医美乱象频现！5万元美容针竟是“骨科材料”

Core Viewpoint - The misuse of hydroxyapatite (CaHA) in the medical beauty industry has come to public attention, highlighting potential violations in the use of products not approved for facial injections [2][3]. Group 1: Incident Overview - A citizen, Ms. Luo, spent 50,830 yuan on an injection of "Filinpril" at Hangzhou Sidarui Medical Aesthetic Clinic, which was later found to lack the necessary qualifications for facial aesthetic injections [2]. - Another complainant, Ms. Zhang, reported a similar issue of being charged for an injection that was not administered [2]. - The product "Filinpril" is developed by Sichuan Baiamon Biological Materials Company and is registered for use in bone defect repair, not for facial aesthetics [2][3]. Group 2: Regulatory and Compliance Issues - The Hangzhou Health Supervision Bureau has initiated an investigation into the clinic, raising questions about the "off-label" use of "Filinpril" [3]. - The use of hydroxyapatite in aesthetic applications is controversial, as it is primarily registered for orthopedic and dental treatments [3][4]. - There is a lack of clear legal guidelines regarding the off-label use of medical devices in China, leading to potential risks in compliance [6]. Group 3: Market Potential and Product Development - Despite the controversies, the market potential for hydroxyapatite in the medical beauty sector is viewed positively, with expectations for more compliant products to be approved by 2025 [7]. - Recent approvals include Aphranel® and Radiesse, which are now recognized for use in facial soft tissue filling, marking significant milestones in the industry [7][8]. - Companies are accelerating their development of compliant hydroxyapatite products to meet market demand while adhering to regulatory standards [9]. Group 4: Regulatory Measures and Industry Challenges - The medical beauty industry faces ongoing challenges, including unqualified institutions performing procedures and the use of non-compliant products [9][10]. - Recent regulatory actions have been taken to address illegal medical beauty practices, with multiple departments collaborating to enforce compliance [10]. - The national regulatory framework is evolving to enhance oversight across the beauty consumption sector, aiming for improved safety and quality standards by 2030 [10].