{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T10:58:06Z","timestamp":1768820286265,"version":"3.49.0"},"reference-count":36,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2020,7,23]],"date-time":"2020-07-23T00:00:00Z","timestamp":1595462400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003569","name":"Ministry of Food and Drug Safety","doi-asserted-by":"publisher","award":["19172MFDS301"],"award-info":[{"award-number":["19172MFDS301"]}],"id":[{"id":"10.13039\/501100003569","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Medicina"],"abstract":"<jats:p>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 \u201cpreferred reporting items for systematic reviews and meta-analyses (PRISMA) pro forma\u201d. 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\u2019 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.<\/jats:p>","DOI":"10.3390\/medicina56080370","type":"journal-article","created":{"date-parts":[[2020,7,23]],"date-time":"2020-07-23T11:26:01Z","timestamp":1595503561000},"page":"370","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A Systematic Review of the National Breast Implant Registry for Application in Korea: Can We Predict \u201cUnpredictable\u201d Complications?"],"prefix":"10.3390","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8957-3950","authenticated-orcid":false,"given":"Woo Jin","family":"Song","sequence":"first","affiliation":[{"name":"Department of Plastic and Reconstructive Surgery, Soonchunhyang University College of Medicine, Seoul 04401, Korea"},{"name":"Korean Academic Association of Aesthetic and Reconstructive Breast Surgery, Seoul 04146, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang Gue","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Plastic and Reconstructive Surgery, Soonchunhyang University College of Medicine, Seoul 04401, Korea"},{"name":"Korean Academic Association of Aesthetic and Reconstructive Breast Surgery, Seoul 04146, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bommie Florence","family":"Seo","sequence":"additional","affiliation":[{"name":"Korean Academic Association of Aesthetic and Reconstructive Breast Surgery, Seoul 04146, Korea"},{"name":"Department of Plastic and Reconstructive Surgery, Uijeongbu St. Mary\u2019s Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu 11765, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nam-Kyong","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Health Convergence, Ewha Womans University, Seoul 03760, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3800-5494","authenticated-orcid":false,"given":"Jung Ho","family":"Lee","sequence":"additional","affiliation":[{"name":"Korean Academic Association of Aesthetic and Reconstructive Breast Surgery, Seoul 04146, Korea"},{"name":"Department of Plastic and Reconstructive Surgery, Bucheon St. Mary\u2019s Hospital, College of Medicine, The Catholic University of Korea, Bucheon 14647, Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2020,7,23]]},"reference":[{"key":"ref_1","unstructured":"ISAPS (2018). International Survey on Aesthetic\/Cosmetic Procedures Performed in 2018. ISAPS Global Statistics, International Society of Aesthetic Plastic Surgery. Available online: https:\/\/www.isaps.org\/wp-content\/uploads\/2019\/12\/ISAPS-Global-Survey-Results-2018-new.pdf."},{"key":"ref_2","unstructured":"ISAPS (2015). International Survey on Aesthetic\/Cosmetic Procedures Performed in 2015. ISAPS Global Statistics, International Society of Aesthetic Plastic Surgery. Available online: https:\/\/www.isaps.org\/wp-content\/uploads\/2017\/10\/2016-ISAPS-Results-1.pdf."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1093\/asj\/sjv227","article-title":"Breast Implant Registries: The Problem with Ambition","volume":"36","author":"Brown","year":"2016","journal-title":"Aesthet. Surg. J."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"S55","DOI":"10.1093\/asj\/sjy310","article-title":"The \u201cGame of Implants\u201d: A Perspective on the Crisis-Prone History of Breast Implants","volume":"39","author":"Deva","year":"2019","journal-title":"Aesthet. Surg. J."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1097\/PRS.0000000000000832","article-title":"Textured silicone breast implant use in primary augmentation: Core data update and review","volume":"135","author":"Derby","year":"2015","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"554","DOI":"10.1097\/00006534-199708000-00065","article-title":"Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant","volume":"100","author":"Keech","year":"1997","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_7","unstructured":"FDA\/CDRH (2020, April 15). FDA Update on the Safety of Silicone Gel-Filled Breast Implants, Available online: https:\/\/www.fda.gov\/media\/80685\/download."},{"key":"ref_8","unstructured":"FDA (2020, April 15). The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication, Available online: https:\/\/www.fda.gov\/medical-devices\/safety-communications\/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue."},{"key":"ref_9","unstructured":"Hopper, I., Parker, E., Pellegrini, B., Mulvany, C., Pase, M., Ahern, S., Earnest, A., Cooter, R., Elder, E., and Moore, C. (2019). The Australian Breast Device Registry 2018 Annual Report, Australian Breast Device Registry (ABDR), Department of Epidemiology and Preventive Medicine, Monash University."},{"key":"ref_10","unstructured":"NHS Digital\u2014Clinical Audit and Registries Management Service (2019). Breast and Cosmetic Implant Registry, BCIR Report 2019, NHS Digital."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"807","DOI":"10.1093\/asj\/sjx153","article-title":"Breast Implant Registries: A Call to Action","volume":"38","author":"Hopper","year":"2018","journal-title":"Aesthet. Surg. J."},{"key":"ref_12","unstructured":"Stark, B. (2018). BRIMP-Breast Implant Register Annual Report 2018, Swedish Plastic Surgery Association and Swedish Society of Aesthetic Plastic Surgey, Karolinska Universitetssjukhuset."},{"key":"ref_13","unstructured":"Becherer, B.E. (2019). Dutch Breast Implant Registry (DBIR) Annual Report 2018, Dutch Institute for Clinical Auditing."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"722","DOI":"10.1097\/SAP.0000000000001907","article-title":"Lessons Learned From Breast Implant Registries: A Systematic Review","volume":"83","author":"Wurzer","year":"2019","journal-title":"Ann. Plast. Surg."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"e017778","DOI":"10.1136\/bmjopen-2017-017778","article-title":"Pilot for the Australian Breast Device Registry (ABDR): A national opt-out clinical quality registry for breast device surgery","volume":"7","author":"Hopper","year":"2017","journal-title":"BMJ Open"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1362","DOI":"10.1016\/j.bjps.2018.05.048","article-title":"High risk device registries: Global value, costs, and sustainable funding","volume":"71","author":"Becherer","year":"2018","journal-title":"J. Plast. Reconstr. Aesthet. Surg."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"2182","DOI":"10.1097\/01.PRS.0000060111.19272.8D","article-title":"The Danish Registry for Plastic Surgery of the Breast: Establishment of a nationwide registry for prospective follow-up, quality assessment, and investigation of breast surgery","volume":"111","author":"Henriksen","year":"2003","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"531","DOI":"10.1097\/01.sap.0000096446.44082.60","article-title":"Incidence and severity of short-term complications after breast augmentation: Results from a nationwide breast implant registry","volume":"51","author":"Henriksen","year":"2003","journal-title":"Ann. Plast. Surg."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1354","DOI":"10.1016\/j.bjps.2017.04.003","article-title":"The new opt-out Dutch National Breast Implant Registry\u2014Lessons learnt from the road to implementation","volume":"70","author":"Rakhorst","year":"2017","journal-title":"J. Plast. Reconstr. Aesthet. Surg."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1607","DOI":"10.1016\/j.bjps.2019.06.023","article-title":"How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch Breast Implant Registry (2015\u20132017)","volume":"72","author":"Spronk","year":"2019","journal-title":"J. Plast. Reconstr. Aesthet. Surg."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1298","DOI":"10.1097\/PRS.0000000000005501","article-title":"The Dutch Breast Implant Registry: Registration of Breast Implant-Associated Anaplastic Large Cell Lymphoma-A Proof of Concept","volume":"143","author":"Becherer","year":"2019","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"NP314","DOI":"10.1093\/asj\/sjz023","article-title":"Patient-Reported Outcome Measures for Breast Implant Surgery: A Pilot Study","volume":"39","author":"Ng","year":"2019","journal-title":"Aesthet. Surg. J."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1186\/s41687-019-0152-z","article-title":"Establishing the acceptability of a brief patient reported outcome measure and feasibility of implementing it in a breast device registry\u2014A qualitative study","volume":"3","author":"Ng","year":"2019","journal-title":"J. Patient Rep. Outcomes"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"e2348","DOI":"10.1097\/GOX.0000000000002348","article-title":"Defining Quality Indicators for Breast Device Surgery: Using Registries for Global Benchmarking","volume":"7","author":"Begum","year":"2019","journal-title":"Plast. Reconstr. Surg. Glob. Open"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1515\/bmt-2015-0142","article-title":"A UK medical devices regulator\u2019s perspective on registries","volume":"61","author":"Wilkinson","year":"2016","journal-title":"Biomed. Tech."},{"key":"ref_26","first-page":"173","article-title":"A Suggested Model for Building Robust Biomedical Implants Registries","volume":"238","author":"Aloufi","year":"2017","journal-title":"Stud. Health Technol. Inform."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"85","DOI":"10.2147\/AMEP.S14103","article-title":"Physician participation in clinical research and trials: Issues and approaches","volume":"2","author":"Rahman","year":"2011","journal-title":"Adv. Med. Educ. Pract."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"201","DOI":"10.5694\/mja13.10695","article-title":"Opting in for opt-out consent","volume":"200","author":"Olver","year":"2014","journal-title":"Med. J. Aust."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"232","DOI":"10.5694\/mja12.10117","article-title":"Transforming Australia\u2019s Breast Implant Registry","volume":"196","author":"Jeeves","year":"2012","journal-title":"Med. J. Aust."},{"key":"ref_30","first-page":"1","article-title":"On Implant-Registries","volume":"4","author":"Ehrl","year":"2019","journal-title":"J. Epidemiol. Public Health Rev."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Lachmansingh, D.A. (2019). Breast implant illness and psychiatric implications. Ir. J. Psychol. Med., 1\u20132.","DOI":"10.1017\/ipm.2019.48"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"74S","DOI":"10.1097\/PRS.0000000000005573","article-title":"Breast Implant Illness: A Way Forward","volume":"143","author":"Magnusson","year":"2019","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"1260","DOI":"10.1093\/asj\/sjz227","article-title":"Breast Implant Illness: How Can We Help?","volume":"39","author":"McGuire","year":"2019","journal-title":"Aesthet. Surg. J."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"765e","DOI":"10.1097\/PRS.0000000000003785","article-title":"Breast Implant Illness: Symptoms, Patient Concerns, and the Power of Social Media","volume":"140","author":"Tang","year":"2017","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1097\/PRS.0000000000005710","article-title":"Silicone Implant Illness: Science versus Myth?","volume":"144","author":"Rohrich","year":"2019","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1016\/j.cct.2011.02.001","article-title":"An evaluation of a distributed medical device safety surveillance system: The DELTA network study","volume":"32","author":"Vidi","year":"2011","journal-title":"Contemp. Clin. Trials"}],"container-title":["Medicina"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1648-9144\/56\/8\/370\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T09:51:14Z","timestamp":1760176274000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1648-9144\/56\/8\/370"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,7,23]]},"references-count":36,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2020,8]]}},"alternative-id":["medicina56080370"],"URL":"https:\/\/doi.org\/10.3390\/medicina56080370","relation":{},"ISSN":["1648-9144"],"issn-type":[{"value":"1648-9144","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,7,23]]}}}