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.

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.

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.

Nasal filling guided by high frequency ultrasound: Reducing risks.

BACKGROUND: Given the significant increase in the quantity of cosmetic procedures utilizing hyaluronic acid fillers, including in the nasal region, the initial evaluation of patients using high frequency ultrasound becomes a crucial instrument in evaluating and handling nonsurgical rhinoplasty. AIMS: The aim of this article is to introduce an assessment methodology for nasal filling guided by high frequency ultrasound. PATIENTS/METHODS: A prospective and single-center study was conducted with 12 Latin American patients. The patients underwent nasal filling with hyaluronic acid following high power ultrasound mapping. RESULTS AND CONCLUSIONS: In the evaluation of the GAIS scale, all patients reported improvement with the treatment. No infections, nodules, ischemia, or other relevant adverse effects were noted. Real-time ultrasound-guided filler techniques have been developed to reduce the risk of vascular compromise, confirming the distribution pattern of blood vessels. It's also crucial to visualize the cannula at the same moment as the vessels, even if the previous vascular mapping was performed. Therefore, the utilization of high frequency ultrasound can act as a pivotal tool in augmenting procedure safety.

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.

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.

Long-term duration and safety of Radiesse (+) for the treatment of jawline.

BACKGROUND: Calcium hydroxyapatite (CaHA)-carboxymethylcellulose (CMC)+ has unique properties that make it optimal for lifting, contouring, and defining the jawline. This long-term follow-up of a randomized, multicenter, rater-blinded trial reports efficacy and safety of CaHA-CMC(+) through 48 and up to 60 weeks post-treatment. METHODS: Eligible patients were randomized (2:1) to the treatment or the control/delayed treatment group to receive CaHA-CMC(+) injections in both jawlines. While touch-ups were permitted 4 weeks post-treatment for both groups, only the treatment group was eligible for optional retreatment after 48 weeks. The primary outcome was ≥1-point improvement on both jawlines on the Merz Jawline Assessment Scale (MJAS); secondary endpoints included the Subject Global Aesthetic Improvement Scale (SGAIS) among others. Post hoc analysis included pooling up to 48-week data from the combined treatment and control/delayed groups and 60-week data for the treatment group. RESULTS: Overall, 175 received treatment. MJAS responder rates were 77.9%, 78.7%, and 62.9% at 12, 24, and 48 weeks post-treatment, respectively. Responder rate on the MJAS at 60 weeks was 74.6% for those who received retreatment and 43.5% for those patients who received only the initial and touchup treatments. SGAIS scores demonstrated 93.4%, 85.6%, and 68.5% of patients rated themselves very much improved after 12, 24, and 48 weeks, respectively. Adverse events consisted of procedure or CaHA-CMC(+)-related events that were mostly resolved and overwhelmingly mild. CONCLUSIONS: CaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03583359.

Singular entry point technique for forehead and temple filler augmentation: Anatomical and clinical perspectives.

BACKGROUND: The depressed volume of the forehead and temple is resolved by filler injection. However, the current method has the potential to cause pain and side effects in patients, depending on the skill of the clinician. Therefore, this study proposes a new method for safer and simpler injection using only one injection entry point. METHODS: Using the novel injection method, the filler was injected into the forehead and temple regions in three unembalmed cadavers and two healthy Korean volunteers. The cannula and filler locations were identified using dissection, ultrasonography, and three-dimensional (3D) scanning. RESULTS: Ultrasonographic images and dissection results showed that the filler injected into the cadavers was in the target layer. The cannula and filler were located on the layer as the supraperiosteal layer on the forehead and the supra deep temporal fascia layer in the temple. Finally, 3D scanning images showed that the filler was injected precisely and effectively into the forehead and temples of the volunteer who underwent the procedure. CONCLUSIONS: This method can reduce pain and minimize externally visible wounds caused by injections. The injected filler was naturally connected from the forehead to the temple and maintained for around 3 months. Additionally, it is possible to inject fillers into the forehead and temple at a constant and safe depth without requiring specific skills. It is expected that this method will become a universal method because it minimizes the burden on both patients and clinicians.

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.

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.

Permanent makeup: A review of its technique, regulation, and complications.

Permanent makeup (PMU) is a popular form of tattooing used to replace or enhance the use of daily makeup. The purpose of this literature review is to provide an overview of PMU, with a particular focus on its use, regulation, and potential complications reported in the literature. In the United States, there is significant variation in the regulation and training required to perform PMU. Adverse outcomes of PMU include infectious, allergic, and inflammatory complications. These complications may be more common if proper hygiene and aftercare practices are not followed. Cosmetically, PMU may shift or have an altered appearance if the underlying skin is treated with cosmetic fillers or local anesthetics. Given the popularity of PMU and its cosmetic uses, dermatologists should be aware of the PMU industry, potential complications, and how best to manage complications.

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.

Resolve and dissolve-An ultrasound-guided investigation on the effects of hyaluronidase on different soft tissue fillers.

BACKGROUND: Nonsurgical cosmetic procedures, particularly the use of hyaluronic acid (HA)-based soft tissue fillers, are becoming increasingly popular. This trend has catalyzed the development of a plethora of HA-based products differing in product characteristics, thereby catering to an ever-widening spectrum of aesthetic applications. However, complications rise concomitant with the increasing number of procedures. Among the strategies to manage such adverse events is the enzymatic breakdown with hyaluronidase. OBJECTIVE: To analyze the response of different HA-based soft tissue filler materials to hyaluronidase injections. METHODS: A total of 11 different HA-based soft tissue fillers were evaluated using noninvasive ultrasound imaging to assess their behavior in response to hyaluronidase injections. The HA-based soft tissue fillers were categorized according to their product characteristics into a structuring, volumizing, and lip volumizing group. Standardized injections of 0.2 cc were performed in chicken breast to simulate human tissue. Ultrasound measurements of width, height, and calculated volume were performed immediately after filler injection, 1 h and 24 h following hyaluronidase injection. RESULTS: Regardless of the soft tissue filler analyzed, the most significant volume reduction occurred within the first h after applying hyaluronidase, with a 64.1% decrease from the initial volume. After 24 h, the total volume reduction reached 81.7%. No statistically significant differences were found when comparing the three groups at each follow-up time period, except for the height measurement after 1 h. While width was statistically significant in all groups between the investigated follow-up groups, the volume reduction was only statistically significant in the groups with the highest and second highest G' values (i.e., Group 1-structuring, Group 2-volumizing). CONCLUSION: The effectiveness of hyaluronidase in dissolving HA-based fillers is initially independent of product characteristics of HA-based fillers such as G-prime, with increased efficacy in fillers with higher G-prime values, as evidenced by significant volume reductions in such groups.

Profiloplasty and facial contouring with injectables: A holistic, practical, and user-friendly approach.

BACKGROUND: Expansion of the aesthetic treatment armamentarium with novel injectable products has greatly improved our ability to reshape and enhance the facial profile. However, full-face "profiloplasty" with injectables remain a nascent concept and is insufficiently considered in daily practice. While techniques have been widely published for treating the individual facial areas that constitute an attractive profile-including the forehead, nose, lips, jawline, and chin-the literature remains fragmented on more universal methods for profile improvement. AIMS: To collate disparate knowledge on profile optimization with injectables, and define a holistic, practical, and user-friendly approach to profiloplasty and facial contouring. METHODS: Consideration is given to key anatomical aspects and the changes that occur with age; patient assessment parameters for planning profiloplasty; and the technical specifications, product selection, and essential safety considerations for minimizing the risk of complications and optimizing the effectiveness of treatment. RESULTS: Relevant case studies are presented. CONCLUSIONS: Holistic approaches of this type are essential if we are to maximize the potential of full-face treatment with injectables-both now and in the future.