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.

Background: Breast device registries monitor devices encompassing breast implants, tissue expanders and dermal matrices, and the quality of care and patient outcomes for breast device surgery. Defining a standard set of quality indicators and risk adjustment factors will enable consistency and adjustment for case-mix in benchmarking quality of care across breast implant registries. This study aimed to develop a set of quality indicators to enable assessment and reporting of quality of care for breast device surgery which can be applied globally. Methods: A scoping literature review was undertaken, and potential quality indicators were identified. Consensus on the final list of quality indicators was obtained using a modified Delphi approach. This process involved a series of online surveys, and teleconferences over 6 months. The Delphi panel included participants from various countries and representation from surgical specialty groups including breast and general surgeons, plastic and reconstructive surgeons, cosmetic surgeons, a breast-care nurse, a consumer, a devices regulator (Therapeutic Goods Administration), and a biostatistician. A total of 12 candidate indicators were proposed: Intraoperative antibiotic wash, intraoperative antiseptic wash, preoperative antibiotics, nipple shields, surgical plane, volume of implant, funnels, immediate versus delayed reconstruction, time to revision, reoperation due to complications, patient satisfaction, and volume of activity. Results: Three of the 12 proposed indicators were endorsed by the panel: preoperative intravenous antibiotics, reoperation due to complication, and patient reported outcome measures. Conclusion: The 3 endorsed quality indicator measures will enable breast device registries to standardize benchmarking of care internationally for patients undergoing breast device surgery.