Rhoda S. Narins

Liquid injectable silicone: a review of its history, immunology, technical considerations, complications, and potential.

Summary: For over five decades, liquid injectable silicone has been used for soft-tissue augmentation. Its use has engendered polarized reactions from the public and from physicians. Adherents of this product tout its inert chemical structure, ease of use, and low cost. Opponents of silicone cite the many reports of complications, including granulomas, pneumonitis, and disfiguring nodules that are usually the result of large-volume injection and/or industrial grade or adulterated material. Unfortunately, as recently as 2006, reports in The New England Journal of Medicine and The New York Times failed to distinguish between the use of medical grade silicone injected by physicians trained in the microdroplet technique and the use of large volumes of industrial grade products injected by unlicensed or unskilled practitioners. This review separates these two markedly different procedures. In addition, it provides an overview of the chemical structure of liquid injectable silicone, the immunology of silicone reactions within the body, treatment for cosmetic improvement including human immunodeficiency virus lipoatrophy, technical considerations for its injection, complications seen following injections, and some considerations of the future for silicone soft-tissue augmentation.

Calcium hydroxylapatite (Radiesse) for correction of the mid- and lower face: consensus recommendations.

Summary: Restoring volume in the middle and lower portions of the face is becoming an indispensable component of modern facial rejuvenation. Radiesse (BioForm Medical, San Mateo, Calif.) is an injectable filler material composed of synthetic calcium hydroxylapatite microspheres (30 percent) suspended in an aqueous carrier gel (70 percent). At present, Radiesse is indicated in the United States for correction of moderate to deep nasolabial folds and for correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Its off-label use in other facial aesthetic indications is widely reported in the literature. The ability of Radiesse to provide immediate and durable effects has fueled interest in its use for expanded aesthetic applications, particularly in the middle and lower face. The authors’ consensus panel, consisting of a cross-section of experts in plastic surgery, facial plastic surgery, and dermatology, was convened to review the scientific literature and compare clinical experiences regarding the use of calcium hydroxylapatite. This report describes the characteristic effects of aging in the middle and lower face and reviews the composition of calcium hydroxylapatite, its safety and durability, and its appropriate use in a variety of facial applications, including nasolabial folds, correction of human immunodeficiency virus–associated lipoatrophy, augmentation of the malar, submalar, and zygomatic regions, and correction of oral commissure defects, marionette lines, and prejowl sulcus. Recommendations for Radiesse use in each area, including anesthesia, and injection techniques are provided. Measures for enhancing patient comfort, anticipating and minimizing potential complications, and optimizing aesthetic results are also discussed.

Evaluation of Variable-Dose Treatment with a New U.S. Botulinum Toxin Type A (Dysport) for Correction of Moderate to Severe Glabellar Lines: Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study

Background: In April, the U.S. Food and Drug Administration approved a new U.S. formulation of botulinum neurotoxin type A (Dysport; Medicis Aesthetics, Inc., Scottsdale, Ariz.). This formulation has demonstrated inhibition of glabellar lines at a 50-unit dose. Standard clinical practice is to adjust the dose based on muscle mass. Methods: Patients stratified by race/ethnicity were randomized to receive a single treatment of Dysport administered in various doses or placebo. Dysport was administered in a total volume of 0.4 to 0.6 ml for women (50, 60, or 70 units) and 0.5 to 0.7 ml for men (60, 70, or 80 units), based on procerus/corrugator muscle mass. Efficacy was assessed by a blinded evaluator and patient self-evaluation on days 14, 30, 60, 90, 120, and 150 after treatment. Results: At day 30, 85 percent and 87 percent of Dysport-treated patients were responders as assessed by blinded evaluator and patient self-evaluation, respectively, compared with 3 percent and 5 percent of placebo-treated patients, respectively (p < 0.001). Median duration of effect was 109 days for Dysport versus 0 days for placebo (blinded evaluator) and 107 days for Dysport versus 0 days for placebo (patient self-evaluation). Response and duration of action were slightly higher in African American patients. The majority of treatment-emergent adverse events were mild or moderate in severity. Conclusion: A single treatment with Dysport, with the dose based on gender and muscle mass, is well tolerated and provides a greater and longer-lasting improvement in glabellar lines compared with placebo.

Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler.

BACKGROUND The porcine collagen–derived dermal filler Dermicol-P35 (Evolence, Colbar LifeScience Ltd, Herzliya, Israel) has low immunogenicity and the potential to provide a long-lasting corrective response for soft-tissue contour deficiencies and deformities. OBJECTIVE The objective was to assess the persistence of the corrective response with Dermicol-P35 up to 12 months after obtaining an optimal cosmetic result (OCR) in a randomized, multicenter study comparing the efficacy and safety of Dermicol-P35 with the hyaluronic acid (HA) filler Restylane (Medicis Pharmaceutical Co.). METHODS & MATERIALS Subjects with moderate to deep nasolabial wrinkles (n=149) were randomized to injections of either Dermicol-P35 or HA on one side of the face and the alternative preparation on the contralateral side. If necessary, one touch-up injection could be given after 2 weeks to obtain an OCR. RESULTS Although the mean Modified Fitzpatrick Wrinkle Scale score increased gradually after achieving the OCR with Dermicol-P35, 95.3 and 76.5% of subjects, respectively, met the criteria for persistence of the corrective response after 9 and 12 months. Persistency rates were similar regardless of the requirement for a touch-up injection at Week 2. No unexpected, severe, or serious injection-related adverse events were experienced. CONCLUSION The effectiveness of Dermicol-P35 appears to be maintained for up to 1 year after achieving an OCR, both for touch-up and for non–touch-up subjects.

Validated Assessment Scales for the Lower Face

Background Aging in the lower face leads to lines, wrinkles, depression of the corners of the mouth, and changes in lip volume and lip shape, with increased sagging of the skin of the jawline. Refined, easy‐to‐use, validated, objective standards assessing the severity of these changes are required in clinical research and practice. Objective To establish the reliability of eight lower face scales assessing nasolabial folds, marionette lines, upper and lower lip fullness, lip wrinkles (at rest and dynamic), the oral commissure and jawline, aesthetic areas, and the lower face unit. Methods and Materials Four 5‐point rating scales were developed to objectively assess upper and lower lip wrinkles, oral commissures, and the jawline. Twelve experts rated identical lower face photographs of 50 subjects in two separate rating cycles using eight 5‐point scales. Inter‐ and intrarater reliability of responses was assessed. Results Interrater reliability was substantial or almost perfect for all lower face scales, aesthetic areas, and the lower face unit. Intrarater reliability was high for all scales, areas and the lower face unit. Conclusion Our rating scales are reliable tools for valid and reproducible assessment of the aging process in lower face areas.

Recommendations and Treatment Options for Nodules and Other Filler Complications

&NA; The authors have indicated no significant interest with commercial supporters in regards to this article.

Persistence and improvement of nasolabial fold correction with nonanimal-stabilized hyaluronic acid 100,000 gel particles/mL filler on two retreatment schedules: results up to 18 months on two retreatment schedules.

BACKGROUND Nonanimal-stabilized hyaluronic acid (NASHA) fillers are frequently used for facial soft tissue augmentation. Their long-term efficacy and the effects of different retreatment schedules are not well established. OBJECTIVE This is an 18-month interim analysis of a 30-month study to evaluate the efficacy and persistence of NASHA 100,000 gel particles/mL filler with two different retreatment schedules. METHODS This multicenter, randomized, evaluator-blinded study enrolled 75 patients with moderate to severe nasolabial folds. Patients were randomized to retreatment of one nasolabial fold at 4.5 months and the contralateral fold at 9 months after correction of both folds at the initial visit. RESULTS Wrinkle Severity Rating Scale scores improved significantly (p<.001) from baseline, with mean improvements ranging from 1.1 to 1.7 grades. Almost all patients (97%) responded satisfactorily, and the efficacy of the retreatment schedules did not differ significantly. Adverse events, primarily swelling and bruising, occurred in 33% of patients; none were serious. CONCLUSION The improvements seen after initial treatment with NASHA 100,000 gel particles/mL filler persisted for up to 18 months with one retreatment. The response was equivalent for retreatment at 4.5 and 9 months.

Cryopreservation of Human Fat for Soft Tissue Augmentation: Viability Requires Use of Cryoprotectant and Controlled Freezing and Storage

BACKGROUND Autologous fat transfer for soft tissue augmentation has been increasing in recent years. Graft longevity may vary greatly from patient to patient, requiring repeat procedures, often using frozen adipose tissue. Storage usually involves placing syringes of fat directly into a -20 degrees C freezer. However, the viability of fat frozen in this way is controversial. OBJECTIVE This study tested methods for the optimal storage of adipose tissue harvested by tumescent liposuction. MATERIALS AND METHODS Aliquots of washed adipose tissue were frozen directly at -20 degrees C or mixed with cryoprotectants, frozen at 1 degree C/min, and subsequently stored in liquid nitrogen vapor phase. Aliquots were subsequently thawed, and adipocyte viability was determined by staining and culture methods. RESULTS Viability of adipocytes frozen at -20 degrees C was very low when analyzed by staining, and no cultures could be established from any of the specimens. In contrast, viable adipocytes were recovered from samples that were controlled-rate frozen in the presence of cryoprotectants and stored in nitrogen vapor. CONCLUSION. Our results indicate that fat frozen at -20 degrees C is not viable and thus provides no advantage over inert fillers. The methods here described could readily be transferred to the clinical setting after further laboratory study.

A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles

BACKGROUND Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable, biocompatible polymer device. OBJECTIVE We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles. METHODS In this randomized, evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals). Wrinkle Assessment Scale scores were calculated at screening; posttreatment week 3; months 3, 6, 9, and 13 (injectable PLLA or collagen groups); and months 19 and 25 (injectable PLLA group). Safety data were obtained from subject interviews and case report forms. RESULTS Injectable PLLA significantly improved mean Wrinkle Assessment Scale scores (all time points, P < .001). Improvements (up to 25 months after last treatment) were significantly greater (P < .001) than with collagen for posttreatment months 3 to 13. LIMITATIONS Mostly white women and subjects with Fitzpatrick skin types II and III were included. CONCLUSION Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.

Overtreatment effects associated with a radiofrequency tissue-tightening device: rare, preventable, and correctable with subcision and autologous fat transfer.

Device complication rates were analyzed in the Regulatory and Quality Assurance departments of Thermage, Inc., Hayward, CA, USA, in consultation with Dr. Whitney D.Tope. Corrective treatment in the case study was performed at the Dermatology Surgery and Laser Center, White Plains, NY.