Post-Treatment Displacement of Facial Soft Tissue Fillers-A Retrospective Ultrasound-based Investigation of 382 Zygomatic Regions.

BACKGROUND: Clinical and ultrasound experience has revealed that after soft tissue injections of the lateral cheek, the filler may displace from the zygoma to the caudal temporal area. OBJECTIVE: To obtain more data to provide insight into product distribution when soft tissue fillers are injected in the zygomatic region. METHODS: Two hundred patients were examined with facial ultrasound imaging of the zygomatic and temporal region. Inclusion criteria were simply a positive response on the screening questionnaire as to whether or not they had filler injections placed in their lateral cheek. Control injections were also performed to the zygomatic regions of a body donor and in 10 patients ultrasound-guided. RESULTS: A correlation was found between the layers in which filler was detected on the zygoma and where it was ultimately found in the temples. Four different redistribution patterns were observed: (1) migration of filler within the superficial muscular aponeurotic system (SMAS) on the zygoma into the superficial temporal fascia. Migration of filler from the lateral suborbicularis oculi fat to (2) the deep interfacial plane of the temple or (3) to the superficial temporal fat pad; (4) migration from the supraperiosteal layer of the zygoma to the superficial temporal fat pad. Body donor and patients: filler deposits injected on the zygoma were witnessed to shift during injection into the caudal part of the temple. CONCLUSION: Soft tissue filler aliquots may be redistributed into the temples after injections of the lateral side of the zygomatic arch. The displacement follows a distinct pattern depending on the initial layer of injection.

Reticulated livedoid skin patterns after soft-tissue filler-related vascular adverse events.

BACKGROUND: For the treatment of vascular adverse events caused by filler injections, duplex ultrasound imaging may be used. The findings of duplex ultrasound examination and the clinical features of reticulated livedoid skin patterns were compared with the hemifaces anatomy. OBJECTIVE: The objective of this study was to link the reticulated livedoid skin patterns to the corresponding duplex ultrasound findings and the facial perforasomes. METHODS: Duplex ultrasound imaging was used for the diagnosis and treatment of vascular adverse events. The clinical features and duplex ultrasound findings of 125 patients were investigated. Six cadaver hemifaces were examined to compare the typical livedo skin patterns with the vasculature of the face. RESULTS: Clinically, the affected skin showed a similar reticulated pattern in each facial area corresponding with arterial anatomy and their perforators in the cadaver hemifaces. With duplex ultrasound, a disturbed microvascularization in the superficial fatty layer was visualized. After hyaluronidase injection, clinical improvement of the skin pattern was seen. Normalization of blood flow was noted accompanied by restoration of flow in the corresponding perforator artery. The skin patterns could be linked to the perforators of the superficial fat compartments. CONCLUSION: The livedo skin patterns seen in vascular adverse events may reflect the involvement of the perforators.

Understanding Platysma Muscle Contraction Pattern and Its Relationship to Platysmal Banding: A Real-Time Ultrasound Study.

BACKGROUND: Addressing neck contouring with surgical and nonsurgical aesthetic procedures includes understanding the origin of platysmal banding. A theory was postulated to explain this phenomenon by isometric vs isotonic muscular contraction patterns. However, no scientific proof had been provided to date for its correctness. OBJECTIVES: The aim of this study was to confirm the correctness of the platysmal banding theory based on isometric vs isotonic muscular contractions. METHODS: Eighty platysma muscles from 40 volunteers (15 males and 25 females) were investigated (mean age 41.8; SD 15.2 years; mean BMI of 22.2; SD 2.3 kg/m2). Real-time ultrasound imaging was utilized to measure the increase in local muscle thickness inside and outside of a platysmal band as well as platysma mobility. RESULTS: Within a platysmal band, the local thickness of the muscle increases during muscular contractions by 0.33 mm (37.9%; P < .001). Outside of a platysmal band the thickness of the platysma muscle decreased by 0.13 mm (20.3%; P < .001). It was identified that within a platysmal band no gliding was detectable, whereas outside of a band an average muscle gliding of 2.76 mm was observed. CONCLUSIONS: The results confirm the correctness of the isometric vs isotonic platysma muscle contraction pattern theory: isotonic muscle contraction (gliding without increase in tension and therefore in muscle thickness) vs isometric muscle contraction (no gliding but increase in tension and therefore in muscle thickness). These 2 types of contraction patterns occur within the platysma simultaneously and are an indicator for zones of adhesion in the neck to guide surgical and nonsurgical aesthetic procedures.

Home-Use Hyaluronic Acid Jet Injectors: Unreliable and Unsafe.

BACKGROUND: Needle-free hyaluronic acid (HA) jet injectors are gaining popularity for rejuvenation treatment. The devices are widely available online and are used for self-injection or in beauty salons by nonphysicians. However, little is known about their performance and safety. OBJECTIVE: To explore the injection efficiency and cutaneous biodistribution patterns administered with home-use compared with medical jet injectors and to assess safety aspects. MATERIALS AND METHODS: The authors injected HA into ex vivo human skin with 4 home-use and 2 medical injectors. The intracutaneous dose of HA was calculated, and the cutaneous biodistribution of HA was assessed using a 3-dimensional Fluorescent Imaging Cryomicrotome System (3D-FICS). Safety aspects were evaluated based on the presence of a manual, CE (conformité européenne) mark, and sterility. RESULTS: The intracutaneous dose delivered by the home-use injectors was markedly lower compared with the medical injectors. 3D imaging for home-use injectors showed superficial epidermal distribution with low distribution volumes. For medical injectors, volumes were substantially larger and mainly middermal. All evaluated safety aspects were lacking. CONCLUSION: Results of this study suggest that the specific combinations of home-use injectors and HA used in this study are unreliable and unsafe, which casts doubts on the performance of these treatments in general.

Treating facial overfilled syndrome with impaired facial expression-Presenting clinical experience with ultrasound imaging.

BACKGROUND: Facial overfilled syndrome is an adverse event following minimally invasive soft tissue filler injections. It presents in most cases as excess midfacial volume and/or as unnatural smile which is difficult to detect due to the absence of standardized evaluation methods. OBJECTIVE: To showcase how to identify, evaluate, and treat facial overfilled syndrome by utilizing facial ultrasound and simultaneous hyaluronidase injections. METHODS: Twenty-eight consecutive patients (26 females, 2 males) were enrolled in this study in which facial ultrasound was performed to evaluate the location previously implanted filler material. The position of the oral commissure was objectively measured in relation to bony landmarks, and the severity of lateral canthal lines was assessed by independent and blinded raters. RESULTS: The material was identified in 35.7% inside the subdermal fatty layer, in 28.6% inside the deep supra-periosteal fatty layer, in 10.7% inside the fibrous layer deep to the subdermal fatty layer, whereas in 25.0%, the product was not possible to locate clearly inside one specific layer. On average, 81.6 I.U. [range: 75-150] of hyaluronidase were injected. Lateral canthal line severity was before the treatment 2.28 (1.4) and was after the hyaluronidase treatment 2.02 (1.3) with p = 0.578. The position of the oral commissure increased by 0.60 cm in vertical and by 0.30 cm in horizontal directions (both p < 0.001). CONCLUSION: Facial overfilled syndrome following aesthetic soft tissue filler injections can present as excess midfacial volume but also as unnatural smile. Targeted hyaluronidase injections into the culprit pockets inside the midfacial soft tissues have shown to re-establish a natural smile, to reduce excess midfacial volume, and to decrease lateral canthal line severity.

Investigating the Anatomic Location of Soft Tissue Fillers in Noninflammatory Nodule Formation: An Ultrasound-Imaging-Based Analysis.

INTRODUCTION: Noninflammatory nodules may be persistent to dissolve. To evaluate the possible reasons, a case series of ultrasound images and medical data of patients who were prospectively referred with noninflammatory nodules were evaluated. MATERIALS AND METHODS: A total of 27 patients with nodules but without signs of inflammation were included. All cases were assessed with an 18-MHz linear ultrasound device. Exact location of the filler material was noted. Relations with clinical data were analyzed using chi-square tests. RESULTS: Early onset of complaints (<2 weeks) was found in 16 patients and late onset (>2 weeks) in 11. All patients had multiple nodules. In all cases, the filler nodule was found to be located inside the fascia. Extension to the subcutaneous tissue was seen in 8 cases and to the deeper planes in 5. In 14 cases, the filler material was completely located inside layers of the fascia, and migration was observed in 5 cases. DISCUSSION: Accumulation of filler material in the superficial musculoaponeurotic system or fascia may be an important cause for the occurrence of persistent noninflammatory nodules, either by initial faulty injection technique or by later accumulation through the pathway generated with a needle or cannula. Ultrasound-guided injections are helpful to dissolve the nodule.

Ultrasonographic Patterns of Calcium Hydroxyapatite According to Dilution and Mix With Hyaluronic Acid.

OBJECTIVES: To assess the ultrasonographic patterns of different calcium hydroxyapatite (CaHA) formulations, including the undiluted, diluted, and mixed with hyaluronic acid (HA) compounds. METHODS: To review the ultrasonographic images of patients ≥18 years with confirmed injections of CaHA clinically and ultrasonographically, and without different concomitant types of fillers in the same region or other systemic or localized cutaneous diseases. RESULTS: Twenty-one patients met the criteria (90% female; 10% male; mean age: 52 years ± 12.8). Of these, 33.3% have been injected with an undiluted formulation, 33.3% with diluted, and 33.3% with a mixed formulation. All cases were studied with devices presenting frequencies that ranged from 18 to 24 MHz. Twelve cases (57%) were also studied with the 70 MHz. The ultrasonographic patterns of CaHA presented differences in the presence and intensity of PAS and the degree of inflammation according to the dilution and mix with HA. Diluted formulations show a milder intensity posterior acoustic shadowing (PAS) artifact than undiluted at 18-24 MHz. In mixed formulations, 57% showed mild PAS, and 43% demonstrated no PAS artifact at 18-24 MHz, besides fewer inflammatory changes in the periphery of the deposits. CONCLUSIONS: The ultrasonographic patterns of CaHA show differences in the presence and intensity of PAS and the degree of inflammation according to the dilution and mix with HA. Awareness of these ultrasonographic variations can support better discrimination of CaHA.

Precision in Midfacial Volumization Using Ultrasound-Assisted Cannula Injections.

BACKGROUND: Soft-tissue filler injections performed with a cannula are perceived to be less precise because of the length of the instrument and the blunt tip, which can deviate in any direction. Midfacial needle injections are favored despite the increased risk for intraarterial product placement. The objective of this study was to demonstrate that ultrasound-assisted cannula injections of the midface result in precise, safe, and effective volumization procedures. METHODS: Midfacial injections with a 22-G cannula were performed in 188 midfaces of 94 healthy volunteers [86 women; age, 53.05 (9.9) years; 23.63 (2.1) kg/m 2 ] under ultrasound-assisted guidance. Precision (ie, administration of product in the same plane as the location of the cannula tip), safety (ie, rate of adverse events), and aesthetic outcome (rated by the patient and the treating physician) were assessed. RESULTS: In 100% of cases, the product was applied into the desired deep midfacial fat compartment, and the product did not migrate into more superficial layers during the injection process or at any follow-up visit. There was a statistically significant ( P < 0.001) improvement in midfacial volume loss and the aesthetic outcome was rated as very much improved. No adverse events were reported throughout follow-up. CONCLUSIONS: Real-time imaging allows for visual feedback during cannula advancement and injection procedures in the midface and can help practitioners achieve safer aesthetic outcomes. It is hoped that practitioners decide to use a cannula more frequently for midfacial volumization, given the results presented in this article. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Facial aesthetic minimally invasive procedure: More than just vanity, a social-psychological approach.

BACKGROUND: Due to the great importance of the face in social interaction, minimally invasive treatments can-besides their ability to rejuvenate and enhance beauty-also change the way facial impressions of a person are perceived. In recent literature, three main character traits (attractiveness, trustworthiness, and competence) and subdomains essential for facial perception were described. OBJECTIVE: To investigate whether minimally invasive procedures truly influence different character traits when evaluated by independent, objective observers. METHODS: Photographs of n = 34 female faces before and after treatment with injectable fillers and botulinum toxin were rated by 393 individuals without aesthetic background with regards to different character traits on a 7-point Likert scale. Tests for dimensionality were performed, and composite scores of the impressions underlying each of the three dimensions were created and compared using within-subjects t tests. RESULTS: Treatments statistically significantly improved the overarching character trait domains attractiveness, trustworthiness, and competence in posttreatment photographs compared with pretreatment. Posttreatment ratings of the respective subdomains also showed a statistically significant difference compared with pretreatment photographs, with the exception of the subdomain dominance which failed to reach statistical significance. CONCLUSION: Impressions of facial attractiveness, trustworthiness, and competence can be improved by injectables while the naturalness of the face is left intact. An implication is that the improvement of traits highly relevant to social interaction will accommodate the patient's desires for beautification and rejuvenation.

Early ultrasound for diagnosis and treatment of vascular adverse events with hyaluronic acid fillers.

BACKGROUND: Hyaluronic acid fillers are known for a reliable safety profile, but complications do occur, even serious vascular adverse events. OBJECTIVE: To improve the treatment outcome after a vascular adverse event with use of hyaluronic acid filler treatments. METHODS: Duplex ultrasonography is used to detect the hyaluronic acid filler causing the intra-arterial obstruction. RESULTS: If treated in time, 1 single treatment of ultrasonographically guided injections of hyaluronidase into the filler deposit will prevent skin necrosis. CONCLUSION: Because the use of duplex ultrasonography adds extra essential information, its use may become an integral part of the prevention and treatment of injection adverse events.

No association found between late-onset inflammatory adverse events after soft tissue filler injections and the adaptive immune system.

BACKGROUND: To date, it is unknown why some individuals develop late-onset inflammatory adverse events after treatment with fillers. These events may result from various factors, including an immunological response of the adaptive immune system. OBJECTIVE: In a pilot study, we looked for evidence that is there a relation between late-onset inflammatory adverse events and the presence of immune cells surrounding the injected filler. METHODS AND MATERIALS: We included 47 patients, of whom 20 experienced late-onset inflammatory adverse events to different fillers (inflammatory group) and 27 who did not (reference group). A biopsy was taken from the area of the adverse event. Hematoxylin-eosin staining and immunohistochemistry analysis with CD3 (T-cells) and CD68 (macrophages) on paraffin tissue sections was used to assess the biopsies. RESULTS: Immune cells were found in biopsies obtained from 18 of 47 patients: Nine biopsies from the inflammation group and nine from the reference group. All these 18 cases showed CD68-positive immune cells. Virtually no CD3-positive immune cells were found. CONCLUSION: Our results indicate that there is no T-cell activity in biopsies from areas with late-onset adverse events after filler injections. The macrophages found in the biopsies are probably not responsible for the inflammatory response.

Bacterial Contamination Is Involved in the Etiology of Soft-Tissue Filler, Late-Onset, Inflammatory Adverse Events.

BACKGROUND: The treatment algorithm in late-onset inflammatory adverse events with soft-tissue fillers depends primarily on the assumed causative factor: immunologic or bacterial. METHODS: The authors included 29 patients, 13 of whom experienced late-onset inflammatory adverse events to fillers (inflammatory group) and 16 who did not (reference group). Biopsies were acquired from both groups with an 18-G needle. Before taking the biopsy, the authors acquired skin swabs for 25 of the 29 patients. The IS-pro method-a new and very sensitive method to detect microbiota-was used. This is a novel broad-range polymerase chain reaction technique based on length and sequence variations of the 16S to 23S ribosomal interspacer region. IS-pro can detect bacteria at low abundances and identify them up to species level. To exclude contamination from skin microbiota, the authors compared the microbiota found on skin swabs with that found in the corresponding biopsies. RESULTS: A high level of Gram-positive bacteria was found in biopsies of soft-tissue fillers, predominantly in patients from the inflammation group. This suggests that these bacteria were introduced during the primary filler injection treatment. The composition of the microbiota on the skin differed markedly from that in the filler, indicating that contamination during the sampling process did not influence results. CONCLUSIONS: Bacteria adherent to soft-tissue fillers or bacteremia probably play a causative role in adverse events. Contamination of samples in the biopsies with skin microbiota was excluded. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Precision of Soft-Tissue Filler Injections: An Ultrasound-Based Verification Study.

BACKGROUND: Uncontrolled product spread is an important issue to consider in facial filler injections. Lack of precision can result in reduced effectiveness and surface projection, as well as irregularities and product visibility. OBJECTIVES: The authors sought to assess the precision of soft-tissue filler injections in the face by employing a cannula. METHODS: This single-center observational study investigated soft-tissue filler distribution utilizing real-time non-invasive ultrasound imaging. Outcome parameters included (1) the tissue plane of product distribution, (2) the extent of horizontal as well as vertical product spread at the injection site, and (3) the product surface area taking into account the multifactorial influence of several independent variables. Participants were followed up to 30 days post-injection. RESULTS: A total 100 facial injections were performed in 8 patients (2 males, 6 females) with a mean age of 37.20 (±6.34) years and a mean BMI of 22.21 (±1.39) kg/m.2. The plane of product distribution remained constant in approximately 90% of cases at day 0 (d0), d14, and d30. Mean horizontal product spread was higher compared with vertical spread, and both significantly decreased over all time points (P < .001). Mean product surface area was 22.51 ± 16.34 mm2 at d0, 15.97 ± 11.28 mm2 at d14, and 12.9 ± 9.15 mm2 at d30. Analysis employing generalized linear models revealed that injection volume and injection depth significantly influenced product surface area. CONCLUSIONS: Injection of soft-tissue filler employing a cannula allows precise application of the product within the intended tissue plane. Precision can be improved by injecting less product into deeper tissue layers.

Filler injections in the pre-auricular space: Be aware of the parotid gland.

BACKGROUD: In recent years the pre-auricular area is increasingly used for filler injections. AIMS: Assessment of depth of the subcutaneous fat and the process of realtime filler injection. MATERIALS & METHODS: Ultrasonographic data of two cases and a video are studied. RESULTS: These show how filler injections may very easily be delivered inside the parotid gland. This may go unnoticed by injector and client. DISCUSSION: This study and data from literature prove that filler injections in the pre-auricular area may end up inside or in the vicinity of the parotid gland, and this can lead to an inflammatory response. CONCLUSION: It is recommended to be careful with filler injections in this area. Prior sonographic assessment of the subcutaneous depth in this area is advised.

Ultrasound-Guided Targeted vs Regional Flooding: A Comparative Study for Improving the Clinical Outcome in Soft Tissue Filler Vascular Adverse Event Management.

BACKGROUND: Adverse vascular event management following hyaluronic acid-based aesthetic injections relies on the administration of hyaluronidase which is capable of enzymatically degrading the injected product and improving clinical symptoms. Two protocols are currently available to manage such complications: "ultrasound-guided targeted" and "flooding". OBJECTIVES: The aim of this study was to compare the 2 protocols in terms of the volume of hyaluronidase utilized, and the onset and degree of clinical improvement. METHODS: A comparative case series of 39 patients was retrospectively evaluated. The patients were initially treated with the "flooding" protocol and then treated with the "ultrasound-guided targeted" protocol due to no or little improvement. RESULTS: The "ultrasound-guided targeted" protocol utilized a mean [standard deviation] total of 122.5 [34] IU of hyaluronidase, whereas the "flooding" protocol utilized 1519.4 [1137] IU, which represents a statistically significant reduced amount of injected hyaluronidase (P = 0.028). There was no clinical improvement in 92.3% and only little improvement in 7.7% of the treated patients following the first applied "flooding" protocol, but there was a 100% immediate improvement when subsequently treated with the "ultrasound-guided targeted" protocol. Ultrasound imaging revealed that the application of hyaluronidase restored normal blood flow both in the perivascular space and in the superficially located subdermal soft tissues. CONCLUSIONS: Despite its limitations in study design, this retrospectively evaluated case series revealed that the "ultrasound-guided targeted" protocol utilized less hyaluronidase and restored clinically visible symptoms faster. The effect of this protocol is best explained by the perforasome concept which will need to be investigated further in future studies.

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