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« Concierge Medicine Blog: Housecalls & cell phones. | Main | Ideal Image: Another medspa franchise. »
Tuesday
May152007

Reactivated Thermage Tips: Thermage responds to supposed study.

Thermage's response to physicians purchasing reactivated tips from abroad.

 
..%5CSA%5CHTML%5Cimages%5Cthumbs%5C1_NewProd_Thermage_C9D92tif.jpgClint Carnell, VP of Thermage, asked me to post Thermages position on reactivating tips. I have posted it in it's entirety and have added an addendum to the previous post on the supposed study in question.

You'll notice that Clint asks me to remove the post to that study. I've exchanged a number of emails with Clint and he's agreed that the best course of action for Thermage to take will be to have this connected to reactivation post. The study in question is posted a number of times on the web and since this site is likely the first stop, it's also Thermages best option to position a counterpoint where someone searching for reactivated Thermage tips will be exposed to Thermage's position and opinion.

Thermage's position on the supposed study for reactivating Thermage tips: 

I am Vice President of Domestic Sales for Thermage, Inc. 

On your Medical Spa MD web page your blog entitled “Study: Safety & Performance of Reactivated Thermage Thermacool Tips,” gives a summary of a study which allegedly investigated the safety and performance of reactivated Thermage treatment tips, as well as a link to the study publication.  The publication claims Thermage treatment tips can safely withstand 50,000 shots.   

blockquote.gif  We have strong reasons to believe the study referred to in the publication never occurred, and that it is a pure fabrication being made by a non-US company to promote their product.  Overusing our treatment tips as suggested by the publication will burn patients.  blockquoteend.gif

We have strong reasons to believe the study referred to in the publication never occurred, and that it is a pure fabrication being made by a non-US company to promote their product.  Overusing our treatment tips as suggested by the publication will burn patients.  

We have conducted a thorough investigation.  We have been unable to locate the supposed author of this study and publication, Michael Stevens M.D., where the study was conducted, any documentation associated with the study other than the study publication, or any of the patients or “experts” who participated in or are referenced in the publication.   

In addition, the data reported by the study is inherently unbelievable.  The study purports to have treated 2,400 patients over a twelve month period (see under “Results” line 1, 1200 patients were treated with reactivated tips, and nine paragraphs earlier reference is made to an equal size control group).  In this industry this would be an enormously large and expensive study (200 patients a month for a year).  Though not impossible to do, it is highly unlikely such a large study occurred (and no one would have heard of it or anyone who was involved in it) given the significant costs and logistics it would require.  For comparison, the largest study we know of involving Thermage is a four year study conducted by Weiss,1 and it only involved 600 patients or one quarter the number Stevens alleges.  In addition, the claims in the Stevens publication are also wildly inconsistent with immense quantities of Thermage quality and reliability data we have compiled on our own products over the years.  We know for a fact the dielectric membrane on our treatment tip will break down when subjected to a tiny fraction of the repeated use this publication alleges can be done.  Dielectric breakdown can result in patient harm.   

So not only does summarizing or republishing a bogus study spread falsehoods, in this case it can endanger patients as well.  The very nature of this study falsely implies that it is a structured, documented and well accepted article.  In fact it is not and the potential use of this study by either a physician and/or patient could lead to poor decision making and patient harm.  We believe it’s in both our best interests to provide the best information possible in order to minimize potential patient complications.  So we ask that you delete your summary blog and link to this publication. 

Of course if you know of any collaborating evidence of any kind supporting either the fact that this study ever happened or the veracity of any of the data or claims made in this publication, we would be very interested in reviewing it.   

We thank you for your cooperation. 

Very truly yours,

Clint Carnell

Vice President of US Sales

1  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.

Reader Comments (8)

Hmmm. The 2cents from the lurker peanut gallery:

I've known about these reactivated Thermage tips for a while. (I hesitate to say I use them.)

I've also been lurking on this site for the last year or so. I've learned much and it's become a valued read thanks to the community here. Thanks all.

While I've been a critic of Thermage in the past, I continue to do the treatments. (I don't know if that's hypocritical or not.) I'm happy to see that Thermage is addressing the concerns on of physicians more directly rather than just issuing a press release. It's something that the other tech companies, Palomar, Cutera, and the rest should take note of. Thermage is far ahead of the PR game when they're willing to post on a site like this and put their point across. I'll bet legal had a say and marketing probably pissed their pants.

While I don't believe everything I read and I'm certainly aware that this is a carefully worded statement, I've gotten a new found respect for Thermage as a company. Thanks Clint.
I agree with Thin Skinned MD,
I appreciate Thermage posting their positions.
I wish my company (Cutera) would do the same out in the open. I guess their afraid that the chinks in the armor might show. Of course unhappy patients / clients usually have the loudest voice. What you can do is appear reasonable and concerned. Although I'm not a Thermage fan I also appreciate that they're posting directly to this site and think slightly more highly of them because of that.

Get off your butt Cutera. If Titan's better than Thermage, (as I was convinced it is and you're constantly telling me it is) let's see the proof.
05.19 | Unregistered CommenterTumsJMD
Turns,
Cutera plays second fiddle to Palomar across the board. I can't see Cutera posting on a site like this (although they should) since they can't totally control what someone might say about them.
05.29 | Unregistered CommenterLurker MD

I am in desperate search of a supplier for refurbished tips or perhaps for the microchip. I don't believe there to be any danger in reusing tips. They can be sterilized for patient safety, and as long as the user logs the number of pulses per tip there should be no danger. I am completely frustrated that I have 15 various tips that are brand new in the package that can not be used because they are "expired". Any information is greatly appreciated.

asummers@paradigmtrials.com

We have expired tips as well and have yet to get a formal answer on what issues can arise with their use. I have used an "expired" eye tip and it work just fine on the machine. I have a box of Deep body tips and Cellulite tips that are expired. Logically I can't think what could possibly be an issue other than the "sterility" guarantee. I've seen this expiration date on other medical products. Considering that the Thermage tips really don't need to be "sterile" because there is no blood or body fluids involved, I will hesitantly use them when the next patient schedules. Any one else have any feedback on using expired tips? Your experience would be greatly appreciated.

I have not had any patients who wanted to have a thermage treatment for some time. Several years ago, I bought multiple tips from thermage when they were offering tips and supplies together. I have 10 tips left and when a patient finally scheduled a procedure, the tip would not work. I thought it was a bad tip, and I put in another with the same result. The remaining tips I have left are expired by 10 months and the microchip prevents their use. I contacted thermage who suggested it was my fault for not rotating my stock. Since there have been no patinets wanting the procedure in a while there has been no rotation. Now I have 10 tips that are useless. Not a company who wants me to keep using their produce.

This shows how greedy a laser company can be.
why it cant work?
why set an expired date on the tips? it serves no purpose but just to fatten the manufacturer.

08.1 | Unregistered Commentermugen

Hi
I have about 15 unused expired thermage tips - does anyone know if these tips can be used or activated?

would be much appreciated.

thanks

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