面部填充材料在医美领域的超范围使用现象，是长期处于灰色地带的。 从业多年，刘菲常会遇到两类求美者：一类是拿着各类新奇项目名称网络分享贴的咨询者，这些营销概 念在刘菲看来或不可取或仅是将常见技术进行重新包装；另一类则是一味追求"即做即效"的求美者，她 们中的一些或被不正规医美机构一次性、大剂量地注射填充剂，造成不可逆的后果。 刘菲是上海交通大学医学院附属第九人民医院整复外科副主任医师，他所谈及的医美市场，更确切地说 是以注射类和光电类为代表的非手术类轻医美市场。罗兰贝格发布的《2025医美行业白皮书》显示，近 五年来，中国轻医美市场占比持续增长，预计到2030年在整个医美市场中占比达到64%。 多名受访业界人士认为，随着行业高速发展，早些年"黑医美""黑产品""医美贷"等恶性医美非法行为盛 行的1.0阶段已经过去；但进入2.0阶段后，伴随医美新产品、新材料不断问世，新技术违规应用、注射 材料超范围使用以及使用未获批医疗器械等问题时有发生。 也就是说，无论是热度持续多年的肉毒毒素、玻尿酸，还是近一年来"火"了的羟基磷灰石，它们在医美 领域应用均需要严格遵循产品说明书的适用范围（适应证）。 今年2月，摩漾生物注射用 ...

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 ...

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].