What is Radiesse?


RADIESSE® is a dermal filler that is indicated for hand augmentation to correct volume loss in the back of the hands, and for smoothing 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).


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Before & After


Important Safety Information & Approved Uses


What are RADIESSE®?
RADIESSE is a dermal filler that is 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.

Who should not use RADIESSE?
You should not use RADIESSE if you have a history of severe allergies or anaphylaxis, or if you are pregnant or breastfeeding. You should not use RADIESSE if you have an allergy to any part of the product, or if you have a bleeding disorder.

What is the most important information I should know about RADIESSE?
One of the risks with using RADIESSE 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 in parts of the face other than facial wrinkles and folds has not been established. Do not use RADIESSE if you have a skin infection or inflammation until it has healed. The microspheres in 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 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?
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?
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 used in the face include bruising, redness, swelling, pain, itching, and other local side effects. These are not all of the possible side effects with RADIESSE. Merz collects information about adverse events seen with these products post-approval. These events are included in the RADIESSE Patient Information Guide based on an assessment of seriousness and potential causal relationship to the products.  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 is available by prescription only.


Frequently Asked Questions


What is RADIESSE®?
RADIESSE® is a dermal filler that temporarily adds volume to help 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).

What is RADIESSE® made from?
RADIESSE is made of tiny calcium-based microspheres suspended in a water-based gel. The calcium microspheres are similar to minerals found naturally in the body so allergy testing is not required. Over time, the body absorbs the microspheres and gel, leaving behind only natural collagen.

Please note that RADIESSE is contraindicated in patients with severe allergies manifested by a history of anaphylaxis, with a history or presence of multiple severe allergies

How does RADIESSE® work?
Once injected, RADIESSE plumps the skin to give the appearance of a smoother surface. Over time, RADIESSE works to stimulate the body to produce collagen naturally. Ultimately the body absorbs the product and leaves behind the natural collagen for long-lasting results.

Where can RADIESSE® be injected?
RADIESSE can be injected in the following locations*:

  • Smile lines: also called the nasolabial folds,
    are the lines that run from the corners of the nose to the
    corners of the mouth
  • Marionette lines: the lines that run downward
    from the corners of the mouth
    Corners of the mouth: also called the oral
    commissure, if these are turned downward it can make you look
    as though you’re frowning
  • Pre-jowl fold: the area on either side of the
    chin, where skin can sag due to loss of facial volume
    Chin wrinkles: horizontal lines that can form
    on your chin and distract from your smile

*RADIESSE is FDA-approved for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.

What makes RADIESSE® different from other leading dermal fillers?
RADIESSE is the only dermal filler available composed of calcium-based microspheres, and has been shown to stimulate the natural production of collagen, for results that may last up to a year or more in many patients. Additionally, in clinical studies with leading hyaluronic acid injectable dermal fillers, results showed that RADIESSE patients were more satisfied with their results than patients treated with other leading wrinkle fillers. In addition, 30% less RADIESSE may be needed for correction when compared to Perlane® injectable gel.

How is treatment with RADIESSE® performed? Is it painful?
RADIESSE is injected under the skin in a quick procedure that can be done over the lunch hour. RADIESSE is also FDA-approved to mix with lidocaine (an anesthetic), which means the procedure will be much more comfortable. In fact, in a clinical study, 90% of patients treated reported significant pain reduction when injected with RADIESSE mixed with lidocaine.

How soon will I see results with RADIESSE®, and how long will they last?
Immediately upon injection, RADIESSE restores volume to smooth out the signs of aging. The natural-looking results may last up to a year or more in many patients.

Who can benefit from treatment with RADIESSE®?
RADIESSE is FDA-approved for correction of moderate to severe wrinkles and folds. Talk to your doctor about what your specific treatment needs may be and to see if RADIESSE is right for you.

What are the side effects of treatment with RADIESSE®?
The most common adverse events include bruising, redness, swelling, pain, tenderness and itching. These side effects generally last for a short time and are mild in nature. These are not all of the possible side effects with RADIESSE. Tell your health care provider about any side effects that bother you or do not go away.

Is there anyone that should not use RADIESSE®?
RADIESSE should not be used in patients with severe allergies manifested by a history of anaphylaxis, a history or presence of multiple severe allergies or patients with known hypersensitivity to any of the components.

The safety of RADIESSE has not been established in patients who are pregnant or breastfeeding or under the age of 18.

Where can I find out more about RADIESSE®?
To get more personalized information, the best thing to do is to schedule a consultation with a health care provider. The first step is to find a provider in your area.

What is the most important information I should know about RADIESSE®?
As with all procedures that involve an injection through the skin, there is a risk of infection. Do not use RADIESSE if you have a skin infection until it has healed.

The microspheres in 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 dermal filler injected into your face.

If you have a history of herpes, you may experience a herpes
breakout after receiving RADIESSE.

For approximately 24 hours after treatment:

  • Avoid significant movement or massage of the treated area
  • Do not apply makeup
  • Avoid extensive sun or heat exposure

Source:https://www.radiesse.com/