Recently, the use of human-derived ECM (extracellular matrix) in an injectable form for skin cosmetic procedures has raised safety concerns. Traditionally, acellular allogeneic dermis, previously used for burn or trauma treatment, was pulverized and injected into the skin. The problem is that these products are classified as 'human tissue' and do not undergo rigorous safety verification procedures like pharmaceuticals or medical devices. Experts argue that a separate safety and efficacy verification system is needed because the form, purpose of use, and administration method of human tissue have changed. The Ministry of Food and Drug Safety (MFDS) is strengthening safety management by shortening adverse event reporting periods and mandating patient information recording, but the core issue lies in how to classify and manage ECM tissue grafts. Consumers should be provided with sufficient information about the ingredients and safety of products before undergoing procedures, and it is crucial to find a balance between innovative technological advancements and ensuring safety.
