Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set

Abstract

Background: The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. Methods: The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. Results: Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. Conclusions: The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.

The impact of Allergan implant-related issues on patients with breast implants for reconstruction

“…The specific purposes of the PROFILE Registry are to determine the recurrence rate and overall survival rate by collecting the demographic, clinical, and pathological features of patients diagnosed with BIA-AL-CL. In addition to the U.S., several countries have established similar breast implant registries, and national plastic surgery societies have gathered to form an international collaboration [23]. After the first BIA-ALCL case in Korea, a pilot project was undertaken through collaboration between the KSPRS and KMFDS.…”

Variation in the use of infection control measures and infection-related revision incidence after breast implant surgery in the Netherlands

“…Exact definitions of all variables used for analysis are based on the ICOBRA (International Collaboration of Breast Registry Activities) core dataset and can be found in the data dictionary (Supplemental Table 1). 30 …”

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

“…Data for each surgical procedure should be limited to the essential information requested to assess breast implant surgery outcomes accurately. Moreover, the registry should collect a "minimum data set" 13 to be comparable with other registries established for the same device. All clinical information, and data regarding the procedure's details, that can affect short or longterm results of this kind of surgery should be collected.…”