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LH's comments:

...I do have to apologize as I did not know that the article had been published. The last I had read was that it was waiting for review. I also want people to understand that I am not saying that the physicians involved in the study did anything wrong with my evaluation of the article. I just think that the company is over marketing the product and charging way too much.

My critique:

1. The first thing they teach you in medical school on how to evaluate research is who paid for the research. In this case the sponsor of the research and article was Erchonia the company that makes Zerona.
2. Who wrote the article? In this case the article appears to have been written by Ryan Maloney. Who is Ryan Maloney? He not only is the medical director of Erchonia he actually has ownership in the patent of the Zerona. Other than that you do not know his background. We know he is not a PhD or physician otherwise it would be behind his name under the authorship of the article. He has a direct financial benefit to write the article in a positive light.
3. 8 Individuals did not have final measurements. The first question is why? 4 were from the treated group and 4 were from the placebo group. At first that seems OK, but when you look further into they kept all of these test subjects included in the study. What they did is they took the last measurements for those subjects and carried them forward. Again seems Ok at first but when you start to look at the trend of circumferential loss at the 2 weeks post treatment the measurements are trending back toward baseline. So if you include these patients last measurement (which by the way is the best overall average circumferential loss during the treatments for the treated group) and carry them forward they will artificially lower the true values two weeks post treatment. All 8 of these subjects should have been eliminated from the study.
4. There is no assessment of cosmetic benefit. To have this be worth something you would need before and after pictures that are reviewed by a group of individuals that are blinded to which treatment the individual participant received. So in other words is a 3 inch loss aesthetically significant.
5. They do not state if participants are male or female. So the question is left, does it work as well on males as it does on females? This could be very important as males tend to have thicker skin so does the laser penetrate as deep in men?
6. the study was limited to patients with a BMI of 25 to 30. Now I think it is fine to have this limitation as you have to start your research somewhere. But the limitation is that the article is implying that it will work for all BMI's. What about the thinner female patient with a BMI of 20 but has a small lower abdominal pooch? Or what about the patient that has a BMI of 35? This should be stated in the conclusion but Mr. Maloney seems to forget this.
7. They also do not state if the patients received their treatments for free or if they were compensated for their time. This is only important for the portion of the study that talked about the patient satisfaction. We need to understand that patients will put a value on the treatment because if something is free their expectations are much lower. their expectations are much higher if they paid $2500 for the treatment. So if this was free to the patient and you have 30% of the treated group that are dissatisfied or neutral what would that mean to a clinic if the patients are paying for it. I would guess you will have a much higher dissatisfied group that either wants their money back or free treatments. I do not want something in my clinic that has a 30% failure rate.
8. They do not discuss if either group was asked to change their diets. This should be stated up front in the methods portion of the article. They also do not mention if there were any dietary supplements required such as niacin. Most clinics using Zerona are having the patients take niacin even Erchonia recommends it.
9. They set the standard for success to be an inch loss of 3 inches or greater. Only 62.86% of the treated group achieved success. So this translates in to a 37.14% failure rate. Again, not something that I would want to stake my reputation on.
10. Now what do the numbers mean? If you look at the numbers the patients baseline combined measurement average was 120.31 inches. At week 2 of treatment (the best measurements achieved) the average was 116.79 inches or an inch loss of 3.52 inches on average. This sounds pretty good until you look at the true numbers. Using the numbers from the study this equates to a 2.9% inch loss as measured over 4 areas. Is this clinically (visually) significant? I do not think that most individuals will be able to see a 2.9% change or if they can it will be meaningful.
11. Lets take a look at the 2 weeks post treatment measurements. Remember, these are not true numbers as 4 patients had their best numbers included in these measurements pulled forward and included here. (I think all of their measurements should have been puled out). At 2 weeks post treatment, you see a 0.31 inch increase from the circumferential measurements at the 2 week treatments. What this equates to is an 8.8% increase in inches in only 2 weeks. So what happens at 4 weeks? 6 Weeks? So if it were a perfectly linear increase it would only take about 20 weeks or so to be 100% back at baseline. That is if it were linear and I highly doubt it is a linear response and if i had to guess most patients will be back at baseline measurements within 6 to 10 weeks and this is why there are no long term studies. The company has had ample time to produce longer term studies they apparently do not want to.

So as you can see, there are a few issues with this article and how it was analyzed and written. The first and foremost problem is that the article was authored by an individual with direct financial interest in the product. The ASLMS journal never should have published this article due to the authors conflict of interest or it should have a disclaimer prior to the abstract. I have no vested interest in any of these non-invasive technologies and would love to see something like this work and have long term benefits for the patients. I think this technology may have better long term benefits on cholesterol etc. I have heard that there are some interesting studies coming. I just hope they are not written by Mr. Maloney. And for others reading this I assume that Chad works for Erchonia or the marketing company that is selling this thing to anyone they can including chiropractors.

Sincerely,
Lornell E. Hansen II, M.D. (LH)

p.s. Sorry for being so long winded but I could not help myself. I want these companies to be held to higher standards. I think the ASLMS should have higher standards as well.

Istockphoto

From Health magazine

Not every doctor is qualified to perform every procedure. Do you really want to turn your body over to someone who doesn’t really know what they’re doing? Here are five questions you should ask before you get a cosmetic tweak from a doctor working outside of her specialty.

How many times have you done this procedure?
Ideally, you should hear “hundreds” or “thousands,” not “dozens” or something vague like “more than I can count.” Also ask the doc how long she’s been doing the procedure (less than a year means there’s still a learning curve) and how many times a week she does it (too few times a week means she’s less likely to have fresh product or offer you free touch-ups if you aren’t happy).

Do you own or rent your laser?
Renting may be a tip-off that the doctor isn’t doing the procedure often enough to make owning worth it. Rented lasers aren’t always calibrated correctly, which could mean an increased chance of a burn. Also, not every laser is suitable for every skin type, so be wary of the physician who has only one. Ask about the number of fillers being offered, too.

What muscle causes the lid to droop?
If a doctor can tell you it’s the levator muscle, then he probably knows enough facial anatomy to avoid or fix this problem that can result from a poorly placed Botox injection.

How did you learn how to do this procedure?

If the answer is, “I took courses,” ask: Who taught them? How long did they last? Look for the MD who has completed multiple courses and takes continuing-ed classes in the field. If she trained with a top plastic surgeon, ask, “How did you find time for that?” She may let it slip that the training only took one afternoon.

Will you be the one doing the procedure?
It doesn’t matter how many hours of training your gyno has in fillers if his assistant is the one shooting you up. If something goes wrong, you want to know that the med school grad is right there to manage the complications. Remember: You’re paying for the expertise of the best-trained person in that practice.

Of course you'll want to be somewhat circumspect when asking all of theses questions. You don't want an angry plastic surgeon performing your liposuction or boob job.

A really nice example of static marketing that borders on installation art.

Seeking to enlarge her buttocks, Argentine model Solange Magnano made a decision that led to her death.

She chose to have injections of microspheres of PMMA plastic (polymethylmethacrilate), which led to a blockage in the main artery in her lungs, the Argentine newspaper Clarin reported.

Other techniques for enlarging the buttocks are more common, including implants or injections of the patient’s own fat, taken from elsewhere on the body.

Plastic surgeon Dr. Val Lambros of Newport Beach explained the alternatives.  “Buttock implants are not big operations. It’s like putting in breast implants.” But “you need a LOT of your own fat to inject into a buttock. If her photo is current she didn’t have anywhere near that amount.”

Dr. Walter Servi, secretary general of the Argentine plastic surgery society SACPER told Clarin that implants and fat injections are the usual methods of buttocks enhancement in Argentina, just as in the United States.

Injections of PMMA are infrequent, he said, including its use as filler to plump up the lips or to smooth out wrinkles, he said.

Such injections were introduced in Argentina two years ago and are less expensive than other techniques, said Dr. Jorge Patané, chief of plastic surgery at Fernández Hospital in Buenos Aires.

In the buttocks, it is injected into the muscles where there are few veins and arteries, he said. But in the case of Magnano, the injection apparently went into the blood stream, he said.

If that happened, Lambros said, it could lead to a pulmonary embolism — a blood clot or other substance blocking the main artery in the lungs. Lambros noted that he does not have direct knowledge of Magnano’s case.

The PMMA technique “has its risks, because it is not a procedure that has been scientifically validated,” said Juan Carlos Seiler, former president of SACPER.

But medical tourism Web sites offer PMMA injections as a “revolutionary procedure also known as bioplasty or Brazilian butt lift … the ideal non surgical solution” for people seeking larger buttocks.

PMMA was the substance injected to enlarge the buttocks of Mexican singer Alejandra Guzman in October, Clarin reported. After her injection became infected, Guzman sued the clinic. The owner of the clinic also faces criminal charges, the Associated Press reported.

Magnano had her injections on Thursday. The next day she was hospitalized with a pulmonary embolism. She died on Sunday.

Dr. Christopher Zachary, chairman of the UCI Department of Dermatology, said that PMMA can be safe when injected properly, usually in the face, but is dangerous otherwise:

PMMA is a safe product when used appropriately for facial rejuvenation. However, if injected blindly with a wide-bore needle into areas with large-caliber veins, the possibility of embolization of this (or any other material) is significant.

Material injected into a vein will be carried to the lungs and block the vessels, resulting in sudden and serious cardiovascular problems and/or death. On balance, it should be avoided ….

Argentina is a “medical tourism” destination for patients seeking relatively inexpensive plastic surgery, but it has a blemished safety record.

In August, a 43-year-old woman died after cosmetic surgery. In addition, a provincial town councilor has been in a coma since July 2008, when she had liposuction.

“It is a shame that stories like this often discourage clients from seeking surgery as people tend to equate the risk of all procedures even those performed in competent hands,” said plastic surgeon Dr. John Di Saia of San Clemente and Huntington Beach. “You need to educate yourself before having any cosmetic procedure performed and have it done by the most qualified practitioner you can have.”

He and other cosmetic doctors also raised the possibility that Magnano was injected with silicone, which can also cause death. Such injections can lead to a pulmonary embolism, as Lambros noted, or pneumonia, as noted by dermatologic surgeon Dr. David Sire of Fullerton.

Di Saia recalled the death of a New York woman last spring after having silicone injected into her thighs.

“Silicone injections are scary. No reputable plastic surgeon offers them to my knowledge. Do not submit to them,” he said.

Active FX laser skin resurfacing is gaining popularity at medical spas, laser clinics and plastic surgery centers. It’s main competitors are Thermage, Fraxel, and other skin tightening or laser skin resurfacing treatments.

Here’s an overview of Active FX and some links to more information.

The goal of laser skin resurfacing is simple: replace damaged skin with new, fresh skin. Techniques for skin resurfacing have made enormous advances, allowing nearly everyone to achieve close to flawless complexions. Many systems allow for light, moderate or deep laser resurfacing. The primary targets of laser skin resurfacing include:

• Fine lines and wrinkles of the face, especially around the upper lip, cheeks and forehead
• Loose eyelid skin
• Crow’s feet around the eyes
• Pucker marks (smoker’s lines) and frown lines
• Brown spots and splotchy, uneven skin tone
• Scars, especially acne scars
• Loose skin around the neck and jowls

How it Works

The gold standard of laser resurfacing systems, the UltraPulse® CO2 laser delivers thousands of tiny laser pulses in a pattern over the skin. Each pulse heats a column of tissue eliminating pigment discolorations at the surface and creating a zone of heating deep in the tissue. Unique to the UltraPulse Encore, these zones of heating shrink collagen and tighten the skin immediately*. The CO2 laser also offers the benefits of heating deeper layers of skin tissue, thereby stimulating collagen remodeling, tightening* the skin further. Patients can select from a range of treatments depending on the needs of your skin and lifestyle.

What is ActiveFX “fractional” laser resurfacing?

ActiveFX is a fractional laser procedure performed in a single treatment with minimal patient downtime. During the procedure, a high-energy beam of laser light is used to smooth out lines, wrinkles and scars, remove brown spots and other irregularities, and tighten the skin. It also stimulates formation of new underlying collagen to continue improvement over time. With fractional laser treatment, only a fraction of the skin’s surface is treated by the laser, leaving small “bridges” of untouched skin. This technique makes the healing process much faster and enables you to get back to normal activities sooner.

Is ActiveFX right for you?

Treated areas should be washed twice a day with cool water and a mild soap. Use our lotion twice daily to treated areas for 3 to 5 days or until healing is complete. Treated areas should be protected from direct exposure to sunlight. Sunscreen with SPF greater than 15 should be used at all times on the treated areas.

ActiveFX is ideal for you if you:

• Have a busy lifestyle or cannot be away from work for a long time
• Want noticeable results with minimal downtime
• Want to treat dyschromia, fine lines, wrinkles and skin laxity*

What you can expect from ActiveFX

Most physicians perform the procedure in the office with a topical anesthetic cream that is applied 30-40 minutes before the ActiveFX procedure begins. There is little to no pain associated with the procedure – most patients say they feel warmth similar to sunburn. You can drive yourself home after the procedure. With a gentle washing and moisturizing regimen, your photodamaged skin will begin to flake off within 2 days. After about 3-5 days, your doctor will probably let you wear make-up. Pinkness should be gone in about a week.

ActiveFX benefits

ActiveFX treatment produces a dramatic effect on the skin:

• Causes immediate skin tightening*
• Reduces wrinkles and fine lines, and softens deeper frown lines
• Noticeably improves skin tone and texture
• Stimulates new collagen formation and plumps the skin

The results of ActiveFX laser treatment are long-term and, with proper sun protection, can persist for many years. Most effects of treatment become visible right away, whereas others – such as new collagen formation, which leads to continued inner tightening – build up gradually and become more evident over time. Therefore, most people look even better 3-5 months after the procedure.

Additional Information on ActiveFX

http://www.aesthetic.lumenis.com/wt/page/activefx

http://www.lumenis.com/wt/page/pr_1170434066

http://www.skinandhealth.com/details/wrinkles_treatment#wrinkles_co2

Redness after IPL & Laser Treatments: DeepFX & ActiveFX

Reliant UltraPulse Fractional CO2 Laser

Active FX: Physician User Group ~ Medical Spa MD

Some fantastic info on Active FX laser resurfacing from Botox Patient. Love it.

Unfazed by a recession and rampant inflation, image-conscious Venezuelans show no signs of cutting back on the facelifts, liposuction, and breast augmentation that have become de rigueur beauty treatments.

"There is never a question of not doing it, but of how you can do it. We all want to get everything done," said Helen Patino, a 37-year-old former model who had her first breast augmentation when she was 21 and her third about three months ago.

Venezuela's inflation is the highest in Latin America, up more than 20 percent in the first 10 months of this year and the South American nation is in recession after a five year boom.

Hard times may even encourage cosmetic procedures as people look for ways to lift their spirits, with many dipping into savings or taking on debt to get operations, surgeons say.

"The financial crisis has spurred people to spend more on themselves ... to console themselves in this crisis. I have not seen demand diminishing," said Peter Romer, a plastic surgeon in Caracas.

For Iris Delgado, a 57-year-old dental technician, a lack of funds was not an obstacle to getting a recent eyelid tuck.

"With the economy, one has to make sacrifices, because you don't have the money. So, you get it from credit cards, from family and you pay for it," said Delgado, who borrowed 7,000 bolivares -- about $3,250 -- for the procedure, a move she saw as a hedge against inflation in plastic surgery prices.

Like Delgado, many go into debt to finance plastic surgery, according to those in the industry.

"It's an investment that people make and they look for money everywhere," said Romer, adding that one of his patients moved into a smaller apartment to get a makeover and another traded her car for a facelift.

Leoncio Barrios, a social psychologist at the Central University of Venezuela, said such stories are the exception. "The majority of middle and lower-income women do not have property to sell or the capacity to save," he said.

Su Huiqing, 32 shows the cut lines drawn for a liposuction procedure to be carried out at a plastic surgery hospital in Fuzhou in southeastern China’s Fujian province. Plastic surgery has become commonplace practice in China as a quick fix solution to looking more beautiful or losing weight. Su became obese after years of taking hormones to treat an illness. She now weighs 150kg and plans reduce her weight to 75kg in a year.