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上万元一支的面部“骨性生物支架”火了!有这些坑→
第一财经· 2025-11-25 05:21
Core Viewpoint - Social media has become the primary information source for young cosmetic surgery consumers, with a focus on a new injectable material called Calcium Hydroxylapatite (CaHA), which is gaining popularity in the aesthetic market [3][5]. Market Overview - In the global dermal filler market, hyaluronic acid holds a dominant 77% market share, while Calcium Hydroxylapatite accounts for 7% [3]. - Merz Aesthetics' Radiesse is currently the only FDA-approved Calcium Hydroxylapatite facial filler, recently launched in China [5]. Regulatory and Compliance Issues - There are concerns regarding the high prices of these new products, leading to potential exploitation by some cosmetic institutions [6]. - Only two approved products for facial injection in China are Radiesse and Aphranel, while others are approved for non-weight-bearing bone defects [6]. - The use of Calcium Hydroxylapatite in aesthetic applications must adhere to strict regulatory standards, with a clear distinction between products intended for medical and aesthetic use [9]. Consumer Awareness and Safety - Consumers are advised to be cautious and verify the legitimacy of products before use, as many products are not intended for aesthetic applications [8][10]. - Misleading advertising and unverified information on social media pose significant risks to consumers, particularly younger individuals [10]. - The importance of using qualified medical professionals for injections is emphasized, as improper techniques can lead to serious complications [10].
上万元一支的面部“骨性生物支架”火遍小红书 还有这些坑需要避
Di Yi Cai Jing· 2025-11-25 05:18
Core Viewpoint - Social media has become the primary information source for young cosmetic consumers, with a growing interest in calcium hydroxyapatite (CaHA) as a regenerative injectable material, often referred to as the "hardest hyaluronic acid" [1] Market Overview - Hyaluronic acid currently holds a dominant 77% market share in the global dermal filler market, while calcium hydroxyapatite accounts for 7% [1] - Merz Aesthetics' Radiesse is the only FDA-approved calcium hydroxyapatite facial filler in the global market, recently approved in China [2] - Domestic companies such as Haohai Biological Technology, Huaxi Biological, and Juzhi Biological are actively developing calcium hydroxyapatite products, intensifying market competition [2] Regulatory and Safety Concerns - Only two calcium hydroxyapatite products are approved for facial injection in China, highlighting the limited scope of approved applications [2] - The use of calcium hydroxyapatite in cosmetic procedures is subject to strict regulatory oversight, requiring clinical trials for injectable products, which can take 6 to 7 years for approval [4] - There are concerns regarding the misuse of calcium hydroxyapatite products, with reports of unqualified products being injected in medical aesthetic clinics [2][4] Consumer Awareness and Risks - The medical aesthetic market faces challenges with misleading advertising and the promotion of unapproved products, leading to potential consumer harm [6] - Experts emphasize the importance of consumers verifying the legitimacy of products and the qualifications of practitioners before undergoing treatments [5][6] - The industry is marked by a disconnect between regulatory bodies, manufacturers, and medical aesthetic institutions, complicating compliance and consumer safety [4]
上万元一支的面部“骨性生物支架”火遍小红书,还有这些坑需要避
Di Yi Cai Jing· 2025-11-25 05:10
Core Viewpoint - Recent consumer complaints regarding unqualified products used in medical beauty clinics have sparked discussions about the off-label use of calcium hydroxyapatite (CaHA) aesthetic products [1][2] Industry Overview - Social media has become the primary information source for young consumers in the medical beauty sector, with many influencers promoting CaHA as a regenerative injection material [1] - In the global dermal filler market, hyaluronic acid holds a dominant 77% market share, while CaHA accounts for 7% [1] Product Approval and Market Competition - Merz Aesthetics' Radiesse is currently the only FDA-approved CaHA facial filler, which received approval from China's drug regulatory authority in March and has recently launched in the domestic market [2] - Domestic companies such as Haohai Biological Technology, Huaxi Biological, and Juzhi Biological are actively developing CaHA products, intensifying market competition [2] Regulatory and Safety Concerns - Only two approved CaHA fillers in China are indicated for facial injection, while others are approved for non-load-bearing bone defects [2] - The safety of CaHA as a biomaterial has been established since the 1970s, but its off-label use can lead to complications such as inflammation and nodules [3] Consumer Awareness and Risks - Approximately 200 CaHA products have been approved in China, primarily for orthopedic and dental use, not for aesthetic applications [4] - The regulatory framework requires medical devices and drugs to undergo strict classification and approval processes, but some manufacturers may use misleading marketing strategies [5] Recommendations for Consumers - Consumers are advised to seek treatment from reputable institutions and verify product authenticity before procedures [6] - Medical professionals performing CaHA injections must have the necessary qualifications and training to minimize risks [6] - Misleading advertising and unverified information on social media pose significant risks to consumers, particularly younger individuals [6]