Aesthetic surgery journal. Open forum · 2026
Toward Successful International Pooling of Breast Implant Registry Data: The Role of Dataset Uniformity.
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Von Fritschen Uwe, Moes Iris, Ahern Susannah, Garduce Patrick, Melse Puck, Ventimiglia Marco, Rakhorst Hinne, Mureau Marc A M, Halle Martin, Campanale Antonella, Stark Birgit, Couturaud Benoit, Chopra Shiv, Sommers Katie, Bumbuc Alexandra-Calina
Аннотация
BACKGROUND: Despite widespread clinical use, the long-term performance of breast implants remains debated. Current evidence is limited by small sample sizes and inconsistent methodologies. National breast device registries provide valuable real-world data, yet their impact is constrained by heterogeneity in variable definitions, data structures, and analytical approaches. The International Collaboration of Breast Registry Activities (ICOBRA) initiative established a harmonized dataset utilized by several countries.
OBJECTIVES: Evaluate the implementation of the dataset of the ICOBRA across national registries, identify inconsistencies in data definitions and structures, and develop an updated international dataset supporting standardized, federated analyses.
METHODS: Datasets from 5 national breast implant registries utilizing the harmonized dataset were systematically reviewed. Variations in data points and definitions were identified and discussed through a series of in-person and online consensus meetings. Structured voting was used to finalize revisions and establish the updated international core dataset.
RESULTS: Key discrepancies were identified in the classification of surgical indications, inclusion of implant types, and variable definitions across registries. As a result, more than half of the original core variables required revision, reclassification, or removal to enable multinational analyses. A federated analysis model was proposed to accommodate privacy regulations and registry diversity while supporting standardized, risk-adjusted analyses.
CONCLUSIONS: The updated international breast implant registry dataset represents a crucial step toward integrated global surveillance. Together with standardized statistical methods within a federated data model, it enables robust pooled analyses without requiring uniform registry structures. Countries are encouraged to adopt the revised dataset and contribute to a collaborative framework that enhances patient safety through structured, large-scale data collection and analysis.
LEVEL OF EVIDENCE 5 THERAPEUTIC: For image description, please refer to the figure legend and surrounding text.
OBJECTIVES: Evaluate the implementation of the dataset of the ICOBRA across national registries, identify inconsistencies in data definitions and structures, and develop an updated international dataset supporting standardized, federated analyses.
METHODS: Datasets from 5 national breast implant registries utilizing the harmonized dataset were systematically reviewed. Variations in data points and definitions were identified and discussed through a series of in-person and online consensus meetings. Structured voting was used to finalize revisions and establish the updated international core dataset.
RESULTS: Key discrepancies were identified in the classification of surgical indications, inclusion of implant types, and variable definitions across registries. As a result, more than half of the original core variables required revision, reclassification, or removal to enable multinational analyses. A federated analysis model was proposed to accommodate privacy regulations and registry diversity while supporting standardized, risk-adjusted analyses.
CONCLUSIONS: The updated international breast implant registry dataset represents a crucial step toward integrated global surveillance. Together with standardized statistical methods within a federated data model, it enables robust pooled analyses without requiring uniform registry structures. Countries are encouraged to adopt the revised dataset and contribute to a collaborative framework that enhances patient safety through structured, large-scale data collection and analysis.
LEVEL OF EVIDENCE 5 THERAPEUTIC: For image description, please refer to the figure legend and surrounding text.