Additional Warnings for Restylane®:

As with any medical procedure, there are risks involved with the use of dermal fillers. Most side effects reported in clinical trials and post- market surveillance occur shortly after injection and go away within a few weeks. In some cases, side effects may emerge weeks, months, or years later.

Common risks include:

• Bruising

• Redness

• Swelling

• Pain

• Tenderness

• Itching

• Rash

• Difficulty in performing activities (Only observed when injected into the back of the hand).

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People should be tested for allergies before receiving dermal fillers made with certain materials, especially materials derived from animals such as Collagen.

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Tips for Consumers about Injectable Dermal Fillers.

1. Do work with a licensed health care provider who has experience in the fields of dermatology or plastic surgery and is trained to inject dermal fillers. The provider should use properly labeled, sealed vials or pre-filled syringes of FDA- approved filler.

2. Do request and read the patient labelling information on FDA- approved injectable dermal fillers from your licensed health care provider.

3. Do you know the type of product to be injected and the possible risks? Know where each product you will be receiving is to be injected. Talk to your licensed health care provider if you have any questions.

4. Do not buy dermal fillers that are sold directly to the public. They may be fake, contaminated, or not approved for use in the U.S. FDA- approved dermal fillers are indicated for prescription use only.

5. Do not inject yourself with dermal fillers or with needle-free injection “Pen” (/Medical devices/ safety- communication / do-not -use needle- free- devices-injection- dermal-fillers- FDA-safety- communication)

6. Do not get any type of filler or liquid silicone injected for body contouring.

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