Radiesse© and Radiesse©(+) Injectable Implants are FDA-approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. RADIESSE® is also indicated for hand augmentation to correct volume loss in the dorsum of the hands. RADIESSE (+) injectable implant is also indicated for deep injection (subdermal and/or supraperiosteal) for soft tissue augmentation to improve moderate to severe loss of jawline contour in adults over the age of 21.

These products are contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies; patients with known hypersensitivity to any of the components; and patients with bleeding disorders. RADIESSE® (+) is contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type.

Warnings

Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. The treating physician should be knowledgeable regarding any pretreatment evaluation and appropriate interventions in the event of intravascular disseminated injection. Prompt intervention by an appropriate medical specialist should be given should these signs or symptoms of intravascular injection occur.

Use of these products in any person with active skin inflammation or infection in or near the treatment should be deferred until the inflammatory or infectious process is controlled.

Do not overcorrect (overfill) a contour deficiency with these products.

Injection into the dorsum of the hand may cause adverse events that last for more than 14 days, and may result in temporary difficulty performing activities (48% of study patients reported this adverse event). RADIESSE® may cause nodules, bumps or lumps in the dorsum of the hand (12% reported this event) and can last up to 1 year.

The safety and effectiveness for use in the lips has not been established. There have been published reports of nodules associated with the use of these products injected into the lips.

Precautions

In order to minimize the risk of potential complications, this product should only be used by healthcare practitioners who have appropriate training, experience and who are knowledgeable about the anatomy at and around the injection site. Healthcare practitioners should fully familiarize themselves with the product, the product educational materials and the entire package insert.

The safety and effectiveness of RADIESSE®or RADIESSE®(+) in the following situations has not been established:

• Beyond 3 years in the face and 1 year in the hand
• In the periorbital area
• Interactions between RADIESSE® or RADIESSE® (+) and drugs or other substances or implants
• Use during pregnancy, or in breastfeeding women
• In the face in patients under 18 years old
• In the dorsum of the hand in patients under 26 years old and over 79 years old
• In patients with increased susceptibility to keloid formation and hypertrophic scarring
• With concomitant dermal therapies such as epilation, UV irradiation, or laser, mechanical, or chemical peeling procedures

These products contain calcium hydroxylapatite (CaHA) particles that are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography.

As with all transcutaneous procedures, injection of these products carries a risk of infection. Injection in the jawline may temporarily alter jaw function.

To help avoid needle breakage, do not attempt to straighten a bent needle or cannula. Discard it and complete the procedure with a replacement needle.

Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection site.

Patients with a history of previous herpetic eruption may experience reactivation of the herpes.

Patients should minimize strenuous activity and exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved.

Adverse Events

Common adverse events observed in clinical studies of RADIESSE®include bruising, redness, swelling, pain, itching, lumps/bumps at site of injection, difficulty chewing and other local side effects.

Information on adverse events from post-market surveillance of RADIESSE®or RADIESSE®(+) are included in the Instructions for Use (IFU) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to RADIESSE®or RADIESSE®(+). Please see the IFU and PIG available at www.radiesse.com for a complete list of these events.

To report a problem with RADIESSE®or RADIESSE®(+), please call MyMerz Solutions at 1-844-469-6379.

For complete Safety Information please refer to the Instructions for Use at www.radiesse.com.

Rx only

References:

1. Radiesse [Instructions for use]. Franksville, WI. Merz North America, Inc; 2016.
2. Radiesse Instructions for use]. Franksville, WI. Merz North America, Inc; 2016.
3. Jansen DA, Graivier MH. Evaluation of a calcium hydroxylapatite-based implant (Radiesse) for facial soft-tissue augmentation. Plast Reconstr Surg. 2006;118(3 Suppl):22S-30S, discussion 31S-33S.
4. Radiesse Hands Instructions for use]. Franksville, WI. Merz North America, Inc; 2019.
5. Goldman MP, Moradi A, Gold MH, et al. Calcium hydroxylapatite dermal filler for treatment of dorsal hand volume loss: results from a 12-month, multicenter, randomized, blinded trial. Dermatol Surg. 2018;44(1):75-83.

To read instructions for use for RADIESSE® and RADIESSE® (+), please click here.

RADIESSE®injectable implant is FDA-approved for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Treatment with RADIESSE is unique because it utilizes a calcium-based microsphere technology to provide immediate volume restoration and stimulates the body to produce new collagen. The long-lasting effects of RADIESSE may provide your patients with the duration of effect they desire.1-3

Radiesse® for Lower Face

RADIESSE provides an instant lift and definition for natural-looking results that can last a year or longer in many patients.

• Provides immediate lift and definition by restoring lost volume in areas of the lower face
• Replicates the body’s process of generating collagen

Radiesse® for Hands

RADIESSE is the only CaHA dermal filler proven to immediately restore volume loss in the back of the hands for smooth, natural-looking results.

• Helps restore a more youthful appearance to hands
• Reduces the appearance of tendons and veins
• Delivers smooth, natural-looking results that last up to a year in most patients

Radiesse® for Jawline

Radiesse (+) is the first and only injectable FDA approved to improve the contour of the jawline.

• For adults over the age of 21
• Effective improvement in moderate to severe loss of jawline contour
• High patient satisfaction
• Favorable safety profile

RADIESSE® is an injectable implant composed of smooth calcium hydroxylapatite (CaHA) microspheres (diameter of 25 µm to 45 µm) suspended in a sodium carboxymethylcellulose gel carrier. RADIESSE is approximately 30% CaHA and 70% gel carrier by volume.

RADIESSE is injected under the skin in a minimally invasive procedure. Injection of the product provides an immediate and visible correction to the wrinkle. There is no skin sensitivity testing or reconstitution required.

Over time, the gel is absorbed, and fibroblasts appear. The process of neocollagenesis begins, stimulating the gradual growth of the patient’s own collagen.1 The collagen that forms results in extended correction and increased patient satisfaction. RADIESSE® builds structural scaffolding by stimulating collagen production for a year or longer after only 1 injection.

The cosmetic results are immediate, natural and subtle. The correction is long-lasting, but not permanent. The CaHA microspheres naturally degrade to calcium and phosphate ions, which are metabolized by the body’s normal processes.

It is important to remember not to overcorrect (overfill) a contour deficiency with RADIESSE because the depression should gradually improve within several weeks as the treatment effect of RADIESSE occurs.

RADIESSE® has been used to treat patients in over 57 countries worldwide. Radiesse was FDA approved for subdermal implantation for the correction of moderate to severe wrinkles and folds in 2006, and since that time over 10 million syringes have been sold worldwide. Radiesse works to add volume and may instantly hide the signs of wrinkles and creases for a more refreshed look. Individual results may vary.

Less is More

In two separate clinical studies comparing RADIESSE to other leading injectable dermal fillers, overall, patients required less RADIESSE to achieve full correction in comparison.

• 33% less RADIESSE was required for full correction, versus JUVÉDERM® Injectable Gel 1
• 30% less RADIESSE was required for full correction when compared to Perlane® Injectable Gel 1
• 30% less RADIESSE was required for full correction when compared to Restylane® Injectable Gel 2

Radiesse and Radiesse (+) 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)1,2Radiesse is also used for correcting volume loss in the back of the hands.

Radiesse is injected under the skin in a quick procedure that can be done over the lunch hour.

Immediately upon injection, Radiesse helps smooth out lines and wrinkles.

The natural-looking results last a year or more in many patients.

Common side effects of Radiesse or Radiesse (+) include bruising, redness, swelling, pain, itching at the site of injection. For a more comprehensive list of side effects for Radiesse or Radiesse (+) refer to the patient information guides found here.