A Structured Approach for Treating Calcium Hydroxylapatite Focal Accumulations.

BACKGROUND: Radiesse, a widely used calcium hydroxylapatite (CaHA) dermal filler, has shown effectiveness in soft tissue augmentation and regeneration. As with all dermal fillers, the potential for nodules may arise. Understanding the pathogenesis of these nodules and exploring effective treatment methodologies are crucial for optimizing patient outcomes. OBJECTIVES: A literature search was carried out to identify published literature documenting reversal of CaHA nodules. After identification, a consensus panel developed a structured approach, denoted by levels, for applying such reversal methods. METHODS: This concise review presents an algorithmic approach to addressing CaHA focal accumulations (non-inflammatory nodules) based on invasiveness, cost, and potential risks based on published literature. RESULTS: Level 0 involves no intervention, relying on natural degradation for asymptomatic nodules. Level 1 interventions utilize mechanical dispersion techniques, including massage and in situ dispersion, which have demonstrated high success rates, cost-effectiveness, and minimal invasiveness. Level 2 introduces alternative modalities such as pharmacological treatments with 5-fluorouracil and corticosteroids, lasers, and experimental approaches. Level 3 represents last-resort options, including calcium chelating agents, manual removal, and surgical excision. CONCLUSIONS: The article offers a structured approach to manage CaHA focal accumulations.

The Dutch Hyacorp® filler catastrophe: new EU legislation will prevent this from happening again

Background: In 2014, the hyaluronic acid-based fillers, Hyacorp-1000 and Hyacorp H-S (H-800), were withdrawn from the Dutch market after concerns about their safety Objectives: To determine the most plausible factors for the increased number of adverse events, either patient-related factors or those inherent to the filler itself. We also assessed how new European legislation will affect the approval process for new fillers and improve related safety issues Materials & Methods: A total of 42 patients­37 women (88%) and five men (11%)­were included. Patients were separated into three groups: 13 patients injected with Hyacorp-1000 and Hyacorp H-S (H-800) who had reported inflammatory adverse events; 12 injected with Hyacorp-1000 and Hyacorp H-S (H-800) who had not reported inflammatory adverse events; and 17 injected with other HA fillers who had reported inflammatory adverse events Results: Patients treated with Hyacorp-1000 and Hyacorp-S (H-800) who reported adverse events were significantly older than those in the Hyacorp-1000 and Hyacorp-S (H-800) group without adverse events, and the filler remained in situ for significantly longer than in patients who had adverse events related to another HA filler Conclusion: Hyacorp-1000 and Hyacorp-S (H-800) filler is associated with an increased chance of developing adverse events compared to other HA fillers, probably because it remains in the body for a longer period of time. The upcoming legislative EU update of the Medical Device Regulation (MDR) will prevent unsafe filler from entering the EU market and will enable issues related to safety to be identified much earlier

Creating Lift in the Lower Face With Botulinum Toxin A Treatment: An Anatomical Overview With Videos and Case Studies Illustrating Patient Evaluation and Treatment.

Background: Relaxation of depressor muscles in the lower face with botulinum toxin A (BoNT-A) can create a lifting effect and dramatically improve jawline contour and resting facial expression. Even with the recent increase in interest in lower face rejuvenation, BoNT-A is a relatively under-recognized tool for treatment of this area. When treating the lower face, an understanding of anatomy and the relationship between the facial muscles is especially important, as injection patterns must be customized for consistently positive outcomes. Objectives: This study was aimed to provide basic knowledge of the activities of the muscles in the lower face and neck and to describe the basis for injecting BoNT-A to create lift in this area. Expert guidance for injection is also provided. Methods: As part of a continuing medical education course on differentiating botulinum toxin products, a panel of 4 expert physician injectors participated in a live webinar to discuss the implications of increasing toxin use. Results: The practical guidance in this manuscript is based on the most frequently requested information by audience members and the information considered critical for success by the authors. The authors outline the functional anatomy of the lower face most relevant for BoNT-A treatment and case studies as well as methods for patient evaluation and injection technique are also provided. Videos showing treatment planning and injection technique for the lower face and neck are included. Conclusions: BoNT-A is an important nonsurgical tool for creating lift in the lower face.

A split-face comparative performance evaluation of injectable hyaluronic acid-based preparations HCC and CPM-HA20G in healthy females.

INTRODUCTION: Skin revitalizers are used for skin quality improvement purposes. Hyaluronan hybrid cooperative complexes (HCC, Profhilo®, IBSA Pharmaceuticals) are an anti-aging treatment with a large amount of pure hyaluronic acid (HA) based on stable, cooperative, and hybrid complexes. Cohesive polydensified matrix Hyaluronic Acid (CPM-HA20, Belotero Revive®, Merz Pharmaceuticals GmbH) is a slightly cross-linked HA (20 mg/ml) with glycerol (17.5 mg/ml). AIMS: To evaluate the performance of HCC and CPM-HA20G for skin quality improvement in healthy female subjects. METHODS: This was a split-face, single-blinded study that enrolled 24 healthy female subjects. Injections were given on three separate occasions. HCC was injected on the right cheek, while CPM-HA20G was injected on the left cheek. A battery of skin property measurements was used to evaluate the skin. Skin properties and overall satisfaction were analyzed using mixed models with the values at baseline, at week 1, week 8, and week 14 as an outcome and a random effect of subject and fixed effects of treatment, visit, and the treatment by visit interaction. RESULTS: Both products showed evidence of effect relative to baseline on surface hydration (AU), elasticity (N/m) TEWL (g/m2 h), and melanin (AU). CPM-HA20G also showed significant evidence of effect relative to baseline on water content (%), and HCC on pore count (n) and hemoglobin (AU). Satisfaction reported by the subjects themselves showed positive trends of satisfaction over time for multiple skin properties. There were no significant differences between the tested products in the observed skin characteristics over time. CONCLUSION: These devices are effective and safe treatments for skin quality improvement, especially moisturization, with high patient satisfaction and generally mild and transient side effects.

Evaluating the Effect of Incobotulinumtoxin A for Glabellar, Forehead, and Crow's Feet Lines Using A High Dilution.

BACKGROUND: As aesthetic preferences have evolved and patients wish their muscles to be relaxed, but not frozen, a higher dilution of incobotulinumtoxinA (INCO) has allowed for increased spread using fewer units, yet no studies to date have investigated the efficacy, longevity, and safety of hyperdiluted INCO. OBJECTIVE: We evaluated the effect of incobotulinumtoxinA (INCO) in glabellar, forehead, and lateral periorbital lines using a high dilution. METHODS: Subjects with moderate-to-severe upper facial lines at rest according to the Merz Aesthetics Scales™ (Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) received 15U of INCO to the glabellar (n=4 injection sites), 10U to the rest of the forehead (n=10 injection sites), and 5U to the lateral periorbital lines (n=3 injection sites/eye). Primary outcomes were physician- and subject-rated improvement at one month using the Global Aesthetic Improvement Scale (GAIS) and changes in line severity using the Merz Aesthetics Scales™. RESULTS: The study included 15 women aged 35 to 65 years. At one month, physician GAIS scores indicated 91.2% of subjects were very much improved and 8.8% were much improved; 91.5%, 78.0%, and 57.6% of participants remained at least improved at four, five, and six months, respectively. Subject GAIS scores at one month were in agreement with physician scores. At one month, an improvement of at least one point in Merz Aesthetics Scales™ scores in glabellar, forehead, and lateral periorbital lines was reported in 88.9%, 98.3%, and 94.8% of participants, respectively. Subject satisfaction was high throughout the study. No treatment-related adverse events were observed. CONCLUSION: Hyperdilute INCO was effective at improving overall appearance and reducing line severity in individuals with moderate-to-severe upper facial lines. Patient satisfaction was maintained up to six months and treatment was well tolerated.

Consensus on the Use of Hyaluronic Acid Fillers from the Cohesive Polydensified Matrix Range: Best Practice in Specific Facial Indications.

BACKGROUND: As the treatment indications for the Cohesive Polydensified Matrix® hyaluronic acid (CPM-HA) portfolio continue to expand and diversify, injectors new to the range or those who are expanding the treatments they offer may be unsure of the optimal product and injection technique for specific facial areas. Each product in the CPM-HA portfolio has been intentionally designed to provide the best physical properties for a specific indication and target tissue. This document has been developed to provide a comprehensive, one-stop reference for clinicians using the portfolio. METHODS: An international panel of experts in the field of aesthetic medicine convened to develop guidelines on effective and safe injection technique when performing treatments with the CPM-HA range of soft-tissue fillers. RESULTS: Consensus members considered treatment indications in the upper, middle and lower face. Landmark deficiencies and anatomical considerations are described for each indication and consensus recommendations provided on the optimal product, injection depth and treatment technique. This is supplemented by the experts advice on avoidance of complications. Throughout, an evidence-based approach to selection of products and injection techniques is provided. The result is a fully tailored approach to a range of indications covering the full portfolio of CPM-HA products, including the newest addition for skin revitalization. CONCLUSION: The recommendations in this consensus document are provided to assist clinicians in the selection of CPM-HA products, administration techniques and depths of injection with the aim of providing seamless and natural treatment results, enhanced safety and patient satisfaction.

Delayed Inflammatory Reactions to Hyaluronic Acid Fillers: A Literature Review and Proposed Treatment Algorithm.

BACKGROUND AND OBJECTIVES: There is a wide diversity of opinions regarding the management of delayed inflammatory reactions (DIRs) secondary to hyaluronic acid (HA)-based fillers. The plethora of approaches has led the authors to conduct a review regarding management and treatment of DIRs as well as establish therapeutic guidelines for this purpose. MATERIALS AND METHODS: A review of the literature was performed through databases such as PubMed using keywords including HA-fillers and complications, delayed HA filler sequelae and therapy, soft tissue and dermal filler reactions and management. Additionally, a survey comprised of questions regarding the management and treatment of DIRs was sent to 18 physicians highly experienced with soft-tissue filler injections in 10 countries. Their answers and recommendations were analyzed and debated amongst these panelists. RESULTS: Sixteen panelists favored antibiotic therapy as first-line treatment for DIRs, specifically dual antibiotic therapy consisting of a fluoroquinolone along with a tetracycline or macrolide for a period of 3-6 weeks. The majority refrained from the use of intralesional (IL) or systemic steroids except in the case of disfiguring or recalcitrant reactions. IL hyaluronidase was recommended by 13 panelists; however, some preferred a watchful waiting approach for a period of 48 hours to 2 weeks prior to IL hyaluronidase, and in cases where antibiotics did not lead to improvement. CONCLUSION: A consensus was reached and summarized to propose a clear, easy-to-follow, stepwise algorithm for the treatment of DIRs.

Managing intravascular complications following treatment with calcium hydroxylapatite: An expert consensus.

BACKGROUND: Inadvertent intra-arterial injection of dermal fillers including calcium hydroxylapatite (CaHA) can result in serious adverse events including soft tissue necrosis, permanent scarring, visual impairment, and blindness. When intra-arterial injection occurs, immediate action is required for optimal outcomes, but the infrequency of this event means that many physicians may never have experienced this scenario. The aim of this document is to provide evidence-based and expert opinion recommendations for the recognition and management of vascular compromise following inadvertent injection of CaHA. METHODS: An international group of experts with experience in injection of CaHA and management of vascular complications was convened to develop a consensus on the optimal management of vascular compromise following intra-arterial CaHA injection. The consensus members were asked to provide preventative advice for the avoidance of intravascular injection and to produce a treatment protocol for acute and delayed presentation. To ensure all relevant treatment options were included, the recommendations were supplemented with a PubMed search of the literature. RESULTS: For prevention of intra-arterial CaHA injection, consensus members outlined the importance of a thorough knowledge of facial vascular anatomy and patient history, as well as highlighting potential risk zones and optimal injection techniques. Individual sections document how to recognize the symptoms of vascular occlusion leading to vision loss and tissue necrosis as well as detailed treatment protocols for the management of these events. For impending tissue necrosis, recommendations are provided for early and delayed presentations with treatment protocols for acute and follow-up treatment. A separate section details the treatment options for open and closed wounds. CONCLUSIONS: All physicians should be prepared for the eventuality of intra-arterial injection of a dermal filler, despite its rarity. These consensus recommendations combine advice from aesthetic experts with the latest reports from the published literature to provide an up-to-date office-based protocol for the prevention and treatment of complications arising from intra-arterial CaHA injection.

Use of calcium hydroxylapatite in the upper third of the face: Retrospective analysis of techniques, dilutions and adverse events.

Calcium hydroxylapatite (CaHA) is a commonly used soft tissue filler for aesthetic facial improvement, in particular for the lower and mid-face. The golden standard for upper facial filler indications is hyaluronic acid (HA) injection. In this report we investigate the safety, efficacy and complication rates after injections of CaHA to the upper third of the face using a variety of different techniques. This was a retrospective analysis performed on patients who had received CaHA in 2016 and 2017 at various dilutions in the upper third of the face (frontal area, eyebrows and temporal hollows) using a number of injection techniques and both blunt-tipped cannulas as well as sharp needles. Records of adverse events and side effects were studied. Seventy patients had been injected with CaHA in the upper third of the face. There were 36 treatments to the frontal area, most with a cannula in the subgaleal space with standard dilution of CaHA (16.7% lidocaine containing epinephrine). There were 13 treatments to the brow, mostly with a cannula and multilevel technique, and 66 treatments to the temporal hollows, mostly with a cannula in the interfascial space with standard CaHA dilution. No serious complications were recorded. CaHA was effective and well-tolerated for a range of upper-face indications. More (prospective) research is required to further determine the value of CaHA treatments in these areas.

Sensitivity of aspiration as a safety test before injection of soft tissue fillers.

BACKGROUND: Embolism due to accidental intra-arterial injection of a soft tissue filler (STF) can lead to serious complications. Physicians practice aspiration as a safety test before injection to rule out intra-arterial placement of the needle tip. The value of aspiration as a safety test is evaluated in this study, which also considered the rheological properties of different STFs and their needle dimensions. METHODS: Aspiration with eleven different needle sizes and 24 different STFs was performed using Ringer's lactate (RL) colored with blue skin marking ink and secondly an empty saline bag containing anticoagulated blood, both pressurized to 150 mm Hg to mimic arterial blood pressure. Time between the start of aspiration and liquid in the needle hub was recorded. RESULTS: A total of 340 individual aspiration tests with different STFs and needles were performed, of which 112 yielded true-positive results within 1-s and 128 yielded false-negative results after 10 s. Positive results between one and ten seconds were seen in 101 aspiration tests. CONCLUSIONS: True-positive results were seen in 33% of the tests performed with STFs within 1 s of aspiration. Aspiration test results are influenced by needle diameter, needle length, and rheological properties of STFs. Additional safety measures are necessary to further reduce risk of inadvertent intravascular injection of STFs.

Complication Management following Rejuvenation Procedures with Hyaluronic Acid Fillers-an Algorithm-based Approach.

BACKGROUND: Hyaluronic acid is an ideal facial filler, however, although established as both safe and effective, complications do occur. Treatment recommendations that combine both expert opinions and clinical trial data are currently lacking, partly due to difficulties with diagnoses, nonspecific diagnostic investigations, and certain disorders presenting with similar symptoms, thereby confounding diagnosis and treatment. METHODS: The purpose of this article was to provide the aesthetic clinician with practical recommendations regarding complication diagnosis arising as a consequence of hyaluronic acid filler rejuvenation treatment. It also provides recommendations for their management using step-wise treatment algorithms that are based on published expert opinions, as well as the author's clinical experience. RESULTS: Algorithms are provided for the most common categories of complication associated with hyaluronic acid filler treatment, that is, skin discoloration, edema, nodules, infection, and vascular compromise. CONCLUSIONS: These guidelines are not intended to be complete or exhaustive but may prove informative for aesthetic clinicians who are responsible for treating patients with hyaluronic acid fillers. It may help to guide them on recognizing potential complications and it provides clear guidance on optimum treatment pathways.

Combined aesthetic interventions for prevention of facial ageing, and restoration and beautification of face and body.

The Merz Institute of Advanced Aesthetics Expert Summit was held in Prague, Czech Republic, from 19-20 November 2016. The meeting had a distinct advisory board character and invited aesthetic practitioners from all over the world to hear an international faculty present a range of keynote lectures and conduct live injection sessions with an emphasis on recent developments in combination aesthetic interventions for face and body rejuvenation and beautification. Aging is associated with changes in bones, muscles, ligaments, adipose tissue, and skin and, moreover, involves interactions among these tissue types. To achieve the most natural and harmonious rejuvenation of the face, all changes that result from the aging process should be corrected, which generally involves treatment with more than a single agent or technology. Presentations described innovative treatment algorithms for the face and body and focused on patients' desires for natural-looking rejuvenation and how this requires a three-dimensional approach combining products that relax the musculature, volumize, and re-drape the skin. Besides treating the aging face, these procedures are increasingly used to enhance facial features as well as to delay facial aging in younger patients. The presentations covered patients from different ethnicities as well as the treatment of non-facial areas, with a particular focus on the use of Ultherapy® for skin lifting and tightening, and new aesthetic procedures such as Cellfina® and diluted Radiesse®. The current report provides a summary of key presentations from the meeting.

Left/Right Pain Asymmetry With Injectable Cosmetic Treatments for the Face.

BACKGROUND: Pain is processed and experienced differently on the left (L) and right (R) sides of the body; however, L/R pain asymmetry with cosmetic treatments of the face has not been evaluated. OBJECTIVES: The authors compared patient ratings of L/R facial pain during and immediately after injectable cosmetic treatments. METHODS: In this cross-sectional multicenter pragmatic study, pain levels were evaluated for 302 patients who underwent facial treatments with botulinum toxin (BTX) and/or impermanent soft-tissue filler (STF). Patients indicated pain intensity on each side of the face with a visual analogue scale (VAS; 0, no pain; 10, worst pain). RESULTS: Combined mean VAS scores for BTX and STF treatments (L, 3.79 vs R, 3.42), and individual scores for BTX (L, 3.60 vs R, 3.30) or STF (L, 4.22 vs R, 3.69) treatments were significantly different, with pain rated as worse on the L side of the face (all P < 0.01). When treatments were performed first on the L side, patients rated the overall experience as significantly less painful than when treatments were begun on the R side. BTX treatments with a 29-gauge (G) needle were significantly more painful than with a 33-G needle. CONCLUSIONS: To lessen pain with injectable facial treatments, the authors recommend placing the first injection on the L side of the face and, when possible, employing a high-G needle.

Cannula Versus Sharp Needle for Placement of Soft Tissue Fillers: An Observational Cadaver Study.

BACKGROUND: Soft-tissue fillers have become important products for facial rejuvenation. Deep fat compartments and facial bones lose volume during the natural aging process. For the most natural-looking results, deep volumetric injections at strategic sites are therefore preferred. Supraperiosteal placement is performed with a sharp needle or a non-traumatic cannula. OBJECTIVES: The primary objective was to determine whether there is a difference in precision between supraperiosteal placement with a sharp needle compared with a non-traumatic cannula in cadaver specimens. A secondary objective was to analyze the safety profiles of both injection techniques. METHODS: Cadaver heads were injected with dye material and soft-tissue fillers at multiple aesthetic facial sites on the supraperiosteum and subsequently dissected for observation of dye and filler placement. RESULTS: The non-traumatic cannula technique resulted in product being confined to the deep anatomic layers. In contrast, with the sharp needle technique, material was placed in multiple anatomic layers, from the periosteum to more superficial skin layers. For both techniques results were consistent for all facial sites. CONCLUSIONS: Although direct extrapolation from cadavers to the in vivo situation cannot be made, cannulae showed more precision in placement of product. With the sharp needle, the material was injected on the periosteum, and then migrated in a retrograde direction along the trajectory of the needle path, ending up in multiple anatomic layers. The sharp needle technique also showed a higher complication risk with intra-arterial injection occurring, even though the needle tip was positioned on the periosteum and the product was injected with the needle in constant contact with the periosteum.