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国家重拳整治胶原蛋白注射乱象:械三资质成安全“生死线”

Core Viewpoint - The recent crackdown on illegal use of Class II collagen injections in the medical beauty industry highlights significant consumer risks, with over 23% of medical beauty institutions violating regulations, and a staggering 68% in beauty salons, leading to severe health consequences for consumers [1][3]. Group 1: Health Risks and Violations - A significant number of medical beauty institutions are found to be using unapproved or counterfeit collagen products, leading to severe health issues such as infections and deformities [3][5]. - A case study of a consumer in Nanchang revealed that she was injected with a lower-quality collagen product than promised, resulting in adverse effects and financial loss [4][5]. Group 2: Comparison of Collagen Types - Class II collagen injections are subject to less stringent regulations, requiring only provincial-level registration, while Class III collagen requires extensive clinical trials and safety data, with a failure rate exceeding 70% [10]. - The production environment for Class II collagen is less controlled, increasing the risk of contamination compared to the sterile conditions mandated for Class III products [11]. - The safety profile of Class II collagen is significantly poorer, with adverse event rates exceeding 32%, while Class III products report serious adverse reactions below 0.8% [13]. Group 3: Regulatory Actions and Consumer Protection - The National Medical Products Administration (NMPA) has initiated a "100-day action" to combat illegal practices in the medical beauty sector, emphasizing the need for compliance and consumer safety [1][23]. - Consumers are advised to verify the authenticity of collagen products through official channels and to be wary of suspiciously low prices, which may indicate the use of Class II products [18][22]. - Legal consequences for using Class II collagen can be severe, with operators facing criminal charges for causing harm, as demonstrated by a recent case where a practitioner was sentenced to 7 years in prison for causing a client's blindness [23].