2026 80th Anniversary
International Convention of PSK

D+12
October 21-23, 2026

Abstracts

P11-1

Adverse event report analysis and safety signal detection using the IMDRF standardized terminology

  • Changho Noh1, Jaesuk Yun*2
  • 1College of Pharmacy, Chungbuk National University, Republic of Korea
  • 2College of Pharmacy, Chungbuk National University, Republic of Korea

This study analyzed adverse event reports for two implantable medical devices with safety concerns—breast implants and artificial hip joints—submitted to Korea\'s Ministry of Food and Drug Safety and coded using the International Medical Device Regulators Forum(IMDRF) standardized terminology(2019–2025). Breast implants recorded 75,158 reports, led by material rupture (45,381 cases), capsular contracture (28,707), and device explantation (20,455). Artificial hip joints yielded 23,525 reports, led by malposition of device (4,174), failure of implant (6,393) and device revision/replacement (6,305). Safety signals were detected by data mining, with a finding defined as a signal when it met at least two of three criteria (PRR, ROR, IC). For breast implants, material rupture, patient–device incompatibility, capsular contracture, and deformation met all three; BIA-ALCL and breast mass met two. For artificial hip joints, no code met all three, though material disintegration, corrosion, erosion, limb-length asymmetry, metallosis, and hip fracture emerged as signals. Comparison with product approval data revealed new breast-implant signals—autoimmune disorder, hair loss, myalgia, headache, depression, and fatigue—resembling Breast Implant Illness (BII) reported by U.S. FDA, indicating comparable systemic symptoms in products approved in Korea. These findings can inform future safety reviews, though spontaneous-reporting limitations such as under-reporting bias. 


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