SAYPHA® VOLUME with Lidocaine

Once Saypha® VOLUME Lidocaine injected, lifetime has been estimated to be 9-12 months. The durability of the filling effect of the device depends on the treatment site, skin layer, and injected volume.

Saypha® VOLUME Lidocaine is a viscoelastic solution to correct deeper wrinkles in nasolabial folds. It is indicated to be injected into the deep dermis.

• SAYPHA® Volume Lidocaine consists of transparent, sterile, isotonic, consistent, cross-linked hyaluronic acid with a concentration of 25mg/mL and 0.3% lidocaine to enhance patient comfort.
• The hyaluronic acid undergoes cross-linking using BDDE and contains a phosphate buffer and sodium chloride.
• The injection of SAYPHA® Volume Plus with Lidocaine into patients results in increased skin moisture due to the hyaluronic acid, promoting the generation of collagen and elastin to enhance dermal health.
• This process volumizes sunken facial areas and minimizes wrinkles, yielding natural-looking outcomes.
• The hyaluronic acid is produced using a patented S.M.A.R.T. (Supreme Monophasic And Reticulated Technology) technique, resulting in enduring, natural-looking results.

• Saypha® VOLUME Lidocaine is designed to be injected in the appropriate areas requiring treatment by an authorized healthcare professional who has had appropriate training and experience in injection techniques for volume restoration and creation.
• Saypha® VOLUME Lidocaine must be injected into non-inflamed, disinfected, healthy skin.
• Inject the product slowly and apply the least amount of pressure necessary.
• The technique used is essential for the success of the treatment (e.g., microdroplet technique). Therefore, this device must only be used by doctors who have received specific training on the injection technique for filling wrinkles.
• A maximum volume of 2.0 mL and 1.0 mL per nasolabial fold is recommended for initial and touch-up treatments, respectively.
• After the injection, doctors may apply a light massage in order to distribute the product uniformly. However, patients should be advised not to massage by themselves for one week following the injection in order to avoid a possible risk of product mobility.
• The area to be treated should be disinfected thoroughly prior to the injection.
• Use the 27G ½” needle which is provided with the syringe and inject slowly by applying the appropriate injection technique.
• If the 27G ½”needle is blocked, do not increase the pressure on the plunger rod but stop the injection and replace the needle.
• Do not inject into blood vessels.
• Do not use Saypha® VOLUME Lidocaine in bones, tendons, ligaments, or muscles.
• Do not inject Saypha® VOLUME Lidocaine into naevi.
• Do not overcorrect.
• Discard the syringe and remaining product after use. Do not use if packaging has been damaged.

Contraindications:

You should not use this product if:

• you tend to develop hypertrophic scarring.
• you have a history of autoimmune disease or are receiving immune therapy.
• patients who are known to be hypersensitive to hyaluronic acid, lidocaine hydrochloride, or to amide-type local anesthetics.
• you are pregnant or breastfeeding.
• patients under 18 years of age.
• Patients on anticoagulants or patients receiving platelet aggregation inhibitors (e.g. ASS) should not be treated with Saypha® VOLUME Lidocaine without consulting their doctors.
• Saypha® VOLUME Lidocaine must not be used in areas presenting cutaneous, inflammatory, and/or infectious processes (e.g., acne, herpes).
• Saypha® VOLUME Lidocaine must not be used in association with laser therapy, chemical peeling, or dermabrasion.

After-care:

• Do not apply any make-up for 12 hours after the injection and avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths for one week after the injection.
• Do not massage or put pressure on the treatment site for a few days following the injection.