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

 
Clint 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.   

  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 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.