TY - JOUR
T1 - Pilot study of the Korean national breast implant registry
T2 - Experiences and lessons learned
AU - Song, W. J.
AU - Kang, S. G.
AU - Seo, B. M.F.
AU - Choi, N. K.
AU - Lee, J. H.
N1 - 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
PY - 2022/6
Y1 - 2022/6
N2 - 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.
AB - 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.
KW - Breast implants
KW - Mammaplasty
KW - Patient Safety
KW - Registries
UR - http://www.scopus.com/inward/record.url?scp=85124401676&partnerID=8YFLogxK
U2 - 10.1016/j.bjps.2022.01.024
DO - 10.1016/j.bjps.2022.01.024
M3 - Article
C2 - 35151594
AN - SCOPUS:85124401676
SN - 1748-6815
VL - 75
SP - 1833
EP - 1841
JO - Journal of Plastic, Reconstructive and Aesthetic Surgery
JF - Journal of Plastic, Reconstructive and Aesthetic Surgery
IS - 6
ER -