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宁夏加强医美行业监管 筑牢“美丽消费”安全防线
Sou Hu Cai Jing· 2025-12-31 09:54
中新网银川12月31日电 (杨迪 裴媛)记者31日从宁夏药品安全监管工作新闻发布会上获悉,针对医美行 业快速发展伴生的消费投诉问题,宁夏药品监管部门通过强化部门联动、聚焦重点整治、正确引导消费 等举措,持续规范市场秩序,保障群众身体健康和生命安全。 在严格执法同时,监管部门通过召开约谈培训会、开展法规解读、结合典型案例强化警示教育等方式, 引导医美机构压实主体责任;推行"边检查边普法"模式,执法人员现场指导机构健全质量管理体系,以 长效引导推动行业合规、健康发展。(完) 随着消费者爱美需求和健康意识的提高,医疗美容行业显现快速发展的态势,随之而来也出现了一些消 费投诉。据了解,宁夏药品监管部门通过加强与卫健、公安等部门的协作,开展"综合查一次"联合执 法,对医美机构的执业资质、药械采购使用、广告宣传等关键环节进行全方位排查,构建了"执法联 动、协作互补、信息共享"的工作格局。 监管部门聚焦三类违法违规行为重拳出击:严厉打击无资质执业、超范围诊疗;严查购进使用未批准备 案、无合格证明及过期失效的医美药械;整治虚假宣传、价格欺诈等侵害消费者权益的行为。据介绍, 专项整治成效显著,仅银川市就对全市87家医疗美容机构 ...
医美乱象频现!5万元美容针竟是“骨科材料”
Jing Ji Guan Cha Wang· 2025-11-20 02:31
公开信息显示,菲林普利是成都睿合医药旗下的医美品牌,产品由四川拜阿蒙生物材料公司研发生产。国家药监局官网信息明确其注册全称为"羟基磷灰石 生物陶瓷",适应范围为"各种原因所致的骨缺损修复或填充;各种原因所致的软组织修复或增强,如眼球摘除或眼内容物剜除后的义眼台植入"。 日前,杭州电视台官微发布一篇名为《杭州思达芮医疗数万元打的美容针 竟是"骨科材料"疑似违规用药》的报道,再度将羟基磷灰石(CaHA)这一医美新 材料的使用乱象推向公众视野。 报道披露,今年8月,市民骆女士在杭州思达芮医疗美容诊所花费50830元,注射了宣称可以刺激胶原蛋白再生、让皮肤变得更有弹性的"菲林普利",然而事 后发现该产品不具备面部医美注射的资质。 骆女士同时反映,该诊所仅告知产品功效,未详细说明注射部位及次数,且事后核对发现,诊所收取了鼻基底1针的费用,但她并未接受该部位注射。无独 有偶,另一位投诉人章女士也反映,其在该诊所注射"菲林普利"时,遭遇了与骆女士一样的"未注射却收费"问题。 目前,上城区卫生监督所已对杭州思达芮医疗美容诊所立案调查。而这背后,"菲林普利"是否构成"超适应证"使用?羟基磷灰石类材料在医美领域的类似应 用是否存 ...
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].