A Systematic Review of the National Breast Implant Registry for Application in Korea: Can We Predict "Unpredictable" Complications?

Abstract

Background and Objectives:Since silicone breast implants were introduced to the market several decades ago, the safety of breast implants has remained controversial. Recently, several studies have explored breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and breast implant illness (BII). Several countries have developed national breast implant registries to improve the safety and quality of breast implant surgery. We performed a systematic review of the current status of national breast implant registries and propose a pilot form of an appropriate breast implant registry model for Korea.Materials and Methods:The systematic review was conducted in accordance with the "preferred reporting items for systematic reviews and meta-analyses (PRISMA) pro forma". PubMed and Google Scholar databases were searched to identify all articles containing information on national breast implant registries. We limited the search to articles written in the English language from 2010 to 2020. Articles were reviewed by two independent authors.Results:A total of 63 articles related to national breast implant registries, registry principles and national breast implant registry annual reports were identified. After reviewing the literature, 25 national breast implant registry-related articles were included in the full-text synthesis. Currently, four countries, The Netherlands, Australia, Sweden, and the UK, have breast implant registries with well-formed sources for big data. Overall, similarities in data points were detected for three categories: implant-related complications, operation details, and device information. However, there were differences for each registry in terms of governance, funding, and capture rate.Conclusion:After reviewing other countries' experiences, tentative datasets for the Korean Breast Implant Registry (K-BIR) were developed. The K-BIR can improve the quality of breast implant surgery in Korea by providing datasets on overall processes and outcome measures with quality indicators and risk adjustment factors. This approach will register characteristics of patients and monitor breast implants, complications, and surgical procedures to improve the outcomes of breast implant surgery in Korea. In addition, it can be used as a track-and-trace system with automated notifications to patients in the event of a product recall or other safety concerns related to a specific type of implant. Background and Objectives:Since silicone breast implants were introduced to the market several decades ago, the safety of breast implants has remained controversial. Recently, several studies have explored breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) and breast implant illness (BII). Several countries have developed national breast implant registries to improve the safety and quality of breast implant surgery. We performed a systematic review of the current status of national breast implant registries and propose a pilot form of an appropriate breast implant registry model for Korea.Materials and Methods:The systematic review was conducted in accordance with the "preferred reporting items for systematic reviews and meta-analyses (PRISMA) pro forma". PubMed and Google Scholar databases were searched to identify all articles containing information on national breast implant registries. We limited the search to articles written in the English language from 2010 to 2020. Articles were reviewed by two independent authors. Results:A total of 63 articles related to national breast implant registries, registry principles and national breast implant registry annual reports were identified. After reviewing the literature, 25 national breast implant registry-related articles were included in the full-text synthesis. Currently, four countries, The Netherlands, Australia, Sweden, and the UK, have breast implant registries with well-formed sources for big data. Overall, similarities in data points were detected for three categories: implant-related complications, operation details, and device information. However, there were differences for each registry in terms of governance, funding, and capture rate.Conclusion:After reviewing other countries' experiences, tentative datasets for the Korean Breast Implant Registry (K-BIR) were developed. The K-BIR can improve the quality of breast implant surgery in Korea by providing datasets on overall processes and outcome measures with quality indicators and risk adjustment factors. This approach will register characteristics of patients and monitor breast implants, complications, and surgical procedures to improve the outcomes of breast implant surgery in Korea. In addition, it can be used as a track-and-trace system with automated notifications to patients in the event of a product recall or other safety concerns related to a specific type of implant.