Indication and Important Safety Information
The RHA® Collection of fillers is for injection into the facial tissue for the correction of dynamic facial wrinkles and folds that are moderate to severe, such as nasolabial folds, in adults 22 or older.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any RHA® injectable gel formulation?
Do not receive if you have a history of multiple severe allergies or severe allergic reactions; if you are
allergic to lidocaine or gram-positive bacterial proteins; or if you have a bleeding disorder.
What precautions should I discuss with my doctor?
- Tell your doctor if you are pregnant or breastfeeding as the safety of these products for use during
pregnancy or while breastfeeding has not been studied.
- Tell your doctor if you have a history of excessive scarring, keloid formations or pigmentation
disorders, as use of these products may result in additional scars or changes in pigmentation.
- Tell your doctor if you are planning laser treatments or a chemical peel, as there is a possible risk
of inflammation at the treatment site if these procedures are performed after treatment.
- Tell your doctor if you are on immunosuppressive therapy used to decrease your immune
response, as use of these products may result in an increased risk of infection.
- Tell your doctor if you are using medications that can prolong bleeding, such as aspirin,
ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site.
- The safety and effectiveness of RHA® fillers in areas other than those indicated have not been
established in U.S. clinical studies.
- Patients who experience skin injury near the site of injection with this product may be at a higher
risk for side effects.
- Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within
the first 24 hours following treatment.
What are possible side effects?
The most commonly reported side effects included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching.
One of the risks with using these products is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported
for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.
As with all skin injection procedures, there is a risk of infection and recurrence of herpetic eruptions.