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骨科材料“超范围”填充面部,医美超适应证风险频发,如何解
Di Yi Cai Jing· 2025-12-17 12:52
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 ...
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]
高考结束,扎堆整容
36氪· 2025-07-09 13:05
Core Viewpoint - The article discusses the rising trend of cosmetic surgery among younger generations in China, highlighting the psychological release it provides rather than a complete transformation of self [3][43]. Industry Overview - The Chinese medical beauty market is projected to reach a scale of 350 to 400 billion yuan by 2025, with Generation Z (born after 1995) contributing 62% of the consumption share, averaging an annual expenditure of 28,000 yuan, significantly higher than the "post-80s" generation [9][10]. - The demand for medical beauty services is rapidly increasing, leading to the growth of companies like Huaxi Biological, Aimeike, and Haohai Biological, which are referred to as the "three swordsmen of medical beauty" due to their high profit margins comparable to that of Moutai [10]. Consumer Behavior - Young consumers are increasingly seeking cosmetic procedures as a means of personal expression and self-improvement, often driven by social media influences and peer comparisons [17][39]. - The trend has shifted from invasive surgeries to "light medical beauty," where non-surgical procedures are preferred, reflecting a desire for natural and comfortable appearances [26][30]. Psychological Aspects - The article emphasizes that many young individuals view cosmetic surgery as a solution to their insecurities, often influenced by societal standards of beauty propagated through social media [39][41]. - The experiences of individuals like Chuyu and Yezi illustrate that cosmetic surgery can lead to a psychological release, allowing them to accept themselves better and reduce self-criticism [43]. Market Trends - There is a notable trend of younger individuals, particularly high school and university graduates, seeking cosmetic enhancements as part of their transition into adulthood, often viewing it as a necessary step for confidence in job hunting and social interactions [24][25]. - The article also highlights the increasing prevalence of non-surgical procedures, which are perceived as less risky and more accessible, contributing to the growing popularity of the medical beauty industry among the youth [26][29].
高考结束,扎堆整容
虎嗅APP· 2025-07-08 14:19
Core Viewpoint - The article discusses the rising trend of cosmetic surgery among the younger generation in China, particularly focusing on the motivations and psychological impacts of such decisions. Group 1: Market Overview - The Chinese medical beauty market is projected to reach a scale of 350 billion to 400 billion yuan by 2025, with Generation Z (born after 1995) contributing 62% of the consumption share and an average annual expenditure of 28,000 yuan, significantly higher than the "post-80s" generation [4]. - The demand for medical beauty services is rapidly increasing, leading to the growth of companies like Huaxi Biological, Aimeike, and Haohai Biological, which are referred to as the "three swordsmen of medical beauty" due to their high profit margins comparable to that of Moutai [6]. Group 2: Changing Attitudes Towards Beauty - The younger generation's perception of beauty is being reshaped by social media, where they are exposed to idealized images that create a sense of inadequacy regarding their own appearances [9][23]. - The concept of "light medical beauty" is becoming mainstream, with a shift from invasive surgeries to less risky procedures like injections, reflecting a desire for a more natural appearance [15][16]. Group 3: Psychological Aspects - Many young individuals view cosmetic surgery as a means to alleviate personal insecurities rather than a drastic change, indicating a psychological release from long-standing self-criticism [24][25]. - The article highlights that the desire for cosmetic enhancements often stems from external societal pressures rather than internal dissatisfaction, leading to a cycle of anxiety about meeting beauty standards [22][23]. Group 4: Personal Experiences - The experiences of individuals like Chuyu and Yezi illustrate the personal motivations behind cosmetic surgery, where the surgery serves as a rite of passage and a way to boost self-confidence as they transition into adulthood [18][20]. - Both individuals report a change in their self-perception post-surgery, feeling more comfortable and confident in their appearances, which reflects a broader trend among their peers [20][24].
高考结束,扎堆整容
盐财经· 2025-07-07 09:23
Core Viewpoint - The article discusses the rising trend of cosmetic surgery among young people in China, particularly focusing on the motivations and psychological impacts behind their decisions to undergo procedures like double eyelid surgery. It highlights how social media influences perceptions of beauty and self-worth, leading to increased demand for cosmetic enhancements among the younger generation [7][50][54]. Group 1: Market Overview - The Chinese medical beauty market is projected to reach a scale of 350 to 400 billion yuan by 2025, with Generation Z (born after 1995) contributing 62% of the consumption share, averaging an annual expenditure of 28,000 yuan, significantly higher than the "post-80s" generation [7][9]. - The demand for medical beauty services is rapidly increasing, leading to the emergence of companies like Huaxi Biological, Aimeike, and Haohai Biological, which are referred to as the "three swordsmen of medical beauty" due to their high profit margins and market presence [9][29]. Group 2: Changing Attitudes Towards Cosmetic Surgery - There is a noticeable shift in attitudes towards cosmetic surgery, with younger individuals increasingly seeking "light medical beauty" options rather than invasive surgeries. This trend reflects a desire for natural-looking enhancements rather than dramatic changes [27][29]. - The acceptance of cosmetic procedures has evolved, with many young people now viewing them as routine, akin to dental corrections, and not requiring justification for their choices [49][54]. Group 3: Psychological Factors - The article emphasizes that many young individuals experience a form of psychological anxiety regarding their appearance, often exacerbated by social media portrayals of beauty standards. This anxiety can lead to a desire for cosmetic procedures as a means of self-improvement [50][53]. - The narrative illustrates that for some individuals, cosmetic surgery serves as a way to alleviate long-standing self-criticism and to embrace their current selves, rather than a complete transformation [54].
博主鼓吹,网友高喊“很香,才6000元” ?警惕!注射这种产品暗藏风险
21世纪经济报道· 2025-03-14 01:51
Core Viewpoint - The article discusses the emerging competition and regulatory challenges in the calcium hydroxyapatite (CaHA) market within the medical aesthetics industry, highlighting the recent approvals of CaHA products for facial use and the ongoing issues related to compliance and safety [5][7][11]. Group 1: Market Dynamics - CaHA, originally used in orthopedics and dentistry, is gaining popularity as a facial filler material, alongside PLLA and PCL, driven by market education efforts [3][5]. - In January 2024, it was estimated that the domestic market could consume tens of thousands of CaHA injections, potentially reaching 500,000 units annually, despite a lack of fully compliant products [5][11]. - The approval of two CaHA products for facial use in 2025 marks a significant shift towards regulatory compliance in the industry [5][7]. Group 2: Regulatory Landscape - The first approved CaHA product for facial use, Aphranal® by Moyang Biotechnology, received certification in February 2025, followed by Merz North America's Radiesse, which is the first imported CaHA product approved in China [7][11]. - The competition in the CaHA market is intensifying, with a notable reduction in the time required to obtain regulatory approval, leading to a more crowded market [8][9]. - There are concerns regarding the use of CaHA products beyond their approved indications, with many practitioners using them for facial applications despite their original intended uses being for non-weight-bearing bone defects [13][15]. Group 3: Industry Challenges - The medical aesthetics industry faces significant challenges related to the misuse of products beyond their approved indications, which is prevalent across various injectable products [15][16]. - There is currently no clear legal framework in China to regulate the off-label use of medical devices, leading to potential risks for both practitioners and patients [15][16]. - The article emphasizes the importance of proper patient consent and documentation to mitigate compliance risks in the absence of stringent regulations [16][17].
报名!医美新材料交流会:琼脂糖 & 羟基磷灰石
思宇MedTech· 2025-03-07 14:20
近年来,新型医美填充材料倍受市场关注。2025年初,琼脂糖、羟基磷灰石相关产品在 国内获批上市,引发了行业对于其技术特点、临床应用、安全性及未来趋势的广泛讨 论。 本次交流会将聚焦这两类材料的特性及应用,为医美行业从业者、投资人、临床医生及 学者提供一个开放讨论的平台,探讨其技术原理、适用场景、操作经验及发展趋势,并 邀请行业专家共同交流。 会议安排 时间: 2025年3月12日(周三)14:30-16:00 地点: 上海交通大学医学院 会议议程 1.介绍八大处整形医学验证中心服务介绍和年度活动计划。 2.主题分享:琼脂糖与羟基磷灰石的技术综述 分享人:思宇MedTech主编赵清 内容概览: #琼脂糖的技术特点 主要成分、凝胶特性及降解机制 与现有填充材料的对比(吸水性、塑形力、适用部位) 近期行业动态及市场趋势 #羟基磷灰石的技术特点 主要成分、刺激胶原增生的作用机制 适用于面部填充的优势与挑战 规模: 20~30人 对象: 医美行业从业者、投资人、临床医生、学者 医美行业对该成分的监管趋势 注:主题分享来自于文献资料的收集。欢迎相关企业代表参与讨论并分享更多观点。 3. 圆桌讨论 & 观点碰撞 琼脂糖 v ...
报名!医美新材料交流会:琼脂糖 & 羟基磷灰石
思宇MedTech· 2025-03-04 03:52
近年来,新型医美填充材料倍受市场关注。2025年初,琼脂糖、羟基磷灰石相关产品在 国内获批上市,引发了行业对于其技术特点、临床应用、安全性及未来趋势的广泛讨 论。 本次交流会将聚焦这两类材料的特性及应用,为医美行业从业者、投资人、临床医生及 学者提供一个开放讨论的平台,探讨其技术原理、适用场景、操作经验及发展趋势,并 邀请行业专家共同交流。 1.介绍八大处整形医学验证中心服务介绍和年度活动计划。 2.主题分享:琼脂糖与羟基磷灰石的技术综述 分享人:思宇MedTech主编赵清 内容概览: #琼脂糖的技术特点 主要成分、凝胶特性及降解机制 与现有填充材料的对比(吸水性、塑形力、适用部位) 会议安排 时间: 2025年3月12日(周三)14:30-16:00 地点: 上海交通大学医学院 会议议程 注:主题分享来自于文献资料的收集。欢迎相关企业代表参与讨论并分享更多观点。 3. 圆桌讨论 & 观点碰撞 琼脂糖 vs 透明质酸:临床应用上的优劣对比 羟基磷灰石的优势:刺激胶原增生是否带来长期效果? 两种材料的适用人群及部位探讨 医生的使用体验:注射技巧、并发症管理、患者反馈 市场趋势与投资机会:新材料是否会占据更多市场 ...