Demand for body contouring procedures is on the rise and increasingly so in patients with already fit/athletic bodies who have stubborn localized areas of fat or who desire a more defined/contoured aesthetic. Surgical removal by liposuction is still the gold standard for fat reduction and allows for fat harvesting and transfer to improve body disproportion such as a flat or sagging buttocks (Figure 1), or breasts, or poorly sized/defined chest, shoulders, biceps (Figure 2) or calves. So-called “Brazilian butt lifting” and “abdominal etching” procedures are becoming more widespread and popular. In my practice these are known as “high definition” or “superficial liposuction” procedures (Figure 3).  That said, liposculpting is gaining popularity and excellent results can be obtained with very few complications when performed meticulously with skill and artistry by a well-trained surgeon. 

FIGURE 1. Patient shown before and 2 weeks after fat transfer to the buttocks.

FIGURE 2. Patient shown before and 2 weeks after fat transfer to the chest, shoulders and biceps.

FIGURE 3. Patient shown before and 3 weeks after high-definition liposuction of the abdominals, flank and back.

In This Article

‘Interesting’ Side Effects

Hormones and Fat Stores

Mulling Metabolism

What can we learn from this post?

'Interesting' Side Effects

Common complications from skin surgery such as infection, dehiscence, and scarring, are uncommon with surgical body contouring procedures. After many years of performing hundreds body shaping procedures it isn’t uncommon for me to have complaints of “interesting” side effects from surgical body contouring procedures such as a change in menstruation, sexual hypersensitivity or body hair growth.

One patient in a recent realself.com post was curious to know if hunger can increase after a liposuction procedure. Surprisingly, this may be true and have validity, but not a result of the procedure. It may be an indirect effect on the body’s metabolism after large volume fat removal/full body contouring. Here’s why:

Hormones and Fat Stores

Hormones and Fat Stores

The human body is born with a genetically determined number of fat cells, and this number rarely changes in the course of our lifetime. The cells can increase in size (hypertrophy) with poor diet or exercise or a dysfunctional metabolism.  In a condition known as lipedema, the cell number (hyperplasia) and cell size can both increase over the course of a person’s lifetime, predisposing them to other consequences such as fat disproportion causing pain, swelling and functional disability such as joint disease. In this condition, certain herbal/holistic medications have shown benefit, including Selenium for its anti-inflammatory activity and Butcher’s broom, which has also been shown to improve lymphatic pumping/function. Both are utilized by Dr. Karen Herbst in her endocrinology practice for patients with fat disorders and are a recommendation for my patients after liposuction procedures, signifying the importance of alternative supplementation in healing and tissue metabolism.

To continue, after liposuction surgery, the body’s total number of fat cells are permanently decreased, leaving a smaller total number of cells to be influenced by internal and external factors. Although these factors and their integrate associations are not fully defined, there is a significant amount of research ongoing to determine the connection between fat cells, metabolism, hunger and appetite. It is known that leptin is a master hormone in the body helping to regulate the energy balance by inhibiting hunger through the hypothalamus. Leptin is opposed by the actions of the hormone ghrelin, also known as the “hunger hormone.” In obesity, a decreased sensitivity to leptin occurs, resulting in an inability to detect satiety despite high energy stores, thus impact on hunger and fat gain.  Nonetheless, in humans, many instances are seen where leptin dissociates from the strict role of communicating nutritional status between body and brain and no longer correlates with body fat levels such as decreased levels seen during short-term fasting, increased levels during perceived emotional stress, and reduced levels during extreme physical exercise, to name a few. Thus, more research is needed on this hormone’s complete influence on fat stores and internal body metabolism.

Mulling Metabolism

Mulling Metabolism

Knowing that there is a physiological connection between fat cell number and size and body metabolism, can liposuction itself influence weight loss? I have a number of patients who have reported a significant weight loss after liposuction surgery with little change to their diet and exercise routines. However, the majority of my patients seem to get increased motivation post-procedure that impacts their physical change. They go to the extreme of diet and exercise so that their 6- and 12-month follow-up visits are more impressive than could have been predicted by procedure results alone.

FIGURE 4. Patient shown before and 3 months after liposculpting of the abdominals, flanks and back. Theoretically, if the number of fat cells are permanently decreased after liposuction surgery, there should be less available leptin to inhibit hunger and the appetite should increase.  Although this is only speculation, and the intricacies of internal metabolism is much more great than a simple feedback loop, it is an interesting concept as to why significant body changes can be observed well beyond the initial surgical procedure (Figure 4). In my practice I have rarely seen what has been documented in the literature of fat gain in other non-treated areas, likely because the majority of my patients use the liposuction procedure as a life-changing event to compliment their diet, exercise and supplementation.

What can we learn from this post?

What can we learn from this post?

Liposuction results may not be as short-lived as we had thought.  I have my patients utilize this post-procedural “hunger” (or metabolic change) to their advantage by referring them to a nutritionist/anti-aging physician that can help with dietary plans and supplementation. Referrals to personal trainers and body workers (for yoga, pilates, TABATA, etc.) starting 10 to 14 days after the procedure to increase muscle toning, further stimulate the body’s metabolism, and help with skin retraction/tightening. All of my patients receive radiofrequency treatments (Velashape 3 and/or Venus Legacy) post-procedure to improve tissue health and metabolism, decrease swelling and increase further fat loss and skin tightening. Overall, lipocontouring can be very dramatic and satisfying if an integrative approach is used that incorporates nutritional supplementation, hormonal evaluation and implementation of exercise and diet.

Jason Emer, M.D., is a board-certified and fellowship-trained general, cosmetic and procedural dermatologist who is passionate about advancing safe and effective treatments in the field of cosmetic dermatology and laser surgery. Dr. Emer’s expertise and interests include the full range of general dermatological conditions, novel therapeutics, cosmetic face and body treatments, including aging skin, veins, body sculpting, fat harvesting and fat transfer.

Trans Epidermal Pigment Release (TEPR), delivered via a device called the Eclipse MicroPen TR (Eclipse Aesthetics), may provide a viable alternative to laser tattoo removal, according to one expert speaker at this year’s annual American Academy of Cosmetic Surgery (AACS) meeting in New Orleans, LA.

Dr. LeibaschoffTEPR is a non-surgical and low-cost technique that removes all types and colors of pigment in a small number of sessions, says Gustavo H. Leibaschoff, M.D., president of the International Consultants in Aesthetic Medicine.

Dr. Leibaschoff explains that the prevalence of tattoos and the demand for their removal have both increased significantly over the past 20 years. New high-density and color-fast pigments, improved delivery devices for tattoo artists and more multi-colored designs have also become increasingly pervasive, which complicate the removal process.

Further confounding the process is the general lack of knowledge regarding the composition of tattoo inks and pigments, Dr. Leibaschoff says. In addition to the standard ingredients contained in inks such as additives, bonding agents and ethanol, tattoo artists can add their own ingredients to “personalize” the ink. Tattoo pigments have not been approved or regulated by the FDA, and can contain any one or mixture of a myriad of ingredients depending on their color, he explains.

“Currently there is no guaranteed method of removing all tattoo pigment without leaving some sort of mark or evidence that something has been there before,” says Dr. Leibaschoff.

In This Article

Tattoos & TEPR

TEPR Mechanism of Action

Tattoos & TEPR

Tattoo pigments are deposited into the skin using needles that introduce them at an array of intracellular depths, he says. Once the pigment becomes intracellular, it is protected by the immune system and remains within the dermal layer. To remove tattoo pigment, it either has to be expelled from the cells within which it exists, or those cells themselves must be eliminated, Dr. Leibaschoff explains.

Dr. Leibaschoff pointed out that lasers work by destroying the tattoo pigment along with the cells within which they are contained. The body recognizes these broken up and released pigment molecules in the extracellular environment as foreign, causing them to be taken up by the immune system. Studies have linked tattoos to cancer and poisoning, he says, and laser tattoo removal actually releases these potentially carcinogenic or toxic tattoo fragments into the body a second time, eventually depositing them on the lymph nodes or liver. Conversely, the MicroPen TR dissolves the tattoo ink and removes it without releasing it back into the patient’s liver and lymphatic system, he notes.

TEPR utilizes a treatment technique described as System for Trans Epidermal Pigment Removal (SFTEPR). “It works by treating a small surface area with closely spaced partial thickness injuries with intervening skin bridges of intact epidermis and dermis,” he explains. TEPR removes all types of tattoo ink, color and dye, and the pigment is expelled directly from the skin rather than being released back into the body. There is no risk of the body re-absorbing the pigment molecules, he says.

TEPR Mechanism of Action

TEPR Mechanism of Action

According to Dr. Leibaschoff, TEPR uses medical-grade micro-needles set to precise penetration depths to remove the epithelium of the tattooed area. First, circular patches of de-epithelialized skin, measuring about 5 mm in diameter and spaced 3 mm apart in every direction, are created on the skin in a pattern, which covers the tattoo. “The practice is like reverse tattooing,” notes Dr. Leibaschoff.

Once the de-epithelialized patches are exposed, what he refers to as “a proprietary and natural product” is introduced into the dermis, which acts to isolate the tattoo pigment in the deeper layers. Variable thickness skin injury and eschar formation will then occur. Once the TEPR wounds have healed, this method is used on adjacent tattooed skin until the tattoo is completely removed.

It is important to carefully evaluate how the patient’s tattoo was created, the type and color of pigment used, and whether previous removal has been attempted, as these factors can influence the outcome and success of the TEPR method, and will also determine the length of time needed to remove the tattoo, he adds. Complete removal is typically achieved in three treatments, allowing eight weeks between sessions.

Disclosures

Dr. Leibaschoff is a consultant and on the advisory board for ICAM USA. 

Belotero (Merz) has become the treatment of choice and standard of care for the cosmetic treatment of fine, etched-in facial lines, according to a dermatologist Cosmetic Surgery Times interviewed on the topic in 2012.¹

Dr. JonesDerek H. Jones, M.D., clinical associate professor of dermatology, University of California, Los Angeles, and founder and director, Skin Care and Laser Physicians of Beverly Hills, says he uses the highly cross-linked hyaluronic acid filler to treat vertical, etched-in perioral and fine, superficial etched-in radial cheek lines.

But there is a caveat: Belotero requires injection know-how.

“It does take some experience because it is injected differently [than other hyaluronic acid fillers],” he says.

In this Article

Technique Tips

A Closer Look at the Data

Take Caution: Belotero Bruises

Technique Tips

Dr. Jones says he transfers all of the product into a 1cc BD syringe. The particular syringe has a Luer lock, which allows the dermatologist to use a fine 32-gauge needle, without concern that the needle adapter will fly off under higher pressure with injection.

He injects with the 32-gauge needle, using a serial puncture, superficial dermis technique.

An advantage of using Belotero is its Cohesive Polydensified Matrix (CPM) technology feature. The technology allows Belotero to smoothly and homogeneously integrate into the dermis a day or two after superficial injection, according to Dr. Jones, an investigator and consultant for Merz and an investigator in the 118-patient trial that led to Belotero's FDA approval.  

“We have seen that with histologic studies. It has been confirmed by ultrasound studies, and we see it clinically,” Dr. Jones says.

According to Dr. Jones, when injected correctly, Belotero does not form the pools and lakes that can result after Restylane [Galderma] and Juvéderm [Allergan] injections. Injecting too much superficially, however, can result in some beading of material, he says.

A Closer Look at the Data

A Closer Look at the Data

Two recent studies suggest Belotero’s technology makes a difference.^{1, 2} UCLA researchers reported in May 2014 in the Aesthetic Surgery Journal that high-resolution ultrasound shows hyaluronic acid gel fillers with differing production technologies show distinct spread and distribution patterns in the periocular tissues.¹

“Restylane-L formed a localized hypoechoic image within the tissue, with some spread into bubbles or pearl-like configuration. Belotero Balance spread more widely into the tissue plane and diffused into an elongated or spindle-shaped hypoechoic image,” according to the study’s published abstract.¹

Researchers published a study² in October 2013 in Plastic and Reconstructive Surgery suggesting Belotero resulted in greater evenness than Restylane at four weeks. And a five-year retrospective review of 317 patients treated with Belotero Balance showed no adverse events, including no persistent nodules or granulomas.

A study performed in 2012 comparing Belotero Balance with Juvéderm and Restylane showed the fillers perform equally well when used traditionally in usual volumes, according to Dr. Jones.³

One downside of Belotero, however, is its longevity.

“Since we’re using very small aliquots, high up in the skin and superficially, longevity may not be as great as with some other types of volumizing fillers. Generally, I tell patients six to 12 months, and that holds true in my clinical practice,” Dr. Jones says.

Take Caution: Belotero Bruises

Take Caution: Belotero Bruises

Because clinicians use a superficial serial puncture technique, Belotero patients are likely to have swelling and bruising for the first couple of days. Dr. Jones says he avoids using Belotero or any other filler a day or two before a patient has a big social event.

It’s too early to tell whether Restylane Silk [Galderma] might be option in these cases, according to Dr. Jones.

“There has been some burgeoning interest in Restylane Silk. It’s new on the market,” Dr. Jones says. “Some of my colleagues like Restylane Silk quite a bit, but I think we need to develop our experience a bit more in terms of fine line treatment compared to Belotero.”

References

1. Petrou, I. Newly approved Belotero filler appears to rival leading dermal products, clinician says. Cosmetic Surgery Times. Published August 1, 2012. Available at: http://cosmeticsurgerytimes.modernmedicine.com/cosmetic-surgery-times/news/modernmedicine/modern-medicine-feature-articles/newly-approved-belotero-

2. Goh AS, Kohn JC, Rootman DB, Lin JL, Goldberg RA. Hyaluronic acid gel distribution pattern in periocular area with high-resolution ultrasound imaging. Aesthet Surg J. 2014;34(4):510-5.

3. Lorenc ZP, Fagien S, Flynn TC, Waldorf HA. Review of key Belotero Balance safety and efficacy trials. Plast Reconstr Surg. 2013;132(4 Suppl 2):33S-40S.

4. Prager W, Wissmueller E, Havermann I, et al. A prospective, split-face, randomized, comparative study of safety and 12-month longevity of three formulations of hyaluronic acid dermal filler for treatment of nasolabial folds. Dermatol Surg. 2012;38(7 Pt 2):1143-50.

The American Society for Aesthetic Plastic Surgery (ASAPS) released its latest multispecialty statistics March 11, and the 2014 data reveals ups and downs in cosmetic surgery demand.

One notable change was the increase in cosmetic surgery procedures among men, who made up more than 10% of the 10 million-plus cosmetic procedures performed. Surgical and nonsurgical aesthetic procedures in this patient population have soared an additional 43% in five years, with liposuction topping the five most popular procedures among men. Since 2010, these latest stats show notable increases in men opting for facelifts and blepharoplasty, as well as hyaluronic acid, botulinum toxin and more.

In this article

Procedures on the Up

Procedures on the Down

Relevance to Your Practice

Procedures on the Up

Overall numbers reveal an 86% jump in volume on a year-over-year basis in demand for buttock augmentation. Other procedures to see a big boost: labiaplasty, up 49%, and nonsurgical fat reduction, up 42%.

The most popular surgical procedures for men and women last year: liposuction (at number one), breast augmentation, blepharoplasty, abdominoplasty and rhinoplasty. The winners in the category of nonsurgical aesthetic options: botulinum toxin (at number one), hyaluronic acid, hair removal, chemical peel and microdermabrasion.
 

Procedures on the Down

Procedures on the Down

The story wasn’t all about increases, however. Americans spent more than $12 billion in 2014, which was about the same as what they spent on aesthetic procedures the year prior.

The number of breast augmentations went down 8.5%in 2014; ear surgery demand decreased by 12.3%; injectables ticked down 6.5% and photo rejuvenation’s popularity fell 18.9%.

The declining demand for breast augmentation, which also was down in 2013, is surprising to Michael Olding, M.D., chief of plastic surgery at George Washington University and ASAPS member.

“Although this may reflect a changing attitude of American women towards larger breasts, it might also be explained in terms of the pent-up demand following the FDA’s 14-year moratorium on silicone gel breast implants, which were then approved by the FDA in 2006,” says Dr. Olding.

He explains that the pent-up demand could have been the result of a combination of women who were unable to have breast augmentation during the 14-year moratorium, as well as those who were initially skeptical about the procedure’s safety and held off having breast augmentation until years later.

“The decline in the 2014 breast augmentation statistics may just represent the numbers minus that backlogged group who have now had surgery,” according to Dr. Olding.

Relevance to Your Practice

Relevance to Your Practice

The overall increase in procedures indicates an ever-increasing societal acceptance of cosmetic improvement of appearance, according to Michael Yaremchuk, M.D., clinical professor of surgery, Harvard Medical School, and chief of craniofacial surgery at Massachusetts General Hospital.

According to Dr. Yaremchuk, nonsurgical procedures continue to increase in numbers for three reasons: “Although the effect is temporary, it is almost immediate with minimal downtime. It allows patients to enter the cosmetic market who otherwise would be precluded by cost. The statistics include dermatologists, who have expanded their scope of practice into the cosmetic market, thereby, making these procedures more accessible.”

In fact, nonsurgical procedures could also be contributing to the decreased demand for facelifts. ASAPS’s 2013 statistics indicated there were 129,807 facelifts that year, versus 126,713 in 2014.

Facelifting, according to Dr. Yaremchuk, is the most effective “rejuvenative” procedure, as well as the most expansive, in terms of cost and downtime.

“Nonsurgical procedures provide temporary improvement and allow a delay in pursuit of this surgical procedure,” he says. “Also, although the economy is theoretically out of the recession, it has not yet returned to its pre-recession vigor, making cost of surgery prohibitive to significant proportions of the population.”

ASAPS stats reflect overall, nationwide cosmetic surgery trends. However, what cosmetic surgery practices experience at a local level might be different, says Dr. Olding.

“For example, my practice has seen a huge increase in the number of facelifts compared to last year,” says Dr. Olding. “By the same token, nationwide, buttock augmentation procedures increased by 86%. Have I seen that statistic reflected as an increase in the number of buttock augmentations? No! Washington, D.C., is a conservative place, where fewer people aspire to have the derriere of Nicki Minaj or Kim Kardashian. In Miami however, even Jennifer Lopez’s buttocks may not be big enough for that aesthetic.”

For a full copy of the report, go to www.surgery.org.

How are the prices of cosmetic-surgery procedures determined? It’s long been assumed that, like most other commodities and services, those prices depend on the laws of basic economics, including the supply-and-demand model. The fact that procedure prices vary so widely, however, indicates that other economic factors are at work.

Researchers at Loma Linda (Calif.) University decided to find out the extent to which supply-and-demand affects the pricing of cosmetic-surgery procedures — and to identify exactly which economic factors drive pricing most if supply-and-demand were found to be a secondary driver.

The research team randomly selected 10 plastic surgery practices in each of 15 U.S. cities with various population sizes. For each city, the team compared the average prices of breast augmentation, mastopexy, abdominoplasty, blepharoplasty and rhytidectomy with economic and demographic statistics.

The researchers found that the average price of cosmetic-surgery procedures correlated strongly with population size, cost-of-living index, and real-estate ownership and rental costs. Household income and per-capita income were less significant factors. Virtually no correlation was found between pricing and the number of plastic surgeons in a given area or the average age of residents.

The bottom line of this study is that since no correlation was found between procedure costs and number of practitioners in a given area, pricing is determined much less by supply-and-demand than by local economic factors.

“Given the increasing focus on the economics of health care, we wanted to examine the supply-side part of the economics around aesthetic surgery,” study author Subhas Gupta, of the department of plastic surgery at Loma Linda (Calif.) University, tells Cosmetic Surgery Times. “It is fascinating that cosmetic surgery procedures are not subject to classical Keynesian supply-demand economics.”

Dr. Gupta said the study was prompted by questions he often gets from plastic surgery residents who are nearing the end of their training and trying to decide where to set up a practice.

“While it is commonly accepted and advised to establish practice where one will be happy,” he says, “it was important to learn that geography within the U.S. should not be a limiting factor to determining where a new surgeon could set up a practice and survive.”

The study was published online in the Aesthetic Surgery Journal.

University of Manchester researchers have created an enhanced silicone breast implant surface, which could make capsular contracture less likely.

“It has previously been shown that rougher surfaces (also known as textured surfaces) reduce the amount of scar tissue formed around breast implants, but the Manchester scientists felt that they could improve this by creating a pattern which mimicked [the] body's own surface, such as the basal layer of the skin, providing a better environment for the cells to grow on,” according to a university release.

The researchers replicated hierarchical micro and nanoscale acellular dermal matrix features in polydimethylsiloxane, according to the study’s published abstract. They cultured human breast-derived fibroblasts on polydimethylsiloxane surfaces for up to a week and compared what they found to commercially available smooth and textured silicone implant surfaces. They found acellular dermal matrix polydimethylsiloxane surfaces promoted cell adhesion, proliferation and survival compared to traditional implant surfaces. The investigational implant surface also increased focal contact formation and spread fibroblast morphology compared to commercially-available surfaces.

A reduced inflammatory cytokine response was also observed, according to study authors.

"Some of the surfaces seen on implants today were designed originally in the ‘60s and ‘70s and, therefore, there is an unmet need for delivering the next generation of biomimetic breast implant surfaces. The original designers found that surface features so-called 'bumps' on the existing surfaces had an adverse effect, but what we did was to reduce the size, dimension and appearance of these bumps down from the size of say, a hill, to that of a pebble,” the study’s lead author Ardeshir Bayat, Ph.D., M.B.B.S., M.R.C.S., says in the release. “This makes interaction at the cellular level much better. Nevertheless, we need to do a lot more work to bring this to the clinic ….”

Dr. Bayat tells Cosmetic Surgery Times that the University of Manchester has filed a patent application on the new surface for breast implants.

“The fact that existing surfaces are not biocompatible, and there is an established link with fibrosis (leading to breast capsular contracture) and significant abnormal changes can be detected with some of the existing surfaces, makes our work in developing a new biomimetic surface of significant interest. Next steps include a clinical trial of these surfaces against existing surfaces,” he says.

Among the more common postoperative complications of rhinoplasty are edema and ecchymosis, which cause anxiety for patients and physicians alike and can affect cosmetic results. The traditional treatment for these is corticosteroids.

Results of a recent Brazilian study, however, suggest that preoperative use of dexamethasone sodium phosphate alters the occurrence of edema and ecchymosis following rhinoplasty.

The research team designed a randomized, double-blind, placebo-controlled clinical trial, into which they enrolled 42 rhinomegaly patients who were randomized into two groups. The 20 patients in group 1 received an injection of dexamethasone before surgery. The 22 patients in group 2 received an injection of saline solution.

Photos of the patients were taken when they returned for follow-up one week after surgery. The photos were analyzed by five plastic surgeons who were blinded as to whether dexamethasone or normal saline solution had been injected. The surgeons rated the degree of edema and ecchymosis.

The researchers found that the patients in the dexamethasone group showed lower rates of postoperative ecchymosis and edema than those in the saline group.

“Preoperative use of dexamethasone reduced edema and ecchymosis at seven days after rhinoplasty,” the authors write. “Rigorous methods in this trial demonstrate the beneficial effect of preoperative corticosteroid administration in this surgical procedure.”

The researchers are from Pontifical Catholic University of Rio Grande do Sul, Santa Casa Hospital, and Mãe de Deus Health System, all in Porto Alegre, Brazil.

The study was published in JAMA Facial Plastic Surgery.

A compound approved for use in asthma inhalers is reported to begin phase 3 trials during the first half of 2015 for use as an injectable option in fat reduction and body contouring. LIPO-202 (Neothetics) is a physician-administered injectable form of salmeterol xinafoate, a beta-2 adrenergic receptor, which, says researchers, not only helps asthmatics breathe better but also shrinks fat cells.

Dr. PeredoMarina Peredo, M.D., a dermatologist in Manhattan and Long Island, N.Y., and clinical investigator for LIPO 202, says physicians can perform the nonsurgical procedure in less than five minutes. The procedure includes making 20 injections, about 4 cm apart, at the site of an abdominal fat bulge. Patients come back weekly, for a total of eight weeks. Often by the first month, she says, they notice a circumference change in their bodies. It’s painless and requires no downtime.

“I think this product is going to do to body contouring or body sculpting what Botox did to facelifts,” Dr. Peredo says.

IN THIS ARTICLE:  

LIPO-202 Phase 2 Results

Salmeterol Safety Profile

Shrinking Fat – Specs

LIPO-202 vs Liposuction

LIPO-202 Phase 2 Results

Dr. NestorBased on the clinical phase 2 studies, LIPO-202 is effective at reducing abdominal fat and has a side effect profile virtually identical to placebo, says Mark Nestor, M.D., Ph.D., a clinical investigator in LIPO-202 phase 2 clinical trials and co-chair of Neothetics’ scientific advisory board.

ATX-101 receives unanimous support for FDA approval

“Patients in the study appear to be very satisfied with the results,” says Dr. Nestor, director for the Center for Clinical and Cosmetic Research and the Center for Cosmetic Enhancement in Aventura, Fla., and voluntary associate professor, dermatology and cutaneous surgery, University of Miami Miller School of Medicine, Miami, Fla.

Neothetics, formerly Lithera, announced results from its phase 2b RESET clinical study of LIPO-202 in a September 30, 2013, press release. Researchers tested three doses (0.4, 1.0 and 4.0 µg) in a multicenter, randomized, placebo-controlled trial, including 513 healthy, nonobese people with abdominal bulging due to excess subcutaneous fat.

Ideal candidates were those bothered by slight to moderate abdominal bulges, according to Dr. Peredo. “If they were too heavy, this was not an indication, at least for this particular study,” she says.

An additional exclusion criterion was use of inhalers because it’s the same medication, according to Dr. Peredo.

Researchers found the optimal treatment dose was 0.4 µg (20 times 0.02 µg/mL). Adverse events with LIPO-202 were generally mild, transient and similar to placebo. The most common adverse event was injection site reactions, according to the press release, and no patients withdrew from the study for this reason.

As for efficacy, “Responder analyses using a composite endpoint of a patient self-assessment (5-point verbal Patient Global Abdominal Profile Scale – P-GAPS) plus a clinician rating of abdominal contour (6-point visual Clinician Photo-numeric Scale – CPnS) demonstrated significant efficacy of LIPO-202 at the 0.4 µg dose versus placebo…,” according to the release.

Patients in the treatment group showed a mean reduction in circumference at the umbilicus of 1.6 cm versus 0.65 cm for placebo. The average reduction in abdominal volume in the treatment zone was 192 cc for the 0.4 µg LIPO-202 dose versus 68 cc for placebo.

Salmeterol Safety Profile

Salmeterol Safety Profile

The inhaled form of salmeterol, one of the medicines found in Advair (GSK), has a list of side effects ranging from the more common — shortness of breath and chest tightness — to the more dangerous, including irregular heartbeat. Unexplained weight loss is one of the less common side effects.

Dr. Nestor says salmeterol xinafoate is a widely used, very safe medication for lung disease and has been approved for that indication for many years.

“Studies have shown a side effect profile similar to placebo when inhaled directly resulting in much higher blood levels than can be achieved by the amount utilized in clinical trials for fat reduction. Phase [2] studies have confirmed the exceptional safety profile of [salmeterol xinafoate],” Dr. Nestor says.

Shrinking Fat – Specs

Shrinking Fat – Specs

LIPO-202 is intended for limited volume liposuction.

Salmeterol xinafoate is a beta-2 adrenergic receptor, and beta-2 receptors are found in fat cells, says Dr. Peredo. “Injecting this substance bolsters metabolism. We’re not killing fat cells; we’re actually just shrinking them,” she says.

The drug in LIPO-202 diffuses about 2 cm in radius, according to company literature. Physicians inject LIPO-202 with a 30-gauge, half-inch needle.

It’s not clear, according to Dr. Peredo, just how long it takes for patients to notice results. Anecdotally, she says, many have come to her after four sessions commenting they had gone down a jean size.

It’s also too early to tell how long the effects of LIPO-202 treatment last.

“The way the [phase 2] study was designed, we only did it for eight weeks. Now, in the phase 3, we’re going to follow patients longer,” Dr. Peredo says.

LIPO-202 vs Liposuction

LIPO-202 vs Liposuction

As any cosmetic doctor who has experience with liposuction knows, it can be a labor-intensive procedure. “I would just do one case per day because I’d be exhausted,” says Dr. Peredo.

Liposuction also requires patients to take time off of work and for the practice to make large practice investments.

“My malpractice insurance tripled when I was doing liposuction. I had to have a whole OR, a recovery room. With Zeltiq [CoolSculpting], there are also equipment costs, you need room and have to pay for consumables. With LIPO-202, I don’t know how it’s going to be priced, but it’s pretty much just a syringe,” says Dr. Peredo.

But there’s also the familiar tradeoff. Results with LIPO-202 are not nearly as dramatic as those achieved with traditional liposuction and not even as dramatic as results from CoolSculpting, which is also painless and requires no downtime, she says.

“The limitation with CoolSculpting is if they don’t have enough fat to suction with the applicator, they are not candidates,” Dr. Peredo says.

If approved, LIPO-202 could be a stand-alone procedure for localized fat bulges. Conceivably, those might be anywhere on the body, but studies to date are limited to the abdominal region, according to Dr. Peredo.

“I believe that future studies could show additional efficacy in other body areas such as the arms and neck [submental],” Dr. Nestor says.

LIPO-202 could also be an adjunct to CoolSculpting or liposuction for patients who achieve less-than-perfect results. Rather than go back for touchups with another invasive procedure, the physician might use LIPO-202, she says.

LIPO-202 isn’t the only injectable product seeking FDA approval for fat reduction. Kythera Biopharmaceuticals is expecting possible FDA approval for the reduction of submental fat as soon as this May. ATX-101 is a purified synthetic deoxycholic acid, a molecule in the body that helps break down dietary fat. 

Kythera Biopharmaceuticals announced in a press release dated March 9, 2015, that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously voted in support of ATX-101 approval for injectable submental contouring.

This independent panel of experts met yesterday to discuss ATX-101 and offered their recommendation to the FDA, which will be considered during continued review of the product. The FDA typically accepts the panel's recommendations. If it is approved, Kythera plans to launch ATX-101 during the second half of this year, according to the release. 

Related: ATX-101 will create a new market in facial aesthetics if approved

“We look forward to working with the FDA as they continue their review of ATX-101 with the goal of providing patients with the first and only approved non-surgical treatment for submental fullness,” said Frederick Beddingfield, III, M.D., Ph.D., chief medical officer of Kythera.  

The FDA is scheduled to make its final decision by May 13.

Recently released results of a British study suggest that certain breast reconstruction patients can benefit from having their post-operative drains removed earlier rather than later.

The research team, led by B.H. Miranda, M.D., of the plastic and reconstructive surgery department of the Royal Free Hospital in London, has presented and published data for the duration of donor-site back-drain use in latissimus dorsi (LD) flap breast reconstruction in response to insufficient evidence and a requirement for further investigation to be added to the literature. Similar evidence, however, was lacking for deep inferior epigastric perforator (DIEP) flap reconstruction.

According to the study, the DIEP flap is a preferred technique for breast reconstruction as it allows for autologous reconstruction with less donor-site morbidity, as compared with transverse rectus abdominis myocutaneous (TRAM) flap reconstruction. The authors write that for this study, their aim was “to compare inpatient hospital stay, drainage parameters and donor-site complications associated with closed suction abdominal drain removal by post-operative day (POD) three regardless of output — the early group — with removal after POD 3 where instructions were by drainage-volume output consistency — the late group — in post-mastectomy DIEP reconstruction donor sites.”

A Retrospective Review

A Retrospective Review

In order to facilitate one-year minimum follow-up per patient, the researchers undertook a retrospective review of DIEP breast reconstructions that were carried out between January 2011 and July 2012. They found that of 74 patients who underwent DIEP reconstruction and for whom there were complete hospital records, 41 were in the late drain-removal group, 33 in the early-removal group. Both groups were matched for age and number of donor-site drains (two per patient).

The researchers found that mean number of drain-removal days (4.32 vs. 2.87 days), total drainage (518.90 ml vs. 283.79 ml) and hospital inpatient stays were greater for patients in the late group. There were no differences in rates of complications, seroma, dehiscence or hematoma between the two groups.

“These data suggest significant advantages for patients who have abdominal drains removed early by POD 3, without increased post-operative complications including seroma rates,” the authors conclude. “These data are in keeping with our LD data. We recommend drain removal and patient discharge by POD 3.”

The study was published online Feb. 19 in the Journal of Plastic, Reconstructive and Aesthetic Surgery (JPRAS).