Biodegradable polymers and platelet-rich plasma causing visual impairment: a literature review.

BACKGROUND: Dermal fillers are widely used for facial rejuvenation and esthetic enhancement, offering temporary solutions for aging and volume loss. Despite their general safety, a rare but severe complication associated with these fillers is visual impairment, including blindness. This underscores the need for a thorough understanding of risks associated with various filler materials. Historical cases of blindness following filler injections date back to 1963, with increasing reports linked to the expansion of the cosmetic filler industry. While hyaluronic acid (HA) and autologous fat have been extensively studied, other fillers such as calcium hydroxylapatite and poly-l-lactic acid (PLLA) are less understood. OBJECTIVE: This systematic review aims to address gaps in the literature by providing a comprehensive overview of visual impairment caused by fillers other than HA and autologous fat. We systematically examine the prevalence, causes, clinical features, and treatment outcomes associated with these less common fillers. MATERIALS AND METHODS: A comprehensive literature search was conducted across databases including PubMed, Scopus, and Google Scholar using terms related to visual impairment and dermal fillers. Studies published between 2014 and 2021, including observational studies and case reports, were included. Studies were selected based on predefined inclusion and exclusion criteria, and a PRISMA flow diagram was used to illustrate the study selection process. RESULTS: The review identifies and summarizes cases of visual impairment associated with calcium hydroxylapatite, poly-d,l-lactic acid (PDLLA), and PLLA fillers. Key findings reveal that visual impairment following these fillers is rare but can occur suddenly or within a few days of the procedure. Cases of delayed onset up to two weeks are also noted, emphasizing the need for extended post-procedure monitoring. DISCUSSION: The review highlights unique insights into the risks associated with non-HA fillers, such as the heightened risk in the periorbital region and other facial areas. It explores mechanisms of complications, including retrograde flow of emboli leading to retinal ischemia. The discussion also covers emergency protocols and preventative measures, providing valuable guidance for managing and mitigating risks. CONCLUSIONS: Visual impairment caused by fillers other than HA and autologous fat, while rare, represents a serious complication that requires careful attention. This review contributes new perspectives on the differential risks of various fillers, symptom onset variability, and anatomical risk factors. Emphasizing the importance of proper patient selection, technique, and monitoring, it calls for further research to better understand and prevent these complications, ultimately aiming for safer and more effective use of soft-tissue fillers.

A Clinical Histology Study Evaluating the Biostimulatory Activity Longevity of Injectable Poly-L-Lactic Acid for Facial Rejuvenation.

BACKGROUND: Poly-L-lactic acid (PLLA) is an injectable filler used for restoring facial fat volume loss that improves skin quality. OBJECTIVE: To evaluate the histological changes underlying the observed improvement in skin quality after repeated PLLA injections. METHODS: Ten healthy women were enrolled in this randomized, placebo-controlled, single-center study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections, into both sides of the face. Follow-up visits were at week 18 after the last treatment. Assessments included live ratings, patient questionnaires, three-dimensional microtopography imaging analysis, and histological analysis from biopsies taken before and after PLLA treatment. RESULTS: At the 18-week follow-up, there was a significant improvement in investigator- and subject-rated global aesthetic improvement (GAIS) scores, as well as a decrease in wrinkle severity in PLLA-treated but not placebo-treated patients. Skin quality parameters of erythema, pore size, and roughness were significantly improved from baseline and compared with placebo at the 18-week follow-up as assessed by microtopographic analysis and investigator ratings. Histologic analysis revealed increased tissue remodeling and angiogenesis in PLLA-treated tissues at the 18-week follow-up and decreased elastin fragmentation compared with baseline. No treatment-related adverse events occurred. CONCLUSION: Repeated PLLA treatments may improve skin quality through tissue remodeling and neovascularization. J Drugs Dermatol. 2024;23(9):729-734. doi:10.36849/JDD.8057.

Editor's Highlights - September 2024.

Curly textured hair presents unique diagnostic and therapeutic challenges because of its distinct properties. In the September issue of the Journal, we explore recent advancements in understanding and treating various hair disorders, focusing on the specific challenges and treatments for curly hair. We discuss whether glucagon-like peptide-1 agonists contribute to or alleviate hair loss and highlight a promising, innovative therapy using adipose stem cell-derived exosomes to promote hair growth. Additionally, we examine therapeutic options for managing filler-induced alopecia and treating folliculitis decalvans.

Clinical improvement after removal of hypercalcemia-causing granulomas.

In this report, we present the case of a woman with clinical characteristics of hypercalcemia due to ectopic production of 1,25(OH)2D. She reported a history of aesthetic surgery with gluteal fillers. The formation of granulomas after these interventions were previously described. In this case, surgical removal of the foreign formations was attempted with clinical stability during 3 years.

Presentamos el caso de una mujer con características clínicas de hipercalcemia secundaria a la producción ectópica de 1,25(OH)2D. La paciente informó una historia de rellenos glúteos con fines estéticos. La formación de granulomas posterior a este tipo de intervenciones fue previamente descrita por otros autores. En este caso se intentó la extirpación quirúrgica de las formaciones extrañas con estabilidad clínica durante 3 años.

Intralesional hyaluronidase injection to relieve non-hyaluronic acid filler-induced vascular adverse events.

BACKGROUND: Vascular adverse events (VAEs) occurring during injections of soft-tissue fillers are still considered a challenging issue for both patients and practitioners. Hyaluronidase can dissolve hyaluronic acid (HA)-based soft-tissue fillers during a VAE. For VAEs induced by non-HA fillers, the absence of an "antidote" is regarded as exceptionally challenging. METHODS: This multicenter study describes a case series of three VAEs induced by non-HA fillers, for which ultrasound-guided hyaluronidase injections were incorporated into the treatment approach. RESULTS: Two cases of calcium hydroxylapatite and one case of poly-L-lactic acid-induced VAEs are described, all of which were resolved without necrosis or scarring using a treatment approach with ultrasound-guided hyaluronidase injections. CONCLUSIONS: Unlike the mechanical hypothesis, which assumes filler particles travel antegrade to block arterioles in a large skin area, we hypothesize vasoconstriction as the pivot in VAEs. Filler injection-induced spasms could lead to long-lasting vasoconstriction of the perforator arteries stemming from the central facial arteries. Our results underscore that perforasome vasoconstriction might be the leading cause of the ischemia and subsequent necrosis in VAEs and that relaxation of these perforasomes, rather than dissolving the filler material, resolves the clinical symptoms associated with VAEs.

A Prospective, Multicenter, Evaluator-Blinded, Randomized Study of Diluted Calcium Hydroxylapatite to Treat Decollete Wrinkles.

BACKGROUND: Calcium hydroxylapatite (CaHA) dermal filler is used for a variety of aesthetic treatments; however, the safety and effectiveness of diluted CaHA for the treatment of décolleté wrinkles have not been established. OBJECTIVE: To demonstrate the effectiveness and safety of diluted CaHA (Radiesse; 1:2 CaHA:saline) injection for the improvement of décolleté wrinkles in females. METHODS: Eligible females with moderate or severe ratings on the Merz Aesthetic Scale (MAS) Decollete Wrinkles - At Rest received up to 3 injection cycles of diluted CaHA either 8 weeks apart (3 injection cycles) or 16 weeks apart (2 injection cycles). Effectiveness was evaluated by improvement on the MAS. Adverse events were recorded over a 52 week period. RESULTS: Sixteen weeks after the last treatment, the response rate (1-point improvement or greater) on the MAS Decollete Wrinkles - At Rest was 73.5% (P<0.0001; pooled sample) for all patients. The use of diluted CaHA in the decollete also demonstrated a favorable safety profile. CONCLUSIONS: Diluted CaHA is a safe and effective treatment for the improvement of decollete wrinkles in females.J Drugs Dermatol. 2024;23(7):551-556.  doi:10.36849/JDD.8261.

Fibrotic reaction to hyaluronic acid fillers in the face.

BACKGROUND: Hyaluronic acids (HAs) can have very different actions not only depending on injector and host factors but also depending on their molecular weight. Whereas short chain HA has immunological activity long chain HA influences fibroblasts and may stimulate them to produce collagen. Although this is generally thought to be a positive feature it may be disadvantageous in certain localizations. PATIENTS AND METHODS: We have encountered 23 patients who developed fibrous tissue next to the nasolabial folds accentuating them and becoming very obvious while smiling. Hyaluronidase injection did not reduce this mass. RESULTS: Intralesional triamcinolone acetonide injection led to rapid improvement. DISCUSSION: Fibrotic tissue reaction not responding to hyaluronidase may be the result of HA injection and can effectively be treated with intralesional steroid injection.

The role of oculoplastic surgeons in minimally invasive cosmetic injectables.

PURPOSE OF REVIEW: In recent years, the field of aesthetic medicine has witnessed a paradigm shift with an increasing demand for minimally invasive cosmetic procedures, including cosmetic injectables. This review aims to delineate the distinctive role played by oculoplastic surgeons in the administration of cosmetic injectables, comparing their expertise to that of nonphysician practitioners. RECENT FINDINGS: Complications arising from cosmetic injections are discussed, including skin discoloration, inflammation, necrosis, vision loss, retinal pathology, and central nervous system adverse effects. Injector expertise, patient factors, type of filler, location of injection, and management strategies are reviewed. Findings highlight diverse practitioner involvement, common adverse effects like skin necrosis and vision loss, with hyaluronic acid fillers being prominent. Areas at the highest risk for ocular complication include the glabella and nose with potential management involving dissolving fillers and reducing pressure. Emphasis is placed on expert injector selection and patient awareness. SUMMARY: The administration of cosmetic injectables requires a profound understanding of facial anatomy, vasculature, and potential complications. In contrast to nonphysician practitioners, oculoplastic and aesthetic surgeons bring a level of anatomical precision and clinical acumen that is essential for navigating the complexities of cosmetic injectables. Emphasis on training and collaboration among practitioners will be essential in advancing the field while prioritizing patient safety and satisfaction.

Male Rejuvenation: Injectables.

The use of injectables can effectively treat the areas of greatest facial esthetic concern in males. Due to significant differences in the facial anatomy of men compared to women, treatment strategy, dosage, and technique differs. This article will review the pharmacology, preparation, pertinent anatomy, technique, risks, and adverse events associated with injectable agents emphasizing unique differences in male anatomy and esthetics.

Legal analysis of South Korean cosmetic filler litigations for safer medical practices.

Cosmetic filler injections have gained popularity in recent years, but the rise in complications has led to an increase in legal disputes. This study analyzes civil court rulings related to cosmetic filler injection lawsuits in South Korea from 2007 to 2023. A retrospective case analysis was performed using a systematic database search, and a mixed-methods approach was employed for data analysis. The study examined 27 cases, revealing a high rate of liability findings against medical practitioners. Skin necrosis and blindness were the most common complications, and intravascular filler injection was recognized as negligence. Violation of informed consent was found in most cases, with mean compensation awards of ￦193,019,107 KRW ($142,831 USD) for first instance cases and ￦81,845,052 KRW ($60,564 USD) for second instance cases. The findings emphasize the importance of practitioner awareness, adherence to precautionary measures, and proactive prevention and management of complications. Collaboration among stakeholders is crucial for developing strategies that prioritize patient safety and minimize legal disputes in the aesthetic medicine industry. This study provides valuable insights for enhancing medical practices and safeguarding patient well-being in the field of cosmetic filler injections.

Complications of collagen biostimulators in Brazil: Description of products, treatments, and evolution of 55 cases.

BACKGROUND: Complications of temporary and permanent fillers have been extensively studied. However, there is a lack of comparative data regarding poly-L-lactic acid (PLLA), calcium hydroxyapatite (CaHA), and polycaprolactone (PCL) known as collagen biostimulators. AIMS: This study addressed the complications of collagen biostimulators concerning their diagnosis, type of product, treatment, and monitoring. PATIENTS/METHODS: An electronic questionnaire was sent to Brazilian dermatologic ultrasound experts to identify complications related to biostimulators. The type of biostimulator, location of application, number of vials injected, application plan, time between injection treatment and complication, injector profile, treatment, and prognosis were assessed. RESULTS: Fifty-five cases were identified, of which 49.1% were caused by PLLA-Elleva®, 23.6% by CaHA (alone or combined with hyaluronic acid), 20.0% by PLLA-Sculptra®, and 7.3% by PCL. The most affected area was the face (72.7%), with nodules being the most common clinical form (89.1%), generally occurring late (60.0%) (>1 month). Only one case was injected at an incorrect depth (musculoaponeurotic system-SMAS). Despite several treatments, including saline (45.5%), hyaluronidase (25.5%), diluted corticosteroids (23.6%), and energy-based devices (10.9%), only five cases showed complete resolution. Hyaluronidase was beneficial in complications related to fillers when there was an association of calcium hydroxyapatite with hyaluronic acid (p < 0.01). CONCLUSIONS: Complications from collagen biostimulators were more common on the face, typically manifesting about 1 month after treatment. These issues seemed to be related more to the properties of the products rather than inadequate technique. Furthermore, hyaluronidase demonstrated efficacy only in cases where there was an association with HA.

Aesthetic management of lips and perioral region with Hylacross® and Vycross® hyaluronic-acid based fillers: A document of recommendations.

BACKGROUND: Lip volumization and perioral rejuvenation with hyaluronic-acid (HA) based dermal fillers are generating increasing interest and demand. However, this topic is still having many unmet needs nowadays. This document aimed to provide tips and recommendations that may help clinicians to achieve optimal and more predictable aesthetic outcomes. METHODS: A multidisciplinary group of aesthetic medicine doctors from Spain and Portugal reviewed the tools used for assessing the patient and aesthetic outcomes, as well as the different techniques and products used in lips/perioral rejuvenation. RESULTS: The consensus panel provided specific recommendations focusing on the basic information to collect before performing the aesthetic procedure; comprehensive approach to lips/perioral region rejuvenation; clinical and aesthetic assessment tools; product and technique selection; patient profile and needs; and safety issues (complications/adverse-events). CONCLUSIONS: The rapid evolution of techniques and tools for assessing the patient and aesthetic outcomes, as well as the development of new HA-based fillers makes it necessary to update the clinical recommendations that guide the daily practice of clinicians, particularly those who have less experience with these procedures. This document addressed relevant subjects related to lip/perioral-region rejuvenation to perform the correct procedure, with the appropriate HA-based, on the right patient; to help specialists to obtain optimal and predictable aesthetic outcomes.

Efficacy of a New Hyaluronic Acid Dermal Filler on Nasolabial Folds Correction: A Prospective, Comparative, Double-Blinded Clinical Trial.

BACKGROUND: Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition. OBJECTIVE: To assess the efficacy and safety of EST LF compared with RES L for the treatment of nasolabial folds (NLFs). MATERIALS AND METHODS: In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to EST LF on one side of the face and RES L on the other side and were followed up for 9 months. The primary end point was change in WSRS score from the baseline to Month 1 (M1). Secondary end points included changes in WSRS score at other time points, aesthetic improvement, wrinkle volume quantification, adverse events, and local tolerance. RESULTS: The efficacy difference between EST LF and RES L at M1 was in favor of EST LF (-0.16, CI, -0.28 to -0.03]), demonstrating its noninferiority. Considering other time points, significant differences were observed at 3 and 6 months for EST LF , assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated. CONCLUSION: EST LF is effective and well tolerated for the treatment of NLFs.

Injectable Penile Enhancement Procedures: A Review of Agents, Risks, and Complications.

Penile dysmorphophobic disorder describes men who feel their normal penile size is inadequate. Penile fillers have been used to address penile size dissatisfaction. However, unpredictability of these procedures can yield unfavorable outcomes. Reactions to these foreign bodies are inherently uncertain, owing to an array of materials, concentrations, and biocompatibility. Management of complications also varies. As fillers are more commonly used in cosmetic procedures to augment facial features, most genitourinary surgeons are unfamiliar with these therapies. This review seeks to describe the available materials, techniques, and risk profiles of the various types of fillers used for penile augmentation.

Static and Dynamic Filler-Associated Tear Trough Deformities: Manifestations and Treatment Algorithm.

BACKGROUND: Fillers are popular substances for the correction of tear trough deformity. Despite well-documented complications increasing gradually, standardized treatment algorithm for deformity secondary to improper injection is still limited. METHODS: Between April 2020 and April 2023, a total of 22 patients with filler-associated tear trough deformity with static bulges or dynamic swells after injection of tear trough were enrolled. For patients who received hyaluronic acid (HA) and unknown fillers, hyaluronidase dissolution was performed. For patients who received non-HA fillers and unknown fillers that failed to dissolve, a magnetic resonance imaging (MRI) examination was conducted. Surgical approaches were selected based on the filler distribution and the condition of the lower eyelid. Ligament releasement and fat transposition were accomplished when fillers were excised. Aesthetic outcomes were evaluated by double-blind examiners using the Global Aesthetic Improvement Scale after patients were followed up. RESULTS: In total, the study included 3 patients with simple static deformities, 1 patient with simple dynamic, and 18 patients with both. Fourteen patients underwent transconjunctival surgery and 8 patients underwent transcutaneous surgery, among which 18 patients underwent hyaluronidase dissolution and 8 patients underwent MRI prior to surgery. A total of 4 patients with self-limited complications recovered after conservative treatment. 90.9% of patients expressed satisfaction or high satisfaction with the treatment results. CONCLUSION: Filler-associated tear trough deformities could be classified into static and dynamic deformities, which could appear separately or simultaneously. Treatment of deformities should be based on characteristics of fillers, in which MRI could serve as a promising tool. LEVEL OF EVIDENCE IV: 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.

Depth of the subcutaneous tissue in the nose: Application to filler injection.

INTRODUCTION: The nasal region plays a pivotal role in both facial esthetics and functionality. The use of volumizing fillers has emerged as a potential means to enhance nasal appearance. Preliminary findings from cadaveric studies have highlighted potential risks associated with deeper needle injection, leading to cartilage damage and lateral migration of filler material. Understanding the subcutaneous tissue depth is crucial to prevent such complications and ensure safe filler placement guided by anatomical knowledge. METHODS: This study aimed to employ ultrasonographic assessment to precisely measure the depth of soft tissue in the nasal area. Fifty-two participants without prior nasal surgery or filler injections underwent detailed ultrasonographic evaluation, focusing on seven key anatomical points: Glabellar, Sellion, Rhinion, between Rhinion and Pronasal, Pronasal, between Pronasal and Subnasal, and Subnasal. RESULTS: The ultrasonographic observation revealed varying depths of subcutaneous tissue across these points: Glabellar (4.11 ± 0.79), Sellion (5.21 ± 0.97), Rhinion (2.02 ± 0.74), Rhinion to Pronasal midpoint (6.45 ± 3.1), Pronasal (9.5 ± 2.2), between Pronasal and Subnasal (8.8 ± 0.8), and Subnasal (8.5 ± 0.5). DISCUSSION: The discussion underscores the significance of understanding subcutaneous tissue depth in guiding needle length and approach angles during filler injections. This knowledge aids in achieving effective filling while ensuring safe placement within the subcutaneous tissue.

Identifying Levels of Competency in Aesthetic Medicine: A Questionnaire-based Study.

BACKGROUND: In 2022, the US experienced a significant increase in demand for minimally invasive aesthetic procedures, underscoring its rising acceptance amid an unregulated educational environment for practitioners. The absence of standardized educational pathways and quality control in aesthetic medicine, primarily provided by nonacademic institutions, highlights a critical need for establishing educational standards to ensure practitioner competence and patient safety. OBJECTIVES: The aim of this study was to identify levels of competency for the aesthetic practitioner and necessary achievement milestones during the educational path from novice to expert injector. METHODS: A total of n = 386 international study participants responded to an online questionnaire regarding their experience in aesthetic medicine practice. The questionnaire comprised 58 questions focusing on professional data, the perceived difficulty of injection, and risk for the occurrence of adverse events for specific facial regions in soft tissue filler and toxin injections. RESULTS: Regardless of medical specialty and experience level, averages of 3.85 (1.8) years, 786.4 (2628) filler injections and 549.9 (1543) toxin injections were estimated to progress from novice to advanced injector, while averages of 6.10 (3.7) years, 1842.2 (4793) filler injections, and 1308.5 (3363) toxin injections were estimated to advance from advanced to expert injector. The nose and the perioral region have been ranked as the facial regions where it is most difficult to achieve a perfect aesthetic outcome and with the greatest risk for the occurrence of adverse events for filler and toxin injections, respectively. CONCLUSIONS: In this study we establish an educational framework in aesthetic medicine by defining the progression from novice to competent and expert injector levels, suggesting 4 years of practice and over 790 filler and 550 neuromodulator injections for competence, and at least 6 years with 1840 filler and 1310 neuromodulator injections for expertise. We also identify critical facial regions for targeted treatments by different expertise levels.

Update on Blindness From Filler: Review of Prognostic Factors, Management Approaches, and a Century of Published Cases.

Vision loss secondary to aesthetic filler treatment is a rare but disastrous complication. The aim of this review was to update the published cases of blindness after filler injection that have occurred since our group published reviews of 98 cases in 2015 and an additional 48 cases in 2019. A literature review was performed to identify all cases of visual complications caused by filler injection published between September 2018 and March 2023. The cases were analyzed independently and in combination with previously reviewed cases. Analyses were based on the number of cases with data available. A total of 365 new cases of partial or complete vision loss after filler injection were identified. The sites that were highest risk were the nose (40.6%), forehead (27.7%), and glabella (19.0%). The filler injected was hyaluronic acid in 79.6% of cases. The most common associated signs were ptosis (56.2%), ophthalmoplegia (44.1%), pain (31.2%), and skin changes (73.2%). Strokelike features were seen in 19.2% of cases. Of the cases reporting visual outcomes (318), 6.0% experienced complete vision recovery, 25.8% had partial improvement in visual acuity, and 68.2% had no vision recovery. Partially preserved visual acuity at onset was a significant predictor of visual improvement (P < .001). The 3 most common treatments were subcutaneous hyaluronidase at or near the filler site (70.1%), systemic steroids (57.3%), and intraarterial thrombolytic therapy (56.0%). No treatments were significantly associated with visual improvement (P > .05). Although blindness and stroke from fillers is a rare complication, practitioners who inject filler should have a thorough knowledge of prevention and management strategies.