RADIESSE® (+) 1.5ml w / Lidocaine 1-1.5ml prefilled syringe

A dermal filler with Lidocaine in the form of a gel in a pre-filled syringe. The dermal filler gel contains calcium hydroxylapatite (CaHa) microspheres along with sodiumcarboxymethylcellulose, glycerin, water, and the anesthetic Lidocaine. The calcium and phosphate ions are bonded synthetically to produce the particles but similar calcium and phosphate ions are also present naturally in human tissue.

This filler is suitable for plastic surgery and reconstructive surgery. Doctors use it to correct moderate to severe wrinkles and facial folds, to shape and contour facial features, or to restore facial volume after lipoatrophy, which is the loss of facial fat, in HIV patients and others. You can use this dermal filler to correct defects such as the nasolabial folds between the nose and mouth; the radial lip lines, which are lines above the upper lip; marionette lines, also called smile lines, at the corners of the mouth; acne scars or other skin depressions and blemishes; indentations, tips, bumps, or unevenness on the nose or chin; contouring the jaw; plumping shallow cheeks, such as then fat atrophy has occurred; and on aging hands to reduce the look of prominent bones and veins. It is not suitable for correcting glabellar folds because of the risk of localized necrosis (tissue death) or vascular occlusion (blood vessel blockage) in the retinas.

It works by restoring volume to the dermis and supporting collagen growth. When you inject this dermal filler gel, the gel physically adds volume beneath wrinkles or in other areas, supporting the skin above. This helps to smooth the appearance of wrinkles or add volume to contour facial features. The calcium hydroxylapatite particles also stimulate the growth of collagen and provide a sort of scaffold for this collagen to grow. Even as the CaHa particles gradually break down, the collagen framework remains to give the skin strength and support. The Lidocaine in it acts as an anesthetic to reduce pain and discomfort during the treatment.

The results of a it injection are immediately visible as the dermal filler restores volume to the area. As the calcium hydroxylapatite microspheres gradually break down, the new collagen remains, allowing the results of the dermal filler to last about eighteen months or longer.

Only trained medical professionals should inject it. To use it, first disinfect the treatment area and assemble the 27G or larger needle to the syringe. Gently push the syringe plunger until a drop of gel appears on the end of the needle to remove air, then inject the needle into the deep dermis, subcutaneous tissue, or muscle at about a thirty degree angle. Avoid injecting the dermal filler into the bone or epidermis, since superficial injections can cause lumpiness. Inject slowly, and apply threads of gel parallel to each other or layer or cross-layer the threads of gel to correct deeper areas. After the injection, you can use your thumb and index finger to smooth the treatment area, ensuring the implant is evenly distributed. Properly dispose of the needle and any remaining gel left in the syringe since each it syringe is for single-use only. Do not resterilize or use the remaining gel on another patient to avoid cross-contamination. For complete injection instructions, refer to your product leaflet.

You should avoid using it to treat patients with a hypersensitivity to any of its ingredients; patients with a tendency to develop hypertrophic scars or skin inflammation; patients with a disorder causing poor wound healing or tissue deterioration; patients with a bleeding disorder; patients taking aspirin or other drugs that inhibit healing; areas with infected tissue; or areas with liquid silicone or other particulate materials. Avoid injecting this dermal filler into blood vessels or organs. Avoid injecting this dermal filler into the superficial dermis or epidermis as a skin replacement because of possible complications like infection, fistula formation (abnormal connection), extrusions (forced out), nodule formation (abnormal tissue growth), and induration (hardening). Avoid overcorrection. These dermal filler injections may reactivate herpes. No clinical trials have investigated the safety of these injections in pregnant or breastfeeding women, in the lips, or in conjunction with other treatments like laser, epilation, or chemical peels.

For the next twenty-four hours after their injection, your patients can apply ice or a cool compress to the treatment area to reduce swelling. Your patients can also gently massage the area if lumps appear. For the week after their injection, your patients should try to limit facial movement like talking, smiling and laughing, and they should avoid intense facial treatments, excessive sun exposure, tanning or other exposure to UV radiation, and excessive heat such as a sauna.

These may not be all the precautions related to using this filler. Refer to your product leaflet for more information.

Can include:

• Pain
• Soreness or tenderness
• Edema (swelling)
• Pruritus (itching)
• Irritation
• Erythema (redness)
• Discoloration
• Bruising or ecchymosis
• Bleeding at the injection site
• Numbness

Rarer side effects can include:

• Lumpiness, possibly due to incorrect filler placement
• Contour irregularity
• Nodules (abnormal tissue growth)
• Firmness
• Infection
• Rash
• Site rupture if overcorrected
• Scab
• Tightness
• Abrasion
• Headache
• Fever
• Blood shot eyes
• Black eye
• Nerve sensitivity
• Dry, burning sensation
• Warmth
• Flushing
• Stretching
• Puffiness
• Pimples
• Hearing loss
• Hypersensitivity

Most of the side effects resolve within a day or two of the injection. These may not be all the possible it side effects. Refer to your product leaflet for more information.

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