The Food and Drug Administration (FDA) has granted market clearance for Restylane Silk which allows doctors to administer the filler to interested patients. The filler, which contains 0.3 percent lidocaine, has been approved for use in lip augmentations and perioral rhytids in patients 21 years of age or older. Read on to learn more about the results obtained through Restylane Silk.
Clinical Study on the Safety of Restylane Silk
Restylane Silk underwent a clinical study meant to determine its safety and efficacy in regards to lip augmentation and dental implants. Of the 221 patients in the study, 98\\% of those treated reported fuller lips just two weeks after the procedure. 76\\% of them still reported improvements in their lips a full six months after the treatment.
Though patients did experience adverse effects, these symptoms were reportedly mild and in line with the potential side effects of other fillers including swelling and pain. According to the study, the likelihood of adverse effects decreases significantly following the second treatment.
What is Restylane
Restylane is FDA-approved dermal filler made of a biodegradable, non-animal stabilized hyaluronic acid (NASHA). Hyaluronic acid is a natural substance found in all living organisms and provides volume and fullness to the skin. Because it is made of hyaluronic acid, Restylane does not require any allergy or skin test prior to injection.
Restylane is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Restylane is also indicated for lip augmentation in patients over the age of 21.
Restylane is formulated as a clear gel and uses a dual mechanism of action to correct moderate to severe wrinkles and folds. Upon being injected beneath the surface of the skin, Restylane gel integrates into dermal tissue and then attracts and binds to water molecules to help maintain volume. Restylane is gradually degraded by the natural mechanism of the body and disappears without any residue. Results can be seen immediately following a Restylane treatment and they last for up to 6-18 months. Some patients may achieve results that last longer depending on the injection site.
Restylane is also marketed and sold in more than 65 countries outside the United States where it has been used in more than ten million procedures.
Candidates for a Restylane Procedure
Ideal candidates for a Restylane procedure are:
Patients that smoke, have a history of extreme allergies or have an infection or medical condition in, or near, the planned injection site are not good candidates. The procedure hasn't been deemed safe for patients below the age of 18. It is not suitable for breastfeeding or pregnant women
What to Expect After a Restylane Procedure
The aim of the procedure is to restore even and full lips. It also restores a smooth and youthful look to the lips. Following a Restylane procedure, a minimal amount of downtime for recovery should be expected. In most cases, the patient can resume most activities right away but it is generally recommended that intense physical activity be avoided for the first 24-48 hours. Swelling, bruising and redness can occur shortly after the procedure but all of these conditions will dissipate within one week. Patients should avoid lying down for about four hours after the procedure. Patients should also refrain from rubbing or massaging the injection area for about 24 hours. The results of the procedure generally last a period of 6-18 months.
Side Effects Associated with Restylane Silk
In order to ensure a smooth and complication-free procedure, patients are advised to follow all of the post-treatment instructions from their doctor. Although Restylane is a relatively safe procedure, there are a few minor side effects associated with the procedure. They include: