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This document has been prepared to help provide you with information about CoolSculpting™™ for “freezing off” unwanted fat pockets, its risks, and alternative treatments. It is important that you read this information carefully and completely.

Introduction

Men and women alike face the frustrating truth every day: a muffin top, a post-pregnancy pooch, love handles, and back fat—not much, but just enough to show through a snug-fitting T-shirt or blouse. These small areas of fat do not seem to warrant a surgical procedure and losing abdominal fat and back fat through diet and exercise is practically impossible for many of us. NoviSkin is excited to announce the introduction of our exclusive non-invasive fat reduction treatment CoolSculpting™ by ZELTIQ™.

What are the Benefits of using this Treatment?

CoolSculpting™ by ZELTIQ™ has received clearance from the U.S Food and Drug Administration (FDA), the CoolSculpting™ procedure offers a safe, pain-free and effective way to reduce the fat layer of selected areas by 20 – 40% without the need of an anaesthetic or pain medication.

Explanation/Procedure

Each selected area takes approximately two hours and as this procedure is non-invasive, patients can return to normal activities immediately, the perfect treatment for a lunch-break! The patient may feel a sensation of coldness at the beginning which passes and then the feeling of a firm tug and pull. Some patients experience redness, minor bruising, tingling, or numbness in the treated area, but this is temporary. Changes may be noticed as quickly as six weeks after treatment and will experience the most dramatic results after four months.

  • No general/topical anaesthesia or pain medication is needed.
  • The applicator cup uses a strong vacuum pressure to draw tissue between the cooling panels.
  • The patient will feel a pulling sensation caused by the vacuum pressure in the area being treated and a cooling sensation in the procedure area as the fat cells begin to freeze.
  • Patients can either sit or lie down during the procedure, depending on the area being treated.
  • The procedure time per area treated is one hour (meaning one leg equals 1 hour, both legs equal 2 hours), during which time you can read, listen to music or simply relax or even sleep.
  • Some patients experience a sharp but brief pain sensation immediately after the applicator is removed from the treated area. This dissipates within minutes.

Mechanism of action

Developed at a teaching affiliate of Harvard Medical School in the United States, the Coolsculpting™ breakthrough is based on extensive scientific research that demonstrates that fat cells are more susceptible to extreme cold and are selectively and permanently destroyed. This process is called Cryolipolysis (cold lipolysis). The sub-zero temperatures cause the fat cells to die. The dead fat cells are absorbed and then flushed away by the body over the next few months leaving the patient sleeker. The average fat layer reduction of 20% was observed at two months after the procedure.

Alternative Treatments

There are countless anti-ageing treatment options available to the public. There are no real alternative treatments to CoolSculpting™, but for similar results, some substitute treatments can include:

  • Weight loss programs
  • Fitness Programs/Personal Training
  • Mesotherapy for body
  • Laser-Lipo
  • Liposuction
  • Tummy Tuck

Contraindications

It is advised that you do not undergo CoolSculpting™ treatments should you be affected by any of these contra-indications:

  • Pregnant, planning on becoming pregnant or breastfeeding
  • Reynaud’s disease
  • Implanted medical devices
  • Recent surgery in the area to be treated
  • Umbilical or inguinal hernia
  • Cold sensitivities (winter hands and feet)
  • Patients with Hepatitis C (cryoglobulins)

Risks / Side Effects

There are no studies to suggest that there are long term risks associated with using CoolSculting™. This does not mean that there is no risk involved with this treatment.

Common side effects include:

  • Bruising
  • Stiffness/minor swelling
  • Redness
  • Tenderness/sensitivity/discomfort
  • Itchiness
  • Dryness
  • Tingling such as pins & needles
  • Abdominal cramping/soreness
  • A burning sensation
  • Numbness

Pre and Post Care Instructions

Post treatment instructions are fairly simple and easy to understand. In order to achieve optimum results, we strongly recommend the following:

  • Drink a minimum of 2 litres of water a day – this will assist with ‘flushing’ out of the crystallized lipids in the fat cells.
  • Exercise a minimum of 1 hour a week
  • It is extremely important for you to monitor your weight for the three months post the CoolSculpting™ procedure.
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