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Macrolane VRF

 

Pamela Jones   2/26/08

Last Updated   5/28/08

Macrolane VRF is a medical device to be utilized in HCC clinics that are registered with minor surgical rooms. This body contouring treatment uses Stabilized, Non-Animal Hyaluronic Acid (NASHA) to temporarily enhance the breasts. NASHA gel has a minimal risk of transmitting infectious material as well as a minimal risk of allergic reaction. Macrolane doesn’t interfere with detection, diagnosis, or treatment of breast related illnesses.

The VRF in the name stands for Volume Restoration Factor. The difference between Macrolane VRF and Restylane is that Macrolane VRF is a thicker gel used for body contouring instead of facial aesthetics.  It gives greater volume and has a slower rate of absorption.

The treatment involves injecting the breasts with the filler. A local anaesthetic is used to numb the breasts before the procedure, then a thick needle is injected deep into the breast. The procedure takes only 30-90 minutes and the results last 12-18 months.  

The cost of Macrolane VRF depends on the amount of Macrolane utilized. For example, a procedure to enlarge the breasts with 200ml, which would be 100ml for each breast, will cost about £2800 with a touch up treatment after a year costing about £1400.

Macrolane VRF can also be used for concavities caused by liposuction, trauma or surgical scars, and sculpting the buttocks and calves.

 

Only doctors who are trained by Q-Med can utilize Macrolane. Ask to see your physician’s training certificate to check that he or she is certified to perform the procedure.

 

Q & A with Duncan Hesketh, Macrolane, Business Development Director, Q-Med UK Ltd

 

(1). How and by what agency will Macrolane for breast enlargement be regulated throughout the EU?

  •  Macrolane has an EU Licence through KEMA the EU authorities for volume restoration and contouring of body surfaces.
  •  Q-Med is the manufacturer of Macrolane and has sole responsibility of marketing and sales through distributors and subsidiaries in Europe.
  • Macrolane is being used by selected trained surgeons across Europe for body and breast shaping.
  • The responsibility of training surgeons is through Q-Med however the responsibility of the procedure is on the surgeon, their qualifications, experience and expertise.

(2). Is it approved already for breast enhancement or just in clinical trials?

  • We have concluded two pilot studies looking at shaping body concavities and breast shaping. There is now a published study from Japan involving 1100 patients for breast shaping published in the Japanese Journal of Plastic Surgery 2007.
  • There are ongoing studies across Europe specifically looking at the breast and other body areas with Macrolane VRF
  • I have above mentioned our approved indication; however Q-Med placed a precaution in the licence “use within breast enhancement has not been fully established”. Based on this we have trained selected surgeons to further evaluate Macrolane for Breast shaping across Europe. This precaution was removed by KEMA on the 13th of May [2008] and the use of Macrolane in the female breast has now been fully established.

(3). What EU and non-EU countries are using Macrolane for breast augmentation?

  • There are all the subsidiaries’ of Q-Med AB that are now using Macrolane including UK, France, Spain, Italy, Germany, Sweden, Holland, Belgium and other Scandinavian countries.
  • Non-EU countries in Europe are limited at this stage and selected Doctors are only trained by invitation from Q-med AB.

 



Copyright 2008,  Pamela Jones and Human Adjuvant Disease Corp. All rights reserved. Reproduction in whole or in part in any form or medium without express written permission of Pamela Jones is strictly prohibited.

 

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