Considerations on the Demography of BIA-ALCL in European Countries Based on an E(A)SAPS Survey

Abstract

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.

Oncoplastic and reconstructive surgery in SENONETWORK Italian breast centers: lights and shadows

“…BUs are increasingly focusing on screening for BIA-ALCL, in the light of the increase in the number of cases and the capacity for diagnosis, as emerges from a survey conducted by the European Association of Societies of Aesthetic Plastic Surgery E(A)SAPS in 48 European countries [ 24 ]. Indeed, efforts still need to be made in order to increase the adoption of a national implant registry.…”

The Influence of BIA-ALCL on the Use of Textured Breast Implant and its Placement: A Survey of Dutch Plastic Surgeons

“…The Netherlands has one of the highest numbers of BIA-ALCL diagnoses in Europe. 5 This is most likely due to the country’s modern healthcare system, a swift response to surging cases worldwide, and registration in our recently established nationwide databases. Dutch women with breast implants have a 1:35,000 chance of developing BIA-ALCL before they reach the age of 50 years and 1:7000 by the age of 75.…”

“…At least 3 patients from the Netherlands are known to have died from BIA-ALCL. 5 The pathogenesis of BIA-ALCL is thought to be linked to a combination of breast implant texture, biofilm formation due to bacterial contamination, and individual genetic predisposition. 6 In 2018, the Dutch government issued a ban on Allergan’s macrotextured Biocell breast implants (Allergan Inc.; Irvine, CA).…”

Silicone Breast Implants and Disease—Many Questions Unanswered

“…3 Incidence of BIA-ALCL and policy on the use of textured silicone breast implants vary greatly among European countries. 4 This gives rise to many research questions relating to implant-related risk factors, as well as potential genetic predispositions in certain populations. Theories regarding how silicone and biofilm with resulting low-grade chronic infection may trigger inflammatory response that could lead to the development of BIA-ALCL exist.…”

“…Textured implants have been reported to have a risk of complication many times higher than that of smooth-surface implants, and therefore, certain implants have been retracted from the market . Incidence of BIA-ALCL and policy on the use of textured silicone breast implants vary greatly among European countries . This gives rise to many research questions relating to implant-related risk factors, as well as potential genetic predispositions in certain populations.…”