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The injectable implant is an implant RADIESSE sub-dermal and deep cohesive totally biodegradable, semi-solid, non-pyrogenic, latex-free, sterile steam. It is composed mainly of synthetic calcium hydroxylapatite, a biomaterial been used for over twenty years in orthopedics, neurosurgery, dentistry, ear-nose-throat, and ophthalmology. The calcium hydroxylapatite is in fact the main mineral component of bones and teeth. The semisolid consistency of the implant is related to the suspension of calcium hydroxylapatite in a gel carrier composed mainly of water (sterile water for injection USP) and glycerin (USP). The gel structure is determined by adding a small amount of sodium carboxymethylcellulose (USP). In vivo, the gel is dispersed to be replaced by a growth of soft tissues, whereas calcium hydroxylapatite remains at the injection site. The result is a restoration and an increase in long-term although not permanent.

The injectable implant RADIESSE is classified as Class III medical device in Annex IV MDD. The particle size of injectable implants RADIESSE 1.5 cc, 0.8 cc and 0.3 cc varies from 25-45 microns, these implants can be injected with a needle Luer 27 G or more. The utilisationd'aiguilles class less than 27 G may increase the frequency of occlusion.

Use

The implant is indicated for injection RADIESSE plastic and reconstructive surgery, including for soft tissue augmentation of the deep dermis and sub-dermal facial region.

Cons-indications

• Cons-indicated in the presence of inflammation or infection and acute or chronic involving the treatment area.
• Cons-indicated in patients with known hypersensitivity to any component.
• Cons-indicated in patients prone to development of inflammatory skin, as well as in patients who tend to develop hypertrophic scars.
• Do not implant in the epidermis. Do not use skin replacement. The implantation of the epidermis or superficial dermis may result in complications such as fistula formation, infection, product flow, the formation of a nodule or induration.
• Do not use for correcting glabellar folds. A higher incidence of local necrosis was associated with glabellar injection. Complications associated with other injectable products indicate that the forcible injection in the superficial dermal vessels of the glabellar area could cause a retrogression in the arteries leading to retinal vascular occlusion.
• Cons-indicated in the presence of foreign bodies such as liquid silicone or other particulate materials.
• Do not use in areas without adequate coverage of well vascularized tissues.
• Do not use in patients with systemic disorders causing poor wound healing or leading to a deterioration of tissue covering the implant.

Disclaimers

• Do not inject into blood vessels. The injection into blood vessels can cause platelet aggregation, vascular occlusion, infarction, an embolic phenomenon or hemolysis.
• Do not inject into organs or other structures that could be harmed by an implant to fill a volume.
• Do not implant in patients treated with aspirin or other drugs that could inhibit the healing process.
• Do not implant in tissue infected or potentially infected, or open cavities in order to avoid the risk of infection or product flow. An infection can cause significant injury or loss of the skin overlying the implant. Seromas or hematomas may require surgical drainage.
• If hypersensitivity or allergic reaction, inflammation or severe infection may develop and require explantation of the product.
• Some injectable implants have been associated with tissue induration at the injection site, the migration of particles from the injection site to other parts of the body or allergic reactions or autoimmune diseases. The use of RADIESSE should not cause such problems. Indeed, clinical experience, experimental studies on animals and medical documentation did not report this type of problem.
• As with any implanted material, adverse reactions may occur, including (but not limited to) inflammation, infection, fistula formation, flow of material, hematoma, seroma, formation of induration, scarring, inadequate cutaneous depigmentation, increased inappropriate or excessive volume.
• The safety and efficacy of the product during pregnancy or lactating women have not been proven.
• The safety and efficacy of injectable implant RADIESSE used in the lining of the lips have not been proven.

Precautions

• To be easy, percutaneous injection of injectable implant RADIESSE must be practiced in soft tissues. The scar tissue and severely damaged tissues may resent the implant.
• Infection requiring treatment may develop at the injection site. This infection can not be controlled, it may be necessary to explant the product.
• Reactions related to the injection may occur at the injection site, including erythema, swelling, pain, itching, discoloration or hypersensitivity. These reactions usually disappear spontaneously one to two days after the injection.
• One or more nodules may develop and require treatment or removal.
• An irregularity of the implant may develop and require surgical correction.
• Do not inject excessive volume in the treated area. In extreme cases, a tear at the injection site may also occur. It is much easier to add the injectable implant RADIESSE by additional injections to withdraw the amount of product too.
• As with any injection, the injection of the injectable implant RADIESSE has low risk of infection and / or bleeding associated with surgery. The patient may feel a slight pain during and after surgery. We must therefore consider the use of standard anesthetic techniques for this procedure. Please observe the usual precautions of percutaneous injection procedures to prevent infection.
• Do not sterilize. The injectable implant RADIESSE is supplied sterile and nonpyrogenic in a sealed pouch, the product is disposable for a single patient. Carefully inspect the pouch to make sure the bag or syringe has not been damaged during transport. Do not use if the pouch is punctured or if the syringe has been damaged. Do not use if the cap from the syringe or the syringe plunger is not in place. The inside of the pouch contains a low moisture sterilization; this does not indicate that the product is defective.

Individualized treatment

Before treatment, it should assess the criteria for patient selection and the level of pain control appropriate for this patient. The result of treatment varies from one patient to another. In some cases, additional treatments may be needed, depending on the size of the defect and the patient's needs. You can make additional injections, but only after a sufficient time required for patient assessment. Wait at least seven days after the previous injection prior to injection.

Instructions General Instructions

The percutaneous injection procedure requires the following equipment:

• Syringe (s) injectable implant provided RADIESSE ((e) separately)
• Needles (s) of appropriate size with Luer-lock, not supplied (s)). The optimum size varies between 25-27 G with a length of 1.27 to 3.81 cm. Use needles size less than 27 G can increase the frequency of occlusion.

1. Prepare the patient for percutaneous injection using standard procedures of preparation. The injection site of treatment should be labeled marker surgical and prepared with a suitable antiseptic. At the discretion of the physician, can be used to sedation or local anesthesia or topical injection site. After anesthesia of the site, apply ice to the treated area to reduce swelling / distension local.
2. Prepare syringes and injection needles before injecting the skin. It is possible to use a new needle for each injection syringe or ride the same injection needle for each new syringe for a patient. Remove pouch from box. At the appropriate time, open the cover and drop the syringe on the sterile field. The inside of the pouch contains a low moisture sterilization; this does not indicate that the product is défectueux.Retirer luer cap located on the tip of the syringe and needle mount. Screw the syringe to the Luer-lock needle. The needle should be firmly attached to the syringe. Booting the needle with the implant injection RADIESSE. If an excessive amount of implant has passed on the Luer-lock, wipe the excess with sterile gauze. Slowly push the plunger of the syringe until the implant material flows through the tip of the needle. If there is a leak at the luer connector, remove the needle and clean the surfaces of the luer connector or, in extreme cases, replace the syringe and needle.
3. Locate the original site of implantation. It is difficult or impossible to inject the implant in the scar tissue or cartilage. Avoid, if possible, through these types of tissue during penetration of the injection needle. NOTE: Do not inject into a blood vessel.
4. The depth of injection and amount injected depends on the site and extent of the restoration or increase in volume. The injectable implant RADIESSE must be injected deep enough to prevent the formation of nodules on the surface of the skin and tissue ischemia located closer to the surface.
5. Do not overcorrect THE SITE OF TREATMENT. Use a correction factor 1 / 1. During injection, shape or massage the implant regularly injected to keep it smooth contour.
6. If you encounter significant resistance when pressing the plunger of the syringe, the needle moved slightly to facilitate the injection of the material. If significant resistance persists, it may be necessary to remove the needle completely out of the injection site and try again in a new location. If significant resistance still persists, it may be necessary to try a different injection needle. In case of failure of these attempts, replace the syringe and needle injection.
7. Advance the needle into the subcutis to the starting location of the injection. [See below for further instructions concerning the restoration / increase in volume of specific areas of the face.] Gently push the plunger on the syringe and slowly inject the material of the implant while removing the needle to implant a online material at the desired location. Continue the injection of additional lines of material until the level of increase desired.

Increase the cheeks, chin, front or corner of mouth

1. Insert the needle bevel down at an angle of about 30 relative to the surface of the skin. The needle should slide under the skin to where it wants to start the injection. This point should be easily palpable, with the nondominant hand.
2. Apply pressure slowly and continuous light on the syringe plunger to inject the implant while removing the needle, thus leaving in place a thin wire or thin strip implant. Wire implanted material must be completely surrounded by soft tissue without a globular deposits.
3. The son individual implanted material must be placed in parallel adjacent to each other and in layers for the correction of deeper folds. It is also possible to interlace the layers of son on a deeper level to form a support structure.
4. After injecting, smoothing the area with the thumb and forefinger to better distribute the implant in case of deposits of small nodules of material.
5. The injection can be performed in the subcutaneous tissue or muscle, but well away from bone or skin.

Patient Information

To promote normal healing and avoid complications, provide the patient postoperative instructions appropriate. Apply ice or ice packs on treated areas for about 24 hours.

• After surgery, avoid the sun, tanning lamps (ultraviolet), while the sauna and intensive facial treatment.
• Massage the area if the nodules became palpable.
• Ask the patient to reduce movements of the face for a week by limiting the use of words, smiles and laughter.
• Explain to the patient that swelling and numbness are common during the postoperative period. The swelling usually goes away in 7-10 days but can sometimes persist for several weeks. The numbness usually disappears within 4-6 days.
• During one week after surgery, prescribe oral analgesics and ask the patient to rinse mouth 4-6 times daily with saline.

Conditioning

The injectable implant RADIESSE is supplied sterile and nonpyrogenic in syringes packed in aluminum pouches, which are themselves placed in a cardboard box for easy storage.

Each unit consists of a syringe containing 1.5 cc, 0.8 cc or 0.3 cc of injectable implant RADIESSE.

The accuracy of the graduations of the syringe is ± 0.025 cc.

Do not use if package is damaged or syringe, or if the cap from the syringe or the syringe plunger is not in place. The contents of the syringe is disposable for single patient and can not be restérilisé.La reuse of device may affect its functional properties and / or cause its failure. It can also cause contamination of the device and / or infection or cross infection of patients, including but not limited to the transmission of one or several infectious diseases and a transfer of blood between patients . All these consequences may ultimately lead to injury, illness or death of patients.

Preservation

Store RADIESSE injectable implant in its packaging at controlled room temperature between 15 º C and 32 º C. Do not use after expiry date. The expiry date is printed on product labels.

Disposal

The used or partially used syringes and needles should be considered potentially contaminated medical waste. They must be handled and disposed of according to medical practices of the facility and local regulations.

Attention injection of Radiesse requires a medical procedure that can be performed by a physician (doctor specializing in dermo cosmetic, dermatologist, plastic surgeon).