Steven Fagien

Treatment of Injectable Soft Tissue Filler Complications

BACKGROUND Increasing use of dermal fillers, especially with the U.S. introduction of long‐term and permanent fillers, is expected to increase the number of complications seen after treatment with these materials. OBJECTIVES To provide physicians with an overview for treatment of dermal filler complications. RESULTS Complications of dermal filler use can be treated successfully based on a firm understanding of the mechanisms and limitations of filler action and wound healing. Complications can be classified as immediate, early, or delayed onset; available treatment options are presented. CONCLUSION Short‐ and long‐term dermal fillers are increasingly becoming popular treatment options for signs of facial aging. Complications, although not common, can be treated effectively and excellent outcomes achieved. Dr. Sclafani is on the Speakers Panel for Medicis. Dr. Fagien is a consultant for Allergan, Bioform, and Medicis. He is also a clinical investigator for Allergan, Dermik, Medicis, and Mentor.

Botox for the treatment of dynamic and hyperkinetic facial lines and furrows : Adjunctive use in facial aesthetic surgery

Our improved understanding of the pathophysiology of facial lines, wrinkles, and furrows has broadened the treatment options for a variety of facial cosmetic blemishes. The persistence or recurrence of certain facial rhytids after surgery has confirmed the lack of full comprehension of their origin. Glabellar forehead furrows (frown lines) and lateral canthal rhytids (crow’s feet) have been the most popular facial lines that have been shown to be mostly the result of regional hyperkinetic muscles, and their eradication may be more suitable, at times, to chemodenervation than to soft-tissue fillers, skin resurfacing, or surgical resection. Aesthetic surgical procedures that have yielded suboptimal results may also occur from failure to recognize other causative factors including hyperkinetic or dynamic musculature, which may contribute to etiology of the visible soft-tissue changes and lack of persistent effect after surgery. Chemodenervation with botulinum toxin A (Botox) has proven to be useful both as a primary treatment for certain facial rhytids and as an adjunctive agent for a variety of facial aesthetic procedures to obtain optimal results.Although this article was published in 1999, its discussion of the cosmetic use of botulinum toxin remains accurate and pertinent in 2003. Dr. Fagien, a pioneer in the field of chemodenervation for the effacement of facial rhytides, is thorough in his explanation of botulinum toxin type A, or Botox (Allergan, Inc., Irvine, Calif.), and its applications, from its mechanism of action to its use in various regions of the face to potential complications and pitfalls. Since the original publication of this article, the U.S. Food and Drug Administration has approved the use of botulinum toxin for the treatment of glabellar rhytides, as it has been proven both safe and effective.1 It is only a matter of time before its use is approved in other regions of the face and neck; however, for now, its use in areas other than the glabellar region remains “off-label.”2 Our techniques for performing Botox injections are similar to those of Dr. Fagien. We take the same precautions to ensure proper storage and handling, which (as emphasized in the article) are just as important as proper injection technique. Careful reconstitution using nonpreserved saline and avoidance of turbulence and foaming are paramount. Our dilution (4 cc per vial to yield a concentration of 2.5 U/0.1 cc), which is identical to Fagien’s, provides for low volumes and high concentrations, therefore limiting spread of the toxin and subsequent adverse effects. We have also found a decrease in effectiveness and potency beyond 3 to 4 days. We routinely attempt to use the entire vial within 48 hours of reconstitution. Several key points mentioned within the article deserve added emphasis. As Dr. Fagien has pointed out, a thorough understanding of the underlying facial mimetic musculature is fundamental to the treatment of the resultant rhytides. The thickness of the muscles and their proximity to adjacent structures (including other muscles, vessels, and nerves) play major roles in the technique of injection. Specifically, certain areas require deeper injection to have maximal effect (i.e., frontalis and corrugator muscles), while others require more superficial injections (e.g., the orbicularis oculi). Electromyographic studies have demonstrated that the toxin can spread by diffusion to an area up to 3 cm or more from the injection site,3,4 so we recommend accurate intramuscular injection in most cases. Knowledge of this anatomy not only benefits the patients by giving them the most effective, long-lasting aesthetic result but also helps avoid complications, such as hematoma and ecchymosis (especially in the lateral canthal area, where the venous plexus is more dense). In addition, we use ice to help diminish swelling and ecchymosis at the site of injection (especially around the perioral area), and we are careful to avoid massage of the injection site, as this can cause unwanted migration and diffusion of the toxin. Another key point to emphasize is the use of Botox in cosmetic shaping. Fagien’s use of Botox in the brow region has been expanded in recent years, and in some cases, it has been used as a “chemical” brow lift.5 Although the ability to shape the brow contour is neither as directed nor as powerful as traditional surgical approaches, it remains a very effective means

Algorithm for canthoplasty: the lateral retinacular suspension: a simplified suture canthopexy.

Results of aesthetic lower eyelid surgery have improved through a better understanding of the anatomy, indications for surgery, and more effective, individualized solutions for the varied problems. Most treatment options have the potential risk of inducing lower eyelid malposition if support is not applied through either canthoplasty or canthopexy. An algorithm for selecting the most appropriate method of canthal support in lower eyelid and midfacial rejuvenation is presented. A new, simplified, effective, and aesthetic suture canthopexy, the transpalpebral lateral retinacular suspension, is introduced; it can be universally applied.

advanced Rejuvenative Upper Blepharoplasty: Enhancing Aesthetics of the Upper Periorbita

The surgical approach to rejuvenation of the periorbita continues to evolve with the application of procedures that are safe and effective with a greater sensitivity of aesthetics. Most of the topics in the recent literature discuss improvements with techniques relating to the lower eyelid and midface. Improved surgical techniques of the upper periorbita have been mostly limited to advances in brow lifting. The most common and traditional approach to upper blepharoplasty has remained essentially unchanged and has not considered, to the same degree as in the lower periorbita, the actual changes that occur with age or more accurate surgical approaches toward rejuvenation. The author presents an overview of his personal view of the concepts relating to the aging upper periorbita and discusses his experiences with this procedure.

Facial soft-tissue augmentation with injectable autologous and allogeneic human tissue collagen matrix (autologen and dermalogen).

Facial soft-tissue augmentation has become increasingly popular as an option for those patients in whom age-related changes manifest as contour defects or who desire volume enhancement for various areas of the face. A variety of agents and techniques are currently available that, when used appropriately, can improve or correct facial rhytids and regional volume depletion. Failures of some agents are due to reduced biocompatibility, inadequate administration technique, or failure to match the actual underlying defeat with the most appropriate solution. Dermal soft-tissue augmentation with human tissue collagen matrix (Autologen and Dermalogen) is physiologic, appears to be ultimately safe and effective, and has many qualities consistent with an ideal dermal filler. Several autologous, allogeneic (cadaver-derived), heterologous, and alloplastic agents will be discussed in this article with regard to rationale, patient selection, optimum administration technique, and persistence.

A comprehensive review of patient-reported satisfaction with botulinum toxin type a for aesthetic procedures.

Background: The success of any medical procedure can be measured in many ways. Patient-reported outcomes, specifically those related to the patients personal satisfaction, are among the most important measures of success in aesthetic treatments. This analysis assessed satisfaction with botulinum toxin type A treatment in aesthetic indications and identified approaches to help optimize clinical outcomes. Methods: For this comprehensive, evidence-based review, electronic databases were searched for clinical trials, meta-analyses, or randomized controlled trials examining patient satisfaction following botulinum toxin type A aesthetic treatments. Reference lists and meeting/conference abstracts were also inspected to ensure capture of relevant literature. Inclusion and exclusion criteria were established a priori. Twenty-three articles met all inclusion criteria and were analyzed in detail. Results: Studies were highly heterogeneous in the methods used to assess satisfaction. Most utilized Likert-type scales and included other patient-reported outcomes as well as satisfaction. The majority were done in the glabellar area. Nevertheless, patient satisfaction with botulinum toxin type A treatment was consistently and significantly high, typically ranging from more than 65 percent to more than 90 percent, depending on facial area treated, dose, assessment, and other treatment specifics. Treatment also significantly improved patient self-perceptions and reduced perceived age relative to current age by approximately 5 years. Preliminary data suggest that patient satisfaction may improve when botulinum toxin type A is combined with other treatment modalities and when multiple areas of the face, rather than a single area, are treated. Conclusions: Regardless of facial area studied or the specific assessment scale, patient satisfaction with botulinum toxin type A treatment is consistently high, and patient-reported outcomes indicate significant improvement.

Role of new fillers in facial rejuvenation: A cautious outlook

A major shift in facial rejuvenation is well under way. According to statistics published recently by the American Society of Plastic Surgeons, total cosmetic plastic surgery procedures increased 393 percent from 1992 to 2002.1 There has been a nearly two-fold increase in the number of face lifts (from 40,077 to 73,562) and a nearly three-fold increase in the number of forehead lifts (from 13,501 to 37,199). There were also significant increases in nonsurgical procedures during the same time frame: a four-fold increase in fat injections (7,865 to 32,418), almost a two and one-halffold increase in collagen injections (41,623 to 98,092), a four-fold increase in chemical peels (19,049 to 85,379), and 350,469 injections of botulinum toxin type A (no data are available from 1992, as few plastic surgeons were injecting botulinum toxin type A for cosmetic purposes before that time). The numbers reflect the shift in patients’ desires for facial rejuvenation: less invasiveness, less downtime, less pain. Another shift in facial rejuvenation has come by way of what is considered the ideal facial aesthetic. We know that facial aging is caused by much more than mere descent from the effects of gravity. It is also caused by a loss of volume from fat, muscle,2,3 and skeletal atrophy and by chronic animation.4 Therefore, the use of fillers as an adjunct to both surgical and nonsurgical facial rejuvenation techniques is logical and effective in restoring a youthful appearance by helping to “lift and fill.” We have moved away from the pulled back “operated look” and toward one of conservative skin excision, deep fascial–superficial musculoaponeurotic system manipulation,5 volume restoration,6 and modification of facial animation (via chemodenervation).4 Traditional facelifting procedures alone cannot effectively reverse the atrophy of facial soft tissues that occurs naturally with aging. Soft-tissue augmentation dates back more than 100 years,7 and yet the search for the ideal filler continues. The most popular nonpermanent injectables in the United States at present are the bovine collagens and fat (Table I), primarily because of availability and limited options. Bovine collagens (i.e., Zyderm and Zyplast from Inamed Corporation, Santa Barbara, Calif.) have been the mainstay in the treatment of static facial rhytids8,9 because of their generally forgiving nature, ease of injection, and reduced dependency upon accuracy (less sensitive to technique). With the use of these agents, facial lines are improved on the basis of low-grade focal inflammation. Procedures are usually performed in an office setting, where a diluted mixture of lidocaine is added to these agents to reduce the pain of injection that begins to take effect after several initial injections of bovine collagen into the target regions. Fat injections have also risen in popularity as an adjunctive procedure during plastic surgical procedures, as the injections are least painful when the patient is under anesthesia or sedation. However, both bovine collagens and fat have significant disadvantages that make them less appealing as fillers of choice, including the skin testing required for bovine collagens, the need for harvesting required of fat injections, and, of course, resorption in both. Several other recent filler candi-

Comparisons among Botulinum Toxins: An Evidence-based Review

Background: Botulinum neurotoxin treatment is the most common aesthetic procedure in the United States. A number of serotypes and formulations are available worldwide. Similarities and differences among these toxins were evaluated by reviewing the existing literature. Methods: Reports of botulinum neurotoxin for aesthetic use, published in peer-reviewed literature or presented at recent professional congresses, were reviewed to summarize key features of different toxins. Data from therapeutic uses in comparable anatomical areas were included in the review when aesthetic literature was limited. Results: Serotypes of neurotoxins share molecular structures and mechanisms of action but exhibit important differences between serotypes and between different formulations within the same serotype, including differences in distribution/diffusion patterns and risk/benefit profiles. The differences attributable to dissimilarities in bacterial strains, manufacturing techniques, and assays are likely to influence clinical performance. Conclusions: Injection patterns, techniques, dilutions diffusion, and injection volumes established for a specific formulation of botulinum neurotoxin are not likely to be applicable to other formulations, and formulations are not interchangeable by any single conversion ratio. A large proportion of the clinical literature documents the aesthetic uses of the Allergan formulation of botulinum toxin type A. Additional studies are needed to establish optimal procedures for the Ipsen formulation and botulinum neurotoxin, and for diverse aesthetic uses.

Prominent eye: operative management in lower lid and midfacial rejuvenation and the morphologic classification system.

The purpose of this study was to evaluate a standard method for the identification of eye prominence and to review operative modifications necessary in patients with prominent eyes. A Hertel exophthalmometer was used to define a classification system according to the degree of eye prominence. A total of 43 patients undergoing lower lid or midfacial rejuvenation were included in the study. Preoperative parameters, including vector analysis, laxity, scleral show, rotational deformity, lateral canthus-to-lateral orbital rim distance, lateral-to-medial canthal distance, and exophthalmometry measurement, were documented. Intraoperatively, techniques including horizontal shortening and lateral canthoplasty placement were documented. Postoperative evaluation included scleral show, rotational deformity, and lateral-to-medial canthal distance. The proposed morphologic classification system divided patients into four groups on the basis of their degree of prominence, as measured by exophthalmometry, defined as deep-set (<14 mm), normal (15 to 17 mm), moderately prominent (18 to 19 mm), and very prominent (>20 mm). Operative techniques were different between the groups, with correction of laxity in the deep-set eyes and accentuated overcorrection of scleral show in the prominent eyes. The use of an exophthalmometer to classify patients before blepharoplasty may help reduce the risk of complications by identifying high-risk patients.

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.