Background
Cosmetic procedures are growing ever more common, and the use of soft tissue fillers is increasing. Practicing physicians need to be aware of the biological behavior of these products in ...tissue to enable them to respond to any safety concerns that their patients raise.
Objectives
To provide an overview of the metabolism of 1,4‐butanediol diglycidyl ether (BDDE)‐crosslinked hyaluronic acid (HA) dermal fillers and to examine the safety of the resulting byproducts.
Methods
A review of available evidence was conducted.
Results
After reaction with HA, the epoxide groups of BDDE are neutralized, and only trace amounts of unreacted BDDE remain in the product (<2 parts per million). When crosslinked HA, uncrosslinked HA, and unreacted BDDE degrade, they break down into harmless byproducts or into byproducts that are identical to substances already found in the skin.
Conclusion
Clinical and biocompatibility data from longer than 15 years support the favorable clinical safety profile of BDDE‐crosslinked HA and its degradation products. Given the strength of the empirical evidence, physicians should be confident in offering these products to their patients.
Combination of fillers and botulinum toxin for aesthetic applications is increasingly popular. Patient demographics continue to diversify, and include an expanding population receiving maintenance ...treatments over decades.
A multinational panel of plastic surgeons and dermatologists convened the Global Aesthetics Consensus Group to develop updated guidelines with a worldwide perspective for hyaluronic acid fillers and botulinum toxin. This publication considers strategies for combined treatments, and how patient diversity influences treatment planning and outcomes.
Global Aesthetics Consensus Group recommendations reflect increased use of combined treatments in the lower and upper face, and some midface regions. A fully patient-tailored approach considers physiologic and chronologic age, ethnically associated facial morphotypes, and aesthetic ideals based on sex and culture. Lower toxin dosing, to modulate rather than paralyze muscles, is indicated where volume deficits influence muscular activity. Combination of toxin with fillers is appropriate for several indications addressed previously with toxin alone. New scientific data regarding hyaluronic acid fillers foster an evidence-based approach to selection of products and injection techniques. Focus on aesthetic units, rather than isolated rhytides, optimizes results from toxin and fillers. It also informs longitudinal treatment planning, and analysis of toxin nonresponders.
The emerging objective of injectable treatment is facial harmonization rather than rejuvenation. Combined treatment is now a standard of care. Its use will increase further as we refine the concept that aspects of aging are intimately related, and that successful treatment entails identifying and addressing the primary causes of each.
Therapeutic, V.
The recent rapid growth in dermal filler use, in conjunction with inadequate product and injector control, has heralded a concerning increase in filler complications. The 10-point plan has been ...developed to minimize complications through careful preconsideration of causative factors, categorized as patient, product, and procedure related. Patient-related factors include history, which involves a preprocedural consultation with careful elucidation of skin conditions, systemic disease, medications, and previous cosmetic procedures. Other exclusion criteria include autoimmune diseases and multiple allergies. The temporal proximity of dental or routine medical procedures is discouraged. Insightful patient assessment, with the consideration of ethnicity, gender, and generational needs, is of paramount importance. Specified informed consent is vital due to the concerning increase in vascular complications, which carry the risk for skin compromise and loss of vision. Informed consent should be signed for both adverse events and their treatment. Product-related factors include reversibility, which is a powerful advantage when using hyaluronic acid (HA) products. Complications from nonreversible or minimally degradable products, especially when layered over vital structures, are more difficult to control. Product characteristics such as HA concentration and proprietary cross-linking should be understood in the context of ideal depth, placement, and expected duration. Product layering over late or minimally degradable fillers is discouraged, while layering of HA of over the same brand, or even across brands, seems to be feasible. Procedural factors such as photographic documentation, procedural planning, aseptic technique, and anatomical and technical knowledge are of pivotal importance. A final section is dedicated to algorithms and protocols for the management and treatment of complications such as hypersensitivity, vascular events, infection, and late-onset nodules. The 10-point plan is a systematic, effective strategy aimed at reducing the risk of dermal filler complications.
Delayed reactions after facial hyaluronic acid injection are relatively rare complications. Their cause may be infectious or immune-mediated in origin, and their outbreak can be triggered, for ...example, by an influenza-like illness.
To describe potential adverse event of influenza like illness following dermal filler injection.
We report fourteen unusual cases of delayed hypersensitivity reaction to several brands of hyaluronic acid dermal filler following influenza like illness.
Increasing evidence implicates influenza infection in the pathogenesis of late onset filler reaction.
Although there is a low risk of late onset adverse reaction with hyaluronic acid fillers, injecting physicians must be aware of the possible filler reaction following the influenza infection.
Background
OnabotulinumtoxinA (onabotA) is indicated for upper facial lines (UFL). Fear of unnatural‐looking outcomes is a frequently reported treatment barrier.
Aims
Examine patient‐reported ...outcomes (PROs) after onabotA treatment for UFL.
Methods
A post hoc analysis was conducted on two 12‐month pivotal studies of onabotA for forehead and glabellar lines (20 U each), with/without treatment of crow's feet lines (±24 U). This analysis used PROs from the Facial Line Satisfaction Questionnaire: Items 4 (natural look), 5 (treatment effect), 11 (met expectations), and Impact Domain (appearance and psychological impact). The analysis included 458 neurotoxin‐naive adults achieving a ≥2‐grade improvement in forehead line (FHL) severity on the Facial Wrinkle Scale at Day 30 (primary endpoint). Corrections made on 28 December 2023, after first online publication: ‘UFL’ in the previous sentence has been corrected to ‘forehead line (FHL)’ in this version. Data were further stratified into millennials and men.
Results
At Day 30, 90.5% of all participants, 94.6% of millennials, and 85.7% of men were satisfied with receiving a natural look. Millennials had higher odds of being satisfied with natural outcomes at Day 30. This measure remained > 80% for all groups throughout the 12 months. Additionally, ≥80% were satisfied with the treatment effect, and >90% reported results met expectations. At Day 30, ≥50% reported positive impacts on self‐perceived appearance and psychological well‐being, but millennials had higher, and men had lower odds of reporting these improvements.
Conclusions
Participants achieving a ≥2‐grade improvement in FHL severity after onabotA reported high satisfaction with natural outcomes and the treatment effect, with improved self‐perceived appearance and psychological well‐being. Corrections made on 28 December 2023, after first online publication: ‘UFL’ in the previous sentence has been corrected to ‘FHL’ in this version. These results may help aesthetic providers and patients address fears regarding unnatural results with onabotA.
BACKGROUND:With onabotulinumtoxinA approved for the treatment of glabellar and crow’s feet lines and, most recently, for forehead lines (FHL), it is possible to simultaneously treat multiple areas of ...the upper face that are of high concern and treatment priority for aesthetically oriented individuals. This review aims to present key insights on the use of onabotulinumtoxinA for the treatment of moderate to severe FHL.
METHODS:Double-blind, placebo-controlled registration trials of onabotulinumtoxinA for the treatment of FHL were included. Using findings from 3 such published studies, we discuss key concepts and clinical experience for the treatment of moderate to severe FHL with onabotulinumtoxinA (20 U in the frontalis and 20 U in the glabellar complex, with/without 24 U in crow’s feet lines), including injection pattern, dose selection, efficacy and safety data, and considerations for patient selection.
RESULTS:Across the 2 pivotal phase 3 studies, responder rates on investigator- and subject-assessed measures of appearance of FHL severity were significantly higher with onabotulinumtoxinA versus placebo for the treatment of FHL at day 30 (P < 0.0001), and results were maintained through 3 cycles of onabotulinumtoxinA.
CONCLUSIONS:OnabotulinumtoxinA treatment also resulted in high patient satisfaction rates. The incidence of eyebrow and of eyelid ptosis was low, and no new safety signals were detected. OnabotulinumtoxinA is safe and effective and an appropriate option for patients with moderate to severe FHL encountered in clinical practice.
BACKGROUND
A smooth, cohesive, 24‐mg/mL hyaluronic acid (HA) gel with uniform consistency, even flow characteristics, and extended duration was designed for injection into the mid to deep dermis.
...OBJECTIVE
To compare injection pain of a HA gel with preincorporated lidocaine with that with a non‐lidocaine formulation.
METHODS & MATERIALS
This double‐blind study at three centers enrolled 60 subjects, injected with both products, randomly assigned to left or right nasolabial fold. The injecting physician assessed severity of pain and ease of injection. Subjects used a visual analog scale (0–10) for pain assessment. Adverse events were recorded.
RESULTS
Physician assessment of injection pain was none or mild in 81% of HA gel injections with preincorporated lidocaine and 36% of HA‐alone injections (p<.001). Mean pain assessment by subjects was 3.6 for HA+lidocaine and 5.8 for HA alone (p<.001). Ninety‐five percent of the injections were considered easy or very easy; a greater percentage of HA+lidocaine injections were rated very easy. Mild to moderate adverse events were reported for both products.
CONCLUSION
The smooth, cohesive HA gel with preincorporated lidocaine increased subject comfort during treatment and improved the injection experience.
Abstract
This split-face, single-blind study compared the comfort and ease of injection of a new hyaluronic acid facial filler containing pre-incorporated lidocaine (Juvéderm® ULTRA 3) versus the ...established hyaluronic acid facial filler Restylane-Perlane®. A total of 126 individuals were treated with both products, randomly assigned to the right or left naso-labial fold. Injector assessment-indicated mean injection pain, pain of massaging the injected area and post-injection discomfort (based on a scale of 0=no pain to 10=extreme pain) were 2.1, 0.9 and 0.4 for Juvéderm ULTRA 3, and 4.1, 3.3 and 1.7 for Restylane-Perlane, respectively (p<0.0001). Patient assessment of the same parameters were 2.8, 1.3 and 0.4 for Juvéderm ULTRA 3, and 4.9, 3.6 and 1.8 for Restylane-Perlane (p<0.0001). Injectors indicated that 92% of Juvéderm ULTRA 3 injections were 'very easy', compared with 21% for Restylane-Perlane. Post-treatment smoothness was comparable, but 95% of individuals preferred Juvéderm ULTRA 3 for overall injection comfort. A total of 95% of individuals indicated that Juvéderm ULTRA 3 was a more comfortable and gentle experience.
BACKGROUND:Delayed-onset adverse reactions to hyaluronic acid (HA) fillers are uncommon but have received increased attention, particularly with regard to late-onset nodules. Globally, there is a ...need for comprehensive prevention and management strategies.
METHODS:Experts with clinical practices in diverse regions of the world and extensive experience in managing complications related to HA fillers convened to propose and evaluate approaches to prevent delayed-onset adverse reactions after HA filler administration and manage late-onset nodules.
RESULTS:The expert panel agreed to define delayed-onset adverse reactions as those presenting more than 4 weeks posttreatment, with swelling, induration, and nodulation being the most common clinical signs. The panel recommended 5 general key approaches for the prevention of delayed-onset reactions (patient selection, anatomic location of injection/product selection, aseptic technique, injection procedure/filler, and posttreatment care). Strategies recommended for managing late-onset nodules included oral antibiotics, oral steroids, nonsteroidal anti-inflammatory drugs if needed, hyaluronidase for noninflammatory nodules (recognizing the limitations and regional availability of this treatment), intralesional antibiotics, intralesional immunosuppressive drugs such as steroids and fluorouracil, and surgical excision as a last resort. The panel noted that late-onset nodules may vary in both clinical presentation and etiology, making them challenging to address or prevent, and stressed individualized treatment based on clinical presentation. Regional differences in aseptic protocols, antibiotic selection, and steroid formulations were described.
CONCLUSION:Insights from global experts on approaches to prevent and manage delayed-onset adverse reactions following HA filler administration, including late-onset nodules, support clinicians worldwide in optimizing patient outcomes and safety.
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