Treatment of Soft Tissue Filler Complications: Expert Consensus Recommendations.

BACKGROUND: Dermal fillers have been increasingly used in minimally invasive facial esthetic procedures. This widespread use has led to a rise in reports of associated complications. The aim of this expert consensus report is to describe potential adverse events associated with dermal fillers and to provide guidance on their treatment and avoidance. METHODS: A multidisciplinary group of experts in esthetic treatments convened to discuss the management of the complications associated with dermal fillers use. A search was performed for English, French, and Spanish language articles in MEDLINE, the Cochrane Database, and Google Scholar using the search terms "complications" OR "soft filler complications" OR "injectable complications" AND "dermal fillers" AND "Therapy". An initial document was drafted by the Coordinating Committee, and it was reviewed and modified by the experts, until a final text was agreed upon and validated. RESULTS: The panel addressed consensus recommendations about the classification of filler complications according to the time of onset and about the clinical management of different complications including bruising, swelling, edema, infections, lumps and bumps, skin discoloration, and biofilm formation. Special attention was paid to vascular compromise and retinal artery occlusion. CONCLUSIONS: Clinicians should be fully aware of the signs and symptoms related to complications and be prepared to confidently treat them. Establishing action protocols for emergencies, with agents readily available in the office, would reduce the severity of adverse outcomes associated with injection of hyaluronic acid fillers in the cosmetic setting. This document seeks to lay down a set of recommendations and to identify key issues that may be useful for clinicians who are starting to use dermal fillers. Additionally, this document provides a better understanding about the diagnoses and management of complications if they do occur. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Preventing the Complications Associated with the Use of Dermal Fillers in Facial Aesthetic Procedures: An Expert Group Consensus Report.

BACKGROUND: The use of dermal fillers in minimally invasive facial aesthetic procedures has become increasingly popular of late, yet as the indications and the number of procedures performed increase, the number of complications is also likely to increase. Paying special attention to specific patient characteristics and to the technique used can do much to avoid these complications. Indeed, a well-trained physician can also minimize the impact of such problems when they do occur. METHODS: A multidisciplinary group of experts in aesthetic treatments reviewed the main factors associated with the complications that arise when using dermal fillers. A search of English, French and Spanish language articles in PubMed was performed using the terms "complications" OR "soft filler complications" OR "injectable complications" AND "dermal fillers". An initial document was drafted that reflected the complications identified and recommendations as to how they should be handled. This document was then reviewed and modified by the expert panel, until a final text was agreed upon and validated. RESULTS: The panel addressed consensus recommendations about the preparation, the procedure and the post-procedural care. The panel considered it crucial to obtain an accurate medical history to prevent potential complications. An additional clinical assessment, including standardized photography, is also crucial to evaluate the outcomes and prevent potential complications. Furthermore, the state of the operating theatre, the patient's health status and the preparation of the skin are critical to prevent superficial soft tissue infections. Finally, selecting the appropriate technique, based on the physician's experience, as well as the characteristics of the patient and filler, helps to ensure successful outcomes and limits the complications. CONCLUSIONS: This consensus document provides key elements to help clinicians who are starting to use dermal fillers to employ standard procedures and to understand how best to prevent potential complications of the treatment. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A Prospective, Open-Label, Multicenter, Real-World Study of VYC-17.5L Hyaluronic Acid Dermal Filler in the Lips.

Background: Hyaluronic acid (HA) injectable gels are used to define, enhance, and volumize facial regions, such as the lips, a common treatment area. Objectives: To evaluate the effectiveness and safety of the HA injectable gel Juvéderm Volift (Allergan, Aesthetics, an AbbVie Company Irvine, CA) with Lidocaine (VYC-17.5L) for lip augmentation in real-world clinical practice. Methods: This prospective, open-label, multicenter study initially designed for 6 months, then extended to 12 months, enrolled adults with an overall grade of minimal to moderate on the Lip Fullness Scale 2 (LFS2). Optional touch-up and repeat treatments occurred at day 14 and month 12, respectively. The primary endpoint was a ≥1-point improvement on the LFS2 at day 30. Other endpoints included improvements on the FACE-Q Satisfaction with Lips questionnaire, Global Aesthetic Improvement Scale (GAIS), subject assessment of natural look/feel of lips, and investigator assessment of dynamic lip lines upon animation. Injection site reactions (ISRs) and adverse events (AEs) were recorded. Results: Of 60 subjects enrolled (mean age, 36.8 years; 98.3% female), 59 were evaluable for efficacy at day 30; 13 (21.4%) received touch-up treatment. Thirty-six of 40 subjects completed the extension study (month 12). LFS2 responder rates were 93.2% at day 30 (primary endpoint) and 39.0% at month 12. Mean scores on the FACE-Q questionnaire improved from baseline by 45.2 points and 23.6 points at day 30 and month 12, respectively. Most subjects showed improvements on the GAIS. The majority of ISRs were mild/moderate; no serious AEs occurred. Conclusions: VYC-17.5L was effective and well tolerated for lip augmentation through 12 months posttreatment.

Mucosa-associated lymphoid tissue lymphoma in the terminal ileum: A case report.

BACKGROUND: The lymphoma of the mucosa-associated lymphoid tissue (MALT) is predominantly found in the stomach. The few cases reported in the literature of MALT lymphomas affecting the ileum are in patients who are already symptomatic and with clear advanced endoscopic findings. We present the first case of an asymptomatic female patient who underwent colonoscopy as a routine examination with the findings of an ulcer in the distal ileum region, which histopathological examination and associated immunohistochemistry revealed the diagnosis of MALT lymphoma. CASE SUMMARY: A 57-year-old asymptomatic female patient underwent a colonoscopy exam for screening. The examination revealed an ulcer of medium depth with well-defined borders covered by a thin layer of fibrin and a halo of hyperemia in the distal ileum portion. Findings are nonspecific but may signal infections by viruses, protozoa, and parasites or inflammatory diseases such as Crohn's disease. Biopsies of the ulcer were taken. The anatomopathological result revealed an atypical diffuse lymphocytic infiltrate of small cells with a characteristic cytoplasmic halo of marginal zone cells. The immunohistochemical study was performed and the results demonstrated a negative neoplastic infiltrate for the expression of cyclin D1 and cytokeratin AE1/AE3 and a positive for BCL60 in the germinal center. The test also revealed CD10 positivity in the glandular epithelium and germinal center of a reactive follicle with dual-labeling of CD20 and CD3 demonstrating the B lymphocyte nature of the neoplastic infiltrate. In BCL2 protein labeling, the neoplastic infiltrate is strongly positive with a negative germinal center. The findings are consistent with immunophenotype B non-Hodgkin's lymphoma, better classified as extranodal MALT. The patient was treated with chemotherapy and showed complete regression of the disease, as evidenced by colonoscopy performed after treatment. CONCLUSION: MALT lymphomas in the terminal ileum are extremely rare and only 4 cases have been reported in the literature. Given the low sensitivity and specificity of endoscopic images in these cases, the pathology can be confused with other important differential diagnoses such as inflammatory diseases or infectious diseases and which makes the biopsy important, even in asymptomatic patients, paired with anatomopathological analysis and immunohistochemistry which is the gold standard for correct diagnosis.

An expert consensus report on the clinical use of the Vycross® hyaluronic acid VYC-25 L filler.

BACKGROUND: The portfolio of hyaluronic acid (HA) fillers and the techniques of administration have evolved in recent years. The latest innovation in the Vycross® range was the introduction of VYC-25L (Juvéderm Volux® ; Allergan plc), a first-in-class filler effective for chin and facial lower third remodeling. The aim here was to provide clinicians who are starting to use VYC-25L with key advice, and to standardize procedures so that optimal and predictable outcomes can be obtained. METHODS: A multidisciplinary group of experts in esthetic medicine from Spain and Portugal reviewed the properties, treatment paradigms, administration techniques, and potential complications of VYC-25L, on the basis of which they drafted consensus recommendations for its clinical use. RESULTS: The consensus panel provided specific recommendations focusing on the patient profile, dose, administration techniques, and the complications of VYC-25L and their management. The panel identified five different profiles of patients who may benefit from VYC-25L, and they drafted recommendations aimed to facilitate the treatment of these patients, namely, microgenia (women/men), masculinization (men), rejuvenation (women/men), facial laxity (women/men), and submental convexity (women/men). In terms of their safety, no specific recommendations were made beyond those established for other HA fillers. CONCLUSIONS: The evolution of esthetic medicine makes it necessary to update the clinical recommendations that guide patient assessment and treatment with the new HA fillers developed. The current consensus document addresses relevant issues related to the use of VYC-25L on different types of patient, in an attempt to standardize procedures and help specialists obtain predictable results.

Expert Consensus on Injection Technique and Area-Specific Recommendations for the Hyaluronic Acid Dermal Filler VYC-12L to Treat Fine Cutaneous Lines.

BACKGROUND: VYC-12L is a hyaluronic acid (HA) injectable gel designed to treat fine cutaneous lines and improve skin quality attributes such as hydration and elasticity. OBJECTIVE: Expert consensus was sought on VYC-12L injection technique and primary treatment target areas. METHODS: A multinational group of aesthetic medicine clinicians (n = 128) attended product training and each identified ~10 patients for VYC-12L. After treating their first and last patients, the clinicians completed a survey on preferred injection methodology/technique, including injection angle, volume, and spacing. An expert panel (n = 12) discussed survey results and their clinical experiences to obtain consensus on VYC-12L technique and appropriate treatment areas. RESULTS: Recommendations included micro-depot injections of VYC-12L into the deep dermis with a 32G ½ inch needle inserted at <45º to the skin, spaced 0.5‒1.0 cm apart, with 0.01‒0.05 mL volume per injection (full-face total volume: ~2 mL). Recommended primary treatment areas were the malar, perioral, neck, and décolletage regions. Injection techniques for different treatment areas/demographic characteristics were similar, with some variability in treatment approach. Patient selection criteria, pre- and post-treatment guidelines, and managing patient expectations are important components of treatment. CONCLUSION: These consensus recommendations may assist clinicians in optimizing the treatment of fine lines with VYC-12L.

Cross-cultural adaptation of the Brazilian-Portuguese version of the Cumberland Ankle Instability Tool (CAIT).

PURPOSE: To develop and psychometrically test a Brazilian-Portuguese version of the Cumberland Ankle Instability Tool (CAIT), the only questionnaire that provides a numeric measure for functional ankle instability. METHODS: The CAIT was translated and adapted into Brazilian-Portuguese according to the Guidelines for the process of cross-cultural adaptation of self report measures. The Brazilian-Portuguese version of the CAIT was tested for internal consistency, test-retest reliability, ceiling and floor effects and responsiveness in 131 participants. Participants were recruited from the general community in Brazil (N = 101, community group) and from those seeking treatment for an ankle sprain from 2 clinics in Brazil (N = 30, treatment group). RESULTS: The Brazilian-Portuguese version of the CAIT had high internal consistency (Cronbach alpha = 0.86 for right ankles and 0.88 for left ankles), reliability (ICC = 0.95, 95% CI 0.93-0.97); and good responsiveness (ES = 0.75, 95% CI 0.49-1.00). No ceiling or floor effects were observed. CONCLUSIONS: The Brazilian-Portuguese version of the CAIT is as reliable as the English version of the questionnaire, has high internal consistency and good responsiveness. It thus provides the first tool that can be used to assess functional ankle instability by clinicians and researchers working among Brazilian-Portuguese speakers.

Dentes natais e neonatais: revisão integrativa / Natal and neonatal teeth: integrative review

Embora a dentição primária comece a se formar intra-útero, a maioria das crianças não apresenta dentes erupcionados ao nascimento. A avaliação do melhor tratamento é de extrema importância, porque podem evoluir com complicações afetando o crescimento e desenvolvimento do recém-nascido. Esse trabalho objetivou estudar a ocorrência de dentes natais e neonatais, suas complicações e condutas adequadas. Foi utilizada uma metodologia Integrativa, onde os artigos foram oriundos do sistema EndNoteX5, acessando-se o PubMed, além do SciELO, LILACS e outros sistema eletrônicos. Na maior parte dos estudos, a prevalência de dentes natais e neonatais variou entre 1:1000 e 1:30.000 nascidos vivos. A etiologia é desconhecida, tendo fatores genéticos e endócrinos associados. Em mais de 90% dos casos, esses dentes representam uma dentição normal, mas histologicamente, a maioria dos dentes natais possui esmalte displásico ou hipomineralizado, dentina irregular, osteodentina nas porções cervicais e dentina interglobular na porção coronal. Uma complicação importante é a doença ou síndrome de Riga-Fede, uma ulceração na superfície ventral da língua causada pela borda incisal afiada do dente, tendo sempre como a primeira opção um tratamento conservador. Deve ser sempre considerado se o dente é supernumerário ou não, pois os supernumerários devem sempre ser extraídos. Concluindo, embora não seja uma ocorrência comum, a presença de dentes natais e neonatais pode interferir de maneira significativa na vida do recém-nascido, gerando sofrimento para as famílias. Os dentistas devem estar aptos a tomar a melhor decisão indicando, na maioria das vezes, primeiro o tratamento conservador da doença de Riga-Fede, na expectativa de preservar a dentição.

Although primary dentition begins to form in utero, most children do not have erupted teeth at birth. The evaluation of the best treatment is extremely important, because they can evolve with complications affecting the growth and development of the newborn. This work aimed to study the occurrence of natal and neonatal teeth, their complications and appropriate conducts. It was a non-systematic review work, where an Integrative methodology was used. The articles came from the EndNoteX5 system (4.5), accessing PubMed, in addition to SciELO, LILACS and other electronic systems. In most studies, the prevalence of natal and neonatal teeth ranged between 1: 1000 and 1: 30,000 live births. The etiology is unknown, with genetic and endocrine factors associated. In more than 90% of cases, these teeth represent normal dentition, but histologically, most native teeth have dysplastic or hypomineralized enamel, irregular dentin, osteodentin in the cervical portions and interglobular dentin in the coronal portion. An important complication is Riga-Fede's disease or syndrome, an ulceration on the ventral surface of the tongue caused by the sharp incisal edge of the tooth, with conservative treatment as the first option. It must always be considered whether the tooth is supernumerary or not, as supernumeraries must always be extracted. In conclusion, although it is not a common occurrence, the presence of natal and neonatal teeth can significantly interfere in the newborn's life, causing suffering for families. Dentists must be able to make the best decision, indicating, in most cases, first the conservative treatment of Riga-Fede disease, in the hope of preserving the dentition.

A five-patient prospective pilot study of a polycaprolactone based dermal filler for hand rejuvenation.

BACKGROUND: Hand rejuvenation is becoming more popular as a complementary procedure to facial treatments. Current options include the relatively invasive lipofilling and the less invasive dermal fillers treatments, of which the latter often is too short lasting. An ideal product would therefore be minimally invasive, however, providing longer lasting results. OBJECTIVES: The objective of this pilot study is to evaluate the safety and efficacy of a polycaprolactone based dermal filler for hand rejuvenation. METHODS: The dorsum of the hands of five subjects was treated with 1.0 mL polycaprolactone based dermal filler per hand. Subjects were seen for follow-up visits after 1, 4, 16, and 24 weeks. RESULTS: The results showed consistent and high patient satisfaction throughout the duration of the study using a Visual Analog Scale. Satisfaction was rated at 82% at 24 weeks and patients were 88% likely to return for repeat treatments on average. On the subject GAIS assessment, all subjects reported an improvement compared to pretreatment throughout the duration of the study. The physicians' GAIS results were very much improved (90%) and much improved (10%) compared to pretreatment throughout the 24 weeks follow-up. CONCLUSIONS: The data of this small pilot suggest that the polycaprolactone based dermal filler is safe, well tolerated and effective for hand rejuvenation, and potentially offers a valuable addition to the current treatment armamentum. Additional studies in a larger patient population should be performed to confirm these findings.

Current transport mechanism at metal-semiconductor nanoscale interfaces based on ultrahigh density arrays of p-type NiO nano-pillars.

The present work focuses on a qualitative analysis of localised I-V characteristics based on the nanostructure morphology of highly dense arrays of p-type NiO nano-pillars (NiO-NPs). Vertically aligned NiO-NPs have been grown on different substrates by using a glancing angle deposition (GLAD) technique. The preferred orientation of as grown NiO-NPs was controlled by the deposition pressure. The NiO-NPs displayed a polar surface with a microscopic dipole moment along the (111) plane (Tasker's type III). Consequently, the crystal plane dependent surface electron accumulation layer and the lattice disorder at the grain boundary interface showed a non-uniform current distribution throughout the sample surface, demonstrated by a conducting AFM technique (c-AFM). The variation in I-V for different points in a single current distribution grain (CD-grain) has been attributed to the variation of Schottky barrier height (SBH) at the metal-semiconductor (M-S) interface. Furthermore, we observed that the strain produced during the NiO-NPs growth can modulate the SBH. Inbound strain acts as an external field to influence the local electric field at the M-S interface causing a variation in SBH with the NPs orientation. This paper shows that vertical arrays of NiO-NPs are potential candidates for nanoscale devices because they have a great impact on the local current transport mechanism due to its nanostructure morphology.

The overload at work and outside of work: the case of woman operators of blistering.

The internationalization of labor is a prominent feature of the economy today, but is accompanied by adverse effects on operator health. In general, musculoskeletal diseases are the first to appear in this context. The open observations activity and interviews with operators and the hierarchy have been made to discover the organizational constraints. Other interviews were also conducted to account for the determinants of activity outside of work. The use of video has allowed the registration of work cycles, which helped to describe and quantify the postures and gestures to establish a possible link between musculoskeletal diseases and work activity. The collected data were processed using software Actogram Kronos. To understand the process of origin of these diseases, the analysis of the socioeconomic context is also essential because they in part determine the organization of certain companies. The objective of this paper was to discuss the activities of operators of blistering in both work and outside work. The goal is to determine the constraints presents in these two spheres of activity, that may increase the risk of developing musculoskeletal diseases and to define their interaction.

Estudo da confiabilidade intra e entre-examinadores da unidade de biofeedback pressórico na medida da contração do músculo transverso abdominal / Reliability analysis of the pressure biofeedback unit in the contraction of transversus abdominis muscle

A proposta do presente estudo foi investigar a confiabilidade intra e entreexaminadores da Unidade de Biofeedback Pressórico (StabilizerÒ) na contração do músculo Transverso Abdominal em indivíduos assintomáticos. Foi realizado um estudo “teste-reteste” em trinta e um estudantes de fisioterapia com um intervalo de sete dias entre as coletas de dados. Os resultados indicaram uma confiabilidade moderada intraexaminador (ICC = 0,71) e substancial entre-examinadores (ICC = 0,82). Concluiu-se que a utilização da Unidade de Biofeedback Pressórico deve ser incentivada na prática clínica, devido à sua relevância, simplicidade e segurança clínica, porém, maior número de estudos de confiabilidade, principalmente entre-examinadores, devem ser realizados.

The objective of this study was investigating the intra and inter tester reliability of the Pressure Biofeedback Unit (StabilizerÒ) on the contraction of the Transversus Abdominis muscle in non-symptomatic subjects. A test-retest design was done with seven-day interval between them in 31 physiotherapy students. The results showed a moderate intra-tester reliability (ICC = 0,71) and substantial inter-tester reliability (ICC = 0,82). It can be concluded that the Pressure Biofeedback Unit should be used clinically due to its relevance and safety using, however, more reliability studies should be done to check its results.