Evidence map›Paper›PMID 39402199›Full record

ArticleAesthetic plastic surgery2025

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

Antonella Campanale, Marco Ventimiglia, Marco Alfò, Marta Cipriani, Daniela Minella, Lucia Lispi, Achille Iachino

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Article in Aesthetic plastic surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Antonella CampanaleDirectorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy. a.campanale@sanita.it.ORCID 0000-0002-4282-6746
Marco VentimigliaDirectorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy.
Marco AlfòDepartment of Statistical Sciences, Sapienza University of Rome, Rome, Italy.
Marta CiprianiDepartment of Statistical Sciences, Sapienza University of Rome, Rome, Italy.
Daniela MinellaDirectorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy.
Lucia LispiDirectorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy.
Achille IachinoDirectorate General of Medical Devices and Pharmaceutical service, Italian Ministry of Health, Via Ribotta 5, 00144, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccurate 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.

methodsData 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.

resultsFrom 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%.

conclusionsThe 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 .

Indexed as

Breast ImplantationBreast ImplantsBreast NeoplasmsLymphoma, Large-Cell, AnaplasticAdultAgedFemaleHumansIncidenceItalyKaplan-Meier EstimateMiddle AgedRegistriesRetrospective StudiesRisk AssessmentBIA-ALCLBIA-ALCL epidemiologyBIA-ALCL incidenceBIA-ALCL prognosisBreast implants risk

Identifiers

PMID39402199

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.