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【Seoul, South】Debating the ‘Regulatory Gap’ of Injectable ECM Tissue Grafts for Skin

Editor’s Note

**Editor’s Note:** This article highlights growing concerns over the unregulated use of injectable ECM tissue grafts in cosmetic procedures, prompting a symposium to address safety verification gaps. We present this report to inform readers of the ongoing debate among medical, legal, and regulatory stakeholders.

Policy

The Korea Medical Bio Journalists Association will hold a symposium on July 28 titled “Discussing the Regulatory Gap of Injectable ECM Tissue Grafts for Skin – The Need for Safety Verification.” The event is expected to be attended by medical professionals, legal experts, consumer groups, media representatives, and government officials.

Recently, extracellular matrix (ECM) grafts derived from human tissues such as cadaver skin have been used in cosmetic ‘injectable skin booster’ procedures, raising the need for safety management standards and legal system improvements regarding direct skin injection methods.

Accordingly, the Korea Medical Bio Journalists Association announced it will hold the symposium on July 28 at the Korea Press Center in Jung-gu, Seoul, to discuss the safety management system and institutional improvement directions for injectable ECM tissue grafts.

Key Presentations and Panel Discussion

At the symposium, Professor Shin Hyun-young from the Department of Family Medicine at Seoul St. Mary’s Hospital will present on “Clinical Safety and Policy Direction of Injectable ECM Tissue Grafts,” and Attorney Im Won-taek from Law Firm Moonjang will present on “Legislative Intent of the Human Tissue Act and Legal Issues Arising from Changes in Administration Route.”

In the subsequent panel discussion, Professor Yang Sung-il from Seoul National University Bundang Hospital will serve as moderator. Participants from the Korean Dermatological Association, the Korean Society of Plastic and Reconstructive Surgeons, the pharmaceutical academia, consumer groups, media, and the Ministry of Food and Drug Safety will discuss the clinical evidence, risk assessment, and regulatory framework for injectable ECM tissue grafts.

Association President’s Statement

Min Tae-won, President of the Korea Medical Bio Journalists Association, stated:

“The ECM tissue graft market using donated human tissues is growing rapidly in the cosmetic and plastic surgery fields, but safety standards, adverse event reporting systems, and clear guidelines to prevent misuse and overuse are still insufficient. There is a need to establish an institutional safety net that matches technological and market changes.”

He added:

“This symposium is not intended to criticize specific products or industries, but rather to serve as a public forum to discuss safety management systems and institutional improvement directions so that the industry can grow healthily and the public can receive medical services with confidence.”
FAQ

Q1. Why is this symposium being held?
Recently, the use of human-derived ECM tissue grafts in cosmetic injectable skin booster procedures has increased, raising the need for safety management standards and legal/institutional improvements. This symposium was organized to discuss these issues.

Q2. What is an ECM tissue graft?
It refers to a tissue graft using the extracellular matrix (ECM) remaining after removing cells from human-derived tissues. Recently, some products have also been used in cosmetic skin injection procedures.

Q3. What topics will be covered at this symposium?
Discussions will focus on the clinical safety and policy direction of injectable ECM tissue grafts, legal issues under the Human Tissue Act, clinical evidence, risk assessment, and regulatory frameworks.

Q4. Who will participate?
Medical professionals, legal experts, pharmaceutical academia, consumer groups, media, and officials from the Ministry of Food and Drug Safety will participate to share opinions from various perspectives.

Q5. What are the key tasks emphasized by the Korea Medical Bio Journalists Association?
The association sees the need for: ▲Establishing safety verification standards ▲Building an adverse event reporting system ▲Developing guidelines to prevent misuse and overuse ▲Improving systems to match technological advancements.

Q6. What is the purpose of this symposium?
It is not to criticize specific products or industries, but to discuss the safety and institutional supplementation of injectable ECM tissue grafts, thereby creating an environment where the public can use medical services more safely.

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⏰ Published on: July 24, 2026