5万元美容针竟是骨科材料，医美行业再爆黑幕

Core Viewpoint - The article highlights the misuse of hydroxyapatite (CaHA) in the medical beauty industry, particularly focusing on a case where a patient received an injection of a product called "Filinpril" that was not approved for facial aesthetic use, raising concerns about regulatory compliance and patient safety [1][5][12]. Summary by Sections Incident Overview - A citizen named Ms. Luo spent 50,830 yuan at Hangzhou Sidarui Medical Aesthetic Clinic for an injection of "Filinpril," which was claimed to stimulate collagen regeneration but was later found to lack the necessary qualifications for facial aesthetic injections [1][3]. Product Information - "Filinpril" is a brand under Chengdu Ruihe Pharmaceutical, developed by Sichuan Baiamon Biological Materials Co., and is registered as "hydroxyapatite biological ceramics" with a focus on bone defect repair and soft tissue enhancement [3][4]. Regulatory Actions - The Hangzhou Health Supervision Bureau has initiated an investigation into the clinic, questioning whether the use of "Filinpril" constitutes "off-label" use and highlighting the need for stricter regulations in the medical beauty sector [5][8]. Market Context - Hydroxyapatite is recognized for its biocompatibility and is used in various medical applications, including bone and dental treatments. However, its introduction into the aesthetic market has led to concerns about its application beyond approved indications [7][11]. Compliance and Industry Challenges - The article discusses the prevalence of "off-label" use of medical products in the aesthetic industry, with many products being used in ways not specified in their registration, raising compliance risks [8][13]. Regulatory Developments - Recent approvals for compliant hydroxyapatite products, such as Aphranel and Radiesse, indicate a shift towards more regulated use in aesthetic applications, yet issues of off-label use persist [12][13]. Industry Regulation Efforts - The article notes ongoing efforts by various health authorities to enhance regulatory frameworks and combat illegal practices in the medical beauty industry, including the establishment of compliance guidelines and enforcement actions against unlicensed operations [15][16].