Microsoft word - radiesse_e-media_kit_isi.doc

Fair Balance for RADIESSE® Volumizing Filler Important Safety Information for RADIESSE® Volumizing Filler
Indication: RADIESSE® Volumizing Filler is FDA-approved for subdermal implantation for the correction
of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Contraindications: RADIESSE® Volumizing Filler should not be used in patients with bleeding disorders
or in patients with severe allergies manifested by a history of anaphylaxis, with a history or presence of
multiple severe allergies or with a history of hypersensitivity to the components of RADIESSE®
Volumizing Filler.
Warnings: RADIESSE® Volumizing Filler should not be injected into blood vessels. Use of RADIESSE®
Volumizing Filler in any person with active skin inflammation or infection in or near the treatment area
should be deferred until the inflammatory or infectious process has been controlled. 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® Volumizing Filler injected into the lips.
Precautions: Safety for use during pregnancy, in breastfeeding females or in patients under 18 years
has not been established. As with all skin-injection procedures, there is a risk of infection. Patients using
medications that prolong bleeding, such as aspirin or warfarin, may, as with any injection procedure,
experience increased bruising and bleeding at the injection site. Patients should inform their physician if
they are using such medications. 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. Safety and effectiveness in the periorbital area has not been established. The safety of
RADIESSE® Volumizing Filler in patients with a susceptibility to keloid formation and hypertrophic
scarring has not been studied. Patients with a history of previous herpetic eruption may experience
reactivation of the herpes.
Adverse Events: After injection, patients may experience redness, bruising, swelling or other local side
effects. Most side effects of treatment resolve within a few days. More rare side effects may include
swelling that lasts longer, unevenness or firmness in the area injected.
Important: For full safety information, please visit www.Radiesse.com or call Merz Aesthetics Customer
Service at 866-862-1211
Caution: Rx Only
Reference to fair balance if Important Safety Information is not located on the same page as claim(s): Please see Important Safety Information for Radiesse® Volumizing Filler on page #.
Reference to fair balance if only part of the Important Safety Information is located on the same page as claim(s): Please see additional Important Safety Information for Radiesse® Volumizing Filler on page #.

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