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Frequently Asked Questions about Macrolane

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• What is Macrolane™?

  Macrolane is the first hyaluronic acid–based product for body contouring. Macrolane provides instant and long lasting results without the need for open surgery and therefore avoids some of the consequences such as scarring. It is injected subcutaneously for body contouring. The Macrolane gel is based on Q-Med's unique and patented NASHA™ technology. NASHA gels for facial aesthetic treatments have been used in over 15 million treatments in over 70 countries worldwide. The safety and effectiveness of NASHA gels have been clinically proven and well documented in facial aesthetics for over 15 years.

  Macrolane is available in two different formulations, or volume restoration factors, Macrolane VRF20 and Macrolane VRF30. Macrolane VRF20 is suitable for areas with less tissue support and cover, while Macrolane VRF30 is a thicker gel suitable for areas with substantial tissue support and cover.

• What is NASHA gel?

  NASHA gel is a crystal clear gel consisting of biotechnologically derived
  hyaluronic acid that has been purified and stabilized. The hyaluronic acid is of non-animal origin, thus removing any risk of diseases transmitted by animals.

  The hyaluronic acid is stabilized, i.e. minimally modified (~1%), to form a stable three-dimensional network. The unique patented NASHA technology gives a biologically degradable gel that has a long durability in the body.
  

• What are the treatment indications for Macrolane?

  Macrolane is an innovative product indicated for volume restoration and contouring of body surfaces, for example, chest wall deformities, calves and buttocks. Macrolane is also used to fill defects caused by liposuction and surgical scars.

• Are there any conditions preventing a patient from undergoing a Macrolane treatment?

  There should be no active disease, such as inflammation, infection or tumours in or near the intended treatment site.

  Patients with bleeding disorders or patients who are taking thrombolytics or anticoagulants should not be treated. Patients who are using substances that affect platelet functions, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.

  Surgical and trauma scars involving more pronounced fibrosis should be treated with caution as the scars may need release of fibrous bands. Markedly indurated defects may be difficult to treat.

  Do not use in patients who have experienced delayed inflammatory reactions or implant complications in connection with previous NASHA treatments and have required further medical treatment.

  There is no data on the use of Macrolane in children or pregnant or lactating women.

  For further information please refer to the instructions for use.

• Can Macrolane be used for facial aesthetic treatments?

  No, Macrolane is indicated for body contouring. For facial aesthetic treatments use the Restylane® range of products. The size of the cannula for Macrolane treatment is accordingly larger than the needle used for Restylane treatment.

• Is Macrolane an approved product?

  Yes, Macrolane is CE marked, meaning the relevant requirements for marketing of medical device products in the European Union are met.
  

• How does Macrolane compare to fat injection?

  Both Macrolane and autologous fat tissue are biocompatible. Unlike fat tissue, the advantage of Macrolane is that it does not need to be extracted from the body. This is particularly significant for patients with limited tissue suitable for fat grafting. The results of fat grafting may also be more unpredictable, whereas the results Macrolane can be instantly evaluated.

• How does Macrolane compare to synthetic non-biological fillers on the market?

  Synthetic non-biological fillers contain components that do not naturally occur in the body. As non biological components, they exhibit different biocompatibility profiles and are not naturally biodegraded in the body. Further, synthetic fillers can be either semi-permanent or permanent and can induce different tissue responses. As the residence time in vivo is semi-permanent or permanent for synthetic non-biological fillers, also the awareness for the risk of long-term complications has to be in the same time scales.

• Is Macrolane active in the body?

  No, Macrolane is a medical device, acting by adding volume to the tissue thereby restoring and enhancing body contours.

• Is Macrolane safe?

  Macrolane is considered a safe product based on preclinical and clinical studies.
  Furthermore, Macrolane is based on the same stabilized hyaluronic acid that has been used in more than ten million facial aesthetic treatments with no related life threatening events reported.
  

• What are the benefits of Macrolane to patients?

  Macrolane provides instant and long-lasting results without open surgery and with minimal scarring. The non–permanent and biocompatible nature provides several advantages, including safety and easy adaptability to individual needs.

  Market research has shown that a significant number of women would like to adjust the shape of their body in a natural, non-permanent way that does not involve the use of permanent implants or body fat in a surgical procedure. Many women are also very hesitant about undergoing general anaesthesia or being left with a scar. The Macrolane procedure is fast and only requires a local anaesthetic and minimal time away from work or daily activities.
  

• How long does Macrolane last?

  In our experience, the aesthetic improvement usually lasts up to one year. The gel breaks down slowly, as part of a normal process in the body but all bodies are different and individual variability exists.

  To achieve and maintain the desired aesthetic result, Macrolane requires periodic replenishment. Based on feedback from major users, replenishment of Macrolane is generally provided 9-12 months after the initial injection to maintain a satisfactory aesthetic result. For certain individuals, further adjustments may be needed. Since much of the Macrolane remains at this time, approximately 50% of the original treatment volume may be needed. Thereafter, replenishment treatments can be scheduled every 9-12 months with probably less than 50% of the original treatment volume, depending on individual wishes and needs. Please observe that treatment programs vary between practitioners, depending on your own and your patients’ preferences.
  

• What studies have been made with Macrolane gels?

  The use of Macrolane for body contouring has been investigated in several clinical studies and post marketing surveillance, supporting both safety and efficacy.

• How is a treatment with Macrolane performed?

  Treatment with Macrolane should only be performed after completing training on the use and injection of Macrolane. Normally, local anaesthesia is sufficient and general anaesthesia is not required. The use of prophylactic antibiotics should be considered. The procedure should be carried out in a clean environment with thorough skin preparation and use of aseptic techniques. The procedure takes between 30 and 90 minutes depending on the treated area and quantity of gel injected.

• What happens after a treatment with Macrolane?

  After a treatment with Macrolane the patient can see the results instantly and return to normal daily routines shortly after the treatment. However, some common injection-related reactions might occur including redness, swelling, tenderness, pain, bruising or itching. Reactions normally resolve spontaneously within one or two weeks. A few weeks after the treatment the patient should avoid strenuous exercise or any activity that could put pressure on the treated area.

• Would you like to be a trained Macrolane user?

  If you would like to be trained in using Macrolane, please contact your local Q-Med subsidiary, local distributor or contact us at infomacrolane@q-med.com. You can find contact details under Contact

• Side effects after treatment with Macrolane

  The most common side effect is slight soreness or swelling at the injection site, as expected for injection treatment. Non-prescription anti-inflammatory pills are usually sufficient to relieve the discomfort.

  Perioperative infections have been reported. The signs and symptoms are usually increasing pain, redness and hardness, with or without systemic symptoms such as fever. A number of measures are recommended to minimize the potential risk for infection. The use of prophylactic antibiotics should be considered. It is important to ascertain that the patient does not have any concurrent skin infections prior to treatment. The procedure should be carried out in a clean environment with thorough skin preparation and use of aseptic techniques. Antibiotics treatment is best initiated after obtaining material for microbiological investigations.

  Sometimes a capsule around the implant occurs. For detailed information regarding side effects, please review the Instructions for Use.