Moving breast implant registries forward: Are they FAIR and Functional?

Breast Implant Anaplastic Large Cell Lymphoma (BIA- ALCL): A Systematic Review and Case Report Regarding Incidence and Pathology Workup

“…The mean start of the registries was 2014, the median 2015. According to Bargon et al seven out of ten countries have a better registration coverage for public hospitals than in private clinics 16 . Six of nine countries claim up to 100% registration coverage for the public sector, in comparison to only three of ten countries with a private clinic coverage of over 90% (Tab.1).…”

“…Additionally, unreleased sales data of breast implants account this mathematical uncertainty. Furthermore, the reporting rates of breast implant placement through breast implant registries yielded between 0% and 100% in public and private practices, respectively 16 . The reason for this heterogeneity lies within the political setting of these registries as most countries use opt-out systems leaving the reporting option to the surgeon.…”

Clinical recommendations for diagnosis and treatment according to current updated knowledge on BIA-ALCL

“…The incidence of BIA-ALCL is considered low and typically associated with macrotextured surface implants (according to International Organization for Standardization [ISO] classification) [ 7 , 12 , 13 ].Nevertheless, further investigation is required to clarify the etiopathogenesis of the disease and the association with different implant types and textures [ 14 , 15 ]. In order to accurately estimate the incidence and risk by country, the single country prevalence of women having breast implants should be known, which is difficult due to the lack of centralized databases and surgical tourism [ 16 , 17 ]. In a study published in 2018 and conducted in The Netherlands, de Boer et al found a cumulative risk of BIA-ALCL in women with implants of 29/million at 50 years and 82/million at 70 years [ 18 ].…”

National Breast Implant Registry in Italy. Competent Authority Perspective to Improve Patients’ Safety

“…Consequently, their feeding should not be left to the surgeons' goodwill, and patients should be mandatorily registered. The OPT-OUT method, i.e., all patients are included unless they do not actively opt-out, results in higher inclusion rates than the OPT-IN option 15 . However, patients should be made aware of the necessity to include their breast surgery data in the registry and assured that all the security measures (according to EU General Data Protection Regulation) are satisfied.…”