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Cosmetic Injectables: Emerging Uses, Techniques, and Data

By: Faculty: Vic A. Narurkar, MD, FAAD, Chair; Macrene Alexiades-Armenakas, MD, PhD, FAAD; David E. Bank, MD, FAAD; Susan H. Weinkle, MD, FAAD

This course has expired. You can still review the content but course credit is no longer available.

Supplement Credits: 1

This certified CME activity is designed for dermatologists and dermatology residents.

Expiration Date: Monday, June 30, 2014
Release Date: June 24, 2013

Learning Objectives

Upon completion of this activity, the participant should be able to:

  • Identify various uses of injectable fillers, their associated treatment regimens, and manage adverse events
  • Know the current developments in the field of cosmetic surgery and implement them in practice
  • Apply strategies to improve management of complications and proper patient selection to avoid dissatisfaction
  • Effectively educate patients about known risks associated with cosmetic therapies
  • Establish protocols in their practices to monitor and disseminate accurate information about emerging therapeutic concerns
  • Formulate and implement advanced patient satisfaction evaluation methods
  • Utilize cosmetic treatment procedures that result in patient satisfaction, low risk-benefit ratio, and improved quality of life for patients

Accreditation and Designation Statement

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of The Dulaney Foundation and Practical Dermatology. The Dulaney Foundation is accredited by the ACCME to provide continuing education for physicians. The Dulaney Foundation designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit.™ Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Statement of Need

Office-based surgical procedures are safe and cost-effective, according to a recent review, increasing their appeal to a broad range of patients.1 With the aging Baby Boom generation seeking out these procedures, demand will continue to grow. According to the American Society for Aesthetic Plastic Surgery (ASAPS), Americans spent around $10 billion on cosmetic procedures in 2010 and again in 2011. In 2010, approximately 62 percent of that expenditure was on surgical procedures, 18 percent was on injectables, 16 percent was on skin rejuvena- tion, and 4 percent was on other treatment options.2 In 2011, $1.7 billion was spent on inject- able procedures; $1.6 billion was spent on skin rejuvenation procedures; and over $360 million was spent on other non-surgical procedures, including laser hair removal and laser treatment of leg veins.3
It is essential that physicians be prepared to provide superior outcomes to meet this significant demand. Assessing outcomes of aesthetic procedures is important because patient satisfaction is the predominant factor in determining success.4 Improvement in patients’ qual- ity of life is another important but under-studied factor.5
There have been many developments in the field of cosmetic surgery in the past few years. Nonetheless, clinicians face challenges achieving patient satisfaction. A recent systematic review in cosmetic procedures proposed that measurement of patient satisfaction must be procedure-specific, formally developed, reliable, valid, and responsive and should determine multiple domains of satisfaction. This review identified that current ad hoc and generic tools of evaluation are inadequate.6 Most patient dissatisfaction in aesthetic surgery is based on failures of communication and patient selection criteria, not on technical faults. Therefore, appropriate patient selection and effective communication are also important.7,8 In addition to these crite- ria, there is an increasing emphasis on evidence-based medicine in plastic surgery.9 In the field of cosmetic surgery, it is difficult for algorithms to determine the type of aesthetic procedure. However, evidence-based medicine and clinical trials in cosmetic surgery have the potential to provide high-grade practice recommendations in the future, 14 which could give scientifically proven and effective treatment for patients. This prompts for the discussion of such concepts with practicing aesthetic surgeons.
Non-surgical facial aesthetics and rejuvenation are evolving rapidly due to changes in prod- ucts, procedures, and patient demographics. These procedures are now the most commonly performed aesthetic treatments.10 From 1997 to 2011, there was almost a 200 percent increase in the total number of minimally invasive procedures, such as injectable, skin resurfacing, and laser procedures.3
Clinicians can benefit from ongoing guidance on products, tailoring treatments to individual patients, treating multiple anatomic areas, using combinations of products, and techniques to optimize outcomes.11 According to a report in Plastic Reconstructive Surgery, a multidisciplinary group of aesthetic treatment experts convened to review the properties and uses of botulinum toxin type A and hyaluronic acid fillers and to update consensus recommendations for facial rejuvenation using these two types of products. The group considered paradigm shifts in facial aesthetics; optimal techniques for using botulinum toxin type A and hyaluronic acid fillers alone and in combination; the influence of patient sex, ethnicity, cultural ideals, and skin color on treatment; general techniques; patient education and counseling; and emerging trends
and needs in facial rejuvenation. The group provided specific recommendations by facial
area, focusing on relaxing musculature, restoring volume, and re-contouring using botulinum toxin type A and hyaluronic acid fillers alone and in combination. These experts concluded that optimal outcomes in facial aesthetics require in-depth knowledge of facial aging and anatomy, an appreciation that rejuvenation is a 3D process involving muscle control, volume restoration, and re-contouring, and thorough knowledge of properties and techniques specific to each product in the armamentarium. In addition, patient satisfaction plays a pivotal role in the success of aesthetic procedures such as botulinum toxin treatment. The duration of effect is an important measure that influences the factors such as retreatment intervals, costs, and convenience to the patients.12 Using such advanced measures of satisfaction, a Canadian study recently identified two more effective injection regions in addition to the conventional site.13 CME activities are crucial so that expert physicians can share this type of information with practitioners.
Botulinum neurotoxin treatment is the most common aesthetic procedure in the United States, and has been since 2000. It is the most popular non-surgical procedure among men and among women.3
A number of serotypes and formulations are available worldwide,14 and the last three years have seen the approval of two new formulations on the US market. Clinicians desire education on the differences between formulations, and the FDA has imposed strict guidance on dosage discussions, as the agents are not interchangeable. A review revealed that 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.15 Furthermore, the duration of effect as well as the proportion of patients relapsing after 16 weeks seems to vary among specific formulations.8 Therefore, it is important that practitioners are aware of the specific properties and techniques associated with each product. In April 2009, FDA issued warnings and required labeling updates for all botulinum toxins. The agency cautioned that the effects of agents may spread beyond the injection site, producing unintended paralysis and/or symptoms of botulism poisoning.16
According to ASAPS, of the more than 10 million cosmetic procedures performed yearly, 1.3 million were soft-tissue augmentation procedures using hyaluronic acid fillers.11,14 Dermal fillers have recently found a new use in non-surgical injection rhinoplasty to enhance nasal aesthetics that can last up to three years.14 Another recent advance is the addition of local anesthetic into the filler formulation. In a recent clinical study, 93 percent of patients reported less procedural pain with this new formulation compared to the original one.14 The addition of anesthetic did not significantly change the safety profile.14 Dermatologists and plastic surgeons injecting fillers must be aware of complications such as facial danger zones and how to treat an adverse reaction.14 Consensus statements clearly indicate the need for education in aesthetics.
Due to the increasingly popular and accessible nature of cosmetic procedures, there is also an imminent need for the reevaluation of the factors that physicians use for patient selec- tion. In addition to the cutting-edge facial analyses and operative techniques, the physician should be aware that patient’s expectations, psychosocial co-morbidities, and perioperative interaction with the surgeon are the prime factors for patient satisfaction. Recent reports have identified that a striking number of patients seeking cosmetic procedures meet the criteria
for psychological problems and are tabulated as the “dangerous dozen” types of patients.17 While most patients undergoing cosmetic surgery are satisfied, it has also been noted that patients with some psychological problems are dissatisfied. Also, there are gender differences in the satisfaction of patients, with male patients being more dissatisfied postoperatively.18 Administering advanced tools such as structured questionnaires and consultation with psy- chiatrists could minimize risks in practice and prevent the cosmetic surgeon from facing litiga- tions.18 For these reasons, a roundtable discussion of key opinion leaders about how to identify and handle such patients and situations are necessary.19
In an editorial in Practical Dermatology®, Susan Weinkle, MD, President of the American Society for Dermatology Surgery (ASDS) noted, “even I continue to be pleasantly amazed by the aesthetic outcomes that can be achieved through the skilled placement of volumizers and/or toxins. Moving beyond the face, I have had remarkable success treating patients’ hands and the décolleté.
“Over the past few years, it has become increasingly clear that success with cosmetic inject- ables requires both a holistic approach and attention to the art of injectables…Each injectable agent may serve a purpose within your patient population, and achieving optimal results in
a single patient sometimes requires a combination of agents. It is not sufficient to adopt one filler into practice or to limit oneself to HA fillers, when the range of deep and persistent fillers offers critical cosmetic benefits.”
There were close to 10 million surgical and non-surgical cosmetic procedures performed in the United States in 2010, according to ASAPS. A total of 17 percent of these were surgical procedures and 83 percent were non-surgical. Since 1997, there has been a 155 percent increase in the total number of procedures. Americans spent almost $10.7 billion on cosmetic procedures last year.8 Recent data from the AAFPRS suggest that nearly two-thirds (63 percent) of the procedures performed by members are cosmetic rather than reconstructive in nature.20 Moreover, more than one-third of facial plastic surgeons (37 percent) have seen an increase in 2011 in cosmetic surgery or injectables with patients under age 25.20
Joseph L. Jorizzo, MD, Former (Founding) chair of the Department of Dermatology at Wake Forest said in an interview with Practical Dermatology that cosmetic surgery is growing as a result of increased consumer demand and dermatologists as a specialty are responding to patient needs—something that ultimately strengthens the specialty. Aesthetic dermatology is emerging as a cornerstone of many successful dermatology practices.21 Data from the American Academy of Dermatology Association indicate that in 2009, dermatologists spent 25 percent of their patient care time, on average, performing cosmetic services.22 According to this same survey, despite the fact that they dedicate a significant proportion of their time to cosmetics and face substantial demand for cosmetic services, only 2.1 percent of dermatologists have completed a cosmetic surgery fellowship, and 2.7 percent have completed one in lasers.
New procedures and products are being approved at a rapid rate, and it is crucial that physicians are aware of the latest developments and how to implement them into their practice. Along with the new products and procedures, there are emerging changes to safety warnings and other concerns surrounding some key cosmetic procedures, such as botulinum toxin and hydroquinone, emphasizing that today’s clinicians truly have no room for error.10,23 In efforts to enhance the safety of patients undergoing therapy with both medical and cosmetic treatments, FDA has announced new safety monitoring and reporting initiatives. Since they were introduced in 2007 REMS (Risk Evaluation and Mitigation Strategy) programs have been implemented for several dermatology drugs, including bio- logics for psoriasis and botulinum toxins. Furthermore, in 2009, as an effort to update the REMS, the FDA came out with the “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications” events to address the impact of REMS on the healthcare system. As a result, the role and responsibility of the physician in identifying and reporting treatment-related adverse events is growing. Clinicians must be prepared to educate patients about risks and clarify misinformation.
Not only are there ever-changing additions to the dermatologist’s armamentarium that they must be educated about, there is also evidence that residents in training are lacking in their knowl- edge about aesthetic dermatology. A recent survey from the University of Southern California found that nearly 50 percent of dermatology residents felt unprepared for the type of practice they intend to have.24 According to Heidi A. Waldorf, MD, Director of Laser & Cosmetic Dermatology at Mount Sinai Hospital in New York, educational efforts are vital in the continued evolution of the knowledge and application of cosmetic procedures.18

The following underlying educational needs should be addressed to bridge the gap between existing and ideal knowledge in today’s cosmetic surgery milieu.
• Increased understanding of the available botulinum toxin agents and their safety con- siderations
• Improved appreciation of the use of injectable fillers, their associated treatment regi- mens, and the management of adverse events
• Improved ability of patient selection and to manage complications
• Strategies to improve communication between patients and physicians regarding 
patient expectations, postoperative outcome, and patient satisfaction.
If these learning needs are properly met, more patients will benefit from clinical advancements that can improve treatment outcomes and quality of living. Health care authorities increasingly call 
for dermatologists and other physicians to follow evidence-based recommendations to maximize treatment efficiency, increase effectiveness of care, and to ensure optimal patient outcomes. In order to achieve these goals, dermatologists need to arm themselves with the most current knowledge, which were discussed in the previous section, to effectively monitor treatment effectiveness and alter treatment plans when necessary. 
Like other medical professionals, dermatologists routinely turn to expert colleagues for knowledge that will help them develop the most effective patient management and therapeu- tic strategies. This proposed CME activity will provide evidence-based information from experts addressing the critical decisions required of practicing dermatologists during cosmetic surgery procedures. The activity will also provide perspectives to help clinicians plan for near-term future therapeutic developments in this clinical area. 
Dissemination of information by experts experienced in clinical research and patient care is critical to address practicing dermatologists’ underlying educational needs, allowing them to confidently overcome demonstrated practice gaps. In the field of cosmetic procedures, patient satisfaction, low risk-benefit ratio, and patient’s quality of life are the primary success goals to be achieved by the physicians. Addressing patient management and thera- peutic options for cosmetic surgery can provide education that is immediately applicable to clinical practice.
1. Hancox JG, Venkat AP, Coldiron B, Feldman SR, Williford PM. The safety of office-based surgery: review of recent literature from several disciplines. Arch Dermatol. 2004 Nov;140(11):1379-82.
2. http://www.surgery.org/sites/default/files/Stats2010_1.pdf
3. http://www.surgery.org/sites/default/files/ASAPS-2011-Stats.pdf
4. Ching S, Thoma A, McCabe RE, Antony MM. Measuring outcomes in aesthetic surgery: a comprehensive review of the literature. Plast Reconstr Surg. 2003 Jan;111(1):469-80.
5. Sadick NS. The impact of cosmetic interventions on quality of life. Dermatol Online J. Aug 15;14(8):2.
6. Clapham PJ, Pushman AG, Chung KC. A systematic review of applying patient satisfaction outcomes in plastic surgery. Plast Reconstr Surg. 2010 Jun;125(6):1826-33.
7. CotterillJA.Damagelimitationincosmeticdermatology.JCosmetDermatol.2002Dec;1(4):211-3.
8. Blackburn VF, Blackburn AV. Taking a history in aesthetic surgery: SAGA–the surgeon’s tool for patient selec- tion. J Plast Reconstr Aesthet Surg. 2008 Jul;61(7):723-9.
9. Cheung MC, Allan BJ, Yang R, Thaller SR. Evidence-based medicine and its role in plastic surgery. J Craniofac Surg. 2011 Mar;22(2):385-7.
10. Bray D, Hopkins C, Roberts DN. A review of dermal fillers in facial plastic surgery. Curr Opin Otolaryngol Head Neck Surg. 2010 Aug;18(4):295-302.
11. Matarasso SL, Carruthers JD, Jewell ML; Restylane Consensus Group. Consensus recommendations for soft- tissue augmentation with nonanimal stabilized hyaluronic acid (Restylane).Plast Reconstr Surg. 2006 Mar;117(3 Suppl):3S-34S; discussion 35S-43S.
12. FlynnTC.Botulinumtoxin:examiningdurationofeffectinfacialaestheticapplications.AmJClinDermatol. 11(3):183-99.
13. Sepehr A, Chauhan N, Alexander AJ, Adamson PA. Botulinum toxin type a for facial rejuvenation: treatment evolution and patient satisfaction. Aesthetic Plast Surg. 2010 Oct;34(5):583-6.
14. AmericanSocietyforAestheticPlasticSurgery.CosmeticSurgeryNationalDataBankStatistics.2008.
15. Klein AW, Carruthers A, Fagien S, Lowe NJ. Comparisons among botulinum toxins: an evidence-based review. Plast Reconstr Surg. 2008 Jun;121(6):413e-422e.
16. FDA Gives Update on Botulinum Toxin Safety Warnings; Established Names of Drugs Changed. http://www. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm175013.htm.
17. Karimi K, Adamson P. Patient analysis & selection in aging face surgery. Facial Plast Surg. Feb;27(1):5-15.
18. Waldorf, H. Physician Focus. Practical Dermatology. 2012; 9:50.
19. Shridharani SM, Magarakis M, Manson PN, Rodriguez ED. Psychology of plastic and reconstructive surgery: a
systematic clinical review. Plast Reconstr Surg. 2010 Dec;126(6):2243-51.
20. 2011 AAFPRS Membership Study
21. Winnington, P. Profit vs science in rejuvenation medicine. Practical Dermatology. 2007;4:47-9.
22. American Academy of Dermatology Association. AAD.org
23. Not fading away: Hydroquinone remains on market, but FDA decision looms. http://dermatologytimes.
modernmedicine.com/dermatologytimes/Modern+Medicine+Now/Not-fading-away-Hydroquinone-remains-on- market-but/ArticleStandard/Article/detail/607908.
24. LabanJ,ZacharyC.Residenttrainingneedsinaestheticdermatology.PracticalDermatology.(6)6:27-9.

Faculty and Disclosures

<u>Faculty Credentials</u>
Macrene Alexiades-Armenakas, MD, PhD, FAAD is Assistant Clinical Professor at Yale University School of Medicine, New Haven, CT. She is founder and Director at NY Derm LLC in New York, NY.
David E. Bank, MD, FAAD is Director, The Center for Dermatology, Cosmetic & Laser Surgery in Mt. Kisko, NY.
Vic A. Narurkar MD, FAAD is the cofounder of Cosmetic Boot Camp LLC and founder of the Bay Area Laser Institute in San Francisco. He serves on the board of directors of the ASDS and is the chair of dermatology at California Pacific Medical Center, San Francisco, CA.
Susan H. Weinkle, MD, FAAD is board-certified in dermatology. She is a Fellow of the American College of Mohs Surgery and Cutaneous Oncology and a Diplomat of the American Board of Dermatology. She is in private practice in Bradenton, FL.<p>
<u>Faculty/Staff Disclosure Declarations</u>
Dr. Alexiades-Armenakas has disclosed no relevant conflicts of interest.
Dr. Bank has disclosed the following relevant financial relationships: Allergan, Inc. and Medicis Pharmaceutical Corporation.
Dr. Narurkar has disclosed the following relevant financial relationships: Allergan, Inc.; Merz, Pharmaceuticals, LLC; Myoscience; Palomar Medical Technologies, Inc.; Philips Healthcare and ZELTIQ Aesthetics, Inc.
Dr. Weinkle has disclosed the following relevant financial relationships: Allergan, Inc.; DermAdvance; Ethicon, Inc.; Galderma Laboratories, LP;Kythera; Medicis Pharmaceutical Corporation; Myoscience; Procter & Gamble Pharmaceuticals; TEOXANE Laboratories; and Valeant Pharmaceuticals International.
All of those involved in the planning, editing, and peer review of this educational activity report no relevant financial relationships.


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Cosmetic Injectables: Emerging Uses, Techniques, and Data

Faculty: Vic A. Narurkar, MD, FAAD, Chair; Macrene Alexiades-Armenakas, MD, PhD, FAAD; David E. Bank, MD, FAAD; Susan H. Weinkle, MD, FAAD