Gentlewaves LED: no better than placebo

About a year or two ago, a new type of LED device started appearing at the various plastic surgery meetings. It was suggested that certain frequencies (colors) of light could have beneficial properties on the skin, through a theory known as photomodulation. There was no heat, no pain, no downtime, no complications... Sitting under a bank of pulsing colored LED's for a short treatment was supposed to improve your skin.

Well, longtime readers of this blog will begin to notice their noses twitching. We've often commented "when you do less, you get less". So how could this low-power, non-thermal photomodulation thing work?

A group of investigators from the Massachusetts Eye and Ear Infirmary tried to confirm some previously published good results on the GentleWaves LED system, which uses an amber LED bank for facial skin treatments. Good scientists regularly do this - confirming earlier experiments. But something surprising happened. I'll let their abstract published earlier this year in Dermatologic Surgery tell the story.....

"METHODS AND MATERIALS: Facial skin was exposed to pulses of 588+/-10-nm-wavelength light from a photomodulation device for 40 seconds once a week for 8 weeks. Photographs, clinical assessment, and a subjective questionnaire were taken at baseline, at the last follow-up, and 1 month after that. Thirty-six patients' pre- and post-treatment photos were arbitrarily scrambled, and 30 independent blinded observers were asked to pick the post-treatment photo. Two time-point comparisons were evaluated.

RESULTS: For every facial characteristic studied and for both time-point comparisons, patients reported highly statistically significant improvements. In extremely sharp contrast, neither the physician's assessment nor the independent observers' evaluation indicated any improvement.

CONCLUSION: Patients genuinely believed that several of their facial features had improved, even though there was no detectable objective change. Our data therefore suggest that the LED photomodulation treatment from the device tested is a placebo."


Take-home lesson: This device was FDA approved. This means it is safe, as in non-damaging. FDA approval of devices, unlike FDA approval of drugs, does not imply that the device is effective. Gentlewaves LED photomodulation device appears to be hype. Don't waste your money.

Lesson #2: when reading scientific studies, look for objective evidence of improvement - rather than just the subjective opinions of the patients' themselves.

Recent bulletin on Carboxytherapy and Mesotherapy

Here is a recent press release from the Physicians Coalition for Injectable Safety - a group of 7 American, Canadian and International Surgery groups, including plastic surgeons, facial plastic surgeons and ophthalmic surgeons - who review & study the latest and best methods regarding injectable cosmetic products. For the record, I agree with this bulletin, and do not currently recommend mesotherapy and carboxytherapy, based on lack of proven efficacy.

PHYSICIAN GROUP URGES CONSUMERS TO BE AWARE OF NON-APPROVED COSMETIC INJECTIONS

July 29, 2009 - The Physicians Coalition for Injectable Safety today issued a consumer warning about carboxytherapy and mesotherapy injections. These products, touting everything from cellulite treatment to weight loss are not FDA approved, and do not have clinical data that demonstrates results or safety.

Carboxytherapy uses carbon dioxide gas injected under the skin to reduce the look of cellulite, treatment of dark under-eye circles, and stretch marks and is also touted for fat sculpting on the face and the body. “Although many websites or providers claim carboxytherapy is safe and FDA approved, it has not been clinically tested or FDA approved for these purposes,” says Coalition leader Robert Weiss, MD of Baltimore, MD. “Carboxytherapy for use around the eyes is especially dangerous. It could potentially release gas bubbles into blood vessels causing blindness. In addition, the risks of putting carbon dioxide in your body are currently unknown.”

Mesotherapy, also known as injection lipolysis, is a mixture of vitamins, drugs and enzymes that are compounded (mixed together) to make the injected substance. “There is no conclusive, authoritative information that exists, such as unbiased, peer-reviewed clinical studies that meets the standards of an accepted medical journal, measuring both the efficacy and safety of mesotherapy,” says Coalition leader Mark Jewell, MD, Eugene, Oregon. “We don’t know the safety or efficacy of these compounds and, until there exists credible evidence, consumers are advised not to have these injections.”

The Coalition urges consumers to be very selective about cosmetic treatments, and the individuals who provide them. “Only accept treatment prescribed by a qualified physician and administered under that physician’s supervision. Whether an injection or treatment is to treat aging conditions, to treat cellulite or a similar body contouring condition, whether it sounds reasonable or too good to be true, you should always be aware of false claims,” says Coalition leader Jeffrey Kenkel, MD of Dallas, TX. “Verifying that the drug or device that is recommended for your injection is FDA approved is an important first step. It should be approved specifically for cosmetic use as prescribed or similarly to what is prescribed for you.”

The Lipo-laser: does it work?

We are now starting to see ads in Orlando for a new fat-melting treatment, a laser beam that melts fat after shining the beam on the the skin. Known as the "lipo-laser", or more properly, the Zerona, the manufacturer claims that its use can result in the loss of inches of fat - without surgery, injections or other invasive procedures.

The laser used in this machine, is a 635 nm wavelength diode - the very same laser that is commonly used in many hand-held battery-powered laser pointers. According to the manufacturer's website, the laser power is listed variably in different parts of the webpage, between 7.5 milliwatts and 14 milliwatts, which again is only slightly more than the typical 5 milliwatt laser pointer. (By way of comparison, most lasers used for ablative skin resurfacing treatments are in the neighborhood of 30 watts or more, or four-thousand times more powerful.) Thus, this new machine falls into the category of "low-level laser therapy".

The FDA has approved this device - in the same category as an infra-red heating lamp - according to the FDA's own 510(k) document posted on the laser manufacturer's website. N.B: it's not currently approved as a fat melter.

Neira and associates have been enthusiastically promoting the use of low level lasers to help with liposuction for several years. They claim that use of this type of laser leads to a deflation effect on the individual fat cells, resulting in the contouring effect.

This claim is certainly controversial. A study published in the Plastic and Reconstructive Surgery Journal, performed by the well-respected Plastic Surgery & laser group of Brown, Rohrich, Kenkel, Young and associates at UTSW, carefully duplicated the Neira protocol for laser fat treatment. However, they found no appreciable difference with this laser treatment, comparing the fat before and after treatment under a scanning electron microscope. Zip. Zilch. Nada. There was no effect whatsoever on the fat in the treated area, and certainly no evidence of any fat-cell deflation.

I have no personal experience with the new Zerona machine, and while I would love to have a non-invasive method to treat fat, the physics of the device make it hard to believe that the beam could possibly penetrate through the skin down to the underlying fat with enough energy to do anything.

I'll need to see better evidence from independent researchers before I can accept and recommend this treatment. To me, it seems like waving a laser pointer over the skin, and somehow expecting the fat to magically disappear. Caveat emptor.

Thread Lifts Don't Work

For those of you who are unfamiliar with the term, the Thread Lift was a much-hyped procedure in which a special type of barbed suture would be placed under the skin, to draw the loose facial tissue upward. The idea was to get a facelift-like lift, without actually doing a real facelift. It sounded so promising - just have a few of these magic threads inserted into your cheeks during your lunch break - and voila! - a younger looking you. A number of companies make and promote these barbed sutures, under a variety of trade names.

Well, as we've said before - when you do less, you get less.
Here's some more evidence: in this month's issue of Archives of Facial Plastic Surgery, a study looked at how well the thread lift procedure held up over a two year follow-up period. The answer: not good.

The authors evaluated the results of 33 patients who underwent a thread-lift procedure alone or in combination with other facial rejuvenation procedures to the brow, midface, jowl, and neck. Long-term aesthetic results were evaluated by 4 independent, blinded surgeons.

The thread lift group had a much smaller degree of improvement than the groups that were treated with standard procedures. Furthermore, any early improvement from the thread lift had vanished by the end of the two year study period.

The authors concluded that the short-term improvement of the threat lift was largely attributed to "post-procedural edema and inflammation" (swelling). After evaluating the thread lift extensively, they've decided to abandon it, stating "Given these findings, as well as the measurable risk of adverse events and patient discomfort, we cannot justify further use of this procedure for facial rejuvenation."

Take home lesson: there is no substitute for a properly-performed facelift for facial rejuvenation. Don't waste your time & money on thread lifts.

Marketing hype in cosmetic surgery

Hype. Spin. Puffery. Exaggerated claims. Call it what you will - there is a lot of it out there in the world of cosmetic surgery. Unlike most other fields of medicine, the commercial influences on cosmetic surgery and aesthetic medicine have changed the traditional doctor-patient-medical supplier relationship - and not for the better.

Where does the hype come from?

1. Marketers of new technologies: Claims of wonderful new technology that works "better than anything that has come before" should always be viewed with caution. Most progress is evolutionary, not revolutionary. Laser-assisted liposuction is a great example of marketing hype getting way ahead of what has been scientifically proven. For example, is there any solid data that has been published in a reputable journal showing that laser-assisted liposuction tightens the skin? Nope. Yet, claims of skin tightening are all over the internet.

2. Marketers of "new procedures": It's become fashionable for physicians to put their name on a variation of a standard surgical technique. This is especially true for the various forms of mini-facelifts. Call it a "fill-in-the-blank" lift using some cutesy name, and market the heck out of it - and patients will seem to flock to the door. But, as we've discussed in earlier chapters of this blog, mini operations usually have mini results - and subsequent disappointment for the patient.

3. Commercial Media: Take for example, the various websites that claim to be give lists of the "best surgeon in town" or "top cosmetic surgeons in the state". Usually these are paid listings. The only qualification required is that the physician pays the bills for this marketing exposure!

The same is true with many of the local lifestyle magazines. Did you ever notice that the surgeons that are awarded "best surgeon" or who are featured on the cover by these magazines are typically the ones with the biggest advertising budgets? Hmmm....

And don't even get me started on some of the over-the-top hyperbole seen on some surgeons' websites. The descriptions make it sound like they could part the Red Sea, or walk on water! Take it with a grain of salt, people!

So, what's a consumer to do?

It boils down to old-fashioned research.

1. Ask around - get referrals from people you trust - your own doctor, OR nurses, close personal friends that have had a good experience with a local plastic surgeon. See who has good "word of mouth" endorsements.

2. Check out the ASAPS website (www.surgery.org), the ASPS (www.plasticsurgery.org) or the Florida Society of Plastic Surgeons (www.fsps.org) website to see some of the possible people you should interview in your neighborhood.

3. Interview several highly experienced, Board-certified Plastic Surgeons who do your procedure of interest routinely. Make notes and compare.

4. Look at plenty of "before and after" photos with a critical eye - we've discussed how to do this in an earlier chapter of this blog.

5. Has the staff had surgery by that surgeon? Do you like how their results look?

6. Does the surgeon have a list of actual patients that you can speak with?

7. Do you like the "feel" or "vibe" of the office? Do you feel sure that these people will look after you if you should happen to have a complication from your procedure?

8. While price is important to many people, don't always be tempted by the lowest price. If it seems too good to be true, it probably is.

Problems with laser-liposuction: who's the Smart one now?

Over the last few months, I have seen an alarming increase in the number of patients that come in for a second opinion about poorly-performed liposuction (done elsewhere, I might add.) All of these casse have been performed with new high-tech liposuction machines, either laser-assisted (like the SmartLipo) or ultrasonic (like the VASER).

I've seen major skin laxity, uneven liposuction, and obvious over-resection of fat leaving major divots and dents. Many of these problems are very difficult to fix, even with fat grafting techniques.

Here's a few observations:

1. All of these cases were performed by physicians and surgeons operating way outside of their specialty. They were not done by plastic surgeons or dermatologists, who are trained during residency in this technique.

2. In the majority of these patients, physical examination of the patient revealed crummy skin tone and poorly elasticized skin. In other words, since this skin won't contract like we want it to after liposuction, it's completely predictable that the post-op results will be poor, with floppy, deflated areas, and a worsened appearance. A surgeon with any significant training or experience in liposuction would have recognized this - and would have avoided performing liposuction in these patients. It's the wrong tool for the job!

3. All of these patients were preoperatively told by their physicians, "This new wonder lipo machine will tighten your skin".

4. All of these patients now say, "Skin tightening clearly did not happen...now I look worse."

5. None of these patients have an easy fix for their issues. All will require complex and expensive revisional surgery.

Lessons:

A fancy hammer does not a good carpenter make. Any doctor can buy (or rent) a fancy lipo machine.

There is, as yet, no reliable scientific evidence that laser-assisted liposuction:
a) tightens the skin, or
b) works better than standard liposuction.
Any claims to the contrary are "spin" or marketing hype; consider the source and what they're selling.

That being said, the problems seen here were not caused by the type of liposuction machine - but by the doofus using it! While the concept of liposuction is easy, getting excellent results with liposuction takes significant skill.

Please be careful about whom you choose to perform your liposuction. Even if it's performed in an office setting, with local anesthesia, liposuction surgery is still SURGERY. Training, experience and credentials matter.