Is restylane approved by fda?

RESTYLANE FAMILY IMPORTANT SAFETY INFORMATION Do not use if you have severe allergies with a history of severe reactions (anaphylaxis), if you are allergic to lidocaine or gram-positive bacterial proteins used to produce hyaluronic acid, are prone to bleeding, or if you have a bleeding disorder. The safety of its use during pregnancy 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 (for example,.

Tell your doctor if you are taking medications that lower the 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. Use of these products at 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, lumps, itching at the injection site, and impaired hand function. Serious but rare side effects include late-onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site.

The risk of an involuntary injection into a blood vessel is small, but it can occur and cause serious complications, which can be permanent, such as vision abnormalities, blindness, stroke, temporary crusting, or permanent scarring of the skin. As with all skin injection procedures, there is a risk of infection. Follow us on social media for current news and patient stories You are about to leave the Nestle Skin Health global site. Are you sure you want to leave this page?.

Ultimately, even if you go to your doctor specifically requesting Restylane Contour, they may recommend a different option for you. The U.S. Food and Drug Administration (FDA) has approved Restylane Kysse (Galderma), a hyaluronic acid (HA) filler for lips and upper perioral rhytids in adults 21 and older. A doctor (dermatologist or plastic surgeon) injects Restylane Defyne gel into the chin area to temporarily add volume and fullness.

Galderma has announced that the newest member of its Restylane family of hyaluronic acid (HA) injectables, Restylane Contour, has just received approval from the U. While its results are safe and predictable, Restylane Contour, like all dermal fillers, carries some risks. Restylane Kysse joins a variety of other aesthetic injectables in Galderma's portfolio, including Restylane Defyne, Restylane Refyne, Restylane Lyft with Lidocaine and Restylane Silk. Now may be the right time to consider a professional treatment with Restylane: you'll get lips that look beautiful, natural and just the way you want them.

Melanie Palm, certified dermatologist and cosmetic surgeon in San Diego, CA, and clinical researcher in the Restylane Kysse phase 3 trial. The Food and Drug Administration has approved Hyaluronic Acid Lip Filler, Restylane Kysse, in Patients 21 and Older. This product was previously approved for injection into facial tissue to improve the appearance of smile or expression lines (nasolabial folds) in patients over 21 years of age. Treatment volume should be limited to 6.0 ml for wrinkles and folds, such as nasolabial folds, and limited to 1.5 ml per lip (Restylane and Restylane-L only), as larger amounts significantly increase moderate and severe injection site reactions.

Stacy Chimento, a Miami board-certified dermatologist, is very excited about what Restylane Contour brings, and tells Allure that the fine integration of the product will allow providers to create subtle and beautiful improvements in the midfacial and lateral areas of the cheeks. As for how Restylane Contour will be administered, Ramanadham says it has been studied for use with needles and cannulas and has been shown to be effective with both injection and administration methods. A doctor (dermatologist or plastic surgeon) injects Restylane Contour into the cheeks or midface to temporarily add volume and fullness. In a clinical study, 12 weeks after treatment, Restylane Defyne was found to improve the appearance of the chin profile in 86.1% of patients.

The May 5 announcement follows positive results from the phase 3 trial demonstrating that an improvement in lip fullness was achieved with a lower amount of Restylane Kysse (1.82 ml) compared to the comparator (2.24 ml). . .

Gwendolyn Steckler
Gwendolyn Steckler

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