Frequently Asked Questions about Macrolane

Show all answers

  • What is Macrolane™?

    Macrolane is the first hyaluronic acid–based product for body contouring and breast enhancement. 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 into the breast in the sub-glandular level and 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 10 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 10 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 breast enhancement, 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?

    Patients should have no pathological findings in their breasts on preoperative screening. There should be no active disease, such as inflammation, infection or tumours in or near the intended treatment site.

    Patients with a history of breast cancer or pre-cancerous breast lesions and patients assessed to have a higher risk for developing breast or ovarian cancer have not been studied.

    Furthermore, patients need to have realistic expectations about the results that can be achieved; they should also have sufficient tissue cover and no pronounced ptotic (sagging) breasts.

    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 and breast enhancement. 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 and the breasts?

    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 and breast enhancement 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.

  • Will Macrolane adversely affect the evaluation of mammograms?

    It is known that the presence of breast implants can affect the interpretation of mammograms. In some instances, additional views or additional investigations may be indicated. Of course, patients should comply with standard breast screening procedures as recommended by their doctors or local health authorities. Pre-implant mammograms can facilitate post-treatment mammography evaluations. It is recommended that the treating doctor ensures that pre-implant mammography has been performed. If difficulties with the interpretation of mammograms occur, an ultrasound examination can be performed in order to give complementary information. The radiologist should be informed about the implanted Macrolane gel.

    A clinical study and clinical experience show that the breast tissue behind the
    Macrolane gel is visualized to a higher degree than it would have been behind silicone or saline breast implants on mammogram. However, the visualization is reduced compared to when no Macrolane gel is present. A recent study indicates that the presence of Macrolane may affect the diagnostic quality of parts of the mammograms performed for breast cancer screening purposes in patients with small breasts (cup size A or B). Ultrasound is the first option if complementary examinations are needed. Patient self examination is also an important method for breast cancer screening and the patients should be instructed that during self examination, the texture of implanted Macrolane gel may be different from that of breast tissue.

  • Can you breast feed with Macrolane enhanced breasts?

    There is no data on pregnant or breast-feeding women following Macrolane treatment. It can be reasoned that the injection technique to place the Macrolane gel below the mammary gland makes it unlikely that breast feeding will be affected. Also, as Macrolane is degraded with time, we expect that the Macrolane gel becomes less and less likely to affect breast feeding over the 9 months period of pregnancy.

  • 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 affecting one breast, 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 becomes contracted. This can happen with both traditional permanent implants as well as for Macrolane. If a patient with a traditional permanent implant gets a severe capsular contracture, commonly the implant has to be surgically removed.

    If capsules arise in patients with Macrolane implants, most can be treated with closed capsulotomy (the breasts are manually compressed by the physician). The breasts usually soften after this treatment. Other options for treatment of capsules include gel aspiration or puncture of the capsule using a cannula.
    Sometimes the capsular contracture reoccurs.

    For detailed information regarding side effects, please review the Instructions for Use.

  • Can Macrolane cause breast cancer?

    No cases of cancer have been reported.

    Note that breast cancer is one of the most common types of cancer affecting women. Approximately one in every 8-10 women will develop breast cancer at some stage of her life and the risk depends on a number of factors including family history and reproductive history. Therefore, it is not unexpected that women who have undergone Macrolane treatment may also develop cancer, without any relation to the use of Macrolane.