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Nonsurgical Medical Aesthetics and Patient Quality of Life: An Umbrella Review. 非手术医学美学与患者生活质量:综述。
Pub Date : 2024-10-30 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae096
Barbara Hemsworth, Cody Hemsworth, Sarah A Richmond

Nonsurgical cosmetic facial procedures have become popular treatment options for individuals seeking aesthetic improvements. Despite a breadth of literature on patient satisfaction with treatment outcomes, there is a lack of information specific to changes in quality of life outcomes. The objective of this umbrella review is to report the effectiveness of nonsurgical facial aesthetic treatments on reported quality of life in cosmetic treatment-seeking patients. The authors also aim to identify gaps in the literature on measures of quality of life outside of patient satisfaction. The authors completed a comprehensive, systematic search of review articles across 6 databases, including Medline, CINAHL Plus, EMBASE, APA PsycINFO, Cochrane Reviews, and Google Scholar. They included review-level studies that examine the changes in quality of life measures following treatment. A critical appraisal was completed for each review article included. A total of 7 reviews were included. One review was of strong quality, 2 moderate, and 4 were weak. Several nonsurgical procedures were evaluated across reviews, including injectable neurotoxins, dermal fillers, and laser skin resurfacing. The majority of included studies reported increases in measures of quality of life, posttreatment in the same patient or compared with controls. The most commonly reported measure was psychological well-being, followed by self-perception. There was a lack of measures outside of improvements to aesthetics, including those specific to mental health (eg, depression). Overall, based on the studies on nonsurgical treatments, the authors report increases in overall quality of life. This conclusion should be interpreted with caution, as the majority of reviews included were of moderate-to-weak quality. A major gap in this literature includes mental health outcomes. Future research should focus on increasing the rigor of reporting for systematic reviews.

Level of evidence 2 risk:

非手术美容面部程序已成为流行的治疗选择,个人寻求美观的改善。尽管关于患者对治疗结果满意度的文献广泛,但缺乏关于生活质量结果变化的具体信息。本综述的目的是报告非手术面部美容治疗对寻求美容治疗的患者的生活质量的有效性。作者还旨在确定文献中的差距,在病人满意度之外的生活质量的措施。作者在Medline、CINAHL Plus、EMBASE、APA PsycINFO、Cochrane Reviews和谷歌Scholar等6个数据库中完成了综述文章的全面、系统搜索。其中包括审查水平的研究,检查治疗后生活质量的变化。对每篇综述文章都进行了批判性评价。共纳入7篇综述。1篇评价为高质量评价,2篇为中等质量评价,4篇为弱质量评价。综述中评估了几种非手术治疗方法,包括注射神经毒素、真皮填充物和激光皮肤换肤。大多数纳入的研究报告了生活质量测量的增加,治疗后同一患者或与对照组相比。最常见的衡量标准是心理健康,其次是自我认知。除了改善审美,包括针对心理健康(如抑郁症)的措施外,缺乏其他措施。总的来说,基于对非手术治疗的研究,作者报告了总体生活质量的提高。这个结论应该谨慎地解释,因为大多数的评论都是中等到较弱的质量。这一文献中的一个主要差距包括心理健康结果。未来的研究应侧重于增加系统评价报告的严谨性。证据2级风险:
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引用次数: 0
The Social Area of the Breast: An Evolution Through Cultures and Centuries. 乳房的社会区域:跨越文化和世纪的演变。
Pub Date : 2024-10-24 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae095
Amitkumar M Bagdia, Nicola Rocco, Giuseppe Catanuto, Fabrizia Calenda, Ernesto Buccheri, Amedeo Villanucci, Madhusudan S Bagdia, Chaitanyanand Koppiker, Maurizio Bruno Nava

Breasts have evolved as a functional and aesthetic unit. The perception of society toward social exposure of the breast has been extremely diverse, not only temporally through the same civilization but also among contemporary parallel societies in geographically diverse areas. This article explores the spatial and temporal evolution of the outlook toward social exposure of breast over the past 3000 years among different societies, countries, and religions. The level of "acceptance" or "tolerance" toward visibility of breast in social situations was historically guided by social conditioning. Recently, the personal attitudes and preferences of the women themselves have become more deterministic of the clothing choices. Consequently, the conventional oncoplastic notion of a "no-scar zone" being the upper-inner quadrant of the breast must also be redefined to match the dynamic personal preferences of the patient. It is important to know what the patient thinks is the "most social" area of the breast for her, and then to avoid scars in those areas if possible. The article discusses the quest to minimize scars and the importance of shared decision making.

乳房已经进化为一个功能和审美单位。社会对乳房暴露的看法是非常不同的,不仅在同一文明时期,而且在地理上不同的当代平行社会中也是如此。本文探讨了近3000年来不同社会、国家和宗教对乳房社会暴露观的时空演变。在历史上,对社会场合中乳房可见性的“接受”或“容忍”程度是由社会条件决定的。最近,女性自己的个人态度和偏好对服装选择的决定作用越来越大。因此,传统的肿瘤肿瘤学概念“无疤痕区”是乳房的上内象限,也必须重新定义,以符合患者动态的个人偏好。重要的是要知道病人认为什么是她乳房上“最社交”的区域,然后尽可能避免在这些区域留下疤痕。这篇文章讨论了如何尽量减少创伤和共同决策的重要性。
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引用次数: 0
Manipulation of the Nasal Superficial Musculoaponeurotic System to Enhance Midvault and Supratip Contouring. 操纵鼻浅肌腱神经系统以增强鼻中点和鼻尖上轮廓。
Pub Date : 2024-10-24 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae089
Adam D Glener, Virginia E Bailey, Derek Sheen, Spencer Cochran

Background: Management of dorsal dead space and the aesthetics of a supratip break are paramount to achieving reproducible and reliable results in rhinoplasty.

Objectives: The authors present a modified technique of redraping the nasal soft tissue envelope in structural rhinoplasty by utilizing the nasal superficial musculoaponeurotic system (SMAS) to help obliterate dorsal dead space and restore normal anatomy, thereby enhancing midvault and supratip contouring.

Methods: A standard open rhinoplasty approach is utilized. A planar transition from supraperichondrial to subperichondrial/subperiosteal is completed during the dorsal dissection. The open structural rhinoplasty then proceeds as previously published by the senior author. After any desired tip work is completed, the cephalically based SMAS layer is reconstituted with suture fixation laterally along the caudal border of the upper lateral cartilages. A more robust technical discussion is borne out in the manuscript.

Results: At submission, the senior author has performed >100 rhinoplasties employing this technique over roughly 1 year. Subjectively, patients have had better immediate supratip contour with less residual dorsal soft tissue edema. A case example with photographs is included at a 1 year postoperative time point.

Conclusions: Using this described technique, surgeons can employ an open, structural, approach to rhinoplasty while using restoration of natural anatomy to achieve a refined postoperative result, accentuating supratip break while minimizing dorsal soft tissue dead space.

Level of evidence 5 therapeutic:

背景:在鼻整形术中,背侧死腔的处理和鼻尖上断裂的美观对于获得可重复性和可靠的结果至关重要。目的:提出了一种利用鼻浅肌腱神经系统(SMAS)重新包裹鼻腔软组织包膜的改进技术,以帮助消除背侧死亡空间,恢复正常解剖结构,从而增强中天和鼻尖上轮廓。方法:采用标准的开放性鼻成形术。在背侧剥离过程中完成了从骨膜上到骨膜下/骨膜下的平面过渡。开放结构鼻成形术,然后进行之前发表的资深作者。在完成任何所需的尖端工作后,沿上外侧软骨尾侧缘沿外侧缝合固定,重建以头侧为基础的SMAS层。手稿中有一个更有力的技术讨论。结果:在提交时,资深作者在大约1年的时间里使用该技术进行了100例鼻整形手术。主观上,患者有较好的即时尖端上轮廓,较少残留的背侧软组织水肿。一个病例的照片包括在术后1年的时间点。结论:使用该技术,外科医生可以采用开放的、结构性的鼻整形方法,同时使用自然解剖结构的恢复来实现精细的术后效果,突出鼻尖上骨折,同时最大限度地减少背侧软组织死亡空间。证据等级为5,具有治疗作用:
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引用次数: 0
Comparison of Different Types of Poly-L-Lactic Acid Microspheres In Vitro and In Vivo Studies. 不同类型聚l -乳酸微球的体外和体内研究比较。
Pub Date : 2024-10-22 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae091
Ruilin Liu, Tong He, Ruizhi Li, Shiwei Wang, Chen Lai, Kun Zhang

Background: Biodegradable polymers are commonly used as dermal fillers in plastic surgery. Among these, poly-L-lactic acid (PLLA) distinguishes itself owing to its good biocompatibility, degradability, and ability to act as a collagen stimulator.

Objectives: In this study, the differential behavior of PLLA microspheres with varying microscopic morphology and surface hydrophilicity was investigated both in vitro and in vivo.

Methods: The introduction of short hydrophilic polyethylene glycol (PEG) chains into the PLLA molecule was employed to modify the morphology and enhance the surface hydrophilicity of the microspheres. The morphology and physicochemical properties of the PLLA and PLLA-b-PEG microspheres were characterized. Irregular PLLA particles, PLLA, and PLLA-b-PEG microspheres were implanted into the subcutaneous tissue of rabbit models, and at 4, 26, and 52 weeks after implantation, biopsy samples were collected for hematoxylin and eosin and Masson's trichrome staining to evaluate differences in the tissue response between different implants.

Results: The results of in vitro research demonstrated that while the addition of short-chain hydrophilic PEG afforded a smoother surface for the microspheres, it had no significant effect on the molecular weight and degradation rate of PLLA. The histological examination revealed that the PLLA-b-PEG microspheres exhibited enhanced biocompatibility compared with the pure PLLA microspheres, while the irregular PLLA particles showed the highest inflammatory response among the 3 materials.

Conclusions: In this study, we found that the properties of PLLA were improved upon modification by short-chain PEG without reducing the collagen regeneration ability, thereby affording a better histocompatibility.

Level of evidence 5 therapeutic:

背景:可生物降解聚合物是整形外科中常用的真皮填充物。其中,聚l -乳酸(PLLA)因其良好的生物相容性、可降解性和作为胶原蛋白刺激剂的能力而脱颖而出。目的:研究不同微观形态和表面亲水性的聚乳酸微球在体外和体内的差异行为。方法:采用在聚乳酸分子中引入亲水短聚乙二醇(PEG)链来修饰微球的形态,增强微球的表面亲水性。对PLLA和PLLA-b- peg微球的形貌和理化性质进行了表征。将不规则PLLA颗粒、PLLA和PLLA-b- peg微球植入兔模型皮下组织,在植入后4、26和52周采集活检标本进行苏木精、伊红和马松三色染色,评估不同植入物对组织反应的差异。结果:体外实验结果表明,虽然短链亲水聚乙二醇的加入使微球表面更加光滑,但对聚乳酸的分子量和降解率没有显著影响。组织学检查显示,与纯PLLA微球相比,PLLA-b- peg微球的生物相容性增强,而不规则PLLA颗粒的炎症反应最高。结论:在本研究中,我们发现经短链PEG修饰后的PLLA在不降低胶原再生能力的情况下,性能得到改善,具有更好的组织相容性。证据等级为5,具有治疗作用:
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引用次数: 0
Utilization of Artificial Intelligence to Improve Equitable Healthcare Access for Breast Implant Patients. 利用人工智能改善乳房植入患者的公平医疗服务。
Pub Date : 2024-10-22 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae093
Louisa B Ragsdale, Aurora M Kareh, Rohun Gupta, Peter K Firouzbakht, Christina M Plikaitis, Katherine A Rodby

Recently, mandated FDA patient decision checklists were developed with the goal of improving the informed decision-making process for patients considering breast implants. However, these checklists are written at reading levels far higher than recommended by the National Institutes of Health and the American Medical Association. This study aims to improve the accessibility, and therefore, the utility of the mandated FDA patient literature for the average breast implant patient using the assistance of artificial intelligence (AI). Patient decision checklists were obtained from the 3 most utilized breast implant manufacturers in the United States-Allergan, Mentor, and Sientra. A novel patient decision checklist was synthesized by AI, written at the sixth grade reading level, using these checklists as source material. The AI-assisted checklist was edited by plastic surgeons for both formatting and content. The overall readability of Allergan, Mentor, and Sientra patient checklists correlated with the college reading level. These documents were of a statistically significantly higher reading level than the AI-assisted checklist, which was written at the recommended sixth grade level. Text composition analysis similarly demonstrated substantial differences between the AI-assisted and FDA-mandated literature. The currently mandated breast implant patient checklists are written at a college reading level and are inaccessible to the average patient. The authors propose a new patient decision checklist, generated with the assistance of AI, to improve healthcare access within plastic surgery. This simplified material can be used as an adjunct to the current checklists to improve shared decision making.

最近,美国食品和药物管理局(FDA)强制制定了患者决策核对表,目的是改善考虑植入乳房的患者的知情决策过程。然而,这些核对表的阅读水平远远高于美国国立卫生研究院和美国医学会的建议水平。本研究旨在通过人工智能(AI)的帮助,提高 FDA 规定的患者文献对普通乳房植入患者的可及性和实用性。我们从美国使用率最高的三家乳房植入物制造商--Allergan、Mentor 和 Sientra 获得了患者决策核对表。人工智能以这些核对表为素材,以六年级的阅读水平合成了一份新颖的患者决策核对表。整形外科医生对人工智能辅助核对表的格式和内容进行了编辑。Allergan、Mentor 和 Sientra 患者核对表的整体可读性与大学阅读水平相关。据统计,这些文件的阅读水平明显高于人工智能辅助核对表,后者是按照建议的六年级水平编写的。文本构成分析同样表明,人工智能辅助检查表与食品药物管理局规定的文献之间存在很大差异。目前规定的乳房植入患者核对表是按照大学阅读水平编写的,普通患者无法使用。作者提出了一种新的患者决策清单,该清单由人工智能辅助生成,以改善整形外科的医疗服务。这份简化的材料可作为现有核对表的辅助材料,以改善共同决策。
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引用次数: 0
Comparing ChatGPT vs Surgeon-Generated Informed Consent Documentation for Plastic Surgery Procedures. 比较 ChatGPT 与外科医生生成的整形手术知情同意书。
Pub Date : 2024-10-22 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae092
Ishan Patel, Anjali Om, Daniel Cuzzone, Gabriela Garcia Nores

Informed consent is a crucial requirement of a patient's surgical care but can be a burdensome task. Artificial intelligence (AI) and machine learning language models may provide an alternative approach to writing detailed, readable consent forms in an efficient manner. No studies have assessed the accuracy and completeness of AI-generated consents for aesthetic plastic surgeries. This study aims to compare the length, reading level, accuracy, and completeness of informed consent forms that are AI chatbot (ChatGPT-4; OpenAI, San Francisco, CA) generated vs plastic surgeon generated for the most commonly performed aesthetic plastic surgeries. This study is a cross-sectional design comparing informed consent forms created by the American Association of Plastic Surgeons (ASPS) with informed consent forms generated by ChatGPT-4 for the 5 most commonly performed plastic surgery procedures: liposuction, breast augmentation, abdominoplasty, breast lift, and blepharoplasty. The average word count of ChatGPT forms was lower than the ASPS-generated forms (1023 vs 2901, P = .01). Average reading level for ChatGPT forms was also lower than the ASPS forms (11.2 vs 12.5, P = .02). There was no difference between accuracy and completeness scores for general descriptions of the surgery, risks, benefits, or alternatives. The mean overall impression score for ChatGPT consents was 2.33, whereas it was 2.23 for ASPS consent forms (P = .18). In this study, the authors demonstrate that informed consent forms generated by ChatGPT were significantly shorter and more readable than ASPS forms with no significant difference in completeness and accuracy.

Level of evidence 5 risk:

知情同意是患者手术护理的一项重要要求,但可能是一项繁重的任务。人工智能(AI)和机器学习语言模型可为高效书写详细、可读性强的同意书提供另一种方法。目前还没有研究对人工智能生成的美容整形手术同意书的准确性和完整性进行评估。本研究旨在比较人工智能聊天机器人(ChatGPT-4;OpenAI,加利福尼亚州旧金山)生成的知情同意书与整形外科医生生成的知情同意书在最常进行的美容整形手术中的长度、阅读水平、准确性和完整性。本研究采用横断面设计,比较了由美国整形外科医师协会(ASPS)创建的知情同意书和由 ChatGPT-4 生成的知情同意书,后者适用于最常实施的 5 种整形手术:吸脂、隆胸、腹部整形、乳房提升和眼睑整形。ChatGPT 表格的平均字数低于 ASPS 生成的表格(1023 对 2901,P = .01)。ChatGPT 表格的平均阅读水平也低于 ASPS 表格(11.2 vs 12.5,P = .02)。对于手术的一般描述、风险、益处或替代方案,准确性和完整性得分之间没有差异。ChatGPT 同意书的平均总体印象分数为 2.33,而 ASPS 同意书的平均总体印象分数为 2.23(P = .18)。在这项研究中,作者证明了由 ChatGPT 生成的知情同意书明显比 ASPS 表格更简短、更易读,但在完整性和准确性方面没有显著差异:
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引用次数: 0
Is There An "Ideal Instagram Face" for Caucasian Female Influencers? A Cross-Sectional Observational Study of Facial Proportions in 100 Top Beauty Influencers. 高加索女性影响者有 "理想的 Instagram 脸型 "吗?对 100 位顶级美妆影响者面部比例的横断面观察研究》(A Cross-Sectional Observational Study of Facial Proportions in 100 Top Beauty Influencers)。
Pub Date : 2024-10-10 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae085
Rafael Loucas, Bruno Sauter, Marios Loucas, Sebastian Leitsch, Omar Haroon, Aljosa Macek, Silke Graul, Alexander Kobler, Thomas Holzbach

Background: In the digital arena, wherein younger generations predominantly spend their time, social media continues to determine what is considered beautiful. Social media, particularly Instagram (Meta, Menlo Park, CA), is becoming a prominent aspect of the plastic surgeon-patient relationship. Therefore, the beauty ideal escalates without any barriers and breaks. The majority of influencers look alike. This sets a new trend for a beauty ideal.

Objectives: In this study, the authors aimed to analyze the facial proportions of 100 top female beauty influencers, to evaluate them for identifying the "ideal Instagram face," and to determine whether there existed a deviation from the standard golden ratio.

Methods: The authors identified the top 100 beauty influencers, according to the latest rankings of November 2022. A detailed facial analysis has been conducted using the Fiji biomedical image analysis software. The primary outcome parameters included facial proportions such as lip ratio, Ricketts' line, and nasal dimensions. Secondary outcomes comprised BMI, age, and ethnicity. The results were collected and analyzed descriptively using graphs and statistics.

Results: Complete datasets were obtained from the top 100 female beauty influencers with a mean age of 31.3 ± 6.3 years (range, 24-38 years). The majority of influencers were Americans, followed by Germans and British. Based upon the mean of the aforementioned parameters, we could design the ideal Instagram face. There was no significant difference between the golden ratio and the new trend of the ideal Instagram face.

Conclusions: Despite the existence of varied ethnic population groups and nonstandard measurements, the ideal Instagram face represents today's ideal trending face. The ideal Instagram face is symmetrical, matching the golden ratios, with a small and neat nose, full and lush lips, high cheekbones, as also a sharp and chiseled jawline. Further studies on this topic, involving a greater number of influencers with standardized measurements, should be advocated to identify the ideal facial proportions. This will lead to improvements in invasive and noninvasive cosmetic treatments.

Level of evidence 5 diagnostic:

背景:在年轻一代主要消磨时间的数字领域,社交媒体继续决定着什么是美丽。社交媒体,尤其是 Instagram(Meta,加利福尼亚州门洛帕克),正在成为整形外科医生与患者之间关系的一个重要方面。因此,美丽的理想没有任何障碍和突破,不断升级。大多数有影响力的人都长得很像。这为美容理想树立了新的趋势:在这项研究中,作者旨在分析 100 位顶级女性美妆影响者的面部比例,对她们进行评估,以确定 "Instagram 理想脸型",并确定是否存在偏离标准黄金比例的情况:方法:作者根据 2022 年 11 月的最新排名,确定了 100 位顶级美妆影响力人物。使用斐济生物医学图像分析软件进行了详细的面部分析。主要结果参数包括面部比例,如嘴唇比例、里克特线和鼻部尺寸。次要结果包括体重指数、年龄和种族。收集的结果通过图表和统计数据进行描述性分析:从排名前 100 位的女性美容影响者那里获得了完整的数据集,她们的平均年龄为 31.3 ± 6.3 岁(24-38 岁)。大多数影响者是美国人,其次是德国人和英国人。根据上述参数的平均值,我们可以设计出理想的 Instagram 人脸。黄金比例与 Instagram 理想脸型的新趋势之间没有明显差异:尽管存在不同的种族群体和非标准的测量方法,Instagram 的理想脸型代表了当今的理想趋势脸型。Instagram 的理想脸型是对称的,符合黄金比例,鼻子小巧整齐,嘴唇饱满丰润,颧骨高耸,下巴线条清晰有致。应提倡对这一主题进行进一步研究,让更多有影响力的人参与进来,并进行标准化测量,以确定理想的面部比例。证据等级 5 诊断:
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引用次数: 0
Screens, Blue Light, and Epigenetics: Unveiling the Hidden Impact on Skin Aging. 屏幕、蓝光和表观遗传学:揭示皮肤老化的隐性影响。
Pub Date : 2024-10-09 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae088
Diala Haykal
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引用次数: 0
Multimodal Pilot Evaluation of a Hyaluronic Acid Infraorbital Filler Using Precise, Multipositional, 3-Dimensional Imaging Quantification, Patient-Reported Outcomes, and Anatomic Cadaveric Assessments. 使用精确、多位置、三维成像量化、患者报告的结果和解剖尸体评估透明质酸眶下填充物的多模式试点评估。
Pub Date : 2024-10-07 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae086
Stephanie E Honig, Yoshiko Toyoda, Jane N Ewing, Mehdi S Lemdani, Zachary Gala, Chris Amro, Alexander T Wilson, Robyn B Broach, Ivona Percec

Background: Despite the high demand of filler in the infraorbital area, there remains debate on injection practices, precise anatomical placement, and hyaluronic acid (HA) filler behavior.

Objectives: We aimed to contribute to the clinical and anatomic understanding of infraorbital HA injection through a prospective patient injection study in combination with a cadaveric analysis.

Methods: Patients were injected with Volbella XC (JUVÉDERM, Allergan Aesthetics, an AbbVie Company, Irvine, CA) into the tear trough region by a single experienced aesthetic plastic surgeon. Over a 90-day period, precise undereye volumetric measurements using 3-dimensional photogrammetry (VECTRA-M3, Canfield Scientific, Inc., Fairfield, NJ) and patient-reported outcomes (PROs; FACE-Q) were collected and analyzed relative to 2 pretreatment severity scales. Juvéderm Vycross (Allergan Aesthetics, an AbbVie Company, Irvine, CA) and Restylane NASHA (Galderma, Lausanne, Switzerland) products were injected into the infraorbital and malar region in 6 cephalus specimens and evaluated with regards to the anatomic injection location with and without common clinical physical manipulations.

Results: Eleven patients participated with a 100% retention rate. Infraorbital HA volume maintenance was 70% to 81% at 30 days and 50% to 70% at 90 days. Significant improvement was noted in the eyes, overall facial appearance, and cheekbones (P < .05) with FACE-Q outcomes, irrespective of pretreatment severity. In the cadaver examination, we observed differences in the anatomic locations occupied by Juvéderm and Restylane products as well as in behavior after physical manipulation between gel types.

Conclusions: Volbella XC effectively augments undereye volume to diminish infraorbital hollowing as measured over a 90-day period with significantly improved PROs. Enhanced knowledge of the behavior of Volbella XC and other HA fillers in this sensitive anatomic region will lead to improved patient outcomes.

Level of evidence 4 therapeutic:

背景:尽管眶下区域对填充物的需求量很大,但关于注射方法、精确的解剖位置和透明质酸(HA)填充物的行为仍然存在争议。目的:我们旨在通过一项前瞻性患者注射研究,结合尸体分析,促进眶下透明质酸注射的临床和解剖学理解。方法:由一名经验丰富的美容整形外科医生将Volbella XC (JUVÉDERM, Allergan Aesthetics, an AbbVie Company, Irvine, CA)注射到撕裂槽区域。在90天的时间里,使用三维摄影测量仪(VECTRA-M3, Canfield Scientific, Inc., Fairfield, NJ)和患者报告的结果(PROs;收集FACE-Q)并相对于2个预处理严重程度量表进行分析。将juvderm Vycross (Allergan Aesthetics, an AbbVie Company, Irvine, CA)和Restylane NASHA (Galderma, Lausanne, Switzerland)产品注射到6个头颅骨标本的眶下和颧区,并在有无常见临床物理手法的情况下评估解剖注射位置。结果:11例患者参加,留置率100%。眶下HA容量维持在30天为70% ~ 81%,90天为50% ~ 70%。与预处理严重程度无关,FACE-Q结果的眼睛、整体面部外观和颧骨均有显著改善(P < 0.05)。在尸体检查中,我们观察到不同类型的凝胶在juv和Restylane产品所占据的解剖位置以及物理操作后的行为上的差异。结论:Volbella XC在90天的时间内有效地增加了眼下体积,减少了眶下空洞,并显著改善了PROs。加强对Volbella XC和其他HA填充物在这一敏感解剖区域的行为的了解将改善患者的预后。证据等级4:治疗性:
{"title":"Multimodal Pilot Evaluation of a Hyaluronic Acid Infraorbital Filler Using Precise, Multipositional, 3-Dimensional Imaging Quantification, Patient-Reported Outcomes, and Anatomic Cadaveric Assessments.","authors":"Stephanie E Honig, Yoshiko Toyoda, Jane N Ewing, Mehdi S Lemdani, Zachary Gala, Chris Amro, Alexander T Wilson, Robyn B Broach, Ivona Percec","doi":"10.1093/asjof/ojae086","DOIUrl":"10.1093/asjof/ojae086","url":null,"abstract":"<p><strong>Background: </strong>Despite the high demand of filler in the infraorbital area, there remains debate on injection practices, precise anatomical placement, and hyaluronic acid (HA) filler behavior.</p><p><strong>Objectives: </strong>We aimed to contribute to the clinical and anatomic understanding of infraorbital HA injection through a prospective patient injection study in combination with a cadaveric analysis.</p><p><strong>Methods: </strong>Patients were injected with Volbella XC (JUVÉDERM, Allergan Aesthetics, an AbbVie Company, Irvine, CA) into the tear trough region by a single experienced aesthetic plastic surgeon. Over a 90-day period, precise undereye volumetric measurements using 3-dimensional photogrammetry (VECTRA-M3, Canfield Scientific, Inc., Fairfield, NJ) and patient-reported outcomes (PROs; FACE-Q) were collected and analyzed relative to 2 pretreatment severity scales. Juvéderm Vycross (Allergan Aesthetics, an AbbVie Company, Irvine, CA) and Restylane NASHA (Galderma, Lausanne, Switzerland) products were injected into the infraorbital and malar region in 6 cephalus specimens and evaluated with regards to the anatomic injection location with and without common clinical physical manipulations.</p><p><strong>Results: </strong>Eleven patients participated with a 100% retention rate. Infraorbital HA volume maintenance was 70% to 81% at 30 days and 50% to 70% at 90 days. Significant improvement was noted in the eyes, overall facial appearance, and cheekbones (<i>P</i> < .05) with FACE-Q outcomes, irrespective of pretreatment severity. In the cadaver examination, we observed differences in the anatomic locations occupied by Juvéderm and Restylane products as well as in behavior after physical manipulation between gel types.</p><p><strong>Conclusions: </strong>Volbella XC effectively augments undereye volume to diminish infraorbital hollowing as measured over a 90-day period with significantly improved PROs. Enhanced knowledge of the behavior of Volbella XC and other HA fillers in this sensitive anatomic region will lead to improved patient outcomes.</p><p><strong>Level of evidence 4 therapeutic: </strong></p>","PeriodicalId":72118,"journal":{"name":"Aesthetic surgery journal. Open forum","volume":"6 ","pages":"ojae086"},"PeriodicalIF":0.0,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142820302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Energy-Based Medical Devices in Plastic Surgery: A Comparison of FDA-Approved Indications to Advertised Claims. 整形外科中的能量型医疗设备:FDA 批准的适应症与广告宣称的比较。
Pub Date : 2024-10-01 eCollection Date: 2024-01-01 DOI: 10.1093/asjof/ojae083
Diego A Gomez, Isra Abdulwadood, Aaron Bogan, Bryn E Morris, Jeffrey M Kenkel, Robert W Bernard, Edward M Reece

Background: Lasers and energy-based devices are commonly employed in aesthetic medicine. In the United States, the FDA regulates lasers as medical devices, restricting marketing to approved indications and making off-label claims illegal. Despite this, no comprehensive analysis of off-label marketing prevalence exists.

Objectives: The authors of this study aim to compare the FDA-approved indications for 2 popular aesthetic lasers to their online advertising claims. Additionally, they seek to educate aesthetic providers on the current regulatory restrictions surrounding off-label advertising.

Methods: FDA-approved indications for 2 lasers-helium plasma dermal resurfacing and 2940 nm fractional erbium-doped yttrium aluminum garnet-were obtained from the publicly available Establishment Registration & Device Listings Database. Online advertisements regarding the capabilities of each laser were collected from practice websites in the United States.

Results: Our analysis of 100 online claims for each laser revealed that more than half of the websites advertising helium plasma (n = 59) and 44 websites advertising fractional lasers made at least 1 off-label claim. Both plastic surgeons and nonplastic surgeons made at least 1 off-label claim, with no statistically significant difference between the groups.

Conclusions: Despite FDA regulation of medical devices, online advertising regarding the indications and capabilities of popular medical lasers varies widely. Patients who seek information regarding aesthetic laser treatments may encounter inaccurate and differing claims for these treatments, potentially leading to false expectations and poor patient outcomes.

Level of evidence 4 risk:

背景:激光和以能量为基础的设备通常用于美容医学。在美国,FDA 将激光作为医疗设备进行监管,限制在批准的适应症范围内进行营销,并规定标示外声明为非法。尽管如此,目前还没有对标示外营销的普遍性进行全面分析:本研究的作者旨在比较美国食品及药物管理局批准的两种常用美容激光器的适应症与它们的网络广告宣称。此外,他们还试图让美容服务提供者了解目前有关标示外广告的监管限制:方法:从公开的 "机构注册与设备列表数据库"(Establishment Registration & Device Listings Database)中获取了美国食品与药物管理局(FDA)批准的两种激光器的适应症--氦等离子体真皮换肤和2940纳米点阵掺铒钇铝石榴石。我们还从美国的医疗网站上收集了有关每种激光功能的在线广告:我们对每种激光器的 100 项在线声明进行了分析,结果显示,半数以上的氦等离子广告网站(59 家)和 44 家点阵激光器广告网站至少做出了一项标签外声明。整形外科医生和非整形外科医生都至少做了一次标签外声明,两组之间的差异没有统计学意义:结论:尽管美国食品及药物管理局对医疗器械进行监管,但有关常用医用激光的适应症和功能的在线广告却大相径庭。寻求有关激光美容治疗信息的患者可能会遇到对这些治疗的不准确和不同的说法,从而可能导致错误的期望和不良的治疗效果:
{"title":"Energy-Based Medical Devices in Plastic Surgery: A Comparison of FDA-Approved Indications to Advertised Claims.","authors":"Diego A Gomez, Isra Abdulwadood, Aaron Bogan, Bryn E Morris, Jeffrey M Kenkel, Robert W Bernard, Edward M Reece","doi":"10.1093/asjof/ojae083","DOIUrl":"https://doi.org/10.1093/asjof/ojae083","url":null,"abstract":"<p><strong>Background: </strong>Lasers and energy-based devices are commonly employed in aesthetic medicine. In the United States, the FDA regulates lasers as medical devices, restricting marketing to approved indications and making off-label claims illegal. Despite this, no comprehensive analysis of off-label marketing prevalence exists.</p><p><strong>Objectives: </strong>The authors of this study aim to compare the FDA-approved indications for 2 popular aesthetic lasers to their online advertising claims. Additionally, they seek to educate aesthetic providers on the current regulatory restrictions surrounding off-label advertising.</p><p><strong>Methods: </strong>FDA-approved indications for 2 lasers-helium plasma dermal resurfacing and 2940 nm fractional erbium-doped yttrium aluminum garnet-were obtained from the publicly available Establishment Registration & Device Listings Database. Online advertisements regarding the capabilities of each laser were collected from practice websites in the United States.</p><p><strong>Results: </strong>Our analysis of 100 online claims for each laser revealed that more than half of the websites advertising helium plasma (<i>n</i> = 59) and 44 websites advertising fractional lasers made at least 1 off-label claim. Both plastic surgeons and nonplastic surgeons made at least 1 off-label claim, with no statistically significant difference between the groups.</p><p><strong>Conclusions: </strong>Despite FDA regulation of medical devices, online advertising regarding the indications and capabilities of popular medical lasers varies widely. Patients who seek information regarding aesthetic laser treatments may encounter inaccurate and differing claims for these treatments, potentially leading to false expectations and poor patient outcomes.</p><p><strong>Level of evidence 4 risk: </strong></p>","PeriodicalId":72118,"journal":{"name":"Aesthetic surgery journal. Open forum","volume":"6 ","pages":"ojae083"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11546647/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142633503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Aesthetic surgery journal. Open forum
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