Saypha Volume 1ml

Sterile, viscoelastic, safe and flexible filler.

An isotonic, fully biodegradable gel based on cross-linked hyaluronic acid, it provides natural and long-lasting filler results.

Its single-phase structure, provides a soft gel consistency. As a result, it spreads slowly under the skin, giving it a smooth and attractive appearance.

Its features include high elasticity and the ability to volumize the skin, and the results are long-lasting (6 to 12 months) and natural.

The use of Saypha Volume effectively smooths fine lines and wrinkles on the face, enlarges the lips, lifts the corners of the mouth, emphasizes the cupid's bow and corrects facial scars.

Indications

• Lip modeling
• Correcting wrinkles and scars
• Smoothing nasolabial furrows

Composition

Cross-linked hyaluronic acid 23 mg/1 ml

Package

• 1 x ampoule-syringe 1 ml
• 2 x 27G 1/2 needle

The product must not be used in

• patients with a tendency to hypertrophic scars, pigmentation disorders or a tendency to scarring;
• patients with a history of autoimmune disease or using immunotherapy;
• patients with known hypersensitivity to hyaluronic acid;
• patients who have previously had permanent fillers applied to the area where the procedure is to be performed:
• pregnant or breastfeeding women;
• patients under the age of 18.

Saypha Volume 1ml product should not be used in patients taking anticoagulants or platelet aggregation inhibitors (such as acetylsalicylic acid) without prior consultation with their healthcare provider. The product must not be used in areas where there are skin lesions, inflammatory reaction and/or infectious process (e.g. acne, herpes). The product must not be used in combination with laser therapy, chemical peeling or mesotherapy.

Precautions for use:
Saypha Volume 1ml product should only be used by individuals who have completed special training in injection techniques for restoring facial tissue volume. People with sensitive skin may be premedicated with a topical anesthetic in the form of a patch or cream. Dispose of the used syringe, needle and product residue in a special container.

Adverse side effects:
The person performing the procedure must inform the patient of potential side effects and/or incompatibilities associated with implantation of the device, which may occur immediately or with a delay.

The following events and reactions have been observed after use of the device or similar products: angioedema, bacterial infections, thickening/thickness formation, bleeding, subcutaneous eruptions, burning, color change (skin pigmentation disorder), discomfort, swelling, erythema, induration, granulomas, hematoma, reactivation of herpes virus, hypersensitivity accumulation of material at the implant site, implant visibility, thickening, inflammatory reaction, irritation, pruritus, bruising after accidentally causing arterial congestion, swelling of the infraorbital (zygomatic) area, migration/movement, necrosis due to vascular damage, nodules (inflammatory and non-inflammatory), numbness, pain, paresthesias, visible puncture marks, redness, retinal artery occlusion, sarcoidosis, scarring, generalized lichen sclerosus, swelling, telangiectasias, tenderness, vasculitis, vasospasm, reaction during injection, loss of vision due to retinal artery obstruction.

In very rare cases, the injection of other soft tissue fillers in the glabellar and nasal wing area caused obstruction of the retinal artery.

In rare cases, it is possible to induce herpes virus reactivation due to direct damage to nerve axons caused by needle manipulation or tissue interference and the development of an inflammatory reaction after filler injection.

The splitting of the subepidermal plane due to the use of a fan-shaped needle may increase the incidence of local side effects. Injecting the filler too shallowly or unevenly distributing the injected product can lead to visible, pale nodules in the skin.

Therefore, it is important to consider these potential complications. Patients must notify their doctor as soon as possible of any inflammatory reactions lasting longer than a week or any other side effects.

The doctor should address the treatment of these side effects as appropriate. Any adverse side effects associated with injections of the device should be reported to the distributor and/or manufacturer of the product.

The products are intended for professional use.