As you age, your facial skin begins to lose its elasticity and volume. As a result, your “laugh lines”, the creases that run from the sides of your nose toward the corners of your mouth, become more pronounced. Restylane® Defyne injectable gel is designed to temporarily help counter this by smoothing out these wrinkles and folds and restoring a natural, soft look to your face. Restylane® Defyne may also be used for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion over the age of 21. This means it may be used in the chin area to improve the profile, shape and size of your chin. Restylane® Defyne has been shown to maintain this effect for up to 12 months. Note: Facial features can differ. Speak to your doctor about the lines on your face that are appropriate for treatment with Restylane® Defyne.

Restylane® Defyne is injected into the facial skin through a small needle to smooth facial wrinkles and folds (laugh lines), resulting in a more youthful appearance of the skin. Restylane® Defyne may also be injected in your chin improve the profile, shape and size of your chin. For most patients, the procedure only takes 15 – 30 minutes.

Patients with any of these conditions should not use Restylane Defyne:

- Have severe allergies with a history of severe reactions (anaphylaxis). Use of Restylane® Defyne may result in an allergic reaction.

- Are allergic to the anesthetic lidocaine or to any of the proteins used to make the hyaluronic acid in Restylane® Defyne (bacterial proteins). Use may result in an allergic reaction.

Restylane® Defyne helps improve the profile and appearance of your chin and helps treat laugh lines – the natural facial wrinkles and folds that can occur due to aging. Restylane® Defyne has not been tested to treat any other types of wrinkles.

Restylane® Defyne may be unintentionally injected into a blood vessel during the procedure. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your doctor immediately.

The use of Restylane® Defyne if you have skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of Restylane® Defyne in these instances could delay healing or make your skin problems worse.

Any time a dermal filler gel like Restylane® Defyne is injected into facial skin there is risk of infection, which could appear as small, swollen or red bumps. These are called inflammatory papules. These infections are rare, however you should talk to your doctor about further treatment if you see any of these signs or symptoms.

Restylane® Defyne is for adults over the ages of 21.

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The safety of Restylane® Defyne has not been studied in women who are pregnant or breastfeeding. The risk of using Restylane® Defyne in pregnant or breastfeeding women is unknown.

Tell your doctor about any medication you are taking. You may have a greater risk of developing an infection if you use Restylane® Defyne while taking any medication that reduces your body’s natural defense system. These medications are called “immunosuppressants” because they stop your body’s immune system from functioning normally.

Tell your doctor about any medication you are taking. Some medication like aspirin and warfarin can thin your blood, which may increase your risk of bleeding or prolong any bleeding that occurs. These medications also increase your risk of bruising or bleeding at the injection site.

As with any injection procedure, you may have a higher risk of bruising or bleeding at the injection site if you have a bleeding disorder.

If you have any history of scarring, particularly thick and stiff scars, or any skin color (pigmentation) disorders, talk to your doctor about this before your procedure. Scarring and skin color changes can occur with hyaluronic acid fillers in general. When Restylane® Defyne was studied in patients with different skin tones (pale to dark), there were no reports by patients of excessive scarring (keloids) or changes in skin color.

The use of Restylane® Defyne with skin therapies such as laser treatment, mechanical or chemical peels or hair removal may lead to other side effects such as redness, swelling, heat and/or pain of the skin (inflammatory reaction). Tell your doctor if you have had any of these procedures.

If you have had cold sores in the past, there is a risk that they will return after your procedure with Restylane® Defyne.

Within the first 24 hours after treatment with Restylane® Defyne, you should avoid or minimize hard (strenuous) exercise. You should also minimize exposure to extensive sun, UV lamps, indoor tanning beds/booths, or extreme heat and cold as any of these may cause temporary redness, swelling, and/or itching at the injection site. Exposure to UV sources may result in irritation at the site of treatment. An ice pack can be applied for relief, if needed.

Most side effects were mild or moderate in nature and their duration was short lasting (7 days or less). The most common side effects included, but was not limited to, temporary injection site responses such as: redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration.