What are RADIESSE®, RADIESSE® (+), and BELOTERO BALANCE®?
RADIESSE, RADIESSE (+), and BELOTERO BALANCE are dermal fillers that are FDA-approved to smooth moderate-to-severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth). RADIESSE is also used to correct volume loss in the back of the hands.
BELOTERO BALANCE, RADIESSE, and RADIESSE (+) Important Safety Information
Who should not use RADIESSE, RADIESSE (+), or BELOTERO BALANCE?
You should not use RADIESSE, RADIESSE (+), or BELOTERO BALANCE if you have a history of severe allergies or anaphylaxis, or if you are pregnant or breastfeeding.
You should not use RADIESSE or RADIESSE (+) if you have an allergy to any part of the product, or if you have a bleeding disorder.
You should not use RADIESSE (+) if you have an allergy to lidocaine or medicines like it.
You should not use BELOTERO BALANCE if you have an allergy to gram-positive bacterial proteins.
What is the most important information I should know about RADIESSE, RADIESSE (+), and BELOTERO BALANCE?
One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, 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 of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
As with all procedures that involve an injection through the skin, there is a risk of infection.
The safety and effectiveness of RADIESSE, RADIESSE (+), or BELOTERO BALANCE in parts of the face other than facial wrinkles and folds has not been established.
Do not use RADIESSE, RADIESSE (+), or BELOTERO BALANCE if you have a skin infection or inflammation until it has healed.
The microspheres in RADIESSE and RADIESSE (+) can be seen in X-rays and CT scans. It is very important that you tell your health care provider that you have had RADIESSE or RADIESSE (+) dermal filler.
If you have a history of herpes, you may experience a herpes breakout after treatment.
Injection in the back of the hand may result in temporary difficulty performing activities. RADIESSE may cause nodules, bumps, or lumps in the back of the hand and can last up to 1 year.
You should minimize strenuous activity and avoid extensive sun or heat exposure for about 24 hours after treatment and until any swelling or redness has resolved.
What should I tell my doctor before using RADIESSE, RADIESSE (+), or BELOTERO BALANCE?
Tell your health care provider if you are taking blood thinners or medicines that can interfere with the clotting of blood, such as aspirin or warfarin. These medicines might make it more likely that you will experience bruising or bleeding at the injection site. Tell your health care provider if you have any diseases, injuries or disabilities of the hand, if you have a history of forming large, raised scars, or if you have had any other skin treatments such as skin peels.
Before treatment with BELOTERO BALANCE, tell your doctor if you have frequent sore throats, or if you are on any immunosuppressive therapy.
What are the most common adverse events with RADIESSE, RADIESSE (+), or BELOTERO BALANCE?
The most common adverse events seen in clinical studies of RADIESSE used in the hands include bruising, redness, swelling, pain, itching, nodules or bumps/lumps, difficulty performing activities, loss of sensation, and other local side effects. The most common adverse events seen in clinical studies of RADIESSE or RADIESSE (+) used in the face include bruising, redness, swelling, pain, itching, and other local side effects.
The most common adverse events seen in clinical studies with BELOTERO BALANCE were swelling, bruising, redness, hardening of the skin, pain, altered color, and itching. Other adverse events that have occurred with BELOTERO BALANCE include headache, swelling of the side of the nose, moderate cold sore, lip numbness, and lip dryness. Side effects were often mild to moderate and usually resolved within 7 days.
These are not all of the possible side effects with RADIESSE, RADIESSE (+), or BELOTERO BALANCE. Merz collects information about adverse events seen with these products post-approval. These events are included in the RADIESSE, RADIESSE (+), and BELOTERO BALANCE Patient Information Guide based on an assessment of seriousness and potential causal relationship to the products. Please see the Patient Information Guides available at www.Radiesse.com and www.belotero.com for a list of these events. Tell your health care provider about any side effects that bother you or do not go away.
Important: For full safety information, please visit www.Radiesse.com, www.Belotero.com, or call MyMerz Solutions at 1-844-469-6379
RADIESSE, RADIESSE (+), and BELOTERO BALANCE are available by prescription only.