South Korea medical device serious adverse events double in five years

Reports of serious adverse events involving medical devices in South Korea have more than doubled over the past five years. According to data from the Ministry of Food and Drug Safety, analyzed by National Assembly member So Byeong-hun, total adverse event reports rose from 1,482 in 2021 to 2,226 in 2025.

Of particular concern is the surge in ‘serious adverse events’—those involving hospitalization, life-threatening situations, or permanent disability—which increased by 120.6%, rising from 389 cases in 2021 to 858 in 2025. These serious incidents accounted for 33.1% of all reported cases.

The majority of these incidents are concentrated in high-risk, implantable medical devices. Class 4 devices, categorized as having high risk, accounted for 70.1% of all reports. Within the category of implantable devices, silicone breast implants were the primary driver, representing 90.4% of all implant-related adverse events.

While these reports do not inherently prove a direct causal link between a device defect and patient harm, they serve as indicators for further investigation. Lawmaker So Byeong-hun has called for faster cause identification and increased transparency regarding safety measures and investigation results.