Abstract:Background
Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) epidemiological studies focus on incidence and risk estimates.
Objectives
The aim of this manuscript is to perform a thorough review of scientific literature, and provide an accurate estimate of BIA-ALCL prevalence in Europe.
Methods
For the review, we searched PubMed, Web of Scien… Show more
“…With special regard to the large number of countries still using textured implants according to the survey, it is extremely important to collect aggregated long-term data in a European breast implant database. The total number of cases in the current study is in line with a recent study by Santanelli et al, where 420 cases of BIA-ALCL were estimated, according to data collected by the EURAPS-CDSD, following the WHO definition and the NCCN guidelines for diagnosis (PMID: 30715173) in the EU-28 (numerator) [16]. It is worth noting that this number was generated through an estimation, where only 61% of the EU-28 population countries were described to have implemented specific measures to tackle BIA-ALCL and actively reported 382 cases (PMID: 33022037).…”
Background
A growing body of evidence indicates that breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is associated with the use of certain breast implants. Regional variations have been reported, and a genetic susceptibility has also been suggested. However, large variations in the ability to correctly diagnose BIA-ALCL and to further report and register cases exist between countries and may in part explain variations in the demography.
Material and Methods
A survey was conducted by The European Association of Societies of Aesthetic Plastic Surgery E(A)SAPS and sent to 48 European countries. The primary aim was to identify the total number of confirmed cases of and deaths from BIA-ALCL in each country during four consecutive measurements over a two-year period.
Results
An increase in BIA-ALCL cases during four repeated measurements from a total of 305 in April 2019 to 434 in November 2020 was reported by 23 of the 33 responding countries. A nearly 100-fold variation in the number of cases per million inhabitants was noted, where Netherlands had the highest rate (4.12) followed by Finland (1.99). Countries with the lowest reported rates were Austria (0.078), Romania (0.052) and Turkey (0.048).
Conclusion
The current study displays a notable variation ßin the number of confirmed BIA-ALCL cases across Europe, even for countries with established breast implant registers. Variations in diagnosis and reporting systems may explain the differences, but the influence of genetic variations and the prevalence of high-risk implants cannot be excluded. Incomplete sales data along with medical tourism preclude an absolute risk assessment.
Level of Evidence IV
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.
“…With special regard to the large number of countries still using textured implants according to the survey, it is extremely important to collect aggregated long-term data in a European breast implant database. The total number of cases in the current study is in line with a recent study by Santanelli et al, where 420 cases of BIA-ALCL were estimated, according to data collected by the EURAPS-CDSD, following the WHO definition and the NCCN guidelines for diagnosis (PMID: 30715173) in the EU-28 (numerator) [16]. It is worth noting that this number was generated through an estimation, where only 61% of the EU-28 population countries were described to have implemented specific measures to tackle BIA-ALCL and actively reported 382 cases (PMID: 33022037).…”
Background
A growing body of evidence indicates that breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is associated with the use of certain breast implants. Regional variations have been reported, and a genetic susceptibility has also been suggested. However, large variations in the ability to correctly diagnose BIA-ALCL and to further report and register cases exist between countries and may in part explain variations in the demography.
Material and Methods
A survey was conducted by The European Association of Societies of Aesthetic Plastic Surgery E(A)SAPS and sent to 48 European countries. The primary aim was to identify the total number of confirmed cases of and deaths from BIA-ALCL in each country during four consecutive measurements over a two-year period.
Results
An increase in BIA-ALCL cases during four repeated measurements from a total of 305 in April 2019 to 434 in November 2020 was reported by 23 of the 33 responding countries. A nearly 100-fold variation in the number of cases per million inhabitants was noted, where Netherlands had the highest rate (4.12) followed by Finland (1.99). Countries with the lowest reported rates were Austria (0.078), Romania (0.052) and Turkey (0.048).
Conclusion
The current study displays a notable variation ßin the number of confirmed BIA-ALCL cases across Europe, even for countries with established breast implant registers. Variations in diagnosis and reporting systems may explain the differences, but the influence of genetic variations and the prevalence of high-risk implants cannot be excluded. Incomplete sales data along with medical tourism preclude an absolute risk assessment.
Level of Evidence IV
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.
“…Estimates of risk and incidence have increased significantly recently, reaching 1 in 2,969 women with breast implants (12), and 1 in 355 patients with textured implants after breast reconstruction (13).…”
Section: Figure 1 Flowchartmentioning
confidence: 99%
“…23) did not identify BIA-ALCL cases since 2013 (26). The theory that an infection triggers the disease would mean that the cause is related to the technique used by surgeons, a notion disagreed by several authors who believed that the discovery of a cluster of cases by certain surgeons does not indicate a lack of technical skills, but most likely an increased awareness for its diagnosis (12,27).…”
Section: Different Theories About the Etiology Of Bia-alclmentioning
confidence: 99%
“…Cordeiro et al(13) identified an overall risk of 1:355 patients after an average exposure time of 11.7 (range, 7.4-11.8) years. Moreover, 96.7% of the patients used Allergan Biocell implants(12). In France, Ruffenach et al(19) recently reported 36 cases of BIA-ALCL, 70% of implants were made by Biocell, with an average exposure time to diagnosis of 11 years.…”
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare form of non-Hodgkin's T-cell, CD30-positive, and anaplastic lymphoma kinase-negative lymphoma that develops around breast implants, especially those with a textured surface, used in both cosmetic surgery and reconstructive surgery (1, 2). The first case was reported in 1997 by Keech and Creech (3). In June 2011, the Food and Drug Administration (FDA) identified for the first time a possible association between breast implants and the development of large cell anaplastic lymphoma. In 2016, the World Health Organization admitted BIA-ALCL as a possible long-term complication of breast implants (4), and in 2017, this variant of T-cell lymphoma was included in the classification of lymphoid neoplasms (5).
“…Although the incidence is reported between 1:355–1:30,000 women with textured implants, there is a big bias about the real epidemiology due both a lack of information of implanted devices and about undiagnosed cases [ 24 , 25 , 26 , 27 ].…”
Background: Breast-implant-associated anaplastic large cell lymphoma is a rare malignancy linked to texturized breast implants. Although many researchers focus on its etiopathogenesis, this topic is affected by a lack of evidence. Materials and Methods: A literature review about BIA-ALCL was made. Results and conclusions: Although the incidence is reported between 1:355–1:30,000, there is great attention to BIA-ALCL. The incidence is uncertain due to many reasons. It may well be lower, due to inclusion in multiple databases as pointed out by the FDA and undiagnosed cases. The role of chronic inflammation, bacterial contamination, and mechanical forces was discussed. Clarification is needed to understand the mechanisms underlying the progression of alterations and mutations for BIA-ALCL; new molecular analysis and pathogenetic models should be investigated.
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