COSMETIC TOWN JOURNAL



Restylane Silk - Injectable Filler and Natural Results

Posted November 26, 2014

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:

  • Healthy individuals who have moderate to severe folds or wrinkles
  • Nasolabial folds or deep nose to mouth lines
  • Sunken cheeks due to loss of cheek volume
  • Thin or unevenly shaped lips
  • A receding chin
  • Minor nose deformities such as a nasal hump

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:

  • Restylane injection may cause hyperpigmentation of the skin at the injection site
  • Restylane should be used with caution in patients on immunosuppressive therapy
  • Bruising or bleeding may occur at the injection site
  • Patients who have undergone therapy with thrombolytics, anticoagulants or platelet inhibitors in the previous three weeks should inform their doctor about the medication they've taken or are currently taking
  • A possibility of an inflammatory reaction may exist prior to, or after Restylane injections, if combined with dermal procedures
  • Restylane injections may reactivate herpes in patients with a history of a previous herpetic eruption
  • There could be injection site reactions such as lip swelling, lip pain, bruising, tenderness, itching, burning, redness, swelling, pain/soreness, injection site scabbing and injection site infection
  •  Restylane Silk may interact with aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), high doses of vitamin E supplements, immunosuppressive therapy or other skin treatments
  • The safety of Restylane Silk for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established

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