The Restylane family of hyaluronic acid (HA) injectables is the broadest and most diverse portfolio of dermal fillers in the U. S. With more than 40 million treatments worldwide and counting, it is no surprise that the FDA has approved the newest member of the Restylane family, Restylane Contour. This product was previously approved for injection into facial tissue to improve the appearance of smile or laugh lines (nasolabial folds) in patients over 21 years of age.
Now, with the approval of Restylane Defyne for chin, Galderma has added another option to its growing portfolio. Before considering a professional treatment with Restylane, it is important to understand the safety information associated with these products. 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. It is also important to 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 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. A Galderma representative tells Allure that the FDA approval process took approximately eight months and that over the next few weeks injectors will have the opportunity to purchase Restylane Contour for their offices and participate in training with Galderma.
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).So what does this mean for patients? A doctor (dermatologist or plastic surgeon) injects Restylane Contour into the cheeks or midface to temporarily add volume and fullness. It is a great option for patients who want to improve cheek volume but want a natural look. It can replace fat that has been lost with aging or weight loss or it can simply provide volume and definition for those who want the look of a higher cheekbone. A doctor (dermatologist or plastic surgeon) injects Restylane Defyne gel into the chin area to temporarily add volume and fullness. Ultimately even if you go to your doctor specifically requesting Restylane Contour they may recommend a different option for you.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. The safety or efficacy of treatment in areas other than nasolabial folds and lips (Restylane and Restylane-L only) has not been established in controlled clinical studies.
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. Now may be the right time to consider a professional treatment with Restylane you'll get lips that tell you they look beautiful natural and the way you want them.
