Fuel Injected

More and more spa-goers are conquering their fear of needles and focusing on the fountain of youth a few pokes can deliver. According to the American Society of Plastic Surgeons (ASPS) National Clearinghouse of Plastic Surgery Procedural Statistics from 2014, injectables continue to top the list of minimally invasive cosmetic procedures. In 2014, there were 6.7 million botulinum toxin (Botox) procedures, an increase of 6 percent from 2013. Soft tissue fillers also saw an increase in popularity, up 3 percent from the previous year to 2.3 million. 

These gains are expected to continue, and staying up to the minute on the newest approved injectable options and techniques helps your medical spa appeal to the growing market. “Injectables are in high demand,” says Bruce Katz, M.D., director of Juva Skin and Laser Center (New York City). “Our patients want treatments that are noninvasive and have no downtime but make a difference. Injectables are the answer.”

Stamp of Approval

The U.S. Food and Drug Administration (FDA) has been busy approving new injectables and new uses for those already on the market. Here’s a look at the most buzzworthy launches.

Radiesse Cleared for Hand Augmentation

In June, the FDA approved the injectable Radiesse to correct volume loss on the back of the hands. This opaque dermal filler, composed of synthetic calcium hydroxylapatite microspheres suspended in a water-based gel carrier, was first approved in the U.S. in 2001, and it has since had subsequent approvals, including for the correction of nasolabial folds in 2006. According to manufacturer Merz, Radiesse provides an immediate volumizing effect and can help to reduce the prominence of tendons and veins in the hands, delivering smooth, natural-looking results that can last up to one year.

Bellafill Approved for Acne Scarring

The FDA has approved Bellafill as the first dermal filler to be used to treat pitted scarring of the cheeks caused by acne, the most common skin disorder in the U.S. afflicting 40 to 50 million people. Bellafill, developed by Suneva Medical, is made primarily of bovine collagen, and when injected, it is designed to lift and smooth scars to the level of the surrounding skin. “Until now, multiple laser treatments or other injectables have been used to treat acne scars but are limited both in terms of efficacy and longevity and are hampered by potential side effects,” says Ava Shamban, M.D., an assistant clinical professor of dermatology at UCLA who was involved in the Bellafill study.

FDA Approves Fat-Burning Injectable

Cosmetic practitioners have a new tool at their disposal designed to noninvasively reduce fat. The FDA has approved Kythera Biopharmaceuticals’s fat-burning injectable Kybella (also known as ATX-101). The injectable is a patented formulation of a pure, non-animal-derived version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat and is intended to reduce submental fat (double chin) in adults. According to the company, patients can receive up to 50 injections in a single treatment. Treatment sessions typically take 15 to 20 minutes, and many patients experience visible results after two to four treatments. Once the desired appearance is achieved, results are expected to be permanent. “For the first time, people have access to an FDA-approved non-surgical treatment for submental fullness, a condition that can negatively impact the overall appearance of the face and can result in a person feeling older and heavier,” says Keith Leonard, Jr, cofounder, CEO, and president of Kythera. More than 20 clinical studies support the Kybella treatment, and a majority of participants reported reduced fat in the chin area and high satisfaction with the results.

Restylane Lyft Given the Okay for Cheeks

Galderma, a global healthcare company focused on skin health, received FDA approval to market Restylane Lyft for cheek augmentation and the correction of age-related midface contour deficiencies in patients older than 21. Restylane Lyft, formerly marketed as Perlane-L, is an injectable gel used to increase volume and smooth wrinkles in the face (nasolabial folds). “Achieving natural-looking lift in the cheek area is one of the most common requests that I receive from my patients,” says Robert Weiss, M.D., principal investigator of the clinical trial and director of Maryland Laser, Skin and Vein Dermatology (Hunt Valley) and clinical associate professor of dermatology at University of Maryland. “Restylane Lyft is an extremely versatile product that has a long, proven history of providing safe, precise, and predictable results. The results of this clinical trial show that Restylane Lyft can provide an effective option for patients when they desire lift, not just volume, in their cheeks.” This FDA approval marks the fifth major indication in the U.S. for the Restylane family of products. It joins Restylane, which corrects and smoothes smile lines as well as augments the lips, and Restylane Silk, which is approved for lip enhancement and the treatment of wrinkles and lines around the mouth.

The Fine Print

While injectables deliver a wealth of beauty and anti-aging benefits, clients should be informed of the potential risks involved with these procedures. Recent research has revealed side effects worth investigating and sharing.

Bacterial Infection Linked to Injectables

Many cosmetic treatment customers experience unpleasant side effects in the form of tender subcutaneous lumps that are difficult to treat, and in isolated cases, have led to lesions that simply will not heal. Research recently published by the University of Copenhagen in the journal Pathogens and Disease now supports that, despite the highest levels of hygiene, this unwanted side effect is caused by bacterial infection. “Previously, most experts believed that the side effects were caused by an auto-immune or allergic reaction to the gel injected,” says Morten Alhede, a postdoc at the Department of International Health, Immunology, and Microbiology, University of Copenhagen. “Research involving tissue from patients and mouse models has now shown that the disfiguring lesions are actually due to bacteria injected in connection with the cosmetic procedure. What is more, we have demonstrated that the fillers themselves act as incubators for infection, and all it takes is as few as 10 bacteria to create an ugly lesion and a tough film of bacterial material, known as biofilm, which is impossible to treat with antibiotics.” According to researchers, bacterial infections occur in about .1 to 1 percent of patients, so it is rare. Experts recommend adding a prophylactic antibiotic treatment with the filler to best prevent infection.

Botox Travels to Central Nervous System

New research published in the journal Neuroscience might bring a frown to even the most heavily botoxed faces. Scientists at The University of Queensland have shown how the potent toxin used for cosmetic surgery escapes into the central nervous system. “The discovery that some of the injected toxin can travel through our nerves is worrying, considering the extreme potency of the toxin,” says Frederic Meunier, Ph.D. “However, to this day, no unwanted effect attributed to such transport has been reported, suggesting that Botox is safe to use.”

Researchers found that most of the toxin is transported to a cellular dump where it is meant to be degraded upon reaching the central nervous system. Says Meunier, “We found that some of the active toxins manage to escape this route and intoxicate neighboring cells, so we need to investigate this further and find out how.”

Needle Work

Botox has a myriad of practical benefits and uses beyond treating facial wrinkles for purely cosmetic gain.

Botox Improves Skin Elasticity

For clients who want to improve skin pliability and elasticity, Botox may be just what the doctor ordered. According to a report published online by JAMA Facial Plastic Surgery, both improved after treatment with Botox for mild facial wrinkles, and the effect lasted for up to four months. The authors observed that injections in the facial skin resulted in increased pliability and elastic recoil. These biomechanical changes mimic those of more youthful skin. The mechanism for this skin change is unclear, but the effect of the Botox injections is similar to a radiofrequency skin-tightening procedure. However, after four months, the skin reverted back to its previous look and feel. The changes occurring in patients’ skin appear to be the opposite of those associated with the aging process and UV radiation exposure and inflammation. Future studies are required to determine and quantify the histologic changes that are occurring. Says Catherine P. Winslow, M.D., of the Indiana University School of Medicine, Bloomington, “Piecing together this research with continued studies on elasticity and collagen content of injected skin will further the ability of facial plastic surgeons to refine their strategy for long-term planning of anti-aging strategies with patients and educate them as to the importance of nonsurgical therapies for maintenance, in addition to opening new fields of potential treatment options for difficult scars and skin conditions.”

Botox Helps Children with Facial Paralysis

Botox is bringing beautiful smiles to youngsters’ faces. It has been shown to safely improve smiles in children with facial paralysis, a condition they can be born with or acquire because of trauma or a tumor, according to a report published online by JAMA Facial Plastic Surgery. When treated with Botox, the injection is given to weaken the strong muscles on the nonparalyzed side of the face. Siba Haykal, M.D., Ph.D., of the University of Toronto, and coauthors reviewed medical records of children with facial paralysis and observed an improvement in facial symmetry with no complications. Says Haykal, “We have shown that Botox significantly improves symmetry of the lower lip, is safe, and has the potential for restoration of permanent symmetry.”

innovative new botox treatments for sweatingBotox Treats Hyperhidrosis

For patients suffering from hyperhidrosis, or excessive sweating, Botox is a popular solution. While treatments in the underarms, palms, and feet are common ways to target sweat, Dendy Engelman, M.D., at Manhattan Dermatology & Cosmetic Surgery opts for a different approach and injects Botox into the scalp. This is especially valuable to fitness fanatics seeking to extend the life of their blowouts without missing out on heart-pumping classes. “I now have patients coming in who are asking for Botox injections all over their scalps in order to decrease sweating, so they can prolong their blowouts, even when attending hot yoga or spin class,” says Engelman. “In fact, there are some ongoing studies that are using injected Botox as a treatment for hair loss. It could potentially have the added benefit of creating thicker hair.” Injections targeting sweat glands on the scalp last six to 12 months and have been proven safe and effective. Says Engelman, “There is no danger in doing this, it is just a new phenomenon we are seeing, and I expect to see it grow in more cosmopolitan cities or wherever a Soul Cycle pops up.”

Botox Reduces Pain in Breast Reconstruction

Research published in Aesthetic Surgery Journal in May suggests that Botox injections may help manage pain as well as expedite expansions in breast reconstruction. Based upon the
neurotoxin’s successful use to temporarily obliterate muscle mobility for either functional or esthetic gain, researchers conducted a pilot study to evaluate its potential role in expander-based breast reconstruction after mastectomies. Half of the patients who underwent mastectomies with immediate expander or acellular dermal matrix reconstruction received 40 units of Botox injected into each pectoralis major muscle, and the other half of participants received saline injections. Researchers recorded patients’ progress for the following year. The neurotoxin group experienced less pain and an increase in the volume of expansion during each visit. No additional complications resulted from the neurotoxin injections.

Hot Off the Press

Take a sneak peek at the potential power of new and improved imaging technology.

A 3-D imaging technique often used in the automotive and aerospace industries for accurate measurement may be useful in measuring the efficacy of injectable wrinkle reducers such as Botox and Dysport, according to new research from the Perelman School of Medicine at the University of Pennsylvania (Philadelphia). The procedure, called 3-D speckle tracking photogrammetry, has the potential to measure the efficacy of several injectable treatments, not only for cosmetic purposes but also to reduce facial paralysis asymmetry arising from stroke and Bell’s palsy. Using the new technique, researchers can measure dynamic facial wrinkles and their subsequent reduction following injection. Results are presented as a color-coded heat map. By comparing before and after treatment heat maps of patients, physicians can objectively evaluate wrinkle reduction and other variables such as optimal dosage for obtaining maximum aesthetic benefit. “There is a growing body of evidence that injectable fillers for both cosmetic and reconstructive purposes can have significant psychological benefits,” says Ivona Percec, M.D., Ph.D., senior author, director of Basic Science Research, and associate director of cosmetic surgery at Penn. “With more people turning to this procedure, it is important to have evidence-based ways of improving cosmetic and reconstructive surgical results.”

Application of the technique raises the possibility of objectively determining the most effective wrinkle treatments. “As new therapies and expanded applications become available, this method may make it possible to quantify clinical efficacy and establish precise therapeutic regimens,” says Percec. “Though future studies will need to explore the use of digital image correlation in larger groups, our results are the first to show the modality can be applied to study a range of challenges in plastic surgery.”

Who’s a better injector?

Find out how a newdebate about cosmetic injectables is affecting training guidelines.

As Botox and fillers have increased in popularity, a growing number of nonesthetic health professionals have emerged to perform procedures to help meet demand. Kevin Small, M.D., and Henry M. Spinelli, M.D., from the division of plastic surgery at Presbyterian Hospital (New York City) and Kathleen M. Kelly, M.D., from Columbia University (New York City) have assessed the capability of various providers to administer cosmetic injections. Based on the survey responses from more than 880 plastic surgeons from around the world, plastic surgeons consider themselves and dermatologists the most capable injectors. “Because most of the growth in the field of cosmetic injectables is driven by providers other than plastic surgeons and dermatologists, it appears that further clarification of training requirements and practice guidelines is necessary to ensure a consistent, reproducible, and safe experience for the patient,” says Spinelli, primary investigator on this study. These findings may provide a foundation to further investigate the relationship between patients and their injectable provider, as well as the role of various practitioners in an increasingly competitive injectables market.

Predicting the Future

The minimally invasive esthetics market is constantly evolving. Here are what top surgeons and dermatologists hope to see next.

“I anticipate micro injections of hyaluronic acid fillers to come to the market to allow for global facial rejuvenation.”—Dendy Engelman, M.D., director of dermatologic surgery and laser medicine for Metropolitan Hospital and dermatologist for Manhattan Dermatology and Cosmetic Surgery

“In the next few years, I expect more technology that assists with skin tightening, as well as different fillers to decrease the appearance of fine lines and wrinkles. Currently, tear-trough injections to diminish undereye circles is considered an off-label use. This treatment in very skilled hands, however, can be incredible, and once FDA approved, we will be able to educate more patients about this advanced but helpful technique.”—Yael Halaas, M.D., facial plastic surgeon and member of AAFPRS

“Injectables will become longer-lasting and more economical. This will translate into less need for surgery to rejuvenate the face. Also, topically applied Botox cream is very exciting to me. It still requires a visit to a doctor’s office, however, there will be no needles or bruising. I anticipate its availability in the U.S. by early next year.”—Norman Rowe, M.D., board-certified plastic surgeon for Rowe Plastic Surgery (New York City)

“We will be using Kybella in other areas, not just the neck. We’ll see it used in areas that also accumulate excess fat, such as abs, arms, ankles, thighs, and more. The options are endless.”—Bruce Katz, M.D., director of Juva Skin and Laser Center (New York City)