Beauvais Daniel, Ferneini Elie M
Resident, Department of Oral and Maxillofacial Surgery, University of Connecticut School of Dental Medicine, Farmington, CT.
Director, Beau Visage Med Spa; Greater Waterbury OMS; and Associate Clinical Professor, Department of Oral and Maxillofacial Surgery, University of Connecticut, Cheshire, CT.
J Oral Maxillofac Surg. 2020 Jan;78(1):133-140. doi: 10.1016/j.joms.2019.08.003. Epub 2019 Aug 9.
Soft-tissue injectable fillers are a popular treatment option for patients seeking minimally invasive facial rejuvenation. The use of soft-tissue fillers has increased significantly in the past 10 years. In 2017 alone, clinicians administered nearly 2.7 million soft-tissue fillers, up from 1.3 million in 2007. Although injectable fillers have a relatively high safety profile compared with more invasive rejuvenation procedures, serious adverse events, including intra-arterial injections, necrosis, and visual symptoms such as blindness, have been documented. Complications from injectable fillers have also been a source of litigation, which has been shown to be associated with a perceived lack of informed consent. We sought to document the reported complication rates associated with injectable facial fillers from a national database and to report on the available cases of malpractice litigation.
The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was used to collect the reported complications from 2013 to 2017 for the following injectable fillers: Artefill, Bellafill, Belotero, Juvederm, Radiesse, Restylane, Sculptra, and Kybella. Complications were organized by filler type, injection location, and complication type. The Thomson Reuters Westlaw Edge database was used to collect the reported jury verdicts and settlements from 2008 to 2017 for injectable facial fillers.
A total of 2813 adverse events were analyzed. The most common locations for complications were the cheek (915 [32.5%]), lips (503 [17.9%]), and nasolabial fold (412 [14.6%]). The commonly reported adverse events were swelling (1,691 [60.1%]), nodule (948 [33.7%]), and pain (636 [22.6%]). Severe complications included intra-arterial injections resulting in necrosis and visual symptoms (eg, blurred vision and blindness). Forehead and dorsal nasal injections were significantly associated with intra-arterial complications resulting in necrosis and visual symptoms (P < .01). Injections with Radiesse were significantly associated with intra-arterial injections resulting in necrosis and visual symptoms (P < .01). A total of 11 malpractice cases were analyzed. The median award in the cases resolved by a verdict in favor of the plaintiff or settlement was $600,000. In 10 of the 11 cases, a lack of informed consent had been alleged.
The complications associated with injectable facial fillers varied greatly, depending on factors involved with their application. The most common adverse effects were swelling, nodule formation, and pain. Serious complications stemming from intra-arterial injections included necrosis and visual disturbances, including blindness. These complications have been raised in legal cases, in which the lack of informed consent was frequently alleged. The present analysis has documented some of the potential risks involved with injectable facial fillers and demonstrated the need for a thorough informed consent process before their administration.
软组织可注射填充剂是寻求微创面部年轻化治疗的患者常用的治疗选择。在过去10年中，软组织填充剂的使用显著增加。仅在2017年，临床医生就注射了近270万支软组织填充剂，而2007年为130万支。尽管与侵入性更强的年轻化手术相比，可注射填充剂的安全性相对较高，但已记录到严重不良事件，包括动脉内注射、坏死以及失明等视觉症状。可注射填充剂引起的并发症也是诉讼的根源，诉讼显示与知情同意的认知不足有关。我们试图从国家数据库中记录报告的与可注射面部填充剂相关的并发症发生率，并报告医疗事故诉讼的现有案例。
使用美国食品药品监督管理局的制造商和用户设施设备经验数据库，收集2013年至2017年以下可注射填充剂报告的并发症：爱贝芙、贝拉菲、贝洛特罗、乔雅登、瑞蓝、瑞得喜、塑然雅和酷塑。并发症按填充剂类型、注射部位和并发症类型进行分类。使用汤森路透Westlaw Edge数据库收集2008年至2017年可注射面部填充剂报告的陪审团裁决和和解情况。
共分析了2813例不良事件。并发症最常见的部位是脸颊（915例[32.5%]）、嘴唇（503例[17.9%]）和鼻唇沟（412例[14.6%]）。常见的不良事件是肿胀（1691例[60.1%]）、结节（948例[33.7%]）和疼痛（636例[22.6%]）。严重并发症包括动脉内注射导致的坏死和视觉症状（如视力模糊和失明）。前额和鼻背注射与导致坏死和视觉症状的动脉内并发症显著相关（P <.01）。使用瑞得喜注射与导致坏死和视觉症状的动脉内注射显著相关（P <.01）。共分析了11例医疗事故案例。裁决支持原告或达成和解的案件的中位赔偿额为60万美元。在11例案件中的10例中，均指控存在知情同意不足的情况。
与可注射面部填充剂相关的并发症差异很大，取决于其应用相关因素。最常见的不良反应是肿胀、结节形成和疼痛。动脉内注射引起的严重并发症包括坏死和视觉障碍，包括失明。这些并发症在法律案件中被提及，其中经常指控存在知情同意不足的情况。本分析记录了可注射面部填充剂的一些潜在风险，并表明在给药前需要进行全面的知情同意程序。
