What s New in Aesthetic Plastic Surgery?

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1 What s New in Aesthetic Plastic Surgery? by David S. Kung, MD, FACS and Lee L.Q. Pu, MD, PhD, FACS Despite the economic downturn, aesthetic plastic surgery remains an industry that has managed to stay afloat. According to the most recent national statistics report from the American Society of Plastic Surgeons (ASPS), in 2008 total cosmetic plastic surgery procedures were up 3 percent from 2007 at 12.1 millions. 1 One major reason for the positive increase was the surge in minimally-invasive cosmetic procedures, up 5 percent from 2007, as opposed to surgical cosmetic procedures, which fell 9 percent. In 2008, popular surgical cosmetic procedures such as breast augmentations, liposuction and rhinoplasties all experienced declines not only when compared to the previous year, but also when compared to the year Meanwhile, minimallyinvasive procedures such as Botox and filler injections are up in both comparisons. 1 The authors believe that this trend is in accordance with rising hot topics in aesthetic plastic surgery today and wide acceptance by consumers to have minimalinvasive cosmetic procedures as their initial or repeated means for facial rejuvenation. What s New in Botox? Botox, or botulinum toxin treatment, is by far the most popular minimallyinvasive cosmetic procedure with 5 million cases performed in The number of Botox procedures increased a monumental 537 percent from 2000 and 8 percent from 2007, respectively. Botox injections are effective in treating dynamic animation lines of the face without the patient having to undergo a surgical facelift. 1 This increase in consumer d e m a n d h a s wa r ra n t e d t h e development of several new subtypes, such as PurTox and Reloxin, now known as Dysport. PurTox is currently under development by Mentor Corporation, a medical supplier for the aesthetic surgery market that Johnson & Johnson acquired last December. Prior to that, Mentor announced the successful completion of the first of three Phase 3 clinical trials in October The study measured subjects satisfaction with the use of PurTox to treat glabellar rhytids (frown lines). Four hundred subjects at 10 sites in the United States received either a single treatment of PurTox or a placebo. 2 Investigators, independent reviewers, and the subjects themselves scored their reduction in line severity over the course of six months using a 4-point photo scale; satisfaction was measured using a standard global assessment tool. The study found a high degree of satisfaction with the treatment outcome by a large percentage of participants. The results will be used to spur PurTox s Biologics License Application (BLA) filing with the U.S. Food and Drug Administration. PurTox is expected to launch in While Pur Tox has been pending, Dysport obtained FDA approval in April and made its way into doctor s offices shortly thereafter, marking it as the first U.S. rival to Botox. Dysport, formally referred to as Reloxin, is already popular internationally it is approved and used in the European Union, Brazil, Argentina, and more than 26 other countries worldwide. 3 Dysport is marketed in the U.S. by Medicis, an independent specialty pharmaceutical company known for its popular Restylane and Perlane facial fillers. This product addition places Medicis on a similar playing field as Allergan, the company that markets Botox and the Juvéderm hyaluronic acid filler. Although Botox sales are consistently strong, an FDA ruling for stronger Botox product safety warnings may give Dysport a head start. 3 According to physicians who have worked with both injections, differences between the two products may lead to preference of one over the other in certain facial areas. Dysport may have a faster effect and a greater spread,, while Botox has a more localized effect, allowing greater precision and predictability. It is suggested by some that Dysport may take fewer injections and provide a longer result than Botox of up to a month or two. 3 Studies on both Volume 13 > Number 12 >

2 products are continuing. What s New about Fillers? Fillers are beneficial for static, rather than dynamic facial depressions, lines and furrows, and can last up to six months and longer. Hyaluronic acid has quickly become the most popular of eight types of fillers available. They are the second most popular minimally-invasive cosmetic procedure, with 1.1 million cases performed in 2008, experiencing a 6 percent increase from Nearly 20 fillers are available and approved by the FDA. Two of the most popular dermal fillers are currently Juvéderm and Restylane, as mentioned earlier. Fillers are distinguished by the level of dermis and hypodermis the injection is intended for. Restylane and Juvéderm Ultra are injected into the mid to deep dermis, while Juvéderm Ultra Plus and Perlane are injected into even deeper rhytids. The more superficial a filler is injected, the greater the development of superficial irregularity, but the more apparent the result. 4 Eyelash Rejuvenation Latisse is the first and only FDA approved prescription treatment for eyelash hypotrichosis, or inadequate e y e l a s h e s. T h e b i m a t o p r o s t ophthalmic solution 0.03 percent is applied once a day to the base of the upper eyelashes. This stimulates eyelash growth, making them longer, darker and fuller, with full results at 12 to 16 weeks. Latisse was clinically tested in a Phase III study, which assessed its safety and efficacy. The solution s effectiveness in all areas improved eyelash prominence, length, thickness and darkness were met. Bimatoprost, the active ingredient, was first approved in 2001 to treat an eye condition; eyelash growth was merely a side effect. Now, as the exclusive patent owner, Allergan is the only company with the right to use bimatoprost, other prostaglandins and prostaglandin analogs to stimulate eyelash growth. 5 While Latisse was just launched this year, RevitaLash Eyelash Conditioner from Athena Cosmetics, Inc., has been on the market for two years. RevitaLash is now the cosmetic alternative to Latisse and does not require a prescription. As a cosmetic product, its purpose is to enhance the appearance and beauty of a person s existing eyelashes, rather than treat a medical condition. Like Latisse, RevitaLash is also a solution applied once a day to the base of the upper eyelashes. 6 Laser Skin Resurfacing Currently, laser skin resurfacing experienced the largest increase of all minimally-invasive cosmetic procedures at 15 percent from 2007 to Fractional laser resurfacing is a treatment used to alleviate wrinkles, acne scarring, hyperpigmentation and other skin conditions. While earlier laser technologies used blanket ablation, fractional lasers deliver isolated laser spots in an even distribution across the skin, thus preserving the healthy skin in between. Rather than have one large burn, the skin contains microscopic surface wounds, enabling rapid recovery. 7-9 Fractional laser technology has now merged with the CO2 laser, used for deep wrinkling and skin damage. The CO2 laser vaporizes the outermost layers of the skin to produce new skin that is smoother and suppler. However, the treatment requires a longer recovery time of 10 to 14 days and the skin tends to retain a pinkish/reddish hue for as long as several months. There is also risk of infection if the patient fails to follow the post-treatment regimen. Combining the two technologies will enable a deeper treatment into the dermis than the minimally-ablative fractional treatments alone can provide. Meanwhile, the inherent risks, longer recovery and excess skin pigmentation associated with the CO2 laser are minimized. 9 Figure 1. Laser-rejuvenation of the face. Pretreatment and two week post-treatment s photographs of laser-assisted facial skin rejuvenation for hyperpigmentation with fractional technology after one treatment. (Photographs courtesy of Dr. David Kung) Liposuction Water-assisted liposuction is a new FDA-approved body-contouring modality that utilizes water to gently free fat from its attachments so it can be removed from the body. Since preinfiltration with tumescent fluid is not necessary with this technique, there is less distortion and swelling in the tissues, allowing for more accurate contouring results. Local anesthetic is placed in the water so the technique is not very painful. In fact, this is one of the few liposuction modalities that can be performed in an office setting without general anesthesia or sedation. There is also increasing data showing that recovery is faster with little bruising or swelling when compared to traditional liposuction. 26 Volume 13 > Number 12 >

3 The body collects fat in both a superficial and deep plane. Waterassisted liposuction works well for deep plane fat and is especially effective for pockets of fat that are hard to get rid of naturally. Figure 2. Water-assisted liposuction. Preoperative and one month post-operative photographs of water-assisted lipoplasty of the abdomen and flanks performed under local anesthesia in an office setting. (Photographs courtesy of Dr. David Kung) Cell-assisted Lipotransfer A l t h o u g h a u t o g e n o u s f a t transplantation has been used by many surgeons for cosmetic rejuvenation in the face, hands, and buttock and even for the breasts, the overall success of this procedure has been questioned by other surgeons because of its unpredictable long-term results due to a lower rate of fat graft survival. In order to address the problem of autogenous fat transplantation, Dr. Yoshimura s group from Japan has pioneered a new strategy of autogenous fat transplantation called cell-assisted lipotransfer (CAL). This new technique is based on the findings that aspirated fat tissue contains fewer vessels and adiposederived stem cells (ADSCs) than that of intact fat tissue. It is also based on their hypothesis that the relative deficiency of tissue-specific progenitor cells in aspirated fat tissue might contribute to the low survival rate and progressive atrophy of transplanted fat tissue. After they confirmed their hypothesis in an animal study, 10 they proposed a cell assisted lipotransfer strategy because they believe the progenitor deficiency can be compensated by supplementation with stroma vascular fraction isolated from a separate volume of aspirated fat tissue. They have speculated the roles of adipose derived stem cells in CAL to be: (1) to differentiate into adipocytes and contribute to adipose regeneration; (2) to differentiate into vascular endothelial cells or mural cells that may promote angiogenesis; (3) to release angiogenic growth factors; and (4) to survive as original adipose derived stem cells which serve as adipose tissue progenitors. Since 2003 Dr. Yoshimura s group had pioneered this fat transplantation technique and has performed more than 230 clinical cases, primarily for breast and facial soft tissue augmentation. 11,12 In the CAL technique, fat is collected via a conventional liposuction. Approximately half of the collected liposuction aspirates are used in isolation of adipose derived stem cells via collagenous digestion and centrifugation. The process takes about 90 minutes. While processing the ADSCs, the other half of the fat grafts is also harvested. Once the ADSCs are mixed with aspirated fat grafts, relatively progenitor poor aspirate fat tissue can be converted into progenitor enriched tissue. The ADSCs enriched fat grafts are then injected into the desired area of the patient. The experience with the CAL technique showed absorption of transplanted ADSCs enriched fat grafts is minimal and the clinical results are generally satisfactory without major complications. Dr. Yoshimura estimates the surviving volume of the fat graft taken range from 40% - 80% among the patients. Although the safety and efficacy of the CAL technique needs to be confirmed by others, some remarkable results have been accomplished by Dr. Yoshimura with this technique. With a combination of stem cell technology, the technique of fat transfer pioneered by Dr. Yoshimura and his colleagues in Japan may represent a significant breakthrough in aesthetic plastic surgery. Figure 3. Concept of cell-assisted lipotransfer (CAL). Relatively progenitor-poor aspirated fat is converted to progenitor-rich fat by supplement with the stromal vascular fraction (SVF) isolated from one-half of the aspirated fat. SVF cells are attached to the aspirated fat, which acts a scaffold in this transfer. (Photography courtesy of Dr. Kotaro Yoshimura) Volume 13 > Number 12 >

4 Figure 4. A 26-year-old Asian woman, who had a hypoplastic breast along with thoracic deformity on the right side, underwent CAL augmentation for both sides (325 ml and 105 ml on the right and left, respectively) Preoperative (left) and postoperative (right) views at 12 months. Pre- and post-operative CT scans (bottom, left and right) show that adipose tissues were augmented not only subcutaneously but also under the mammary glands with no abnormal nodules or calcifications detected.(photographs courtesy of Dr. Kotaro Yoshimura) Mini Facelifts Mini facelifts have become an attractive option for younger clientele in their thirties to forties who are just starting to experience the signs of aging. This procedure is best for addressing minor sagging and can target problem areas customized to the patient. Often known as weekend facelifts, they can be performed quickly and less invasively than a standard facelift and are associated with faster recovery. Patients who choose this flexible and less stressful treatment can enjoy the mini facelift s subtle changes without feeling as great a burden in their wallets. Branded mini facelifts are also available. The Lifestyle Lift (removal of preauricular skin with some suturing of the tissue beneath) is specifically designed to tighten the jowls and neck and address wrinkles and frown lines in about an hourlong procedure. Nearly 100,000 patients received the Lifestyle Lift in the last decade. The Quick Lift is an improved version of the S-Lift and devotes attention to the lower face and neck. Both procedures utilize local anesthesia and boast a short recovery time. About 10,000 patients received Quick Lift since While these quick-fix options may be desirable, some surgeons are concerned that branded facelift advertising will deter patients from seeking a second opinion. Patients should select a treatment course from a range of options and fully be aware of the limitations of the branded mini facelift. 7 Conclusion Many of these hot topics and emerging technologies in aesthetic plastic surgery stem from non-invasive or minimal invasive procedures which are the fastest-expanding segment of the cosmetic treatment spectrum because of the lower cost, faster recovery time and likely noticeable results achieved by these procedures. The authors predict that minimal invasive cosmetic surgical procedures will possibly replace the most of traditional cosmetic surgical procedures in the near future because of a strong and popular demand by patients. Acknowledgement The authors greatly appreciate Dr. Kotaro Yoshimura of University of Tokyo, Japan who kindly provide the photographs used in the article. 28 Volume 13 > Number 12 >

5 Biography Maryland plastic surgeon Dr. David Kung is a multiple board certified plastic, reconstructive, and maxillofacial surgeon. He holds doctorates with honors from both Harvard Medical School and Columbia University, and has completed residencies with distinction at the Massachusetts General Hospital as well as the University of North Carolina/Duke University Medical Center. Dr. David Kung is a leading provider of cosmetic plastic surgery, at the forefront of several exciting new techniques, and an innovator in his own right. He has written influential articles on cosmetic eyelid incisions and the correction of rare congenital facial deformities, as well as a new book entitled A New Face - The Art of Facial Enhancement. Dr. Kung has invented medical instruments involved in wound closure that are awaiting patents and will soon be used by the US military. He was also invited to speak at the Extreme Makeover Expo in Philadelphia and nominated for the International Health Provider of the Year award in Website: Biography Dr. Lee L.Q. Pu is Board Certified by the American Board of Plastic Surgery and an active member of the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS). Dr. Pu is physician first and his relationship with his patients and their safety is a priority in his practice. Dr. Pu s patients receive personalized care with compassion and have the best possible results after surgery. As a surgeon, innovator, and educator, Dr. Pu possesses a unique set of skills and always strives to be the best in a procedure of your choice. lee.pu@ucdmc.ucdavis.edu Volume 13 > Number 12 >

6 References Report of the 2008 Statistics. American Society of Plastic Surgeons. 10 June 2009 < plasticsurgery.org/media/press_kits/procedural_statistics.html/>. 2. Mentor Corporation Announces Completion of PurTox 3A Study. Business Wire. 1 Oct June 2009 < 3. American Health and Beauty. VC Cubed Medical Marketing Specialists. 10 June 2009 < americanhealthandbeauty.com/>. 4. Dhaliwal J and Friedman O. Injectables and Fillers in Male Patients. Facial Plastic Surg Clin N Am. 2008;16: Latisse. Allergan, Inc. 10 June 2009 < 6. RevitaLash. Athena Cosmetics, Inc. 10 June 2009 < 7. Lewis W. The Scoop on Lumixyl, the Newest Skin Lightener. HealthNewsDigest.com. 31 May June 2009 < 8. Saint-Louis C. Want a Mini-Facelift? Surgeons Advise Getting a Second Opinion. The New York Times. 2 July Aug 2009 < 9. The American Society for Aesthetic Plastic Surgery. 13 Aug 2009 < 10. The DOT CO2 Fractional: The Next Step in Laser Skin Resurfacing. PRNewswire. 1 Mar Aug 2009 < 12. The DOT CO2 Fractional: The Next Step in Laser Skin Resurfacing. PRNewswire. 1 Mar Aug 2009 < 13. Matsumoto D, Sato K, Gonda K, Takaki Y, Shigeura T, Sata T, Aiba-Kojima E, Iizuka F, Inoue K, Suga H, and Yoshimura K. Cell-assisted lipotransfer: Supportive use of human adipose-derived cells for soft tissue augmentation with lipoinjection. Tissue Eng 2006;12: Yoshimura K, Sato K, Aio N, Kurita M, Hirohi T, Harii K. Cell-assisted lipotransfer for cosmetic breast augmentation: Supportive use of adipose-derived stem/stromal cells. Aesth Plast Surg 2008;32: Yoshimura K, Sato K, Aio N, Kurita M, Inoue K, Suga H, Eto H, Kato H, Hirohi T, and Harii K. Cellassisted lipotransfer for facial lipoatrophy: Efficacy of clinical use of adipose-derived stem cell. Dermatological Surgery 2008;34: Volume 13 > Number 12 >