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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.
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may experience increased bruising or bleeding at the injection sitio.
Use of RADIESSE® in the dorsum of the hand may result in significant swelling of the dorsum of the hand.
Histology slides demonstrate deposition of new collagen around CaHA microspheres over an extended period of time. Collagen fibers stain red, while other tissue elements appear more yellow.
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.
Interactions between RADIESSE® or RADIESSE® (+) and drugs or other substances or implants Use during pregnancy, or in breastfeeding women
Healthcare practitioners should fully familiarize themselves with the product, the product educational materials and the entire package insert.
Delayed-onset inflammation near the site of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment sitio following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.
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.
Cases of delayed-onset bioestimulador de colágeno inflammation have been reported to occur at the dermal filler treatment sitio following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.
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 sitio.
1 Successful completion of this indication-specific training by providers is necessary prior to their administration of fillers for such new indications.
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.