The Beauty and the Buzz at ASLMS

Just like many of you, my day is scheduled from morning to night and I am lucky if I can grab a bite to eat in between patients. It’s a real challenge to carve out time for professional development (and lunch). That’s why I appreciate the annual conferences hosted by the professional organizations. I can block out that time months in advance knowing that I will come back with new ideas.  

The American Society for Laser Medicine & Surgery (ASLMS) is on my must attend list year after year. It’s probably the best in the world for exchanging ideas and real science in the world of aesthetics, and not just marketing hype.

This year was no different. The 2014 meeting held in Phoenix, AZ was full of ideas. So many ideas that I wish I had a longer flight home to research them all.

When I returned my staff asked “What was the highlight”? The truth is there were so many highlights. I came home with so many pearls of wisdom about so many different areas of practice. I’d like to share a few of them with you.

Privacy Laws    
This year brings changes in HIPAA privacy and security rules. There are new rules addressing the sale of protected health information for marketing and fund raising purposes. There are new rules surrounding business associates that you contract with. There are also new waves of audits to ensure compliance. The meeting was a call to action to get my staff prepared for the new guidelines.
Under Eye Bags
For those of you not familiar with Neotensil, I suggest you take a look. It is a new film-like substance, made by a hair care line Living Proof, which reduces the appearance of undereye bags. It’s sold through physicians’ offices, but applied by the patient at home.  
Injectable Filler Technique
Take that extra care, that extra wipe step, with Voluma and other facial fillers. When injecting fillers in the hollows of the lateral orbit, think microcannulas with a lateral point temple zygomatic point of entry.  And on those crow’s feet, think of almost individual dosing per severity of lines at those two to three lateral orbit injection points. I also learned about pre-injection disinfecting wipe pads that combine clorhexidine with isopropyl alcohol.
Acne Suppression
There was a lot of buzz about keeping acne at bay using combinations of both short pulsed and long pulsed YAG lasers. It seems a paradox, but patients did better long term when they did laser acne treatments after finishing a course of antibiotics.  For patients with unresponsive rosacea pustular acne, think SIBO or small intestinal bacterial overgrowth and order a lactulose breath test screen.  
Bruising
For that post treatment unintended or inconvenient bruise, think of speeding up its disappearing act with an IPL treatment about 2 days after.  
Tattoo Removal
Here is a tip for tattoo removal for those of you not yet into Picosecond lasers. Treat the area through a hydrocolloid dressing, such as Second Skin.  
Noninvasive Fat Removal
There was a ton of chatter, all of it exciting, about noninvasive fat removal. The players are CoolSculpting,  Liposonix and the newest kid on the block, Vanquish.

Some of the above ideas are reality for me. We added Vanquish to our list of noninvasive fat removal a few months back. It’s a great fit for our practice and patients. Other ideas may not be a fit. But that’s the beauty of the meeting. With so many new products and protocols shared in one space, you are bound to come back with ideas to push your practice forward.  

Fairwarning: The LipoTron 3000 FDA UnApproved $85k Massager

According to a new story on Fairwarning.org, RevecoMED claims that their LipoTron device is really being marketed and sold as an $85,000 massager.

I just got off the phone with Myron Levin or Fairwarning.org who contacted me about Advanced Aesthetic Concepts attempts to have comments and reviews about the Lipotron 3000 and their business removed from Medical Spa MD claiming that some negative comments were costing them sales. It was an intersting discussion and Myron filled me in on some of the background that went into the story which has some interesting twists including anonymous calls to the FDA and secretive meetings with criminal investigators.

Read the entire article here: Fat-Melting Device a Weighty Matter for FDA on Fairwarning.org

From the Fairwarning.org article: 

According to interviews and records, Reveco first sought a green light from the FDA in 2007. It chose the FDA’s market clearance procedure, which is less demanding than the formal approval process.

To get a new device cleared this way, the manufacturer must show it is similar in safety and effectiveness to products that are already on the market.

However, Reveco’s bid failed. The company’s initial application “wasn’t in-depth enough,” Rosen said, and the FDA repeatedly sought additional data. Finally, according to Rosen, “We said, ‘You know what, it’s not worth it.”

According to interviews and a document reviewed by FairWarning, the FDA then told Reveco that the device could not be marketed.

LipoTron sales continued, however. Rosen wouldn’t disclose how many of the devices have been sold, but the number is believed to be in the low hundreds.

In 2011, Reveco took another tack with the FDA. It classified the LipoTron as a massager used for relief of minor pain. That would make it, in FDA parlance, a Class 1 device — a category that includes such simple, low-risk items as elastic bandages and examination gloves.

The advantage for Reveco is that massagers can be sold without a green light from the FDA. They automatically are exempt from FDA review and can be put on the market once a notice is filed.

Yet doctors and med spas have been promoting the device on the Internet not for massages but for removing fat.

Rosen said that was not Reveco’s responsibility, stating that the company can’t dictate what doctors do or “police everything out on the Internet.”

Asked who would pay $85,000 for a massager, Rosen replied: “Anybody that wants to buy it.”

Wow. It would take some really big cajones to claim that you're selling an $80k+ device named LipoTron to cosmetic clinics from a company named RevecoMED but you're only marketing it as "a massager for minor pain" and that it's the doctors who are running around uncontrolled promoting it for fat-melting. I'm actually somewhat impressed. I guess the real lesson is that if you can't get your device approved by the FDA as a medical device the first time, reclassify it as a band-aid and declare yourself in full compliance. That seems simple enough. 

Of course it also seems fairly clear from the article that if you have one of these devices and you're promoting it as FDA approved or as a treatment for anything other than a 'massager' you might not be in lock-step with the FDA, a fact that might be exacerbated by the fact that this story has been picked up by major media outlets like MSN.com.

I'm curious; Does anyone have one of these Lipotron devices that they're using as a massager for minor pain? You might want to see if it works on yourself because I'm guessing you have a headache about now.

Update on 2012-07-19 14:46 by Medical Spa MD

More bad news for LipoTron, RevecoMED (the manufacturer of LipoTron), and probably for it's resellers... as well as all the physicians and clinics who are offering LipoTron treatments.

Public Citizen, a consumer watchdog organization with 300k members, has contacted the FDA urging, among other things, that all LipoTron devices should be seized immediately.

Here is what Public Citizen is asking for; from their letter to the FDA:

Immediately seize all LipoTron devices that have been manufactured by RevecoMED and either (a) are being held in inventory by the manufacturer in the U.S. or (b) have been sold and distributed to user facilities in the U.S.

(2) Immediately order RevecoMED and any distributors of the LipoTron device to cease and desist all activities involving the distribution, sale, and promotion of the LipoTron device.

(3) Expeditiously complete its criminal investigation of the distribution, sale, and promotion of the LipoTron device and take appropriate legal action against those individuals, companies, and user facilities that are found by the agency to have engaged in any illegal marketing or promotion of this device

This can not be good news for any of the medical spas and clinics who already have this device.

Read the entire letter to the FDA

View attachments regarding the letter

View the Public Citizen press release

Zerona Lasers

Thoughts on Zerona Lasers

LH (Dr. Lornell E. Hansen II MD) has this comment on the latest Zerona Lasers review discussion around the effacacy of Zerona for 'fat melting' and a study that was just released.

Here's the Zerona Body Sculpting Study

Low-Level Laser Therapy Effectiveness for Reducing Pain After Breast Augmentation American Journal of Cosmetic Surgery Vol. 26, No. 3, 2009
Robert F. Jackson, MD; Gregory Roche, DO; Todd Mangione, DO

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)
www.LazaDerm.com

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.

If you read the thread there's some interesting thoughts that spring to mind. If Chad is not with Zerona it would be the first time in my experience that a patient has been searching for peer-reviewed medical studies before deciding to have a treatment... I'm just saying.

Of course this qualifies as a guest post and a well deserved back link.

Any other physicians using Zerona have any thoughts?