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® and RADIESSE® (+) IMPORTANT SAFETY INFORMATION:
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.
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. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an 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.
The safety and effectiveness of RADIESSE or RADIESSE (+) in the following situations has not been established:
Use in the lips. There have been published reports of nodules associated with the use of these products in the lips.
In patients with very severe loss of fatty tissue with marked visibility of veins and tendons.
Injection volumes over 3 cc of RADIESSE® per hand in a treatment session
Avoid injection into veins or tendons in the hand, as this may weaken tendons and cause tendon rupture or cause embolization or thrombosis.
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). Fitzpatrick Skin Types IV-VI may have an increased risk (68% of Fitzpatrick Skin Types IV-VI reported this 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.
Increased bruising is associated with higher volume injection. Retreatment with RADIESSE® of volumes greater than approximately 1.6cc per hand in a treatment session can result in increased adverse events (redness, pain, swelling, and difficulty performing activities).
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 these products in the following situations has not been established:
In patients with diseases, injuries, or disabilities of the hand
Beyond 3 years in the face and 1 year in the hand
In the periorbital area
Interactions between RADIESSE® or RADIESSE® (+) with drugs or other substances or implants
Use during pregnancy, or in breastfeeding women
In the dorsum of the hand in patients under 26 years old and over 79 years old
In the face in patients under 18 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.
Care should be used in treating patients with autoimmune disease affecting the hand, hand implants, Dupuytren—™s contracture, history of hand tumor, vascular malformations, Raynaud—™s disease and patients at risk for tendon rupture.
Use of RADIESSE® in the dorsum of the hand may result in significant swelling of the dorsum of the hand.
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.
Common adverse events seen in clinical studies of RADIESSE® injected into the dorsum of the hand include bruising, redness, swelling, pain, itching, nodule or bumps/ lumps, difficulty performing activities, loss of sensation, and other local side effects. Common adverse events seen in clinical studies of RADIESSE® or RADIESSE® (+) injected into the face include bruising, redness, swelling, pain, itching, and other local side effects.
Information on adverse events from post-market surveillance of RADIESSE®and 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.