Medical Devices

Juvéderm Volbella® XC – P110033/S018

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 Volbella® XC
PMA Applicant: Allergan
Address: 2525 Dupont Drive, Irvine, CA 92612
Approval Date: May 31, 2016
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110033S018a.pdf

What is it? It is a clear, colorless injectable gel. It is a dermal filler that can increase lip volume and smooth lines around the mouth in adults over the age of 21. Juvéderm Volbella XC It has crosslinked and other hyaluronic acid. It is made by Streptococcus bacteria. It has some local anesthetic (lidocaine).

When is it used? Doctors use it for patients older than 21 who want fuller lips and fewer wrinkles around their mouths.

How does it work? Doctors inject it to fill lips and around mouths temporarily. They use ultrafine needles.

What will it accomplish? It can fill lips and smooth the skin temporarily. Patients may need more than one treatment.

In the clinical study, lip filling and line smoothing lasted for a year in 6 of every 10 subjects.

Common side effects in the clinical study
Side EffectSubjects with the Side Effect (Percentage)
Swelling93 of every 100 (93%)
Tenderness90 of every 100 (90%)
Bruising89 of every 100 (89%)
Firmness89 of every 100 (89%)
Lumps or bumps88 of every 100 (88%)
Redness83 of every 100 (83%)
Pain81 of every 100 (81%)
Discoloration42 of every 100 (42%)
Itching31 of every 100 (31%)
Dryness5 of every 100 (5%)

When should it not be used? (Contraindications)

It is not for patients who have:

  • severe allergy with history of a severe reaction (anaphylaxis),
  • allergy to lidocaine, or
  • allergy to proteins from Gram-positive bacteria.

More information: The Summary of Safety and Effectiveness Data and labeling are available online:

 

Page Last Updated: 09/09/2016
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