

‘Miracle cure’ paralyzes legs… ‘Giseung’, an illegal device experience room for the elderly
2024-10-25

Used by unqualified people, not professionals
Need to be careful about excessive advertising in free trial rooms for devices
Last August, Kim Sun-rye (78, pseudonym) visited an experience room in Jungnang-gu, Seoul after hearing from a medical device company that “sore 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 areas throughout the body. They even attracted customers by advertising that attaching the device to the face would smooth out wrinkles. However, a 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 equipment have been received by the Korea Consumer Agency, with more than 350 cases occurring each year. A total of 98 cases were received as of March of this year, showing a 7.7% increase compared to the same period last year.
Looking at age, elderly consumers in their 60s or older accounted for the most damage at 28.4% (333 cases). As age 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 with the finding that 58% of his nerves were damaged, demanded compensation for the damage from Company A. 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 for being injured.”
Company A distributed daily necessities such as soap and toothpaste for free to elderly people when they visited the free experience 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 in the experience room to the general public other than medical personnel, medical institution founders, or medical institution workers, or if labeling and description requirements are violated, it may be a legal problem.
Lee Seo-hyeong, a lawyer at Daeryun Medical Litigation Group, pointed out, "If you make false or exaggerated advertisements about the performance, efficacy, or effects of a medical device, such as saying that it is effective for obesity and lumbar disc problems in addition to relieving muscle pain, which is a permitted item, or if you make an advertisement that misleads people into thinking that it is a medical device by claiming to have a medical purpose such as improving cervical disc problems even though it is an industrial product, or if you label or describe information that is false or may cause misunderstanding, it may be a violation of the Medical Device Act."
In fact, Company A was caught by the Ministry of Food and Drug Safety's so-called 'pop-up' surveillance network in January 2017 for false and exaggerated advertising. At that time, the Ministry of Food and Drug Safety detected 52 medical device experience rooms, including Company A, and filed criminal charges.
In particular, in these illegal experience rooms, unqualified people, not professionals, usually take the lead in using the devices, and even in the event of damage, there are no compensation or relief measures in place, so consumers must be especially careful.
Lee Seo-hyung, a lawyer at Daeryun Medical Litigation Group, pointed out, "If an unqualified person goes beyond simply assisting in the use of a medical device and performs medical activities such as relieving muscle pain using a medical device, it may be considered unlicensed medical practice prohibited by Article 27 of the Medical Service Act."
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)
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