Restylane

Vayda Cosmetic

RESTYLANE® FAMILY HCP KEY MESSAGES

Below, please find key product messages for the Restylane portfolio of fillers, part of Galderma
Aesthetics. This document can serve as a guideline when speaking with media about the
Restylane portfolio of fillers, and the brand’s unique XpresHAn Technology™.

Priority Messages

  •  Restylane offers the broadest line of hyaluronic acid (HA) dermal fillers in the U.S, and is the only line of HA fillers with products FDA-approved for both the face and hands.1-7 The fillers smooth away facial wrinkles and folds (Restylane Lyft, Restylane Refyne and Restylane Defyne), enhance lips and smooth lines around the mouth (Restylane Silk), add lift and volume to the cheeks (Restylane Lyft), and is the only HA filler portfolio with a filler that is FDA-approved to help to reverse the signs of volume loss in the back of
    aging hands (Restylane Lyft).1-7
  •  Restylane has been available for more than 20 years worldwide8 and I have used it in my practice for more than [NUMBER HERE] years. With 40 million treatments completed worldwide, the Restylane portfolio of fillers are safe, effective, and have high patient satisfaction.8
  • I use Restylane Refyne and Restylane Defyne to smooth away “smile lines” – the wrinkles and folds that may form at the sides of the nose and run down toward the corners of the mouth. They are the only fillers manufactured with Galderma’s unique XpresHAn Technology™, which creates a smooth, injectable gel that can give your skin a natural, soft look, and is proven to maintain natural movement in the lower part of the face. 2,4,9,10
  • The lower part of the face is constantly in motion, so it’s important to use a filler that supports natural movement and facial expressions.
  • Restylane Refyne and Restylane Defyne provide youthful-looking results. For most of my patients, the procedure only takes 15 – 30 minutes, and results typically last up to 12 months.2,4 Secondary Messages
  • Galderma, maker of Restylane, recently conducted a national survey of women ages 25 – 55, and 94 percent reported that they would consider getting an injectable hyaluronic acid (HA) filler for a specific event, such as a milestone birthday (41%), class reunion (32%), or their wedding (26%).11
    o I recommend the Restylane line of HA fillers to my patients for natural-looking results for all of life’s special occasions and everyday life.
  • Galderma’s survey also showed more than 60 percent of women said that they would consider getting fillers if it would help them look as good as their social media filters. Another 63 percent of women would consider fillers to help them look as young as they feel on the inside.11 Some of my own patients have considered fillers for these reasons. USMP/RES/0375/0619 June 2019
  • For the most natural-looking results, it is important to see a trained aesthetic
    professional who has experience with Restylane HA fillers and knowledge of facial anatomy.
  • The Restylane portfolio of fillers is also designed with NASHA Technology, Galderma’s other unique manufacturing process found in Restylane, Restylane Lyft and Restylane Silk. NASHA Technology creates a firmer gel texture that allows for precise injection, leading to a more pronounced lift and smoother looking skin.
  • HA fillers are the second most popular non-surgical cosmetic treatment in the U.S.,12 but many women are still hesitant to try them. The most common concerns are results that don’t look natural (57%); potential side-effects (62%); and that the treatment is painful (36%).11 I assure my patients that Restylane is safe and effective, and offers natural looking results.
  • The Restylane portfolio of HA filler helps to fulfill a variety of aesthetic needs for my patients. They are also dissolvable, and contain lidocaine, a medication used to numb a specific area to decrease pain and reduce discomfort associated with the treatment.1-6,8
  • The most commonly observed side effects are swelling, redness, pain, bruising,
    headache, tenderness, lump formation, itching at the injection site, and impaired hand function.1-6 To learn more about the serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.
  • To earn rewards and savings during your facial aesthetic journey, join Galderma’s patient loyalty program ASPIRE Galderma Rewards by visiting eww.AspireRewards.com.

Important Safety Information
The Restylane family of products includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, and Restylane® Defyne.

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® Lyft with Lidocaine is also indicated for injection into the subcutaneous plane in the dorsal hand to correct volume deficit in patients over the age of 21. USMP/RES/0375/0619 June 2019 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
    Are there other precautions that I should discuss with my doctor?
  • 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. Restylane® Lyft with Lidocaine is also intended for injection in the dorsal hand to correct volume loss. Treatments in other areas of the face or body 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. USMP/RES/0375/0619 June 2019
  • 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.
  • Tell your doctor if you have diseases, injuries, or disabilities of the hand.

What are the possible side effects?

The most commonly observed side effects are swelling, redness, pain, bruising, headache,
tenderness, lump formation, itching at the injection site, and impaired hand function. 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.
© 2019 Galderma Laboratories, L.P.
All trademarks are the property of their respective owners.
1 Restylane. Instructions for Use. Galderma Laboratories, L.P., 2016.
2 Restylane Defyne. Instructions for Use. Galderma Laboratories, L.P., 2016.
3 Restylane-L. Instructions for Use. Galderma Laboratories, L.P., 2016.
4 Restylane Refyne. Instructions for Use. Galderma Laboratories, L.P., 2016.
5 Restylane Lyft. Instructions for Use. Galderma Laboratories, L.P., 2018.
6 Restylane Silk. Instructions for Use. Galderma Laboratories, L.P., 2017.
7 U.S. Food & Drug Administration. Medical Devices, Restylane Lyft with Lidocaine – P040024/S099.
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Re
cently-ApprovedDevices/ucm609592.htm. Accessed on May 18, 2018.
8 Data on file. Fort Worth, TX: Galderma Laboratories, L.P., 2019.
9 Philipp-Dormston et al. Evaluating Perceived Naturalness of Facial Expression After Fillers to the
Nasolabial Folds and Lower Face with Standardized Video and Photography. Dermatol Surg 2017; 0: 1-7.
10 Segura S, Anthonioz L, Fuchez F, Herbage B. A complete range of hyaluronic acid filler with distinctive
physical properties specifically designed for optimal tissue adaptations. J Drugs Dermatol. 2012;11(1
Suppl):s5-s8.
11 Data on file. Restylane Survey Demographic Report (Wakefield Research), March 2019.
12 2019 National Plastic Surgery Statistics. American Society of Plastic Surgeons. April 2019

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