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Ultra Shape

UltraShape – The Latest Non-Invasive Medical Bodyshaping Solution A safe and painless procedure for long-lasting effects

By Dr Leslie Kuek
Consultant Plastic, Reconstructive & Aesthetic Surgeon

Invasive surgery, such as liposuction, used to be the only way to destroy fat cells and induce long-term body contouring effects. The complexity of liposuction procedures, accompanied by the inconvenience to patients, a relatively long recuperation period and a variety of hidden dangers* highlight the pressing need for a method that combines the simplicity and safety of non-surgical methods of body-shaping, with the effectiveness of the surgical techniques that ensure effective body contouring.

A device for non-invasive destruction of fat cells by focused ultrasound has been developed by UltraShape. The treatment procedure is painless and performed in a medical clinic. Being non-invasive, the treatment does not incur any recovery time.

When fat tissue is treated by UltraShape, the focused ultrasonic beam is directed towards a specific area within the fat layer. The ultrasound wave causes mechanical disruption of the membranes of the fat cell, sparing the blood vessels, peripheral sensory nerves and connective tissues. Since the effect is focused on a specific depth, overlaying skin is not damaged. The result is selective fat lysis by breaking the fat cells with no damage to neighboring structures. Clearance is performed naturally by the body through the physiological pathways – the triglycerides from the broken cells are released into the interstitial fluid, then gradually transported through the lymphatic or venous system to the liver, where they are utilized through the physiologic metabolic pathways.

* Liposuction is associated with a statistical mortality rate of 19.1 per 100,000 procedures that exceeds that of automobile fatalities over a similar population, ‘Fatal Outcome from Liposuction: Census Survey of Cosmetic Surgeons’, F.M. Grazer and R.H. de Jong, Plast. Reconst. Surg., lO5: 436-446, 2000.

Clinical Trial
Thirty four (34) healthy individuals, aged between 18 and 57, weighing between 52kg and 110kg, participated in the study, which was performed at Dr Jacques Otto’s clinic in London. The study protocol was approved by the Ravenscourt Ethics Committee, London, UK. According to the study protocol, healthy volunteers with no underlying medical conditions were enrolled. Male to female ratio was 1:2 and there was no racial discrimination in the enrollment. All volunteers underwent a screening visit including medical history, physical examination, blood and urine analyses and liver ultrasonography.

The regions treated included the abdomen, external thighs (saddle-bags) and flanks (love-handles).

Results
Efficacy
Reduction in circumference was observed in all patients. The reduction can be attributed to the treatment since the participants did not lose weight nor did they have a reduction in circumference in the control areas during the entire follow-up period.

Fat thickness, as measured by ultrasonic imaging, showed a statistically significant reduction in thickness in the treated areas. There was no significant change in weight of the participants, proving that the measured changes in circumference and fat thickness can be attributed onlt to the effects of the UltraShape treatment.

Safety
No adverse events were encountered during and following the treatment. No sensation of discomfort was noted any time after the procedure. There were no post-treatment skin hyper/hypo-pigmentation changes. Subcutaneous fat remained smooth throughout the entire follow-up period. Physical examination during the follow-up was uneventful.

Blood and urine analysis of all participants stayed within normal ranges. Liver ultrasound showed no change in liver status before and at the end of the study, with no fatty infiltration. These tests prove that fat removed from the treatment area is cleared in the regular fat metabolism pathways, with no adverse physiological effects.

Treatment had no influence on participants’ daily routine, which remained unaffected from immediately after treatment and during the entire follow-up period.

Conclusion
Similar trials have been conducted in other parts of Europe, USA and Japan with more than 150 trial participants and the results were not surprisingly comparable. It may therefore be concluded that the UltraShape treatment is a safe and efficient solution for non-invasive bodyshaping.