what are radiesse® and radiesse® (+)?
radiesse® and radiesse® (+) are dermal fillers used to smooth moderate to severe facial wrinkles and folds, such as the nasolabial folds (the folds that extend from the corner of the nose to the corner of the mouth). radiesse® is also used to correct volume loss on the back of the hands.
radiesse® and radiesse® (+) important consumer safety information
Who should not use radiesse® or radiesse® (+)?
You should not use radiesse® or radiesse® (+) if you are allergic to any component of the product, have a history of severe allergies, have a bleeding disorder, or are pregnant or nursing . You should not use radiesse® (+) if you are allergic to lidocaine or similar medications.
What is the most important information I should know about radiesse® and radiesse® (+)?
One of the risks of using these products is accidental 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, may include vision abnormalities, blindness, stroke, temporary scabbing or permanent scarring of the skin. if you have vision changes, signs of a stroke (including sudden slurred speech, numbness or weakness in the face, arms or legs, trouble walking, droopy face, severe headache, dizziness or confusion), appearance whitening of the skin, or unusual pain during or shortly after treatment, you should tell your doctor immediately.
As with all procedures involving an injection through the skin, there is a risk of infection.
Do not use radiesse® or radiesse® (+) if you have a skin infection until it has healed.
It is not known if radiesse® or radiesse® (+) is safe or effective on the lips or the area around the eyes.
radiesse® and radiesse® (+) microspheres can be seen on X-rays and CT scans. It is very important that you tell your healthcare provider that you have had Radiesse® or Radiesse® (+) dermal filler.
if you have a history of herpes, you may experience a herpes outbreak after receiving radiesse® or radiesse® (+).
Injection into the back of the hand may result in temporary difficulty with activities. radiesse® can cause nodules, bumps, or lumps on the back of the hand and can last up to 1 year.
You should minimize strenuous activity and avoid prolonged exposure to sun or heat for approximately 24 hours after treatment and until swelling or redness subsides.
What should I tell my doctor before using radiesse® or radiesse® (+)?
Tell your healthcare provider if you are taking blood thinners or medicines that can interfere with blood clotting, such as aspirin or warfarin. These medications can make it more likely that you will experience bruising or bleeding at the injection site. tell your healthcare provider if you have any disease, injury, or disability of your hand, if you have a history of large, raised scarring, or if you have had other skin treatments, such as skin peels.
what are the most common adverse events with radiesse® or radiesse® (+)?
The most common adverse events observed in clinical studies of radiesse® used on the hands include bruising, redness, swelling, pain, itching, nodules or 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 on the face include bruising, redness, swelling, pain, itching, and other local side effects.
These are not all the possible side effects with radiesse® or radiesse® (+). merz collects information on adverse events observed with radiesse® and radiesse® (+) outside of clinical studies. These events are included in the Radiesse® and Radiesse® (+) Patient Information Guide based on an assessment of severity and possible causal relationship to Radiesse® or Radiesse® (+). see the patient information guide available at www.radiesse.com for a list of these events. tell your healthcare provider about any side effect that bothers you or that does not go away.
Important: For complete safety information, visit www.radiesse.com or call mymerz solutions at 1-844-469-6379
radiesse® and radiesse® (+) are available by prescription only.
