SEOUL: Human-derived materials in South Korea’s aesthetics industry are attracting criticism, as companies launch extracellular matrix (ECM) skin boosters made from donated human skin.
The number of these products, often positioned as alternatives to synthetic or bioengineered injectables, has been rising, with up to seven products expected to launch in South Korea by the end of 2026, following their debut in 2024.
However, the products remain in a regulatory gray area. Critics have raised concerns over safety and ethics, while the authorities maintain a cautious stance.
The issue was raised in a parliamentary audit in October and further debated at a forum at the National Assembly on April 16, where experts and government officials discussed ways to regulate the use of donated human tissue in medical and commercial settings.
Kwon Dong-ju, a lawyer at Seoul-based law firm Yoon and Yang, said current oversight remains limited to infection control and contamination, lacking broader standards for biological safety and clinical trials typically required for pharmaceuticals and medical devices.
“While other medical devices undergo years of testing and investment before market approval, some human tissue-based products face relatively lax standards,” Kwon said.
Because these products are classified as tissue transplants rather than medical devices, regulatory focus has largely been placed on transplant compatibility.
Critics argue this fails to reflect their actual use, which is similar to conventional skin boosters.
Some forum participants said that donations made out of personal or religious belief should not be used for profit, adding that it could further discourage body donations in South Korea, which stand at around 200 cases a year.
ECM skin boosters work by injecting extracellular materials such as collagen taken from deeper layers of the skin, primarily from donated cadavers.
The process involves freezing, drying, pulverising and removing cells. According to the Ministry of Health and Welfare, the materials are currently imported, and domestically donated bodies are not used for this purpose.
Originally used in reconstructive procedures such as breast reconstruction and burn treatment, the materials have recently spread into the broader aesthetics market, driven by growing consumer demand.
“Doctors who use human-derived materials say it is difficult to run clinics if they refuse patient requests,” said Dr Yoo Byung-wook, a professor at Soonchunhyang University Hospital.
Public sentiment remains largely negative, critics say.
A survey by Professor Lee Dong-han of Sookmyung Women’s University found that 60.9 per cent of 1,034 adults support a ban or strong restrictions on the aesthetic use of human tissue.
Officials acknowledge both ethical and safety concerns, but point to practical challenges in distinguishing between medical treatment and aesthetic use, particularly in cases such as burn care or acne scar treatment.
The Health Ministry said it would take a prudent approach in determining the scope and level of regulation to avoid undermining legitimate therapeutic applications, while the Ministry of Food and Drug Safety is reviewing measures to restrict advertising of procedures for cosmetic purposes. - The Korea Herald/ANN
