Side effects of human implantation medical devices 5573 breast implants for 5 years 'Most '
Oct 11, 2024
In the past five years, 5,573 side effects of human implantation medical devices have occurred.
Seo Young-seok (Democratic Party of Korea, Bucheon-si, Gyeonggi-do), a member of the National Assembly's Health and Welfare Committee, analyzed the data submitted by the Ministry of Food and Drug Safety and found that the side effects of human implantation medical devices have increased rapidly over the past five years.
According to the data, there were a total of 538 reports of adverse effects on human medical devices in 2019, including 459 imported and 79 manufacturing cases, but in 2023, there were a total of 1,357 cases, including 1,274 imported and 83 manufacturing cases, up 152.2% year-on-year. The growth rate of imported products was 177.6%, and manufacturing was 5.1%.
A total of 5573 side effects have been reported in the past five years, meaning that more than three side effects have been reported every day. Among them, 88.5% of the reports of side effects of medical devices inserted into the human body for more than a year accounted for 89.3% for imported products and 80.3% for manufacturing. Dividing imported products by country, the U.S. overwhelmingly accounted for 4,598 out of 5,106 cases. It was followed by France, the Netherlands, Switzerland and Costa Rica.
In the top five reports of side effects according to product type, silicone gel artificial breast had the most cases with 4,788, silicone membrane artificial breast (253), implantable heart shock (44), and artificial cochlear implant and implantable (artificial) pacemaker 42 cases, respectively.
When the reports of side effects of medical devices inserted into the human body for more than a year are divided by product type, silicon gel breasts were the most common with 4,788 cases, followed by implantable (artificial) pacemakers (44 cases), implantable (artificial) pacemakers (42 cases), implantable (artificial) pacemakers (18 cases), and implantable cardiac shocker electrodes (8 cases).
By type of side effect, reports of significant abnormal cases accounted for 38.1% (2123 cases) of the total, and reports of minor cases such as fever, rash, and swelling accounted for 61.9% (3450 cases). In the case of serious abnormalities, ▲5 deaths, ▲6 cases of non-recoverable or severe disability or dysfunction, and ▲ 2112 cases of prolonged hospitalization or hospitalization.
On the other hand, when classifying silicon gel artificial breast with the most side effects reports by company, Korea AbbVie had the most with 62% (2959 cases), Korea Johnson & Johnson Medical 25% (1,180 cases), Hans Biomed 8% (372 cases), Sinex 5% (219 cases), and Motiva Korea 1% (58 cases). The manufacturer with the highest growth rate in 2023 compared to 2019 was Johnson & Johnson Medical Korea, up 720.4%.
Rep. Seo Young-seok said, `Intrusive medical devices may be impossible to recover or cause serious disability and dysfunction birth defects or abnormalities, and in serious cases, may pose a life threat such as death"As reports of side effects increase rapidly, thorough tracking and management are needed, especially for medical devices inserted into the human body for more than a year or medical devices with frequent side effects or that can cause fatal damage."
Seo Young-seok (Democratic Party of Korea, Bucheon-si, Gyeonggi-do), a member of the National Assembly's Health and Welfare Committee, analyzed the data submitted by the Ministry of Food and Drug Safety and found that the side effects of human implantation medical devices have increased rapidly over the past five years.
According to the data, there were a total of 538 reports of adverse effects on human medical devices in 2019, including 459 imported and 79 manufacturing cases, but in 2023, there were a total of 1,357 cases, including 1,274 imported and 83 manufacturing cases, up 152.2% year-on-year. The growth rate of imported products was 177.6%, and manufacturing was 5.1%.
A total of 5573 side effects have been reported in the past five years, meaning that more than three side effects have been reported every day. Among them, 88.5% of the reports of side effects of medical devices inserted into the human body for more than a year accounted for 89.3% for imported products and 80.3% for manufacturing. Dividing imported products by country, the U.S. overwhelmingly accounted for 4,598 out of 5,106 cases. It was followed by France, the Netherlands, Switzerland and Costa Rica.
In the top five reports of side effects according to product type, silicone gel artificial breast had the most cases with 4,788, silicone membrane artificial breast (253), implantable heart shock (44), and artificial cochlear implant and implantable (artificial) pacemaker 42 cases, respectively.
When the reports of side effects of medical devices inserted into the human body for more than a year are divided by product type, silicon gel breasts were the most common with 4,788 cases, followed by implantable (artificial) pacemakers (44 cases), implantable (artificial) pacemakers (42 cases), implantable (artificial) pacemakers (18 cases), and implantable cardiac shocker electrodes (8 cases).
By type of side effect, reports of significant abnormal cases accounted for 38.1% (2123 cases) of the total, and reports of minor cases such as fever, rash, and swelling accounted for 61.9% (3450 cases). In the case of serious abnormalities, ▲5 deaths, ▲6 cases of non-recoverable or severe disability or dysfunction, and ▲ 2112 cases of prolonged hospitalization or hospitalization.
On the other hand, when classifying silicon gel artificial breast with the most side effects reports by company, Korea AbbVie had the most with 62% (2959 cases), Korea Johnson & Johnson Medical 25% (1,180 cases), Hans Biomed 8% (372 cases), Sinex 5% (219 cases), and Motiva Korea 1% (58 cases). The manufacturer with the highest growth rate in 2023 compared to 2019 was Johnson & Johnson Medical Korea, up 720.4%.
Rep. Seo Young-seok said, `Intrusive medical devices may be impossible to recover or cause serious disability and dysfunction birth defects or abnormalities, and in serious cases, may pose a life threat such as death"As reports of side effects increase rapidly, thorough tracking and management are needed, especially for medical devices inserted into the human body for more than a year or medical devices with frequent side effects or that can cause fatal damage."
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