Restylane

Restylane

Restylane

A Long-Lasting Youthful Appearance is yours with the Restylane© Family of Products.

Smooth and fill facial wrinkles and fine lines or add some volume to your lips and cheeks with the Restylane© treatment best suited for you.

Restylane© adds fullness and eliminates the nasolabial folds (the lines that run from the nose to the corners of the mouth).*

Restylane© Silk is specifically formulated for lip augmentation and smoothing wrinkle lines around the mouth.*

Restylane© Lyft lifts and adds volume to your cheeks while also eliminating wrinkles and fine lines.*

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What is Restylane©?

The Restylane© family of products are FDA-approved dermal fillers comprised of hyaluronic acid clear gel formulations that closely resemble the naturally occurring hyaluronic acid of our own bodies. Because the formulation is so similar the results of the enhancements are very natural looking, long lasting and non-permanent.

Each of the Restylane© products is designed for a particular treatment area on your face so moderate to severe wrinkles and folds can be effectively treated with the Restylane© product best suited to the area you’d like to correct.

How do Restylane© Treatments work?

Lines and wrinkles develop as we age due to environmental exposure and the naturel aging process. When we frown, squint or smile, our muscles contract causing the skin to fold and crease. After years of this repeated movement, the skin begins showing the effects.

But Restylane© treatments can temporarily ‘undo’ the damage and age-related changes. Using tiny needles, Restylane© is injected under the skin where it relaxes the muscles, fills and gives the face a fresher, smoother appearance.

Restylane© improves the youthfulness and vibrancy of the face by minimizing the appearance of lines and wrinkles. The skin becomes smoother, lips appear fuller and contouring of the cheeks is enhanced.

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Restylane© Facts

What does Restylane© treatment involve?
When you arrive for your treatment, your nurse may numb your skin to reduce discomfort during the treatment. You may receive a numbing injection, a numbing cream or a cold spray on your skin.

Some people say the injections feel like a slight pinch to the skin. However, you may request that your skin be numbed to reduce discomfort.

A Restylane© treatment can take up to an hour, depending on the extent of treatment areas.

How should I prepare for my treatment?
Before your scheduled Restylane© treatment, you must avoid taking aspirin (ASA) ibuprofen, St. John’s Wort, and vitamin E supplements, these medications have the potential to increase bleeding and bruising at the treatment site(s).

If you have in the past suffered from cold sores you’ll have to let the treatment team know as the doctor may prescribe a medication to mitigate the risk of an outbreak during treatment and recovery.

You may wear your normal clothing to your treatment.

Is there downtime after a Restylane© treatment and what will I look like after treatment?
There is little to no downtime after a treatment session. You can return to your normal activities immediately. We do recommend that you stay upright and refrain from massaging the injection area for 4 hours after the procedure, to prevent the cosmetic from moving beyond the treated area.

You may experience slight bruising and itchiness at the injection site. This should fade within 24-48 hours.

How soon will I see results from the treatment and how long will they last?
Most people notice results immediately following a treatment. You can expect results to last up to 18 months with Restylane©, 12 months in your cheek area and 6 months for lip augmentations (the lip area does not last as long because we move our lips a lot).

You may require two treatments depending on the extent of the corrections you wish to achieve. When the Restylane© begins to breakdown in your body you may opt for additional treatments to maintain your youthful look

Are there side effects to Restylane© treatment?
There are some side effects associated with Restylane© treatments but they vary from person to person and are typically mild. Some people may experience bruising and itching at the injection site, swelling, redness, mild pain and headaches. The side effects may last 7 – 18 days but should lessen as time passes.

Who should not receive Restylane© treatment?
You must be 21 years of age or older to receive the treatments. While Restylane© treatment is a completely safe procedure, there are some individuals who should check with their doctor before receiving the injections.

This includes those who are:

  • Pregnant
  • Nursing
  • Have used blood thinning medications
  • Have a bleeding disorder
  • Have experienced allergic reactions to gram-positive bacteria
  • Have a known allergy to lidocaine
  • Have been hospitalized previously for reactions to medications

FDA INDICATIONS RESTYLANE

Approved Uses

Restylane® and Restylane-L® are for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane® and Restylane-L® are also indicated for injection into the lips in patients over the age of 21.

Restylane® Lyft with Lidocaine is for deep implantation into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and for cheek augmentation and for the correction of age-related midface contour deficiencies in patients over the age of 21.

Restylane® Silk is for lip augmentation and for correction of perioral wrinkles in patients over the age of 21.

Restylane® Refyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.

Restylane® Defyne is for mid-to-deep injection into the facial tissue for the correction of moderate to severe deep facial wrinkles and folds, such as nasolabial folds, in patients over the age of 21.

Are there any reasons why I should not use products within the Restylane® family? (Contraindications)
To ensure a safe procedure, your doctor will talk to you about your medical history to determine if you are an appropriate candidate for treatment. You should not use products within the Restylane family if:

  • You have severe allergies with a history of severe reactions (anaphylaxis)
  • You are allergic to lidocaine or to any of the gram-positive bacterial proteins used to make hyaluronic acid
  • You are prone to bleeding or have been diagnosed with a bleeding disorder

Tell your doctor if you are breastfeeding, pregnant, or trying to become pregnant. The safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied.

Restylane, Restylane-L, Restylane® Lyft with Lidocaine, Restylane Refyne and Restylane Defyne are intended to treat facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are also intended for lip enhancement. Treatments in other areas of the face have not been evaluated in clinical studies.

The safety and effectiveness of Restylane® Silk for areas other than the lips and perioral area have not been evaluated in clinical studies

Tell your doctor if you have any history of scarring, particularly thick and stiff scars, or any pigmentation (skin color) disorders. These side effects can occur with hyaluronic acid fillers in general.

Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment

Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects

Tell your doctor if you are on any medications to decrease your body’s immune response (immunosuppressive therapy). Using these medications may increase your risk of bruising or bleeding at the gel injection site.

Tell your doctor if you are using any “blood thinners” such as aspirin, warfarin, or any other medications that affect bleeding. Using these medications may increase your risk of bruising or bleeding at the gel injection site.

The use of these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete. Use of product in these areas could delay healing or make your skin problems worse.

What are the possible side effects?

The most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, and itching at the injection site. These are typically mild in severity and typically resolve in less than 7 days in nasolabial folds and less than 14 days in lips. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.

One of the risks with using this product is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent.

These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.

As with all skin injection procedures, there is a risk of infection.

To report a side effect with any of the Restylane products, please call Galderma Laboratories, L.P at 1-855-425-8722.

The Restylane family of products is available only through a licensed practitioner.

Complete Instructions for Use are available at www.RestylaneUSA.com .