Additional Information on Thermage

Thermage has received a low incidence (reported less than 0.2% of the total estimated number of treatments) of reports citing the development of focal “surface irregularities”. Such reports have been received for treatments that have been performed in the forehead, and mid/lower face areas. These surface irregularities have been variously described as “small dents in the surface of the skin” (localized) and “rippling”, “ridging” or “waffle patterns” (covering a larger surface area). Frequently these irregularities are not present immediately post-treatment but show up later (1 or more months post-treatment). In a few cases these symptoms have resolved over the course of time.

The procedure may produce heating in the upper layers of the skin causing burns and subsequent blister and scab formation. Burns have been reported at a rate less than 0.3%. There is a small chance of scar formation (rare). Scars may be raised or slightly depressed. Deployment of the technology over areas where metal objects may be present is done with caution to avoid burns. Please inform doctor of such sites (e.g. dental fillings, metal plates, etc.)

Thermage has received a few reports of focal pigmentation changes post treatment (reported less than 0.05%). These have primarily been reports of hyper-pigmentation (increased) (reports of hypo-pigmentation are rate). Cases of hyper-pigmentation have usually resolved over the course of time (within several months). Cases of hyper- and hypo- pigmentation have typically been associated with a burn.

In very rare cases, the treatment may cause bruising which typically dissipates within several days.

The treated area may become temporarily red (erythema) or white (blanching). Erythema typically resolves within a few hours, however, on rare occasions, has been seen to last longer (up to several weeks), blanching typically resolves within twenty-four hours.

Swelling (Oedema)

The treated area may swell. Swelling typically resolves in three to five days or less but can persist up to several weeks.

Pain

Most people will feel some heat-related discomfort (pain) with the treatment. This discomfort is usually temporary during the procedure and localized within the treatment area. A small number of patients have reported transient aching in the treatment area (lasting up to several weeks). In addition, a small number of patients have reported headaches following forehead treatment.

All of the risks of the ThermaCool system are not yet known. Other unexpected risks or complications may occur, and no guarantees or promises can be made concerning the results of the treatment.

Other unknown risks

All of the risks of the ThermaCool system are not yet known. Other unexpected risks or complications may occur, and no guarantees or promises can be made concerning the results of the treatment.

The effects of the procedure on women who are pregnant or breast-feeding are unknown and could be harmful. However, there is no evidence that other radio frequency surgical devices in use for decades have had a significant role in pregnancy.

Autoimmune Diseases

The effect of the procedure on patients with autoimmune disease (eg. lupus) is unknown.

Herpex Simplex

Herpes simplex eruption may result in rare cases in a treated area that has previously been infected with the virus. Reactivation of HSV is generally thought to occur most commonly in the perioral and genital skin areas after various stimuli.

Medication

Patients on steroid treatment and Warfarin are more likely to have problems.

Medical Implants

Pacemakers, defibrillators and internal hearing aids are strict contraindications

Because all individuals are different, it is not possible to completely predict who will benefit from treatment with the ThermaCool device. Some patients will have very noticeable improvement, while others may have little improvement. It is possible that additional treatments may be needed to achieve the desired end result, or that smaller touch-up procedures may be required.