RADIESSE IMPORTANT SAFETY INFORMATION
RADIESSE injectable implant is 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.
Use of RADIESSE in any person with active skin inflammation or infection in or near the treatment area should be deferred until the inflammatory or infectious process is controlled. RADIESSE can cause injection reactions consisting mainly of short-term bruising, redness, and swelling. RADIESSE should not be injected into the blood vessels.
Do not overcorrect (overfill) a contour deficiency with RADIESSE because the depression should gradually improve within several weeks as the treatment effect of RADIESSE occurs. 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 RADIESSE injected into the lips.
RADIESSE contains calcium hydroxylapatite (CaHA) particles that are radiopaque and are clearly visible on CT Scans and may be visible in standard, plain radiography.
Safety of RADIESSE beyond three years has not been evaluated. The safety of RADIESSE in patients with a susceptibility to keloid formation and hypertrophic scarring has not been studied. Safety and effectiveness in the periorbital area or with concomitant dermal therapies or other drugs or implants has not been established.
As with all skin-injection procedures, there is a risk of infection with RADIESSE. Safety of RADIESSE for use during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
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 should inform their physician if they are using such medications. Interactions between RADIESSE with drugs or other substances or implants have not been evaluated.
Patients should minimize 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.
RADIESSE is for Single Patient Use Only. Do not use if needle is bent; discard it and complete the procedure with a replacement needle. Do not re-shield used needles. Discard needles and syringes as if potential biohazards.
Patients with a history of previous herpetic eruption may experience reactivation of the herpes.
The most common serious adverse events that have been seen with RADIESSE when injected into the nasolabial folds include necrosis, allergic reaction, edema, and infection. Common adverse events with RADIESSE are generally mild in nature and short in duration and include bruising, redness, swelling, pain, itching and other local side effects. To report a problem with RADIESSE, please call Customer Service at 1-866-862-1211.
For complete Safety Information, please click here for Instructions for Use.
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