Side effects of implantable medical devices jumped 2.4 folds in the first half of the year compared to last year, a lawmaker said. In particular, Allergan Korea and Johnson & Johnson Medical Korea were responsible for 81.4 percent of the silicone gel breast implants with side effects.

Rep. Seo Young-seok of the ruling Democratic Party released related data of the Ministry of Food and Drug Safety.

According to Seo, 16 medical implants caused 7,285 cases of side effects from 2015 to June 2020. In the first six months this year, the number hit 2,840, a 2.4-fold increase from 2019.

Silicone gel breast implants caused 6,367 side effects, which accounts for 87.4 percent of all side effects between 2015 and June 2020. The second most frequent side effects were 482 cases (6.6 percent) by artificial knee joints, followed by 106 cases (1.5 percent) by implantable cardiac pacemakers. The number of side effects of silicone gel breast implants hit 2,790 in the first half, 2.9 times more than 714 in 2019.

If the uptrend continues, silicone gel breast implants' side effects could record a 7.8-times higher figure this year compared to last year. As for detailed side effects of silicone gel artificial breasts, spherical construction was the most common with 3,272 cases, taking up 51.4 percent of the total 6,367 cases, and rupture occurred in 2,503 cases (48.6 percent).

Among the 6,367 side effects of silicone gel artificial breasts, products of Allergan Korea and Johnson & Johnson Medical Korea accounted for 81.4 percent or 5,186 cases.

Regardless of whether they were subject to the government’s follow-up monitoring, the top five medical implants caused 14,365 side effects, including 6,367 in silicone gel breast implants, 4,733 in silicone membrane breast implants, 1,855 in artificial hip joints, 927 in artificial knee joints, and 482 in special material artificial knee joints.

In particular, the side effects of implants by Johnson & Johnson Medical Korea took up 67.6 percent of all the 14,365 side effects.

Seo noted that among implantable medical devices inserted for more than one year inside a human body, the food and drug safety ministry monitors products that can cause fatal harm to the human body due to side effects or defects.

However, this year's steep rise of the side effects indicates that the food and drug safety ministry needs to improve its monitoring system, he said.

The food and drug safety ministry should revise the management system to prevent side effects of implantable medical devices and order companies and improve devices that cause side effects frequently, Seo emphasized.