Pilot study of the Korean national breast implant registry: Experiences and lessons learned

W. J. Song, S. G. Kang, B. M.F. Seo, N. K. Choi, J. H. Lee

Research output: Contribution to journalArticlepeer-review


Background: To improve the safety and early detection of unexpected breast implant-related complications, the Korean Breast Implant Registry (K-BIR) was launched in 2020 in cooperation with the Korean Society of Plastic and Reconstructive Surgeons and the Korean Ministry of Food and Drug Safety, and a pilot study was conducted. Objective: This article provides an overview of our pilot study and experiences of the K-BIR. Methods: The dataset to be used in the pilot form of K-BIR was constructed by holding online surveys and meetings focusing on the global breast device registry's minimum dataset. A pilot study was implemented from April 1, 2020, to July 31, 2020, with six university teaching hospitals and four private clinics. Results: During the pilot study period, 325 patients, 451 procedures, and 366 implants were entered into the K-BIR. The most common procedure registered was augmentation mammaplasty (30%) for cosmetic indications, followed by direct-to-implant breast reconstruction (27%). Smooth silicone implant was the most common type (73%) of implant used. A feedback survey after the pilot study included questions about the registration rate compared with an actual procedure, entry time, reasons for difficulty in entry, and additional data needed. Conclusions: The continuous maintenance and development of K-BIR will require an effective dataset, a strengthened legal system for an opt-out registry and personal data protection, various incentives for increasing participation rates, and an electronic platform that patients, manufacturers, and clinicians can easily access. K-BIR has the potential to provide quality assurance and outcomes for research and post-market surveillance systems for breast implants as well as methods for enhancing patient safety.

Original languageEnglish
Pages (from-to)1833-1841
Number of pages9
JournalJournal of Plastic, Reconstructive and Aesthetic Surgery
Issue number6
StatePublished - Jun 2022

Bibliographical note

Funding Information:
We are grateful for the support of the Ministry of Food and Drug Safety in 2021 (Grant no. 21173MFDS244 ).

Publisher Copyright:
© 2022 British Association of Plastic, Reconstructive and Aesthetic Surgeons


  • Breast implants
  • Mammaplasty
  • Patient Safety
  • Registries


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