Adverse events of human implantable medical devices soar 152% in 5 years

Adverse events of human implantable medical devices have surged by 152 percent in the last five years, pointing to the need to track and manage the number of adverse event reports and the degree of harm, a lawmaker said.

Democratic Party of Korea Rep. Seo Young-seok said he analyzed data submitted by the Ministry of Food and Drug Safety.

In 2019, there were 538 reports of adverse reactions to human medical devices—459 imported and 79 domestically manufactured ones. In 2023, however, there were 1,357 reports—1,274 imported and 83 homemade devices—an increase of 152.2 percent year-on-year. The increase was 177.6 percent for imported products and 5.1 percent for homemade ones.

In the last five years, 5,573 adverse event reports or more than three adverse events have been daily. Of these, 88.5 percent of adverse event reports were for medical devices inserted into the body for more than one year, with 89.3 percent from imported products and 80.3 percent from homemade ones.

By country, the United States accounted for 4,598 of the total 5,106 reports, followed by France, the Netherlands, Switzerland, and Costa Rica.

The top five adverse event reports by product type were silicone gel artificial breasts (4,788), followed by silicone membrane artificial breasts (253), implantable cardiac shocks (44), and cochlear implants and implantable (artificial) pacemakers (42).

Breaking down adverse event reports for medical devices implanted in the body for more than one year by product type, silicone gel breasts had the highest number of reports (4,788), followed by implantable cardiac shocks (44), implantable (artificial) pacemakers (42), implantable (artificial) pacemaker electrodes (18), and electrodes for implantable cardiac shocks (eight).

By type of adverse event, serious adverse event reports accounted for 38.1 percent (2,123) of the total, followed by minor adverse event reports (61.9 percent (3,450)), including fever, urticaria, and edema. Serious adverse events included:

● Five deaths.

● Six cases of irreversible or serious disfigurement or functional impairment.

● A total of 2,112 cases of hospitalization or extended hospitalization.

When categorized by company, the silicone gel prosthetic breast with the most adverse event reports was AbbVie Korea, with 62 percent (2,959), followed by Johnson & Johnson Medical Korea, with 25 percent (1,180), Hans Biomed, with 8 percent (372), Synex, with 5 percent (219), and Motiva Korea, with 1 percent (58). The manufacturer with the highest percentage increase from 2019 to 2023 was Johnson & Johnson Medical Korea, with a 720.4 percent increase.

“Implantable medical devices can cause irreversible or severely disfiguring and dysfunctional congenital disabilities or abnormalities, and in severe cases, life-threatening conditions such as death,” Rep. Seo said. “As reports of adverse events are increasing rapidly, it is necessary to thoroughly track and manage medical devices inserted into the human body for more than a year, especially those with frequent adverse events or potentially fatal effects.”