Frequently Asked Questions about Restylane

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  • What is the Restylane® tissue tailored product range?

    The Restylane tissue-tailored product range is designed to restore volume and to achieve optimal treatment results. Each product contains gel particles of a different size, especially designed to match the density of the target tissue matrix for which it is indicated. This is a clinically important distinction, which provides unequalled lifting capacity.

    The Restylane range consists of the following products;

  • What is Restylane?

    The Restylane product portfolio comprises a range of products for facial beauty enhancement, designed specifically to reduce lines, folds and wrinkles, to contour and create volume, and to rejuvenate skin. The Restylane products consist of stabilized non-animal hyaluronic acid.

  • What is NASHA™ technology?

    NASHA technology is Q-Med’s unique and patented technology for the production of high purity gels containing stabilized non-animal hyaluronic acid. Stabilization of the HA molecules (minimal modification, less than 1%) results in gel networks characterised by an excellent safety profile, providing unequalled lifting capacity, offering continuous correction over time.

  • What do Restylane products contain?

    All Restylane products consist of stabilized hyaluronic acid 20 mg/ml (Restylane Vital Light 12 mg/ml) and phosphate buffered saline, pH 7 q.s. They are clear, transparent, viscous gels supplied in glass syringes.

  • Who makes Restylane?

    Restylane is produced by Q-Med AB, a Swedish biotechnology/medical device company, in the town of Uppsala, near Stockholm, Sweden and with affiliates all around the world. After more than 13 years of clinical use, 10 million treatments worldwide and continuous research with safety as top priority, Restylane has today been proven to be safe, effective and long-lasting. Q-Med continues to invest in a research and development program, in the interest of improving further patient safety and new product development.

  • How long has Restylane been available?

    Restylane was launched in 1996 and is now one of the world’s most widely used dermal filler. 10 million treatments have been performed worldwide.

  • How is Restylane manufactured?

    The hyaluronic acid in Restylane is obtained biotechnologically, using bacterial fermentation. A specific type of bacteria is used because of its ability to produce a high yield of HA. The HA is then purified and subjected to minimal chemical modification (stabilization is  less than 1%) to create a long-lasting, biocompatible gel network.  The patented technology behind Restylane is unique and should not be confused with other manufacturing processes resulting in highly cross-linked hyaluronic acid.

  • How should Restylane be stored?

    Restylane products should be stored at room temperature, up to 25° C, and remain in perfect condition for three years (Restylane SubQ™ and Restylane Vital™ Light for one and a half years) beyond the manufacture date.

  • If the product is about to expire, will the durability be shorter

    No, degradation of the product does not start until it is injected.

  • Which areas of the face can be treated with Restylane?

    Restylane can be used for smoothing out wrinkles and folds, lip enhancements, shaping facial contours and for skin rejuvenation.

  • Is there a need for overcorrection?

    No.

  • Is pain relief recommended?

    Restylane® and Restylane Perlane™ are available also with lidocaine. When using other Restylane products, a local anaesthetic cream can be applied to the area to be injected.  The cream needs to be liberally applied at least 45 minutes prior to treatment. The lips are a highly sensitive part of the body and therefore anaesthesia is usually required before treatment. This is achieved most effectively by a nerve block.

  • How long does the effect of a Restylane treatment last?

    Lines, wrinkles and folds: In general, follow-up treatment is needed after 6 to 12 months.

    Lips: In general, follow-up treatment is needed within 6 months.

    Overall, the time to when follow-up treatments are needed depends on many factors, such as the structure of the skin, lifestyle, age, the degree of perfection demanded by the patient and the injection technique of the practitioner. Clinical experience indicates that follow-up treatment will add to the duration.

  • Is the efficacy of Restylane clinically proven?

    Yes. Restylane safety and efficacy have both been clinically documented and are supported by robust clinical studies, spanning over 13 years.

  • Is Restylane FDA approved?

    Yes. Restylane was the first hyaluronic acid based dermal filler to be approved by the FDA in 2003.

  • At what depth in the tissue should Restylane products be

    It is recommended that Restylane Touch™ should be injected in the superficial dermal layer, Restylane should be injected in the mid part of the dermis and Restylane Perlane™ should be injected in the deep layer of the dermis and/or the surface layer of the subcutis.

    Restylane Vital™ should be injected in the dermal layer, preferably in the deeper part of dermis, while Restylane Vital™ Light should be injected in mid dermis Restylane Lipp™ should be injected into the deep layer of the dermis and/or into the superficial layer of the subcutis.

    Regarding Restylane SubQ™ the depth of injection may vary from injection into the subcutaneous fatty tissue to supraperiostal administration depending on the treatment site.

  • Which injection techniques are most effective?

    Different injection techniques are applicable for different treatment areas. To learn more about Restylane training opportunities, please contact your local Q-Med representative.

  • What happens if a Restylane product is not injected at the recommended tissue depth?

    Each Restylane product is tailored to match the tissue matrix density at the different dermal layers. To ensure satisfactory results, it is important that each product is injected at the right tissue depth. If Restylane Touch™, for example, is injected too deeply, the line correction will not be achieved. Conversely, if Restylane Perlane™ is injected too superficially, it may cause uneven results.

  • Can Restylane products be combined with other types of implant?

    Restylane products should not be used together with any other injectable implant, except for products within the Restylane range of products. Special caution should be exercised when treating areas in close proximity to permanent implant.

  • Can different Restylane products be used in the same area?

    It is possible, indeed sometimes desirable, for Restylane products to be combined in order to perfect a correction. For example, to correct a deep fold, Restylane Perlane™  may be injected first, followed by Restylane or Restylane Touch™  at a more superficial level to achieve optimal treatment result.

  • Is it necessary to apply more force to inject Restylane products with larger particle sizes?

    No, in practice there is no difference in force needed. This is because the needle/cannula size is tailored to suit each individual product. It is important to use the correct needle for the product being injected – that is, the needle included with the product in the product packaging or, in the case where no needle is included in the product packaging, using a needle size within the recommended range stated in the instructions for use.

  • What needle size should I use?

    Use the needle included with the product in the product packaging or, in the case where no needle is included, use a needle size within the recommended range stated in the instructions for use. Each needle size is matched to facilitate the injection of that specific product. Too small needle can disrupt the gel.

  • Which Restylane products are recommended for the treatment of the lips?

    Restylane Lipp™ is recommended for the enhancement of lips. However, both Restylane and Restylane Perlane™ have also been used to produce fuller lips and a pouting look.

  • How long does the effect of a Restylane treatment of lips last?

    In general, follow-up treatment is recommended within 6 months.

  • How long does swelling normally last after a lip enhancement?

    Normally the swelling resolves within a week of a Restylane injection into the lips. The swelling is not an immunological reaction, but part of a common injection related reaction. 

  • Are there any side effects or adverse reactions?

    After the injection of Restylane®, some common injection-related
    reactions might occur. These reactions include erythema, swelling,
    pain, itching, bruising or tenderness at the implant site. Typically, resolution is spontaneous within a few days after injection into the skin, within a week after injection into the lips and up to two weeks after a treatment with Restylane SubQ .
    The most common adverse events reported post marketing for the Restylane range of products are swelling, bruising, erythema, mass, pain and tenderness. Their reporting frequencies are about 1 in 10,000 to 1 in 20,000.

    Less common adverse events with reporting frequencies about 1 in 50,000 treatments are infection, inflammatory reactions, discolouration, nodules and papules.  Symptoms of inflammation including a combination of redness, swelling, tenderness and induration at the implant site have been reported. These reactions may commence either shortly after injection or after a delay of 2-4 weeks. Infections should be excluded or treated if necessary. In
    pronounced cases a short course of oral corticosteroids may prove effective.

    For patients who have experienced clinically significant reactions, a decision for retreatment should take into consideration the cause and significance of previous reactions. For further information, please see instructions for use for each product.

  • Is the safety of Restylane clinically proven?

    Yes. Restylane safety and efficacy have both been clinically documented and are supported by robust clinical studies, spanning over 13 years. Furthermore, since 1996, 10 million Restylane treatments have been successfully performed worldwide. NASHA™ gels as in Restylane contain high purity stabilized HA (less than 1% of modification), and, as such, are highly biocompatible. Restylane is one of the most tried and tested dermal filler and is recognized as the benchmark for safety.

  • Are there any contraindications for Restylane treatment?

    Patients with skin disorders, a history of anaphylaxis or of tendency to bruising or bleeding should be carefully considered before proceeding with Restylane treatment. Restylane products containing lidocaine should not be used in patients with known hypersensitivity to lidocaine or to amide-type local anaesthetics. These matters should be discussed with the patient at the pre-treatment consultation.

  • Can the products be used for patients who have undergone laser treatment or chemical peeling?

    Yes, although we recommend that these patients should wait until the treated area has totally healed and the skin has normalized.

  • What pre-treatment guidance should be given to patients before a Restylane treatment?

    Patients who are using substances that affect platelet function, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience increased bruising or bleeding at injection sites.  Previous eruptions of herpes simplex can be triggered by needle insertion, but appropriate prescription drugs can minimise the risk.

  • Can Restylane products be used for patients during pregnancy or breast-feeding?

    Treatment with Restylane products during pregnancy or breastfeeding has not been tested. Any therapy should be reconsidered in the light of the pregnancy.

  • Are there any known interactions with antibiotics?

    Treatment with Restylane® products in combination with drugs and other devices has not been tested. Theoretically, there is no basis for any interaction with commonly used antibiotics.

  • If a patient has had problems with recurrent facial herpes simplex, can Restylane treatment contribute to another herpes simplex eruption?

    There is a risk that the injection process itself, i.e. the insertion of a needle into the skin, could contribute to another herpes simplex eruption.

  • Can a person suffering from an autoimmune disease be treated with Restylane products?

    Autoimmune diseases are in general no contraindication for treatment. However, it is Q-Med’s policy to recommend patients with an underlying disease to discuss and ask for approval from the physician treating the disease in question. Thus, a doctor performing the injection should not primarily make such a decision.

  • What is the difference between Restylane Vital™ and Restylane Vital™ Light?

    Restylane Vital and Restylane Vital Light are two different skin rejuvenation products. Both products are based on stabilized hyaluronic acid, ensuring a long-term effect.

    Restylane Vital efficiently rejuvenates mature and photodamaged skin where it gives a profound, long-lasting effect. The product contains 20 mg/ml stabilized hyaluronic acid and should be administered in a treatment cycle of three sessions 4 weeks apart, to be repeated after 6 months.

    Restylane Vital Light is a smoother, softer and more fluid gel designed for younger skin which requires a lighter treatment with a refreshing effect. It can also be used to rejuvenate thin and delicate skin, such as the neck, décolletage and backs of hands.  The product contains 12 mg/ml stabilized hyaluronic acid and should be administered in a treatment cycle of three sessions 2–4 weeks apart, to be repeated after 4–6 months.

  • Why is Restylane Vital Light of a lower concentration than the rest of the Restylane range?

    The lower gel concentration of Restylane Vital Light makes the product more fluid and easier to inject in areas with thin skin such as the neck. Restylane Vital Light distributes evenly upon
    injection, and does not cause bumps if injected correctly.

  • Is Restylane Vital Light a mesotherapy treatment?

    No, neither Restylane Vital nor Restylane Vital Light are mesotherapy treatments. Correct injection technique is essential when using the Restylane Vital products, very superficial injection will cause bumps. Use the multipuncture or short linear threading technique to inject small deposits of gel about 1 cm apart. For safe and easy injection of Restylane Vital Light the Restylane Injector can be used.

  • Can I combine Restylane Vital and Restylane Vital Light on the same patient?

    Yes, use the product suitable for the skin quality (young or mature skin) or skin area that is treated.

  • What is the Restylane Injector?

    The Restylane Injector assists in the delivery of Restylane Vital™ Light. This unique injection device enables controlled dosage of 10 µl of gel per injection site. As the Restylane Injector is preloaded with 2 ml of Restylane Vital Light, one injector can deliver approximately 200 doses.