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What are RADIESSE® and RADIESSE® (+)?
RADIESSE® and RADIESSE® (+) are dermal fillers that are used 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). RADIESSE® is also used for correcting volume loss in 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 have an allergy to any component of the product, if you have a history of severe allergies, if you have a bleeding disorder, or if you are pregnant or breastfeeding. You should not use RADIESSE® (+) if you have an allergy to lidocaine or medicines like it.
What is the most important information I should know about RADIESSE® and RADIESSE® (+)?
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. 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 in the lips, or in the area around the eyes. 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 receiving RADIESSE® or RADIESSE® (+). 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® or 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 forming large, raised scars or if you have had any other skin treatments such as skin peels.
What are the most common adverse events with RADIESSE® or 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® or RADIESSE® (+) used in the face include bruising, redness, swelling, pain, itching and other local side effects.
What is Revanesse® Versa™+?
Revanesse® Versa™+ is an FDA approved hyaluronic acid dermal filler that can be used to treat moderate to severe facial wrinkles and folds, including nasolabial folds in patients 22 years of age or older.
What is Revanesse® Lips™+?

Revanesse® Lips™+ is an FDA approved hyaluronic acid dermal filler that can be used for submucosal implantation for lip augmentation in patients 22 years of age or older.

Are there any reasons (contraindications) I should not receive a Revanesse® Versa™+ or Revanesse® Lips™+ injection?

You should not be treated if you:

  1. are pregnant or breastfeeding, as the safety of these products for use during pregnancy, or in women who are breastfeeding, has not been studied
  2. have a history of hypertrophic scarring or keloid formation
  3. have evidence of scars at the intended treatment sites
  4. have acne and / or other inflammatory diseases of the skin, such as rosacea, seborrheic dermatitis, and psoriasis,
  5. have allergic history including: severe allergic reactions (anaphylaxis), heightened immune responses to common allergens, especially inhaled allergens and food allergens (atopy), allergy to hyaluronic acid products, allergy to lidocaine, Streptococcal proteins or have plans to undergo administration of graded doses of allergens (desensitization therapy) during treatment with Revanesse®.
  6. have acute or chronic skin disease, such as seborrheic dermatitis or rosacea, in or near the injection sites, or any infection or unhealed wound of the face
  7. are under concomitant anticoagulant therapy, antiplatelet therapy, or have a history of bleeding disorders, clotting disorders such as hemophilia or connective tissue disorders such as systemic lupus erythematosus
  8. If you are under the age of 22 you should not be treated with a Revanesse® dermal filler.

It’s not recommended to use Revanesse® dermal fillers in conjunction with a laser, intense pulsed light, chemical peeling or dermabrasion treatments, or with Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4 weeks prior to treatment, as there is a possible risk of inflammation or infection at the treatment site.

What are the risks?

The most common reported side effects are bleeding, bruising, swelling, and pain.

Other risks that are less likely, but may occur, include: Acne-like skin eruptions, skin sensitivity (rash, itching, tenderness), skin infection, damage to nerves or blood vessels, skin lumpiness, scarring, skin necrosis, hyperpigmentation, reactivation of herpes infection (blisters or skin sores).

If you have an adverse reaction or side effect that persists for one week or more after treatment with a Revanesse® dermal filler, please contact your healthcare provider.

Warning: One of the risks of being injected with any dermal filler is unintentional injection into a blood vessel. These complications, which have been reported with facial injectable fillers, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin.

Patient Assistance Information:

If you require immediate medical assistance, please contact your health care provider. For further assistance, please contact Prollenium Medical Technologies Inc. at 1-866-353-3017 (24 hours a day).

For more information about Revanesse® Versa™ or Revanesse® Lips™, please see their Directions for Use or speak to your health care provider.

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