Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation

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Galderma Receives FDA Approval for Restylane® Defyne for Chin Augmentation


“This marks Galderma’s 8 th FDA aesthetics approval in 5 years, illustrating our long-term commitment to advancing aesthetics through new innovation,” said Alisa Lask , General Manager and Vice President of the U.S. Aesthetics Business at Galderma. “The chin is the foundational anchor of the face that brings the rest of your features into balance. 8 Consumers can now address the chin with a non-surgical, safe option from a brand that uses cutting-edge XpresHAn Technology TM to shape and produce long-lasting results.”

Availability of Restylane Defyne for Chin Restylane Defyne has been used in over 2.4 million aesthetic treatments worldwide since the market introduction in 2010 and is approved in over 70 countries. 12 While Restylane Defyne has been available in the United States for 4 years and outside of the U.S. for nearly 10 years, Galderma will work closely with its aesthetic injector partners, while following all safe and proper social distancing guidelines, to introduce the newest offering with Restylane Defyne for chin in respective practice locations across the country.

For more information about Restylane Defyne for chin, visit RestylaneUSA.com.

About Galderma Galderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetic solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com/us.

To earn exclusive rewards, bonuses and discounts on Galderma’s aesthetic treatments, join the ASPIRE Rewards program. To learn more about ASPIRE, visit www.aspirerewards.com.

Follow Galderma on Instagram at @GaldermaAestheticsUSA.

The Restylane family of products are indicated for patients over the age of 21 , and includes Restylane®, Restylane-L®, Restylane® Lyft with Lidocaine, Restylane® Silk, Restylane® Refyne, Restylane® Defyne and Restylane® Kysse.

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.

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. Restylane ® Lyft with Lidocaine is also indicated for injection into the dorsal hand to correct volume loss.

Restylane ® Silk is for lip augmentation and for correction of perioral wrinkles.

Restylane ® Kysse is for lip augmentation and for correction of upper perioral wrinkles.

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.

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. Restylane ® Defyne is also indicated for injection into the mid-to deep dermis (subcutaneous and/or supraperiosteal) for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion.

Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), are allergic to lidocaine or gram-positive bacterial proteins used to make hyaluronic acid, prone to bleeding, or have a bleeding disorder. The safety of use while pregnant or breastfeeding has not been studied. Tell your doctor if you have a history of scarring or pigmentation disorders as these side effects can occur with hyaluronic acid fillers. Tell your doctor if you are planning other cosmetic treatments (i.e., lasers and chemical peels) as there is a possible risk of inflammation at the injection site.

Tell your doctor if you’re taking medications that lower your body’s immune response or affect bleeding, such as aspirin or warfarin, as these medications may increase the risk of bruising or bleeding at the gel injection site. Using these products on gel injection sites with skin sores, pimples, rashes, hives, cysts, or infections should be postponed until healing is complete.

The most common side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, itching at the injection site, and impaired hand function. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. The risk of unintentional injection into a blood vessel is small but can occur and could result in serious complications, which may be permanent including, 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 Restylane® product, please call Galderma Laboratories, L.P at 1-855-425-8722.

To learn more about serious but rare side effects and full Important Safety Information, visit www.RestylaneUSA.com.

 



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