Revanesse® Lips+ – P160042/S010
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: Revanesse® Lips+
PMA Applicant: Prollenium Medical Technologies, Inc.
Address: Prollenium Medical Technologies, Inc.
138 Industrial Parkway N.,
Aurora, CAN L4G 4C3 Ontario
Approval Date: September 21, 2020
Approval Letter: Approval Order
What is it? Revanesse® Lips+ is a clear, colorless injectable gel implant (dermal filler) injected into specific areas of facial tissue. Itconsists of crosslinked hyaluronic acid (HA) made by a species of bacteria and formulated to a concentration of 22 – 28 mg/mL with 3 mg/mL of the drug lidocaine hydrochloride as a numbing agent.
This product was previously approved for injection into facial tissue to improve the appearance of smile or laugh lines (nasolabial folds). This approval expands the use of this product to injection in the lips.
How does it work? A doctor (dermatologist or plastic surgeon) uses a needle to inject Revanesse® Lips+ gel into the lips to temporarily add volume and fullness.
When is it used? Revanesse® Lips+ may be used in adults 22 years of age or older.
What will it accomplish? Revanesse® Lips+ may temporarily add fullness to the lips. In a clinical study, two months after injection with Revanesse® Lips+, 90.7% of patients had an increase in volume and fullness to the upper and lower lips.
Common side effects were:
- Lump formation
When should it not be used? Revanesse® Lips+ should not be used in people who:
- have allergic history including;
- severe allergic reactions (anaphylaxis),
- presence of multiple severe allergies,
- allergy to hyaluronic acid products, gram-positive or Streptococcal proteins,
- allergy to the drug lidocaine or other similar local anesthetics.
Additional information (including warnings, precautions, and adverse events):