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Thursday
May102007

Thermage tackes it's safety reputation among physicians.

This post was written for Medical Spa MD by Thermage.

Thermage Safety - The whole story

Clint Carnell, Thermage, VP Domestic Sales 

 
thermage_logo.gifIn reply to your recent blog entitled “Thermage: Do plastic surgeons hate everything non-surgical?”  I am Vice President of Domestic Sales for Thermage:

Much is written about the risks of Thermage, in particular the risk of fat atrophy and surface irregularities referred to in your blog.  Though there were some initial infrequent reports of such effects associated with Thermage after its product was released in 2002, the simple fact is that today Thermage is an extremely safe procedure, and has been so for several years. 

Thermage invented the concept of using non-invasive radio frequency energy for tissue tightening and contouring.  Thermage launched its first product in late 2002.  Though the overwhelming majority of initial treatments were problem free, fat atrophy and surface irregularities were reported in 0.23% of the procedures (2.3 per 1000 patients) in 2002-2003. 

Thermage’s investigation revealed that 100% of the early reports were from 6% of its physician practitioners. 

Our investigation also revealed the cause was over treatment – using excessively high energy settings.  If relatively high treatment settings are used, it is possible to overheat deeper tissue, especially in thin-skinned individuals.  The use of nerve blocks, tumescent anesthesia, and/or intravenous sedation that completely blocked patient pain perception and feedback was also found to be a contributing factor. 

In response to these findings, in January-February 2004, Thermage launched an aggressive physician education program instructing physicians to adopt treatment techniques to avoid tissue overheating.  The techniques included: 

  1. Use of a treatment grid to avoid pulse stacking.

  2. Use of multiple passes at moderate power settings rather than single passes at higher energy settings.

  3. Allow 2 minutes between passes to allow temperature reequilibration.

  4. Use patient feedback of heat sensation, and treat to a heat sensation level of 2-2.5 on a scale of 0-4 (4 being maximum sensation).

  5. Use minimal pain blocking.

  6. Pay special attention to patient feedback while treating thin-skinned areas. 

As reported by Narins (1), these new treatment techniques proved to be immensely successful.  During the 6 months following their introduction, the reported incidence of fat atrophy and surface irregularities decreased by a factor of roughly 6 (to 0.04%), and there were no reported incidents in the last half of 2004.  This improving trend has continued to the present.  For example, the reported incidence of fat atrophy and surface irregularities for all of 2006 was 0.016% (less than 2 cases in 10,000).  A similar dramatic decline in all other reported adverse events (e.g., burns, welts, swelling/edema, etc.) has also been observed.  Today, Thermage is an extremely safe procedure. 

In addition to significantly increasing patient safety, the new treatment guidelines have also significantly reduced the discomfort of treatment, since physicians now treat to a very tolerable heat sensation level of 2-2.5. 

Finally, the new treatment guidelines, in particular the use of multiple passes at moderate settings, have also significantly increased efficacy from that reported initially in 2002-2003.  Several peer-reviewed studies show Thermage patient satisfaction to be higher than 80%, and continuing to improve over time.2,3,4  Thermage results are most notably perceptible when it comes to an eyebrow lift or softening of the nasolabial fold, and provide a remarkably natural look.  However, we do acknowledge Thermage results can sometimes be subtle and are not nearly as dramatic as those produced by surgery. 
 

References 

1  Narins, RS, et. al.  Overtreatment Effects Associated with a Radiofrequency Tissue Tightening Device: Rare, Preventable, and Correctable with Subcision and Autologous Fat Transfer. Dermatology Surgery 2006;32:115-124; January 2006. 

2  Weiss, R.A. et. al.  Monopolar Radiofrequency Facial Tightening: A Retrospective Analysis of Efficacy and Safety in Over 600 Treatments. Journal of Drugs in Dermatology – Vol. 5; Issue 8; 707-712; September 2006. 

3  Finzi, E. et. al.  Multipass Vector (Mpave) Technique with Nonablative Radiofrequency to Treat Facial and Neck Laxity.  Dermatol Surg 31 (8 Pt 1); 916-22; August 2005. 

4 Biesman, B. et. al.   Monopolar Radiofrequency Treatment of Human Eyelids: A Prospective, Multicenter, Efficacy Trial.  Lasers in Surgery and Medicine 38:890-898; December 2006.

Reader Comments (20)

Well. I'm truly happy to see a technology company who has the gumption to post something other than a press release. I don't offer Thermage but I'm very interested to here what Jeff and others have to say about Thermage, Titan, Fraxel and the rest. I'd like to hope that even if they're not perfected yet, that it might happen and I'll be able to shrink wrap my patients to their hearts content.
05.10 | Unregistered CommenterVexed MD
As a long-time-lurker on this site I'm glad to see this type of post.

I'm a user of Thermage and I'm glad to see that the corporation is addressing this issue. I'm tired of other docs looking at me like I'm doing something clandestine by offering Thermage to my patients. With all the "Thermage burns you and hurts like hell" stuff out on the web it often comes from patients too.

Happy to see Thermage using this site to get the message out. Thanks Jeff.
Windy City Doc,
It says right there and clear as day, "However, we do acknowledge Thermage results can sometimes be subtle and are not nearly as dramatic as those produced by surgery."

"Sometimes"? Thermage is a toy that's built on selling the dream rather than delivering the results. The only real results come from surgery. I'll keep my scalpel.
05.11 | Unregistered CommenterCutterMD
CutterMD,

You keep ahold of your scalpel. I'll take the 8 or 9 out of every 10 patients that you see who opt not to do surgery. Those 80% to 90% who WANT something less obvious love Thermage. Unfortunate that you weren't able to fit a business course in during medical school.

As for the link from "plasticized" look closely at the tip that was being used. It is the original 1cm tip that used much higher energy. Thermage is now on their third or fourth generation tips along with the newer treatment techniques. I have not seen or heard of this happening at all for the last couple of years.
SW Skin Doc,

We've trialed the Titan, Palomar's deep IR, Thermage 18 months ago and now the new Refirme ST from Syneron. Has anyone put together a white paper comparing these systems? So far IMO (need to bring back latest gen Thermage) the Refirme appears to offer the best compromise of speed, safety and efficacy. Problem is I'm told by my local Thermage rep that it's against company policy to leave a unit a few weeks to try out. Hell, I can't even get a demo other than on a specific day and time at a hotel somewhere. Seems to me they have much to learn about how to market a product...
SW Skin Doc,
MBA here good buddy. I've been in the business for a while and have seen the same kind of fad treatments come and go. (I here that Thermage is coming out with a 'cellulite' tip. Oooohhhhh)

I don't doubt that there is a large percentage of patients who are scared by surgery. But, as they say, 'thems the breaks'.

Technology is early and it will get better. But Thermage isn't there yet.

As for the business aspects, I just resent the overpriced consumables. Paying $600 for a piece of plastic and a chip that costs $5 just rubs me the wrong way. I'll trust to skill, knowledge, and a steady hand over an 18 year old with a hot stick.

Not meaning to insult those here in the community which I respect as one of the best on the web and absolutely the best in this area. Don't ban me Jeff. I'll play nice (Yeah, I read that post too.)
05.12 | Unregistered CommenterCutterMD
Oh boy. Here we go with the Plastic Surgeon Attack. I can see this continuing for a number of years yet. In the end, nonsurgical solutions will win because the market wants those kinds of solutions. This site's been preaching it for a long time and I finally started to listen. So to the 18 year old with a hot stick the market says, 'You go girl'.
05.12 | Unregistered CommenterDermGal
Why can't we just all get along.

Just kidding. Do not think that the plastic surgeons are just going to go away because of technology. There will always be patients that need the knife. I wish that I had a plastic surgeon that I could work closely with. They all see me as competition. If they only new how many pts I recommend surgery for.

I agree that you will not get the same results from ANY skin tightening systems as you would with the knife. I have seen some nice results for the eyes with Thermage. As of right now for non-surgical intervention all of the companies are jumping on the bandwagon. It is going to take a little while to figure out the best options and then you will start to see the crappy technology on the used market. Currently, I think Thermage leads the pack but for how long we do not know.

Plasticized, look at the site and who sponsors it. He does not want thermage or any of the skin tightening systems to work because he likes to cut and makes a lot more money for it. When I read that post, I see alterior motives and scare tactics.
05.12 | Unregistered CommenterLH
I have to agree with LH, I'd also like to find a PS that I could work with. It seems that they just can't find it in themselves to share a patient. I guess that greed is part of the make up.

For now I just let the patient find their own surgeon.
05.12 | Unregistered CommenterNin DO
Cutter MD,

I guess we'll have to take your word on the MBA.

I am trying to understand your stance on the disposables. Why do you have recentment for the disposable cost when it is a technology that you neither believe in nor use? When you were going through the economics portion of that MBA were they big advocates of companies selling product for the cost of manufacuring them? For that matter do you charge your surgical patients only the cost of what it costs to perform the surgery? Please let me know where you practice I need a nose job and would love to get one for the price of instruments, disposables, and OR time only! Bet that's cheap.
not sure what the title of this post is supposed to mean. tackle or takes?
in any case, skin tightening with damage to subcutaneous layers and probably fat atrophy does not sound like the answer. most of these people need more volume, not shrinking the package to fit less volume.
05.14 | Unregistered Commenterltx
ltx,

What do you think a face lift does? It is shrinkwrapping. I agree that most need more volume.

05.14 | Unregistered CommenterLH
Fat atrophy does not occur. The damaged collagen is replaced by new collagen. Increases dermal density.
Er, Read the post. All the problems in the early days came from the same docs who were cranking up the machine. We do a lot of Thermage and I've yet to see any harmful effects. I generally don't take sides in these debates but the post does an excellent job of refuting the constant links to fat atrophy.

Yes, they did have some problems. But the complication rate for Thermage is minuscule and much smaller than the 6% serious complication rate (at least that's the number I remember) with surgical face lifts.
I agree. There are still a lot of docs out there thinking the higher the better. They are putting people out with meds or anesthesia and do not get patient feedback. This is what caused and continues to cause problems including fat atrophy. There are 3 providers in my town that do Thermage. I am the only one certified in the new protocols.

My opinion is that Thermage should not sell tips to the docs that refuse to update their protocol. If you look, the studies show that the new protocol is also more effective than the old with fewer non-responders.
05.14 | Unregistered CommenterLH

i had thermage done a year ago its been a nightmare my face has changed so much and i have scarring and fat loss.
it was 1cm tip and felt like a cigerette burn each pulse .
the doctor said the more it hurt the better the results,i think i look older than i did before i got it,im 39

10.29 | Unregistered Commenterlea

I had thermage done on my upper eyelids in the spring of 2010. Today I have fat loss around my entire eye and fragile skin from burns. Before this procedure I had nice full lids with just a little crepiness. My doctor said this would be a wonderful way to smooth the area and make eye shadow easier to apply. Since this procedure I have not been able to wear eye make-up at all because my lids are so damaged. The thermage shrunk the skin to the top of the iris and my eyeball bulged from the socket. My doctor referred to it as the "fish eye". The heat was lowered on the other eye and it is not as bad. Now that the skin has relaxed and the fat disintegrated my lids sag. My brows have dropped because there is nothing to support them anymore. The "old" problems with thermage have not been resolved. This high heat should never be used around the delicate eye area.
The doctor that performed it is a board certified dermatologist and has had this machine for years.

01.13 | Unregistered CommenterAnn

I had thermage done on my upper eyelids in the spring of 2010. Today I have fat loss around my entire eye and fragile skin from burns. Before this procedure I had nice full lids with just a little crepiness. My doctor said this would be a wonderful way to smooth the area and make eye shadow easier to apply. Since this procedure I have not been able to wear eye make-up at all because my lids are so damaged. The thermage shrunk the skin to the top of the iris and my eyeball bulged from the socket. My doctor referred to it as the "fish eye". The heat was lowered on the other eye and it is not as bad. Now that the skin has relaxed and the fat disintegrated my lids sag. My brows have dropped because there is nothing to support them anymore. The "old" problems with thermage have not been resolved. This high heat should never be used around the delicate eye area.
The doctor that performed it is a board certified dermatologist and has had this machine for years.

01.13 | Unregistered CommenterAnn

I had thermage done at skin spectrum in tucson Az. about 10 days ago. I dont see any results. what i do see is that my skin is very shiny, now i think is because they gave me Retin-a samples to use. and that is causing the shine, that is at its best right after i wash my face. It looks nice, but i still think it has nothing to do with thermage. when I went to "SKIN SPECTRUM" it took me by surprise that they did'nt have any before and after pictures of thermage patients. the tech said it was becuase it was hard to have patients agree on taking photos in such a small town. which now makes me wonder... But they do agree to take pictures for other procedures??? MMM... Well I am still waiting on the results. but it just kills me to see the reviews and think that i have been scamed, they are charging 1,800 for 900 pulses. she went over and over the parts of my face that bother me the most.. but really i don't see anything at all. Do you think i can expect a result later..or am i supposed have seen some sort of result by now? Has aynyone had GOOD results with thermage????? anybody?? I would love to hear from someone REAL.. not doctors or techs.. but a real patient with a succes story

02.13 | Unregistered CommenterAngie

Check out RealSelf.com for reviews on thermage. It's by real patients. As you might imagine from your own results the satisfaction rate is only 39%. It is a waste of hard earned cash.

05.15 | Unregistered CommenterAW

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