Long-term 23-year Global Post-marketing Safety Surveillance Review of Delayed Complications with a Supportive Hyaluronic Acid Filler for Infraorbital Hollow Rejuvenation.

长期 23 年的全球上市后安全监测审查延迟并发症与支持透明质酸填料下中空再生。

• 发表时间: 2024 Jul
• 来源期刊: J Clin Aesthet Dermatol
• PMID: 39006808
• 文章类型: Journal Article
• 作者列表: Siperstein R,Cho Y,Hicks J

关键词: Delayed onset complications; HA filler; infraorbital hollows; nodules; swelling

Abstract

HARES is a supportive (high G\') HA filler with a low degree of water affinity (gel swelling) and modification (<1% BDDE) that has a well-established safety and efficacy profile in the literature, especially for infraorbital hollow (IOH) rejuvenation. To further support the safety of this product, a long-term review of delayed-onset adverse events of interest (DAEIs) related to HARES was conducted using reports from a global post-marketing safety surveillance database over the past 23 years. This review demonstrated low reporting frequencies of delayed-onset nodules and inflammatory events, establishing a long-term safety profile for HARES that supports its continued use in clinical practice, especially for IOH rejuvenation.

摘要

HARES是一种支持性（高G\'）HA填充剂，具有低程度的水亲和力（凝胶溶胀）和改性（<1％BDDE），在文献中具有良好的安全性和有效性。特别是对于眶下中空（IOH）复兴。为了进一步支持本产品的安全性，本研究利用过去23年全球上市后安全监测数据库的报告,对与HARES相关的迟发性不良事件(DAEI)进行了长期审查.这篇综述显示延迟发作结节和炎症事件的低报告频率。建立HARES的长期安全性，支持其在临床实践中的持续使用，特别是IOH复兴。