A new class of skin injectables derived from human cadavers is drawing criticism in South Korea, as companies prepare to launch up to seven such products by the end of the year.
Known as extracellular matrix (ECM) skin boosters, these treatments have prompted debate among experts and officials at a National Assembly forum on 16 April.
Concerns raised were largely over safety and ethics, reports The Korean Herald.
Kwon Dong-ju, a lawyer and head of the Biohealth Center at Yoon & Yang LLC, said current regulations on human tissue-derived products are limited to infection control and contamination.
Despite being injected into the human body, these treatments can be distributed on the market without clinical trials or product approval, something that drew concern from consumer groups.
Additionally, there is currently no adverse event reporting system established, Chosun reported.
This is because the skin boosters are classified as tissue transplants rather than medical devices.
ECM skin boosters are produced by extracting the extracellular matrix from a deceased person’s skin tissue.
It is then turned into powder, diluted in saline, and injected directly into the skin.
These were originally used in reconstructive procedures such as breast reconstruction and burn treatment, but have recently become in demand in the aesthetics industry.
The cost of each session is reportedly about KRW600,000 (S$520).
“Doctors who use human-derived materials say it is difficult to run clinics if they refuse patient requests,” said Yoo Byung-wook, a professor at Soonchunhyang University Hospital.
Participants at the forum argued that donations should not be used for profit, adding that it could further discourage body donations in South Korea, which amount to only 200 cases per year.
The Health Consumer Union added: “Donors and their families decide to donate on the premise of therapeutic use, but in reality, it is being used for premium cosmetic procedures.”
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However, the Ministry of Health and Welfare maintained that the bodies used for these injectables are currently imported overseas and are not local donations, The Korea Herald reported.
A survey also found that 60.9% of 1,034 adults support a ban or strong restrictions on the aesthetic use of human tissue.
Additionally, Mr Kwon has called on the government to explicitly ban cosmetic use of human tissue, establish pharmaceutical and medical device approval systems, and strengthen donor notification requirements, among others.
Officials acknowledged the ethical and safety concerns raised, but said distinguishing between medical treatment and aesthetic use can be difficult, particularly in cases such as burn care or acne scar treatment.
They are currently consulting multiple lawyers “on the appropriate level of regulation for the use of human tissue”, Kim Hee-seon, head of the Blood and Organ Policy Division at the Ministry of Health and Welfare, said.
“However, we will carefully set the scope and level of regulation so that rules intended to address certain issues do not end up discouraging therapeutic uses such as existing tissue transplants,” he added.
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