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Thermage Safety Update

Thermage - Is it Safe and is it Effective?

I had a Thermage “facelift” treatment last September. Even though the process was quite painful, I was (and am) pleased with the results.

Visit my Thermage Journal and see the before and after photos.

However, as I continue to research the topic, I have concluded that I am one of the lucky ones in the sense that the equipment and training of the doctors administering the procedure has improved. I have read reports of patients who have been less than satisfied.

Many have allegedly suffered permanent disfigurement. Some claim to have multiple costly reconstructive procedures done to undo the damage they allegedly suffered from Thermage.

As I try to parse through all of the forums and news reports with an objective eye, I can’t help but conclude that I should issue a caution to my readers.

In the wrong hands, Thermage can be dangerous.

If you don’t do your homework, you stand a small chance of undergoing a procedure to improve your confidence and self esteem but ending up looking older or, worse yet, deformed and in long-lasting pain.

If you’re considering Thermage, carefully check the credentials of the doctor who will perform it. S/he should be a Board Certified in dermatology or plastic surgery with at least two years experience in Thermage.

An intimate understanding of the layers and depths of facial tissue combined with extensive experience in calibrating the radio frequency wave machine appear to be the keys to good results with Thermage.

The Forums

Just type “Thermage forums” in your web browser’s search box. Here is a link to a forum on RealSelf.com. You’ll see a very mixed picture.

Some of the stories are heartrending.

The last time I checked at SmartSkinCare.com, only one-third of the posters reported satisfactory or better results with Thermage.

Forty percent saw no benefit; and 27% had adverse effects.

This is by no means a scientific review of the procedure. I believe that people who are displeased or even harmed are more likely to complain on such forums.

They want help and advice. They want to warn others.

People who are satisfied just go merrily along with their lives.

So we need to keep forums in perspective and realize that they might be presenting a very biased picture.

FDA Approval and Complaints

The FDA approved the device for full face treatment in 2004. FDA approval does not signify that the device is effective, only that it is safe.

Approval was granted even though there had been 63 adverse events reported. These included one death, scarring and skin depressions.

Twenty of the complainants reported that they had had subsequent cosmetic procedures to correct the damage from Thermage.

There is an important lesson here – virtually every medical procedure carries some risk. The FDA approved the ThermaCool device as safe because the adverse events were explainable and/or statistically insignificant.

To draw an analogy, since people occasionally die during dental treatment, should the dental equipment used be removed from the market?

The FDA still considers the device as safe.

Company Response

Thermage Inc., the company which manufactures the device and trains physicians in its use was advised of every adverse event during the FDA approval process. They investigated each case and reported that the machines in question were functioning properly.

In other words, mistakes were likely due to operator error.

Thermage did redesign the device to include new treatment tips which make them more foolproof. This has reduced reported complications.

The company says the number of adverse reactions is a fraction of one percent, well below the rates for other common cosmetic procedures.

Again, remember there are risks to almost every medical procedure.

The Thermage website now states that "a rare (0.2%) but longer lasting side effect described as a skin depression has also been reported."

According to Dr. Richard Fitzpatrick, Associate Clinical Professor in the Division of Dermatology at UCSD School of Medicine, recent changes in Thermage technology and treatment approaches have resulted in better patient results, safety and satisfaction.

Specifically, in addition to the improved tip, a grid is used to map out the treatment area to help the doctor to treat in an even manner and avoid “stacking pulses”.

Lower frequencies are also now recommended.

Doctors are advised to closely monitor patient pain, which means patients should be awake for the procedure. Mild relaxants and painkillers may be given.

It’s Statistically Safe; but is it Effective?

Yes. Thermage has become safer and more effective over the years. Practitioners have gotten more practice; the equipment and techniques have been improved.

The most recent study of the efficacy of Thermage was published in the September 2006 issue of the Journal of Drugs in Dermatology.

Doctors Robert and Margaret Weiss of the Maryland Laser, Skin and Vein Institute did a retrospective review of charts and clinical images of over 600 consecutive patient treatments between May 2002 and June 2006 using the ThermaCool device.

They found that, as treatment algorithms evolved over the four year period, measurable results as well as patient satisfaction improved.

There were no long term adverse events among their 600 patients.

One patient had a slight depression in one cheek which resolved itself over three and a half months. Four patients developed acneform subcutaneous erythematous papules which cleared in one week. One had some skin crusting which healed in a week.

All these patients were treated with the original tip design.

The only side effects reported after the new tip was introduced were edema and redness lasting less than 24 hours and neck tenderness in three patients lasting from two to three weeks.

So it appears that with the new tip, Thermage is a safe and effective cosmetic procedure.

What Causes Facial Depression in Some Patients?

Dr. Benjamin Bassichis, medical director of the Advanced Facial Plastic Surgery Center and Clinical Assistant Professor at University of Texas-Southwestern Medical Center, presented a research paper on Thermage to the 2003 Facial Plastic and Reconstructive Surgery meeting in Orlando, Florida.

This study seems to cover some of the earlier problems reported by Thermage patrons.

In his practice, he was seeing patients who had been allegedly injured by Thermage and left with permanent depressions giving patients a hollowed-out and aged look.

The gaunt or deformed appearance could only be rectified by fillers or surgical implants.

Dr. Bassichis’ conclusion was that the device had caused deeper thermal injury than intended in these cases. His opinion was that the machine is fundamentally flawed and dangerous.

The system is designed to uniformly heat large amounts of collagen in the dermal layer of the skin, while the epidermal layer is protected by cooling the treatment tip during the procedure. Dr. Bassichis explained that the next deeper level is the subcutaneous fat layer.

In these adverse events, the device apparently penetrated to the subcutaneous fat layer and literally melted away facial fat pads.

Further, with the facial fat pads gone, the dermal layer could adhere to the next layer – the superficial musculo-aponeurotic system making the problem very difficult to correct.

He noted that this is the same deformity that is caused by overaggressive liposuction of the face and neck.

I find it curious that Dr. Bassichis didn’t mention or perhaps even consider that, as in the case of overaggressive lipo, these complications might be due to operator error (or malpractice) rather than the device itself.

So What’s a Consumer to Do?

This is a very good case of “caveat emptor” – buyer beware. If you were one the pioneers to have Thermage and suffered a bad result, my heart goes out to you.

Techniques, training and level of experience have improved. The machine itself has been refined.

I will repeat that anyone considering Thermage should carefully check the credentials of the doctor who will perform it. S/he should be a Board Certified in dermatology or plastic surgery with at least two years experience in Thermage.

Ask about possible side effects and specifically about damage to facial fat pads.

When the doctor explains the procedure, be sure s/he plans to use a facial grid “tattoo” to assure even coverage and prevent “pulse stacking”. Ask if s/he is using the latest design of tip. Stay awake for the procedure so that you can give the doctor feedback on pain level.

Aftercare

Be sure to follow your doctor’s instructions regarding aftercare to the letter. Thereafter continue with a good antiaging skin care routine to preserve and enhance the gains you achieved through Thermage.

To me, that means broad spectrum sunscreen every day combined with day and night creams/serums containing peptides to stimulate collagen growth and to reverse glycation damage.

Read about cosmeceutical peptides here.

Learn the basics about Thermage.

Read my first person account of a Thermage Face Lift

and see my before and after photos.

Save on skincare with DERMAdoctor Special Offers!

This article is for informational purposes only. It does not purport to offer medical advice.

 

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