treatment, resulting in a three-year overall survival rate estimate of 98.2%.
Conclusions: The BIP formula showed to be an innovative, effective and reproducible tool to make a reliable estimation of the implanted population, confirming that BIA-ALCL is a rare disease with an incidence rate estimate varying from 2.7 to 6.3 cases/100.000 patient-years in the last five years. Eleven-year experience in this field also confirmed that this disease has a favorable prognosis if properly treated.
Level of Evidence Iii: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
(© 2024. Springer Science+Business Media, LLC, part of Springer Nature and International Society of Aesthetic Plastic Surgery.)
Databáze: MEDLINE
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