Description
The injectable implant RADIESSE® is a steam sterilized, latex-free, pyrogen-free, semi-solid, cohesive and fully biodegradable implant, intended to be injected subdermally or into the deep dermis. Its main component is synthetic calcium hydroxylapatite, a biomaterial that has been used for more than twenty years in orthopaedics, neurosurgery, orthodontics, otorhinolaryngology and ophthalmology. Calcium hydroxylapatite is the main mineral constituent of bones and teeth. The semi-solid nature of the implant is obtained by suspending the calcium hydroxylapatite in an excipient gel mainly composed of water (Sterile Water for Injection USP) and glycerol (USP). The gel structure is obtained by adding a small amount of sodium carboxymethyl cellulose (USP). The gel disperses in vivo and is replaced by soft tissue regeneration, while the calcium hydroxylapatite remains at the injection site. The tissue restoration and volumizing effect obtained, although durable in the long term, is not permanent. The injectable implant RADIESSE® is classified as a Class III medical device under Schedule IX of the MDD. The particle size of the RADIESSE® 3.0cc, 1.5cc and 0.8cc injectable implant ranges from 25 to 45 microns. RADIESSE® can be injected with a 25G outer diameter / 27G inner diameter needle, or a larger diameter needle compatible with a standard Luer connector. The use of needles smaller than 27 gauge internal diameter may increase the risk of needle blockage. USE/INDICATIONS RADIESSE® injectable implant is indicated for plastic and reconstructive surgery, including volume augmentation of facial soft tissue by subdermal or deep dermal injection. RADIESSE® is also indicated for the restoration and/or correction of signs of facial fat loss (lipoatrophy) in patients with human immunodeficiency virus.
COMPOSITION
RADIESSE® Injectable Implant is a sterile, non-pyrogenic syringe packaged in an aluminum foil pouch in a cardboard box for easy storage. Each box contains a pre-filled syringe containing 3.0cc, 1.5cc or 0.8cc of RADIESSE® injectable implant and one to two 25G (outer diameter) / 27G (inner diameter) needles. The accuracy of the syringe graduations is ±0.025cc for the 1.5cc and 0.8cc volumes. The accuracy of the syringe graduations is ±0.05cc for the 3.0cc volume. Do not use if the packaging and/or syringe are damaged, or if the syringe tip or plunger are not intact.
