Rejuvenation Treatment Miami
JUVÉDERM VOLUMA™ XC Injectable Gel
JUVÉDERM VOLUMA™ XC injectable gel is the first and only filler FDA-approved to instantly add volume to the cheek area. It gives you a subtle lift, helping to restore contour and a more youthful profile, for up to 2 years, in patients over the age of 21. It’s different than JUVÉDERM® XC and works on a different area of the face. JUVÉDERM® XC smoothes out moderate to severe wrinkles and folds around the nose and mouth, like parentheses. JUVÉDERM VOLUMA™ XC, however, adds volume to the cheek area.
What Else Should You Know About JUVÉDERM VOLUMA™ XC?
- First and only Hyaluronic Acid (HA) filler FDA-approved to instantly add volume to the cheek area, resulting in a subtle lift
- Clinically proven to last up to 2 years with optimal treatment
- JUVÉDERM VOLUMA™ XC is from the makers of the #1 family of fillers
- After 24 hours, you should be able to resume your normal activities
- Side effects are moderate and generally last 2 to 4 weeks. Common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.
Hyaluronic Acid is a naturally occurring, hydrating substance found in your skin. As you age, you start to lose HA, which causes the skin to lose structure and volume.
Juvéderm Voluma XC – P110033
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Juvéderm Voluma XC
PMA Applicant: Allergan
Address: 71 S. Los Carneros Rd., Goleta, CA 93117
Approval Date: October 22, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110033a.pdf
What is it?
Juvéderm Voluma XC is a sterile, biodegradable, viscoelastic gel implant. It consists of crosslinked hyaluronic acid produced by Streptococcus equi bacteria, formulated to a concentration of 20 mg/mL with 0.3% lidocaine.
How does it work?
Juvéderm Voluma XC is injected into facial tissue to temporarily restore volume and fullness to the areas of the mid-face, which include the cheeks and nearby regions confined to the middle portion of the face.
When is it used?
Juvéderm Voluma XC is used by a doctor in areas of the mid-face to correct age-related volume loss. The gel temporarily adds volume and fullness to the face in adults over the age of 21.
What will it accomplish?
Juvéderm Voluma XC temporarily reverses signs of age-related volume loss in the mid-face. In the clinical study, 86% of subjects had an improvement in their cheek fullness 6 months, and the results lasted up to 2 years in a majority of subjects. Most subjects also experienced moderate tenderness, swelling, firmness and/or lumps and bumps at the injection site which generally lasted 2 to 4 weeks.
When should it not be used?
Juvéderm Voluma XC should not be used in subjects who have:
- severe allergies manifested by a history of anaphylaxis
- history or presence of multiple severe allergies
- history of allergies to gram-positive bacterial proteins
- history of allergies to lidocaine