SAYPHA® VOLUME PLUS with Lidocaine

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

SAYPHA® Volume Plus 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. This specific dermal filler is highly effective because the hyaluronic acid is produced using a patented S.M.A.R.T. (Supreme Monophasic And Reticulated Technology) technique. Initially, the hyaluronic acid is created through biofermentation, and then the S.M.A.R.T. process introduces the cross-linking agent BDDE to produce a dense and extensively cross-linked hyaluronic acid that delivers enduring, natural-looking results.

• SAYPHA® VOLUME PLUS Lidocaine is designed to be injected in the appropriate areas requiring treatment by an authorized health care professional who has had appropriate training and experience in injection techniques for volume restoration and creation.
• SAYPHA® VOLUME PLUS 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 to avoid a possible risk of product mobility.
• It usually takes about half an hour to complete a single session.
• 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 PLUS Lidocaine in bones, tendons, ligaments, or muscles.
• Do not inject SAYPHA® VOLUME PLUS Lidocaine into naevi.
• Do not overcorrect.
• Discard the syringe and remaining product after use.
• Do not use if packaging has been damaged.

Contraindications:

• SAYPHA® VOLUME PLUS Lidocaine is only indicated for intradermal injections.
• SAYPHA® VOLUME PLUS Lidocaine must not be used in:
  • Patients who tend to develop hypertrophic scarring.
  • Patients with a history of autoimmune disease or who are receiving immune therapy.
  • Patients who are known to be hypersensitive to hyaluronic acid, lidocaine hydrochloride, or to amide-type local anesthetics.
  • Pregnant or breastfeeding women.
  • 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 PLUS Lidocaine without consulting their doctors.
• SAYPHA® VOLUME PLUS Lidocaine must not be used in areas presenting cutaneous, inflammatory, and/or infectious processes (e.g., acne, herpes).
• SAYPHA® VOLUME PLUS 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.