Pilot study of the Korean national breast implant registry: Experiences and lessons learned
- 주제(키워드) Breast implants , Mammaplasty , Patient Safety , Registries
- 등재 SCIE, SCOPUS
- 발행기관 Churchill Livingstone
- 발행년도 2022
- URI http://www.dcollection.net/handler/ewha/000000193202
- 본문언어 영어
- Published As https://doi.org/10.1016/j.bjps.2022.01.024
- PubMed https://pubmed.ncbi.nlm.nih.gov/35151594
초록/요약
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. © 2022 British Association of Plastic, Reconstructive and Aesthetic Surgeons
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