Hyaluronic acid (HA) fillers and laser treatments: They're part of the armamentarium of countless cosmetic physicians. And for good reason — they work.

Dr. Khoury

A study conducted by Jordan P. Farkas, M.D., James A. Richardson, D.V.M., Ph.D., Spencer Brown, Ph.D., John E. Hoopman, and Jeffrey M. Kenkel, M.D., researchers at the University of Texas, Southwestern, set out to take a deeper look at how subsequent laser application affected previously injected HA in a porcine model.

BEYOND THE SURFACE For the study, "The abdomens of six Yorkshire pigs were injected with three different HAFs: Restylane (Medicis), Perlane (Medicis) and Juvéderm (Allergan Medical)." Two weeks later, the researchers treated the injection sites with one of seven common laser/light ablative or nonablative devices.

After the laser treatment, they obtained 8-mm punch biopsies from the treated tissue, and fixed the samples for histopathologic evaluation, staining them with hematoxylin-eosin and alcian blue stains for identification of the pre-injected HAF.

So, does the use of lasers on skin previously treated with HAF have any influence on the latter? Put succinctly: It depends.

The researchers concluded, "Injected HAFs were unaffected by the nonablative laser/light and superficial ablative treatments. The more aggressive deeper laser treatments demonstrated laser-filler interaction and may have a clinical effect on the longevity of the filler and/or efficacy of laser treatments. Novel ablative fractional lasers have the capability of deep dermal penetration, and this should be taken into consideration when planning to use them in combination with soft tissue fillers for noninvasive facial rejuvenation."

CONSIDERATIONS IN PRACTICE Jane G. Khoury, M.D., private practitioner at The Dermatology Center at Ladera, Ladera Ranch, Calif., reviewed these findings and tells Cosmetic Surgery Times that the study addresses an important topic.

"Combination therapy is an expanding area of cosmetic surgery and as fillers, nonablative and ablative resurfacing become more popular, this issue becomes an important practical consideration," she says.

This study takes steps to definitively determine what happens to the skin — and below the skin's surface — when laser is used subsequent to HA. "The effects of the laser were, in general, above the placement of the filler, although as [the researchers] mentioned, this is very technique-dependent," Dr. Khoury observed. "On the deeper ablative lasers such as DeepFx or Profractional, even though the microablation columns approached the placement of the HA fillers, no denaturation of the filler was seen."

Dr. Khoury says that she is unaware of any other ongoing or completed research on HA fillers and laser treatments, "although there have been anecdotal reports of extrusion of filler with laser resurfacing, as well as reports of no extrusion of superficially placed filler with DeepFx treatment over the nasolabial fold."

Monheit

Neurotoxins PurTox (Mentor Corp.), Xeomin (Merz Pharmaceutical), and, most imminently, Reloxin (Medicis), all appear to be making their way to the U.S. market to give Allergan's Botox a run for its money. But, so far, few true standout attributes have emerged among the products to set any apart from the current gold standard.

The most extensively studied is Reloxin, currently marketed in Europe as Dysport, with phase III clinical trials performed on 2,300 patients and more than 4,800 treatments. The trials looked at factors including the onset of action, the extent of action, or the diffusion, the duration of the product's efficacy and safety.

A Question of Efficacy

"The treatment cycles were looked at because one of the big worries concerned neutralizing antibodies — whether there are more or less of them and whether they will affect the efficacy of the drug as it is used repeatedly with people year after year," says Dr. Monheit, associate clinical professor of the Departments of Dermatology and Ophthalmology at the University of Alabama, Birmingham, Ala.

The trials looked at as many as five treatment cycles of Reloxin and found no differences in efficacy or adverse events. In fact, the researchers found that adverse events seemed to get better as the treatment cycles went on, Dr. Monheit says.

Interestingly, the onset of action was one area in which there could be a difference, with Reloxin appearing to kick in a little earlier than Botox, Dr. Monheit adds.

"Subjects were asked when they first noticed that the [Reloxin] appeared to be working and 50 percent said as early as day two and 70 percent said day three," he explains. "We've always thought the onset of action with Botox was more like about five to seven days, but those studies were never done for Botox and we really don't know for sure if that was an accurate assessment."

The duration of Reloxin's efficacy appeared to be slightly shorter in men than women, but a variable dose study comparing 60, 70 and 80 units in men with 50, 60 and 70 units in women showed duration to level out. "The response curve clearly had to do with individualizing the dosage to the patient's muscle mass," Dr. Monheit says.

The individualizing factor also may come into play in regard to treatment with Botox and other toxins.

Conversion Rate

The basic conversion of rate 2.5 to 1 was used in studies conducted in the U.S. and Europe, but that rate simplified matters when more variables should be considered in the conversion, Dr. Monheit emphasizes.

"Even though we would like to say we could make a one unit conversion to another, it is something that is difficult to do because the units are simply different," he says.

"I think that rather than talk about the units, one has to understand what the details are of the ideal doses used by Ipsen in the various different sites that have been tested."

The bottom line for conversion as well as the dose rate may be to aim for an appropriate range, rather than a specific rate, based on factors including gender, muscle mass and the area of injection.

"We've done this in clinical practice with Botox, but it's never really been studied statistically," Dr Monheit says. "The key is that we shouldn't cookbook our neurotoxin, whether it's Reloxin or Botox. It should be individualized and every patient during the exam should frown or move whatever muscles that will be injected so we can see what the muscle mass is and provide the correct dosage."

Editor's note

The Edison Files is a recurring column in which we showcase the creative ends to which you will go to optimize your cosmetic surgery gear. One theme we see emerging from your e-mails is that every great idea begins with a nettling dissatisfaction with what's already out there. The second is that no nail is driven with the first whack. In fact, this column's namesake ardently shared your passion for iteration — and for stick-to-itivness! So, tell us. What's the big idea? E-mail us with your inventive journey — what was missing and how did you improve it? Was coming up with it the easy part — or getting the prototype right? We'd love to feature your tinkerings or triumph in a future edition of The Edison Files. E-mail us at TheEditors@cosmeticsurgerytimes.com
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Plastic surgeon David S. Kirn, M.D., says he does not know of a single household appliance over the years that he hasn't taken apart and put back together. And while he currently holds several U.S. and foreign patents, his passion for garage-based tinkering hasn't always worked to his advantage.

Dr. Kirn devised the Arm Channel apparatus both to boost patient safety, and to save time in the O.R.

LEAN ON ME Since those days, the Lexington, Ky.-based plastic surgeon has fabricated his way to five U.S. patents, one U.S. patent pending, two foreign patents and two foreign patents pending.

One of his more recent surgical solutions is the trademarked Arm Channel, an armboard that surgeons can attach to standard operating room tables. The device quickly and easily supports patients' arms on the OR table.

"Operating room tables have attachments that fit along rails, to which you attach an armboard. Sometimes, particularly for breast surgery, abdominoplasty and liposuction, we put people into different types of positions that are not well accommodated by the currently available products," Dr. Kirn explains. "I was just tired of wrapping people's arms and went shopping for a solution, but it didn't exist."

The Arm Channel offers a safe alternative to conventional practice, he says. Crude wrapping or taping of arms onto tables can, in and of itself, cause injury because the patient under general anesthesia isn't capable of communicating pain. In addition, making sure to properly wrap patients' arms can take precious minutes in the operating room, while the Arm Channel takes only seconds to click in.

THE UN-YANKABLE FEEDING TUBE Dr. Kirn, voluntary faculty for the University of Kentucky's plastic surgery division, says that his most commercially successful product to date has been a bridle that keeps patients from pulling out their feeding tubes. Its inspiration came when he saw a patient who had an improperly taped nasal tube that had resulted in a nose injury, and he began thinking about the shortcomings of current nasal tube designs.

"When I was a resident, we would make a homemade bridle. It worked well, but I thought that there had to be an easier way," Dr. Kirn relates. "I had been using tissue expanders with magnetic port locators and thought, if we just used those magnets to loop the bridle around, we would have a good device. Sure enough, it works extremely well." Final development of the bridle was completed in concert with Applied Medical Technology who sells the device.

INSTRUMENTS THAT MAKE SENSE Dr. Kirn has also developed a few surgical instruments, including the endoscopic bipolar forceps used for endoscopic brow lifts.

"I couldn't find a cautery that worked very well for endoscopic brow lifts, so I developed this bipolar cautery," Dr. Kirn says. "This is an improvement on what was on the market because it's shaped so that it allows you to use it through a small endoscopic incision while accommodating the curvature of the skull, so that you can get where you need to be."

Teresa McNulty

In the truest tradition of our pledge to you to be the forum "where the exchange on aesthetic perspective begins," we want this to consist entirely of "readers' choice" — your best ideas and light bulb moments.

Have you shot a YouTube video on your most innovative technique? Recorded an audio blog on what you're doing to keep staff spirits up in your practice? How about an excerpt from your blog on what marketing pearl has really panned out for you despite the economy? Snapped stellar before and after pix that wowed 'em at the last congress? This is your issue to share and shine!

If you think you've figured out better, faster, smarter, quicker, cheaper — step into the limelight of the new media.

Put "Best Practices" in your subject line to theeditors@cosmeticsurgerytimes.com
We'll go viral with it!

24-year-old woman with Curri grade IV cellulite before and 13 months following a single treatment combining deep and subdermal Nd:YAG laser lipolysis and autologous fat transplantation. (PHOTO CREDIT: ROBERT GOTKIN, M.D., F.A.C.S. )

SEARCHING FOR A SOLUTION "There is no cure for cellulite," states Robert Gotkin, M.D., F.A.C.S., at Cosmetique Dermatology, Laser & Plastic Surgery, LLP, in New York, N.Y. "What we can do as aesthetic surgeons is try to improve the orange peel-like skin seen in cellulite. However, these improvements will be only temporary as skin laxity worsens with age. In my experience though, more invasive surgical procedures and devices can achieve longer lasting cosmetic results."

Dr. Gotkin co-authored a recent study in which a combination treatment of laser energy and fat transplantation was used to improve the signs of cellulite. In the trial, 52 female patients with grades 3 and 4 cellulite were treated with a 1064 nm Nd:YAG laser, followed by autologous fat transplantation in fat-depleted target areas. The laser technique was first used in the deep fat layers for actual lipolysis, and then superficially to break the fibrous bands causing cellulite. The autologous fat was selectively transplanted to the areas with the most severe concave contour deformities to try to fill those areas out and give a smoother, more even contour to the target skin's surface.

According to Dr. Gotkin, the technique allows the surgeon to work very superficially because the cannula carrying the laser fiber has a very small external diameter that essentially does not leave a footprint. This is different from traditional liposuction in which larger cannulas, used superficially at the dermal-fat junction, may contribute to a worsening of the appearance of cellulite by causing tunneling and dimpling. In addition, traditional liposuction also uses higher vacuum pressures (one atmosphere) to aspirate the fat, whereas this technique uses very low negative pressures for lipid aspiration.

"As a woman gets older and continues to develop skin laxity, cellulite will likely return," Dr. Gotkin says. "However, in the 12- to 30-month follow-up that we had in our study patients, we could significantly improve the cellulite long-term. Most of the approaches currently used in aesthetic surgery are noninvasive and therefore also achieve minimal results. Our goal was to give some permanent improvement in the appearance of cellulite and we were able to achieve that using this surgical technique."

Dr. Monheit

AGE-OLD HAZARD Clearly, biofilms aren't new to medicine, and they can appear on everything from knee joint implants to heart valves, catheters and other solid implants. But only recently have they been identified as the possible culprits behind dermal filler complications such as granulomas and nodules, one practitoner who has researched the association tells Cosmetic Surgery Times .

"Biofilms have become well known in other disciplines, but we're only now being confronted with them as a problem in aesthetic medicine because of the fact that our fillers are longer lasting and are larger, and we're using greater amounts of them for volumizing," says Gary Monheit, M.D., associate clinical professor of the departments of dermatology and ophthalmology at the University of Alabama, Birmingham, Ala.

WAITING GAME What can make biofilms particularly dangerous is their maneuvering into dormancy, where they become protected from antibiotics. "The polymorphic protein develops a genetic diversity in which the bacteria goes into a dormancy phase, making it untouchable by antibiotics," Dr. Monheit explains.

In the dormant stage, the bacteria develop what are ominously known as persister cells, and when they awaken from dormancy, they have the ability to form granulomas, nodules, abscesses and smoldering infections.

"Biofilms have been implicated as causing capsular contraction in breast implants and granulomas from silicone implants, and they have now been identified in fillers ranging from Sculptra, Dermalive, Radiesse, Radience, Artecoll, Arteplast, and many of the longer-lasting, large-volume fillers," he says.

While biofilms haven't been reported in common hyaluronic acid fillers approved in the U.S., there have been reports in Europe of biofilms with granulomatous and infective complications in products that combine hyaluronic acids and permanent particles, such as such as Dermalive Revolution, Dr. Monheit relates.

The three-dimensional structures that biofilms form are particularly nasty, providing a source of infection and resistance to antibiotic therapy. One recent poster described the use of electron microscopy scanning to examine a periocular granuloma that formed following poly-L-lactic acid injection and confirmed that biofilm surrounded the granuloma.

The authors raised the concern that filler granulomas may be caused by bacterial contaminants producing biofilms and urged the use of a meticulous aseptic technique with filler injection.

POSSIBLE PROPHYLAXIS Dr. Monheit agrees, stressing that sterile surgical technique prior to and during injection is essential, and noting that prophylactic antibiotics may be called for in some situations involving permanent fillers.

"There remains the issue whether patients with permanent filler should be placed on prophylactic antibiotics prior to surgical procedures or dental cleaning, but there is currently no good evidence one way or the other."

And, as was concluded in the study, Dr. Monheit notes that the only true resolution for biofilms is excision of the host object or implant.

"The only way to really deal with biofilms at that point is through surgical removal of the object or material they've attached themselves to," he states.

HOLD THE STEROIDS When confronted with nodules or granulomas, doctors' first instinct may be to place the patient on corticosteroids. However, if a biofilm is in place, that therapy may only make things worse, Dr. Monheit cautions.

"Corticosteroids may only allow the bacteria go back into its platonic state. Instead, if there is a tender area over an implant, the first thing that should probably be done is to put the patient on antibiotics."

Prevention, meanwhile, may be elusive until more is known, he says.

"Until we really find out how to prevent biofilms and get rid of them during their sequestered stage and how to inhibit them, I think we can expect to continue to have this problem," Dr. Monheit notes.

"Our implants are only getting bigger, we're volumizing more, the fillers are lasting longer — many a year or more — and I think most fillers that last long enough are simply going to be susceptible to being encapsulated by biofilms."

DISCLOSURE

Dr. Monheit is a consultant and clinical investigator for Allergan, Genzyme, Colbar/J&J and Ipsen/Medicis, and he is a clinical investigator for Dermik.

REFERENCE

Lowe NJ, Maxwell A, Patnaik R, Shah A. Polymerized l-lactic acid for volume replacement: an extended case review of 221 patients [poster]. Presented at: American Society for Dermatologic Surgery Annual Meeting; November 6-9, 2008; Orlando, Florida. Poster 21.