International Importance of Robust Breast Device Registries

Abstract

Recent implant crises have highlighted the need for robust registries. This article argues the importance of securing at least 90 percent data capture, which is achievable through the opt-out consent model. Since adopting this model, the Australian Breast Device Registry has increased data capture from 4 percent to over 97 percent. Simultaneously, it is important to foster international collaboration from the outset to avoid duplication of efforts and enable the development of effective international early warning systems.

Improving the safety of breast implants: implant‐associated lymphoma

“…Following on from other successful international registry consortia, with orthopaedic and vascular networks being the exemplars, 14 the International Collaboration of Breast Registries Activities network brings together countries working on breast implant safety; 15 the Australian Breast Device Registry dataset is provided to these countries to facilitate international data harmonisation. The Netherlands has adopted the dataset in the Dutch Breast Implant Registry, and work is currently underway to amplify the dataset using cloud technology to combine the Australian and Dutch de‐identified datasets.…”

Medical device registries for breast implants - where to?

“…The challenges faced by medical tourism will demand cooperation going beyond national initiatives and all stakeholders could benefit from international collaborations. This drive has already spawned international initiatives among national plastic surgery societies, national health services and national health regulatory agencies [8]. This leading role is inherent to plastic surgeons as representatives of the specialty predominantly involved in and associated with the use of breast implants, but requires to recruit other groups of clinicians to shoulder the efforts in developing orderly standards of care and quality for the patients' benefit.…”

Decisional pathways in breast augmentation: how to improve outcomes through accurate pre-operative planning

“…A national register with compulsory reporting of all breast augmentations with implants and outcomes data would help making a complete picture about different methods of pre-operative planning and their impact on patients' outcomes (24,25).…”