Filler Procedures Research Articles

Using a needle versus cannula: the advantages and disadvantages

With the continuing increase in both men and women seeking out anti-ageing non-invasive cosmetic treatments, techniques and complication management associated with dermal filler and neurotoxin application procedures are more important than ever. Rumi Kisyova et al detail the advantages and disadvantages of using a cannula or needle for such procedures

Rates of Vascular Occlusion Associated With Using Needles vs Cannulas for Filler Injection

Soft-tissue augmentation with skin fillers can be delivered with needles or microcannulas, but unwanted vascular occlusions are possible. To determine whether filler-associated vascular occlusion events of the face occur more often with injections performed with needles than with microcannulas. This retrospective cohort study included a random sample of board-certified dermatologists deemed eligible based on membership in relevant professional societies and attendance at relevant national professional meetings. Participants completed detailed forms in which they could enter deidentified data and volume statistics pertaining to patients undergoing filler procedures in their practices. Data were collected from August 2018 to August 2019. Injectable fillers approved by the US Food and Drug Administration delivered via needles or microcannulas. The primary outcome measure was intravascular occlusion. Occlusion events were graded by severity (no sequelae, scar, and ocular injury or blindness). A total of 370 dermatologists (mean [SD] years in practice, 22.3 [11.1] years) participated and reported 1.7 million syringes injected. The risk of occlusion with any particular filler type using needle or cannula never exceeded 1 per 5000 syringes injected. Overall, 1 occlusion per 6410 per 1-mL syringe injections was observed with needles and 1 per 40 882 with cannulas (P < .001). Of the 370 participants, 106 (28.6%) reported at least 1 occlusion. Multivariate analysis found that injections with cannula had 77.1% lower odds of occlusion compared with needle injections. Participants injecting fillers for more than 5 years had 70.7% lower odds of occlusion than those who were less experienced. For each additional injection per week, the odds of occlusion decreased by 1%, and 85% of occlusions had no long-term sequelae. Nasolabial folds and lips were most likely to be occluded, with mean severity level of occlusions highest at the glabella. In this cohort study, filler injections with either needles or cannulas were associated with a very low risk of intravascular occlusion events. Moreover, the vast majority of such events were minor and resolved without scar or other injury. Injections with microcannulas were less often associated with occlusion events than injections with needles. Occlusion risk per syringe appeared decreased after the first few years of clinical practice and was also lower among those who more frequently inject fillers. Whether a needle or cannula is most appropriate for injection may depend on patient factors, anatomic site, and the type of defect being treated.

High frequency ultrasound assessment of labial glands simulating small nodules or granulomas after lip augmentation.

Aim of the studyThe aim of this study is to evaluate the utility of high-frequency ultrasound in the assessment of the nature and differentiation of lumps occurring in the labial mucosa after lip filling procedures.Material and methodsThe study sample included 5 women aged from 28 to 43 years (mean age: 37.4 years) who previously underwent a lip augmentation or rejuvenation procedure. Photographic documentation was taken and high-frequency ultrasound assessment was performed in all the patients. The presence of deposits, foreign body granulomas, fibrosis and labial glands was mainly investigated taking into account the shape of the abnormalities, their margins, surface area, location and echogenicity. In order to confirm the diagnosis, histopathological examination was performed.ResultsThe examinations performed made it possible to differentiate between granulomas and persistent deposit nodules and to demonstrate the presence of massive fibrosis and of labial glands pushed out by these abnormalities with the glands presenting as hypoechoic oval areas. Histopathological examination confirmed the morphology of labial glands reported by the patients as uncomfortable lumps felt from the side of the mucosa, which clinically simulate persistent deposit nodules or granulomas.ConclusionsHigh-frequency ultrasound is a method that is essential for the correct differentiation between complications of tissue filler procedures. This, in turn, makes it possible to apply the right treatment. In this study, it was demonstrated for the first time that the lumps reported by patients who have had a lip filling procedure may be the result of labial glands being pushed out by deposits, granulomas or massive fibrosis, which are complications of such procedures.

Nonvascular Complications of Injectable Fillers-Prevention and Management.

Injectable filler treatments have increased in popularity because of enhanced safety profile and improved physical characteristics. ISAPS (International Society of Plastic Surgery) put out global data showing 3.7 million hyaluronic acid (HA) filler procedures in 2018, making it the second most often performed procedure in the world, after botulinum toxin. And these are only ‘those’ performed by qualified plastic surgeons. There was a concomitant increase in both the nonvascular and vascular complications, which coincided with the number and type of filler procedures performed. Filler complications were reviewed from existing literature, and an attempt was made to understand etiology, elucidate clinical features, and clarify optimum treatment strategies for each. Complications can be early or delayed in presentation, early consisting of injection site complications like bruising, edema, and hypersensitivity, Tyndall effect, and intravascular injection. Delayed complications included hypersensitivity type IV, acute infections like cellulitis, abscesses, and herpes and delayed ones like granulomas, biofilms, and atypical mycobacterial infections. These were analyzed and treatment options, protocols, and consensus guidelines were suggested. A clear understanding of facial anatomy, physical characteristics of all fillers used, early recognition, and treatment options of complications will ensure optimum outcomes.

Development and Usability of a Virtual Reality-Based Filler Injection Training System

PurposeAs filler procedures have increased in popularity, serious injection-related complications (e.g., blindness and stroke) have also increased in number. Proper and effective training is important for filler procedure safety; however, limitations exist in traditional training methods (i.e. anatomical illustrations and cadaver studies). We aimed to describe the development process and evaluate the usability of a virtual reality (VR)-based aesthetic filler injection training system.Materials and MethodsWe developed the virtual reality hardware for the training system and a short guide, with a lecture regarding safe filler injection techniques. One hundred clinicians who attended a conference tested the training system. Participants completed system usability scale (SUS) and satisfaction questionnaires.ResultsNearly half of the participants were aged 35–50 years, and 38% had more than 5 years of aesthetic experience. The mean SUS score was 59.8 (standard deviation, 12.23), with no significant differences among the evaluated subgroups. Approximately 76% of participants provided SUS scores of more than 51, indicating acceptable usability. Participants aged 35–50 years were more likely to rate the system as having poor usability than were those aged < 35 years (odds ratio = 5.20, 95% confidence interval: 1.35–20.08).ConclusionsThis study was the first to develop and explore the usability of a VR-based filler training system. Nearly three-fourths of participants indicated that the training system has an acceptable level of usability. However, assessments in precise target audiences and more detailed usability information are necessary to further refine the training system.Level of evidence IVThis 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.

The Functional Anatomy of the Ophthalmic Angiosome and Its Implications in Blindness as a Complication of Cosmetic Facial Filler Procedures

Blindness following facial filler procedures, although rare, is devastating, usually acute, permanent, and attributed to an ophthalmic artery embolus. However, blindness may be delayed for up to 2 weeks, sometimes following injection at remote sites, suggesting alternative pathways and pathogenesis. Seeking solutions, fresh cadaver radiographic lead oxide injection, dissection, and histologic studies of the orbital and facial pathways of the ophthalmic angiosome, performed by the ophthalmic artery and vein, both isolated and together, and facial artery perfusions, were combined with total body archival arterial and venous investigations. These revealed (1) arteriovenous connections between the ophthalmic artery and vein in the orbit and between vessels in the inner canthus, allowing passage of large globules of lead oxide; (2) the glabella, inner canthi, and nasal dorsum are the most vulnerable injection sites because ophthalmic artery branches are anchored to the orbital rim as they exit, a plexus of large-caliber avalvular veins drain into the orbits, and arteriovenous connections are present; (3) choke anastomoses between posterior and anterior ciliary vessels supplying the choroid and eye muscles may react with spasm to confine territories impacted with ophthalmic artery embolus; (4) true anastomoses exist between ophthalmic and ipsilateral or contralateral facial arteries, without reduction in caliber, permitting unobstructed embolus from remote sites; and (5) ophthalmic and facial veins are avalvular, allowing reverse flow. The authors' study has shown potential arterial and venous pathways for filler embolus to cause blindness or visual field defects, and is supported clinically by a review of the case literature of blindness following facial filler injection.

A Systematic Literature Review of the Middle Temporal Vein Anatomy: 'Venous Danger Zone' in Temporal Fossa for Filler Injections.

Treatment of a sunken appearance of the temporal region using injectable fillers is a popular procedure. The temporal fossa has very complex anatomy due to multiple vessels running in the different tissue layers. A severe complication in the form of non-thrombotic pulmonary embolism (NTPE) can occur as a result of an inadvertent injection in the middle temporal vein (MTV) while performing temporal fossa filler procedures. Therefore, in-depth knowledge and understanding of the MTV anatomy are essential for successful and safer injectable procedures of the temporal fossa. While there have been many studies to describe the arteries in this region, there is limited information about the location and course of the middle temporal vein. This literature review is aimed at providing detailed information about the course, depth, and size of the MTV to help aesthetic practitioners in performing safer temporal fossa filler injections. This information is imperative to delineate the 'venous danger zone' in the temple region. The preferred reporting items for systematic reviews and meta-analyses guidelines were used for this review. A literature search was performed to find the articles providing details about the MTV anatomy and the measurements related to its course and size. A review of the literature showed that the MTV displays a consistent course and depth in the temporal region, with high variability in its diameter. The middle temporal vein width varied between 0.5 and 9.1mm in various studies. The middle temporal vein receives many subfascial tributaries from the surface of the temporalis muscle, and for most of its course runs in the fat pad enclosed between superficial and deep layers of the deep temporal fascia. A 'venous danger zone,' in the interfascial planes of the temporal fossa, which contain the main part of the MTV and its tributaries, has been proposed in this paper. The temporal fossa filler procedures need great caution, and knowledge of the depth and course of the MTV is essential for avoiding NTPE. 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 .

Using a needle versus cannula: the advantages and disadvantages

With the continuing increase in both men and women seeking out anti-ageing non-invasive cosmetic treatments, techniques and complication management associated with dermal filler and neurotoxin application procedures are more important than ever. Rumi Kisyova et al detail the advantages and disadvantages of using a cannula or needle for such procedures

Low Degree Hyaluronic Acid Crosslinking Inducing the Release of TGF-Β1 in Conditioned Medium of Wharton's Jelly-Derived Stem Cells.

BACKGROUND:Presently, the application of stem cells and their paracrine effect for anti-ageing therapy has commenced. Wharton’s jelly-derived stem cell conditioned medium (WJSCs-CM) is renowned for increasing proliferation, migrate ageing skin fibroblasts and increase consumption of extracellular transforming growth factor-β (TGF-β). With more than 85% of frequently used dermal filler procedures are hyaluronic acid fillers (HA), a mixture of both with optimal HA crosslinking degree has not yet been identified.AIM:This study aimed to determine the discrepancies in the results of various HA crosslinking degree in WJSCs-CM concerning various levels of growth factors (GF).METHODS:Conditioned medium was obtained from mesenchymal stem cells Wharton’s jelly of the newborn umbilical cord with caesarean section procedure, fabricated with hypoxia method (HCM). HA was obtained from preparations on the market with crosslinking degrees of 3%, 4%, and 10%. GF levels were measured using sandwich ELISA method based on the protocol provided by anti-TGF-β1, platelet-derived growth factor (PDGF), and basic fibroblast growth factor (bFGF) antibody producers (Cloud-Clone Corp®, Texas, USA).RESULTS:Low degree HA crosslinking (3% and 4%) elevated TGF-β1 release in WJSCs-CM. HA crosslinking did not provoke increased levels of PDGF and bFGF in WJSCs-CM, both at low and higher degrees.CONCLUSION:Low degree HA crosslinking induced the increase of TGF-β1 release in WJSCs-CM.

Is this a low point for medical aesthetics? An opinion piece

Superdrug's announcement that they will soon supply botulinum toxin A and filler procedures in their high street stores has been the source of much recent debate, both in the industry and the media. Many aesthetic practitioners are concerned that this is contributing to the trivialisation of aesthetic procedures. In this article, Helena collier puts forward her opinions on this controversial decision

Discussion: Nonsurgical Facial Rejuvenation-Outcomes and Safety of Neuromodulator and Soft-Tissue Filler Procedures Performed in a Resident Cosmetic Clinic.

Discussion: Nonsurgical Facial Rejuvenation-Outcomes and Safety of Neuromodulator and Soft-Tissue Filler Procedures Performed in a Resident Cosmetic Clinic.

Nonsurgical Facial Rejuvenation: Outcomes and Safety of Neuromodulator and Soft-Tissue Filler Procedures Performed in a Resident Cosmetic Clinic.

The ability to perform nonsurgical facial rejuvenation procedures is a core competency requirement for plastic surgery residents. However, limited data exist on training models to achieve competency in nonsurgical facial rejuvenation and on outcomes of these procedures performed by residents. The purpose here is to evaluate patient-reported outcomes and safety of nonsurgical facial rejuvenation procedures performed by plastic surgery residents. We prospectively enrolled 50 patients undergoing neuromodulator and/or soft-tissue filler injections in a resident cosmetic clinic between April and August 2016. Patients completed FACE-Q modules pre-procedure, and at 1week and 1month post-procedure. Paired t-tests were used to calculate statistical significance of changes between pre- and post-procedure scores. Effect sizes were calculated to assess clinical improvement from pre- to post-procedure. The magnitude of change was interpreted using Cohen's arbitrary criteria (small 0.20, moderate 0.50, large 0.80). Forty-five patients completed the study. Patients experienced significant improvements (p<0.001) in all FACE-Q domains, including aging appearance appraisal (improved from 49.7±29.4 to 70.1±21.6, effect size 0.79), psychological well-being (44.0±14.6-78.6±20.7, effect size 1.93), social functioning (48.6±16.6-75.5±21.7, effect size 1.20), and satisfaction with facial appearance (50.1±13.7-66.2±19.7, effect size 0.95). At 1month, overall satisfaction with outcome and decision were 75.8±20.7 and 81.1±20.4, respectively. No patients experienced complications. Nonsurgical facial rejuvenation procedures performed by residents can improve patients' quality of life and provide high satisfaction without compromising safety. This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266 .

Bilateral Lower-Lip Foreign Body Granuloma Secondary to Hyaluronic Acid Injection

Hyaluronic acid injection has become one of the most common dermal filler procedures performed by clinicians worldwide. Although it is considered to be a very safe and successful treatment option, several complications have been reported from this type of filler injection. A case of bilateral lower-lip foreign body granuloma secondary to hyaluronic acid injection is presented. The granulomas were successfully resected and histopathology confirmed the diagnosis.

Multicenter prospective cohort study of the incidence of adverse events associated with cosmetic dermatologic procedures: lasers, energy devices, and injectable neurotoxins and fillers.

Common noninvasive to minimally invasive cosmetic dermatologic procedures are widely believed to be safe given the low incidence of reported adverse events, but reliable incidence data regarding adverse event rates are unavailable to date. To assess the incidence of adverse events associated with noninvasive to minimally invasive cosmetic dermatologic procedures, including those involving laser and energy devices, as well as injectable neurotoxins and fillers. A multicenter prospective cohort study (March 28, 2011, to December 30, 2011) of procedures performed using laser and energy devices, as well as injectable neurotoxins and soft-tissue augmentation materials, among 8 geographically dispersed US private and institutional dermatology outpatient clinical practices focused on cosmetic dermatology, with a total of 23 dermatologists. Participants represented a consecutive sample of 20 399 cosmetic procedures. Data acquisition was for 3 months (13 weeks) per center, with staggered start dates to account for seasonal variation. Web-based data collection daily at each center to record relevant procedures, by category type and subtype. Adverse events were detected by (1) initial observation by participating physicians or staff; (2) active ascertainment from patients, who were encouraged to self-report after their procedure; and (3) follow-up postprocedural phone calls to patients by staff, if appropriate. When adverse events were not observed by physicians but were suspected, follow-up visits were scheduled within 24 hours to characterize these events. Detailed information regarding each adverse event was entered into an online form. The main outcome was the total incidence of procedure-related adverse events (total adverse events divided by total procedures performed), as verified by clinical examination. Forty-eight adverse events were reported, for a rate of 0.24% (95% CI, 0.18%-0.31%). Overall, 36 procedures resulted in at least 1 adverse event, for a rate of 0.18% (95% CI, 0.13%-0.25%). No serious adverse events were reported. Adverse events were infrequently associated with known risk factors. Noninvasive to minimally invasive cosmetic dermatologic procedures, including energy, neurotoxin, and filler procedures, are safe when performed by experienced board-certified dermatologists. Adverse events occur in less than 1% of patients, and most of these are minor and transient.

Malar Augmentation With a Polymethylmethacrylate-Enhanced Filler: Assessment of a 12-Month Open-Label Pilot Study

Most filler procedures in the United States are performed with hyaluronic acid (HA) derivatives. Artefill (Suneva Medical, Inc, San Diego, California), the only polymethylmethacrylate (PMMA)-enhanced dermal filler approved by the US Food and Drug Administration (FDA), has been well tolerated by patients for treatment of nasolabial folds and has a safety profile similar to other approved fillers. The authors investigate the safety and efficacy of Artefill for malar augmentation. This prospective, multisite, open-label study included a total of 24 patients with age-related lipoatrophy. Only patients with mild to moderate lipoatrophy were considered candidates for treatment. Artefill was injected in the supraperiosteal layer of the malar region, at a maximum volume of 6 mL (3 mL/side). Touch-up injections were performed at weeks 4 and 6, up to a maximum total volume of 8.8 mL. Standardized assessments of results were made at 2, 6, and 12 months. Outcome measures included the Global Aesthetic Improvement Scale (GAIS), change in malar lipoatrophy grade, and patient satisfaction. Standardized photographs of each patient were collected. Average patient age was 48 ± 5 years. Average volume of injections was 5.55 ± 1.87 mL. Based on both the patient- and physician-rated GAIS, 95.8% of study participants were reported as being "improved" or "very much improved." The change in malar lipoatrophy grade was significantly improved from baseline to 1 year by 0.96 ± 0.98 (P < .0003). Patients also reported high levels of satisfaction, with 87.5% being "satisfied" or "very satisfied." There were no reported adverse safety events in the study. Artefill demonstrated improvement in malar atrophy with a high level of patient satisfaction and an excellent safety profile. The absence of any adverse events in our study patients was notable, and we believe this is a result of the uniform nature of the PMMA particles in the Artefill and the strict and sterile manner in which this PMMA dermal filler is produced.

Injectable biomaterials for adipose tissue engineering

Adipose tissue engineering has recently gained significant attention from materials scientists as a result of the exponential growth of soft tissue filler procedures being performed within the clinic. While several injectable materials are currently being marketed for filling subcutaneous voids, they often face limited longevity due to rapid resorption. Their inability to encourage natural adipose formation or ingrowth necessitates repeated injections for a prolonged effect and thus classifies them as temporary fillers. As a result, a significant need for injectable materials that not only act as fillers but also promote in vivo adipogenesis is beginning to be realized. This paper will discuss the advantages and disadvantages of commercially available soft tissue fillers. It will then summarize the current state of research using injectable synthetic materials, biopolymers and extracellular matrix-derived materials for adipose tissue engineering. Furthermore, the successful attributes observed across each of these materials will be outlined along with a discussion of the current difficulties and future directions for adipose tissue engineering.

Hyaluronic Acid Fillers: A Comprehensive Review

Over the past decade, the popularity of nonsurgical cosmetic procedures has increased exponentially. Last year, according to the American Society of Aesthetic Plastic Surgery, more than 5 million procedures were performed using cosmetic injectables such as botulinum toxin and dermal filling agents. According to the society's recent statistics, more than 85% of all dermal filler procedures occurred with a hyaluronic acid derivative.These numbers are expected to rise in the future as there is currently no other class of filling agent that rivals the popularity of hyaluronic acid. The popularity of hyaluronic acid specifically stems from its effectiveness, ease of administration, and safety profile.

Management of complications after implantation of fillers

Soft tissue augmentation is widely practised by a variety of different practitioners. A new classification of filler substances and procedures, taking into account long-term safety and reversibility of side effects, is proposed: i non-permanent and biodegradable, ii semi-permanent and biodegradable, iii permanent and reversible, iv permanent and non-reversible. Complications and adverse effects occur with all fillers and all filler procedures. Insufficient experience is an important contributory factor. Underreporting is probably common. Commonest are haematomas, ecchymoses, infections, papulopustular or acneiform lesions, non-hypersensitivity related swelling and oedema, erythema, changes in pigmentation, palpability of the implant and necrosis of overlying tissue. Specific therapeutic approaches for these complications and practical recommendations to minimize or avoid them are discussed. Hypersensitivity reactions and granuloma formation are the most distressing adverse effects. They can occur with most fillers. Mostly these hypersensitivity reactions are local granulomas but, rarely, generalized reactions also occur. Case reports of systemic reactions after injection of hyaluronic acid are documented. Treatments include steroids, minocycline and immunomodulatory agents, such as cyclosporin, tacrolimus and ascomycin. In selected cases, surgical procedures are necessary to elimirate granulomatous reactions. Implant migration and facial lipoatrophy are encountered with certain compounds. Extreme caution is therefore advocated before using permanent and non-reversible products for soft tissue augmentation. Those who use fillers need to be familiar with the complications of fillers and with the treatment of those complications.