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Restylane® Treatment

Restylane® has a highly favorable safety profile. It's composed of Non-Animal Stabilized hyaluronic acid. Hyaluronic acid is a substance found naturally in the human body. Restylane® is fully biocompatible.

There is limited risk of animal-based disease transmission or development of allergic reactions to animal proteins. However, no allergy testing is required before use. Unlike rooster-derived hyaluronic acids and bovine collagen products, Restylane® is free from animal proteins. This limits any risk of animal-based disease transmissions or development of allergic reactions to animal proteins. Since 1996, over 3 million Restylane® treatments have been safely administered by dermatologists and plastic surgeons in more than 70 countries. This innovative treatment is now approved in the U.S. for the treatment of facial wrinkles and folds.

Based on clinical studies, Restylane® treatments produce a low occurrence of adverse events. The most commonly reported side effects were temporary redness and swelling at the injection site. These effects typically resolve in less than seven days.

Precautions

* The safety of Restylane® for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.

* The safety of Restylane® in patients with increased susceptibility to keloid formation and hypertrophic scarring has not been studied. Restylane® should not be used in patients with known susceptibility to keloid formation or hypertrophic scarring.

* The patient should be informed that he or she should minimize exposure of the treated area to excessive sun and UV lamp exposure and extreme cold weather until any initial swelling and redness has resolved.

* If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with Restylane® there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Restylane® is administered before the skin has healed completely after such a procedure.

Your healthcare professional should discuss what to do after your treatment. However, be sure to review the information below and discuss any concerns with them.

Post-Treatment Checklist

Please observe the following after treatment with Restylane®.

* After your treatment, you might have some redness or swelling. This will normally last less than seven days. Sunbathing and cold outdoor activities should be avoided until any redness or swelling disappear.

If you are pregnant, breastfeeding, or under 18, you shouldn't use Restylane®.

* Avoid touching the treated area within six hours following treatment. After that, the area can be gently washed.

* Sunbathing and cold outdoor activities should be avoided until any redness or swelling disappear.

* If you have previously suffered from facial cold sores, there is a risk that the needle punctures could contribute to another recurrence. Speak to your physician about medications that may minimize a recurrence.

* Avoid exercise and alcohol for six hours after your treatment.

* Having a follow-up treatment before the product has fully dissipated may enhance the lasting effect. Please be sure to consult your physician about recommendations for touch-up or follow-up treatments.

* One week prior to your next treatment with Restylane®, avoid taking St. John's Wort, high doses of Vitamin E supplements, aspirin, and other non-steroidal anti-inflammatory medications, such as ibuprofen. These agents may increase bruising and bleeding at the injection site.