Radiesse (Radiesse) replenishes the lost volume is there, where it is needed, with wrinkles, stimulate collagen production, tightens cheeks and restores youthful facial contours.
Merz Pharma GmbH & Ko.KGaA, Germany
The injectable implant Radiesse ™ (Radiesse) – it is sterilized by steam, which does not contain latex, non-pyrogenic, semi-solid, cohesive, fully biodegradable deep dermal and subdermal implant.
The main component is synthetic calcium hydroxylapatite – biomaterial for more than twenty years of use in orthopedics, neurosurgery, dentistry, otolaryngology and ophthalmology.
Calcium hydroxylapatite – is the main mineral component of bones and teeth.
The semisolid implant structure is formed by creating a slurry of calcium hydroxyapatite based gel consisting mainly of water (sterile water for injection (USP)) and glycerin (USP).
The gel structure is obtained by adding a small amount of sodium carboxymethyl cellulose (USP).
Gel resorbed in vivo and replaced by growing soft tissue, whereas calcium hydroxyapatite remains at the injection site.
The result is long-lasting, but not permanent restoration and increase.
Plastic and Reconstructive cosmetology, including deep dermal and subdermal augmentation of soft tissue facial area.
- of acute and / or chronic inflammation or infection at the site of the procedure.
- Patients who are prone to inflammatory reactions of the skin, or patients with a tendency to hypertrophic scars.
- Do not implant the product into the epidermis and do not use as a skin substitute. Implantation it into the epidermis or superficial dermis may lead to complications such as the formation of fistulae, infections, extrusion, formation of knots and hardening.
- It is not intended for use in the correction of glabellar folds. A higher risk of local necrosis associated with glabellar infection. Complications associated with other injectable substances indicate that extensive superficial dermal injection into vessels glabellar region retrograde movement can cause retinal artery, which can lead to vascular occlusion.
- is contraindicated in the presence of foreign bodies, e.g., liquid silicone, or other materials factional.
- Do not use in areas with insufficient coverage healthy tissue with good vascularization.
- Do not use in patients with systemic disorders that can lead to poor wound healing or tissue damage over the implant.
How to accept, acceptance rate and dosage
1) Remove the luer cap from the distal end of the syringe before connecting the needle. The syringe can be screwed to the needle luer connector. The needle should be sure to securely on the syringe and fill the injectable implant Radiesse ™ (Radiesse). The surplus on the surface of the implant luer connectors to erase a sterile cloth.
2) Slowly press the plunger to the implant material is released from the needle tip. If there is a leak luer connector may be required to withdraw the needle and clean the surface of the luer connector or, in extreme cases, replace the syringe and needle.
3) Determine the location of the implant type. Injections can be difficult or impossible to carry out in the scar tissue and cartilage. When entering the needle careful not to pierce such tissue types, if necessary.
DO NOT injection into a blood vessel!
4) injection depth and the amount of material administered depend on the location and size of the recovery or augmentation. An injectable implant Radiesse ™ (Radiesse) should be entered deep enough to prevent the formation of nodules on the surface of the skin or tissue overlying ischemia.
5) DO NOT USE overcorrection at the injection site. Apply a correction factor of 1: 1. Periodically during the injection process, straighten or massage the injected implant to get smoother contour.
6) If pressing on the piston there is considerable resistance can slightly move the needle to facilitate the entry of the material. If there is still a considerable resistance, it may be necessary completely remove the needle from the injection site, and try again elsewhere. If you continue to feel significant resistance, should perhaps use a different needle for injection. If the material can not enter, change the syringe and needle.
7) Insert the needle into the deep layer of the dermis to achieve a desired position. (Additional instructions information on special facial augmentation zones cm. Below.) Gently press the plunger to begin entering the implant, and slowly introduce the material, pulling the needle and thereby placing the strip of material in place. Continue to place additional strip of material, until it reaches the desired level of augmentation.
Packaging the implant injected Radiesse ™ (Radiesse) should be stored at a controlled room temperature of 15 ° C to 32 ° C.
- The implant should not be injected into blood vessels. Injection into the blood vessels may cause platelet aggregation, vascular occlusion, infarction, embolism or hemolysis.
- Do not enter into organs or other structures that can be damaged by the space created by the implant.
- Do not perform the implantation for patients taking aspirin or other drugs that may interfere with the healing process.
- It should not be implanted in infected or potentially infected tissue or in open cavities because it can cause an infection or extrusion. Much the infection can cause damage to or loss of skin over the implant. Hematoma or seroma may require surgical drainage.
- In the case of hypersensitivity or allergic reactions may occur significant inflammation or infection requiring removal of the implant.
- Some injectable implants evoked tissue induration at the injection site, migration of particles from the injection site to other parts of the body and / or allergic or autoimmune reactions. Based on the clinical use, in animal studies and relevant literature, these reactions are not observed and are not expected for an injectable implant Radiesse ™ (Radiesse).
- As with any material of the implant, possible side effects may include, but are not limited to, the following: inflammation, infection, fistula formation, extrusion, hematoma, seroma, education hardening, problem healing, skin discoloration and inadequate or excessive augmentation <. / li>
- The safety and efficacy of the product for women during pregnancy or lactation has not been established.
- The safety and efficacy of an injectable implant Radiesse ™ (Radiesse) for use in the mucosa of the lips is not installed.