SAYPHA® FILLER with Lidocaine

SAYPHA® Filler with Lidocaine is processed using the S.M.A.R.T. synthesis, which results in a durable gel that resists rapid degradation. Once injected, patients will notice immediate skin improvements that can last for approximately 6 to 10 months.

Saypha® FILLER Lidocaine is a viscoelastic solution to correct light to moderate nasolabial folds. It is indicated to be injected into the mid to deep dermis.

• Saypha® FILLER Lidocaine is a sterile, biodegradable, and bioresorbable injectable gel.
• Allergic reactions linked to its injection are very rare as the hyaluronic acid present in the gel is a natural substance already present in the body.
• The viscoelastic property of the product allows it to be injected gently without damaging the skin.
• The results of the treatment are immediate, long-lasting but not permanent.

• Saypha® FILLER 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.
• 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.
• The amount injected will depend on the wrinkle or depression which is to be corrected. 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 the area by themselves for one week following the injection in order 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® FILLER Lidocaine in bones, tendons, ligaments, or muscles.
• Do not inject Saypha® FILLER Lidocaine into the periorbital area (crow’s feet, eye circle, eyelids) or glabellar region.
• Do not inject Saypha® FILLER Lidocaine into naevi.
• Do not overcorrect.
• Discard the syringe and remaining product after use. Do not use if packaging has been damaged.

Contraindications:

• Saypha® FILLER is only indicated for intradermal injections.
• Saypha® FILLER 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 anaesthetics.
  • 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® FILLER Lidocaine without consulting their doctors.
• Saypha® FILLER Lidocaine must not be used in areas presenting cutaneous, inflammatory, and/or infectious processes (e.g., acne, herpes).
• Saypha® FILLER Lidocaine must not be used in association with laser therapy, chemical peeling, or dermabrasion.

After-care:

• Patients should be advised not to apply any make-up for 12 hours after the injection and to avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths for one week after the injection.