Important Safety Considerations
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Products in the Restylane family should not be used by people with previous bad allergies, particularly to microorganisms known as gram-positive bacteria, or by people with serious allergies to drugs that have previously required in-hospital treatment. These products should not be used by people with bleeding disorders. Products should not be injected anywhere except the skin, just under the skin (Perlane and Perlane-L only), or in the lips (Restylane, Restylane-L and Restylane Silk only). Restylane-L, Restylane Silk and Perlane-L should not be used by anyone with a known allergy to lidocaine.
Use at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. In these instances, product use could delay healing or make your skin problems worse. After treatment, you might have some swelling, redness, pain, bruising, or tenderness. These are typically mild in severity and normally last less than 7 days in nasolabial folds and less than 14 – 18 days in lips. Swelling may be more likely in patients under 36 years, and bruising may be more likely in patients over 35 years. Rarely, the doctor may inject into a blood vessel, which can damage the skin. Although rare, red or swollen small bumps may occur. If you have had facial cold sores before, an injection can cause an outbreak. To avoid bruising and bleeding, you should not use the products if you have recently used drugs that thin your blood or prevent clotting. Products should not be used during pregnancy, when breastfeeding, or in patients under 18 years for nasolabial folds.
Treatment volume should be limited to 6.0 mL in wrinkles and folds, such as nasolabial folds, limited to 1.5 mL per lip (Restylane, Restylane-L or Restylane Silk only), and 1.0 mL in lip lines (Restylane Silk), as greater amounts significantly increase moderate and severe injection site reactions. The safety of effectiveness of treatment in areas other than nasolabial folds (Restylane, Restylane-L, Perlane, and Perlane-L), lips (Restylane, Restylane-L, and Restylane Silk), and lip lines (Restylane Silk) has not been established in controlled clinical studies.