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Clinical Applications of UltraShape

a report by

Jana Hercogová

President, 10th International Congress of Dermatology

Liposuction is the most commonly used technique for fat reduction;

however, it is associated with severe risks such as embolism, nerve

compression, skin necrosis, problems with anaesthesia, infection, visceral

perforations and seroma.1–3 Furthermore, liposuction success is highly

dependent on the skills and experience of the surgeon, therefore results

can vary considerably. Hence, there is need for a safer, non-invasive

technology to achieve fat reduction and improve the body silhouette.

UltraShape is non-invasive focused ultrasound technology that allows

dermatologists to safely achieve fat reduction without the need for

invasive surgery. Unlike liposuction, UltraShape utilises the natural

physiological and metabolic pathways to clear fat. The first UltraShape

device, Contour I, received the CE Mark in July 2005 and was launched

shortly afterwards. In 2007 it acquired a medical device licence from

Health Canada. The Contour I Version 2 was introduced in May 2007,

and includes the latest technology for body contouring. Contour I

Version 2 has updated software that allows the clinician to control

power levels to refine and personalise treatment. The guidance and

tracking system of the new device uses light-emitting diode (LED)-

based technology with an integral camera to improve its performance.

The ease of use of the device has been enhanced by an icon-based

graphic interface that may lead to shorter treatment times.

Fat Clearance Mechanism

UltraShape uses a focused ultrasound beam directed towards the

subcutaneous fat layer, causing a mechanical rather than a thermal

effect to avoid adverse skin effects. This process selectively causes the

disruption of fat cell membranes, leaving blood vessels, peripheral

nerves and connective tissue intact. Triglycerides from the fat cell are

released into the interstitial fluid between the cells, activating metabolic

pathways that direct the water-insoluble molecules through

the circulatory system. During this process, lipoproteins bind to the

triglycerides and both are then catabolised into free fatty acids and

glycerol molecules. Free fatty acids released from the fat cells

are transported directly to the liver through the bloodstream and are

processed in the normal pathways for fat metabolism. In clinical studies

conducted to evaluate the safety and effectiveness of the UltraShape

treatment, no abnormalities were noted in blood chemistries, including

fasting lipids and liver markers, or in liver ultrasound scans.

Ideal Candidates

UltraShape is intended to reduce localised accumulations of fat tissue

in both male and female patients. The treatment is primarily designed

for patients who are normal to slightly overweight and have a body

mass index (BMI) of less than 30. Subcutaneous fat thickness should be

at least 1.5cm in the intended treatment area. Patients with extensive,

non-localised fat are not suitable for this technique. The ideal

candidates for UltraShape are people aged 18 years and over who are

committed to a healthy lifestyle. This is because in order to optimise

the effects of the treatment patients need to maintain a regular

exercise programme and have a healthy well-rounded diet.

Contraindications for treatment include bleeding disorders, having a

pacemaker, liver disease, inflammatory diseases, pregnancy, disorders of the

connective tissue and metabolic disorders. In addition, fat that is fibrotic or

cellulitic rather than soft may not respond optimally to the therapy. Poor skin

tone and obvious skin laxity may also lead to suboptimal results as the skin

may be slow to shrink in the treatment areas and patients may develop

stretch marks. This is not a contraindication to UltraShape, but these

considerations should be carefully explained.

The Procedure

Uniform fat removal is essential to achieve optimal body contouring.

The UltraShape device is guided by a proprietary tracking and

guidance system that ensures the ultrasound beam is distributed

evenly in the treatment area. The tracking system uses a single video

camera to ensure that the ultrasound beam remains within the

treatment area and that every point is treated only once. The Contour

I device records and synchronises with the body’s position in realtime

to allow for the patient’s movement and breathing. The ultrasound

beam is delivered through a transducer, which provides realtime

optical and acoustic feedback. The temperature and acoustic contact

of the transducer is measured by built-in controls during treatment.

The time taken for the procedure depends on the area that is being

treated. A small area, such as the flanks, can be completed in

approximately one hour. Total procedure time for large or multiple

treatment areas can be two hours or more. Time is also spent on

preparing the treatment area, getting the patient into the correct

position, measuring the patient and setting up the device.

In general, patients undergo three procedures for optimal fat reduction.

In the UK, doctors have been advising more than three procedures for

patients who have higher fat residues in localised areas. In a single

procedure there is an average circumference reduction of 2cm.4

UltraShape does not involve weight gain or loss – the patients usually

remain the same weight, but lose circumference around the body.

Results of UltraShape

To evaluate the clinical efficacy of UltraShape, patients are measured

both before and after the procedure. Measurements are taken in two

ways. First, the circumference of the treatment area is taken using an

adjustable measuring device. A measurement tape is placed parallel to

the floor and the height from the floor and tension of the tape are

Clinical Applications of UltraShape

© T O U C H B R I E F I N G S 2 0 0 82

a report by

Jana Hercogová

President, 10th International Congress of Dermatology

Aesthetic Dermatology Body Contouring

recorded to ensure the same parameters are used in follow-ups. Second,

the thickness of the fat tissue is measured using ultrasound. This is an

objective measurement because the level of fat reduction can be seen in

monthly intervals and it is an ideal tool by which to demonstrate to

patients the benefits of the treatment.

Visible results of the UltraShape procedure can be seen in

approximately two to four weeks, owing to the time taken for the fat

tissue to disperse and be broken down. Some patients have noted

improvements earlier: the results are patient-specific. Based on my

experience, an immediate sign that the treatment has been successful

at breaking down the fat is that within a few hours after the procedure

the patient will begin to feel tired, similar to after physical training,

in the part of the body that was treated.

The main difference between the results of UltraShape and those of plastic

surgery is the immediate effect after surgery. For example, if you undergo

classic surgical liposuction, the amount of fat tissue that has been removed

is immediately obvious and the results may be more pronounced due to the

quantity of fat that can be aspirated. However, while liposuction produces

faster results, this is accompanied by the need for anaesthesia, post-surgical

metabolic and fluid imbalances, long procedure times and painful recovery.

Patients are also required to rest after liposuction and to wear pressure

garments. In contrast, there is no recovery period after an UltraShape

treatment: patients can immediately resume their normal daily routines.

Clinical Evidence

Clinical evidence for UltraShape has been published in two peer-reviewed

journals.4,5 The efficacy of UltraShape has been examined in a worldwide

multicentre controlled clinical trial in which several treatment

areas were assessed, such as the abdomen, thighs and flanks.4 A single

treatment was performed on 164 patients and efficacy was assessed by

measurement of circumference of the treated area. The average loss in

circumference was 2cm and an approximately 2.9mm reduction of skin fat

thickness was achieved overall compared with the control group, which

was statistically significant. The full effect of the treatment was sustained

through a 12-week follow-up and the effect was similar in all treatment

areas. Seven treated patients reported side effects including mild tingling

during treatment, small blisters and mild erythema; however, all were mild

and resolved within the trial period.

The independent multiple treatment clinical trial published in Lasers in

Surgery and Medicine5 included 30 patients who underwent three

treatments at 30-day intervals using the UltraShape CONTOUR I. The

study included treatment of the following areas of the body:

abdomen, flanks, thighs, knees and pseudo-gynecomastia. Results

showed 100% response rate with no adverse effects following the

three treatments. The study also demonstrated a mean fat thickness

reduction of 2.28mm and a mean circumference reduction of 3.95cm.

As a control, weight loss was monitored to ensure results were not due

to weight loss. A blister occurred in one of the patients, although it did

not prevent further UltraShape treatment. The authors concluded that

UltraShape is suitable and safe for body contouring and that it may be

used as an alternative to the conventional invasive liposuction.

In my practice there have been no reports of any serious adverse effects

using the UltraShape device. If the procedure is carried out properly by an

experienced person, it is very rare to encounter any problems. There has

been only one case of a small blister developing on the skin of the

treatment area, but this had no impact on continuation of UltraShape

treatments because the blister healed and no further problems were

encountered. Approximately 200 other patients have been successfully

treated with no side effects. In patients with sensitive skin, a slight

redness can occur or tingling can be felt during the application of the

ultrasound energy. In some cases the redness can last for a few hours

after therapy, but this usually disappears within 24 hours. Patient

selection is important to reduce the risk of potential adverse effects.

The feedback from patients in most cases is excellent, although some

patients can be unhappy with the results if their expectations have not

been properly set. In the majority of cases where patients are less than

happy, they have expected more fat reduction than is possible with

UltraShape. One patient treated in my practice received a refund

because she was very disappointed with the results. However, this case

occurred when the treatment was relatively new and we lacked the

experience to communicate exactly what the patient should expect.

Now we discuss with each patient exactly what we would expect to see

after three sessions and do not make any unrealistic guarantees.

Conclusion

Invasive liposuction is the most commonly used method of fat removal

to date. However, it can result in severe side effects and suboptimal

results. The UltraShape device is a non-invasive fat reduction technique

that allows dermatologists to safely achieve fat reduction without the

need for invasive surgery. The UltraShape device therefore eliminates

any complications that you could see with surgery. If you have a private

practice, it is important to reduce your risks; it is also important to note

that, generally, more invasive procedures carry increased risks and

therefore more potential problems. UltraShape is a safe device that has

been clinically proved to remove 2cm of circumference in one procedure

and 2.3mm in fat thickness. UltraShape allows us to offer patients a

surgery-free way of improving their body shape. ■

Hercogová J, Clinical Applications of Ultrashape, European Dermatology,

2008; 3: 36–37

3E U R O P E A N D E R M A T O L O G Y

Clinical Applications of UltraShape

The UltraShape device is a non-invasive

fat reduction technique that allows

dermatologists to safely achieve fat

reduction without the need for

invasive surgery.

1. Trott SA, Beran SJ, Rohrich RJ, et al., Safety considerations andfluid resuscitation in liposuction: An analysis of 53 consecutiveparticipants, Plast Reconst Surg, 1998;102:2220.

2. Grazer FM, Meister FL, Complications of the tumescent formulafor liposuction (editorial), Plast Reconst Surg, 1997;100:1893.

3. Samdal F, Amland PF, Bugge JF, Blood loss during liposuctionusing the tumescent technique, Aesthetic Plast Surg,1994;18:157.

4. Teitelbaum SA, Burns JL, Kubota J, et al., Noninvasive bodycontouring by focused ultrasound: safety and efficacy of the

Contour I device in a multicenter, controlled, clinical study, PlastReconstr Surg, 2007;120(3):779–89, discussion 790.

5. Moreno-Moraga J, Valero-Altés T, Riquelme AM, et al.,Contouring by Non-Invasive Transdermal Focused Ultrasound,Lasers Surg Med, 2007;39(4):315–23.

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