Pilot study of the Korean national breast implant registry: Experiences and lessons learned. Issue 6 (June 2022)

• Record Type: Journal Article
• Authors: Song, W.J.; Kang, S.G.; Seo, B.M.F.; Choi, N.K.; Lee, J.H.
• Is Part Of: Journal of plastic, reconstructive & aesthetic surgery. Volume 75:Issue 6(2022)
• Page Start: 1833
• Page End: 1841
• Publication Date: 2022-06
• Subjects: Breast implants -- Registries -- Patient Safety -- Mammaplasty; Surgery, Plastic -- Great Britain -- Periodicals; Reconstructive Surgical Procedures -- Periodicals; Surgery, Plastic -- Great Britain -- Periodicals; 617.9505
• DOI: 10.1016/j.bjps.2022.01.024
• Languages: English
• ISSNs: 1748-6815

Abstract

Summary: 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.