Halepas Steven, Lee Kevin C, Higham Zachary L, Ferneini Elie M
Resident, Division of Oral and Maxillofacial Surgery, New York-Presbyterian Hospital/Columbia University Irving Medical Center, New York, NY.
Consultant, Normand Higham, PA, Manchester, NH.
J Oral Maxillofac Surg. 2020 Apr;78(4):619-628. doi: 10.1016/j.joms.2019.12.012. Epub 2019 Dec 31.
The popularity and availability of facial rejuvenation procedures have increased exponentially during the previous decade. The present study aimed to provide an overview of photorejuvenation and evaluate the complications and litigation related to light-based skin resurfacing procedures.
A retrospective study was performed using the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) registry and the Thomson Reuter Westlaw Edge database from May 1, 1999 to May 1, 2019. The MAUDE registry was queried using the manufacturer brands. Adverse events were individually reviewed, and data were gathered regarding the company, complication, body location, and device type. The litigation cases were individually reviewed, and information was gathered on plaintiff gender, defendant specialty, allegation, jury verdict, the appeals verdict, and the award amount, if applicable.
A total of 697 adverse events were included in the final sample. The most commonly reported complications were burns (61.1%), followed by scarring (16.2%), hyperpigmentation (7.8%), and hypopigmentation (7.0%). More rare, noncosmetic complications included infection (3.9%) and nerve (1.4%) and ocular (1.3%) damage. The rates of scarring with facial treatments were greater (24.3 vs 10.3%; P < .01) and the rates of burns with ablative lasers were lower (25.9 vs 66.0%; P < .01). With respect to litigation, of the 9 cases identified, all the plaintiffs were women. The most common allegation was procedural negligence (88.8%), followed by cosmetic deformity (77.7%) and the lack of informed consent (55.5%). The jury ruled in favor of the plaintiff in 4 cases (44.4%), and the mean award was $656,000.
The most common adverse events were burns, scars, and pigmentation changes. Patient expectations could play a role in the reporting of adverse events. Negligence was the most common basis for litigation, consistent with what has been reported for other procedures. Future studies should evaluate whether increasing exposure to cosmetic phototherapies during residency and fellowship training will reduce future complication rates and alleged malpractice.
在过去十年中，面部年轻化手术的普及程度和可及性呈指数级增长。本研究旨在概述光嫩肤，并评估与基于光的皮肤磨削术相关的并发症和诉讼情况。
使用美国食品药品监督管理局制造商和用户设施设备经验（MAUDE）注册库以及汤森路透Westlaw Edge数据库，进行了一项回顾性研究，研究时间为1999年5月1日至2019年5月1日。通过制造商品牌查询MAUDE注册库。对不良事件进行逐一审查，并收集有关公司、并发症、身体部位和设备类型的数据。对诉讼案件进行逐一审查，并收集有关原告性别、被告专业、指控、陪审团裁决、上诉裁决以及适用情况下的赔偿金额等信息。
最终样本共纳入697例不良事件。最常报告的并发症是烧伤（61.1%），其次是瘢痕形成（16.2%）、色素沉着过度（7.8%）和色素沉着不足（7.0%）。更罕见的非美容并发症包括感染（3.9%）、神经损伤（1.4%）和眼部损伤（1.3%）。面部治疗的瘢痕形成率更高（24.3%对10.3%；P <.01），而剥脱性激光治疗的烧伤率更低（25.9%对66.0%；P <.01）。关于诉讼，在确定的9起案件中，所有原告均为女性。最常见的指控是程序疏忽（88.8%），其次是美容畸形（77.7%）和缺乏知情同意（55.5%）。陪审团在4起案件（44.4%）中做出了有利于原告的裁决，平均赔偿金额为656,000美元。
最常见的不良事件是烧伤、瘢痕和色素沉着变化。患者期望可能在不良事件报告中起作用。疏忽是诉讼最常见的依据，这与其他手术的报告情况一致。未来的研究应评估在住院医师和专科培训期间增加美容光疗的接触是否会降低未来的并发症发生率和医疗事故指控。
