‘Miracle cure’ paralyzes legs… ‘Giseung’, an illegal device experience room for the elderly
Equipment used by unqualified people, not professionals Need to be careful about exaggerated advertisements in free trial rooms Last August, Soon-rye Kim (78, pseudonym) visited a trial room in Jungnang-gu, Seoul after hearing from a medical device company that “painful legs can be cured with electrical treatment.” Mr. Kim, who had a chronic illness, used a personal combination stimulator that was said to relieve muscle pain, but soon developed paralysis in his right leg and was taken to the hospital. Mr. Kim explained the situation at the time, saying, “The employee who was helping me use the device raised the temperature too high.” Initially, Company A advertised that using this personal combination stimulator could treat painful parts all over the body. They even attracted customers by advertising that attaching the device to the face would smooth out wrinkles. However, the personal combination stimulator is a medical device that applies electric current to the human body through electrodes, and was initially approved for the purpose of relieving muscle pain. According to Newsis coverage on the 24th, while the 'silver healthcare' market continues to grow ahead of the entry into a super-aging society, illegal medical device and equipment experience rooms that sell products through false and exaggerated promotions to the elderly are still active. Over the past three years (2021 to March 2024) A total of 1,188 applications for damage relief related to medical devices were filed with the Korea Consumer Agency, with more than 350 cases occurring every year. As of March of this year, a total of 98 cases were filed, showing a 7.7% increase compared to the same period last year. Looking at age groups, damage to elderly consumers in their 60s or older was the largest at 28.4% (333 cases). As the age group increased, the proportion of online sales decreased, but for those in their 60s or older, the proportion of general sales and door-to-door sales was higher than that of other age groups. Mr. Kim, who was hospitalized after being found that 58% of his nerves were damaged, demanded compensation from Company A for the damage. However, the only reply that came back was, "There is no problem with the medical device in question and it is Mr. Kim's fault that he was injured." Company A gave out daily necessities such as soap and toothpaste for free to elderly people when they visited the free trial room. After winning their favor in this way, they carried out promotional activities to encourage people to purchase their medical devices. However, if false or exaggerated advertisements are made to medical personnel, medical institution founders, or the general public other than medical institution workers in the experience room, or if labeling and description requirements are violated, it can be a legal problem. Lee Seo-hyung, a lawyer at Daeryun Medical Litigation Group, said, "False or exaggerated advertisements about the performance, efficacy, or effects of a medical device, such as claiming that it is effective in treating obesity and lumbar disc problems in addition to relieving muscle pain, which is permitted, He pointed out, "Even though it is an industrial product, advertising that claims to be a medical device, such as improving cervical disc problems, causing the product to be misunderstood as a medical device, or labeling or listing information that is false or likely to be misunderstood, may constitute a violation of the Medical Device Act." In fact, Company A was caught by the Ministry of Food and Drug Safety's so-called 'floating cafe' surveillance network in January 2017 for false and exaggerated advertising. At the time, the Ministry of Food and Drug Safety detected 52 medical device experience rooms, including Company A, and filed criminal charges. In particular, in such illegal experience rooms, unqualified people, not professionals, usually lead the use of the device, and even in the event of damage, related compensation or relief measures are not in place, so consumers must be especially careful. Lee Seo-hyung, a lawyer at Daeryun Medical Litigation Group, said, "If an unqualified person goes beyond simply helping to use a medical device and performs medical activities such as relieving muscle pain using a medical device, it is a violation of the Medical Services Act. “It may be an unlicensed medical practice prohibited by Article 27,” he pointed out. Meanwhile, Company A told Newsis, “There is no problem with the device in question,” and “I don’t know what the experience room has to do with the medical law.” [View full article] - ‘Miracle cure’ paralyzes legs… ‘Giseung’, an illegal device experience room for the elderly (link)