Mesoestetic Mesofiller Sensitive 1x1ml

Mesofiller is a line of dermal fillers based on cross-linked hyaluronic acid, developed using the unique DensiMatrix technology, which ensures maximum quality, safety and efficacy in clinical practice.

The sterile, pyrogen-free, absorbable medical devices are designed for injections based on cross-linked hyaluronic acid of non-animal origin, produced by bacterial fermentation; they are supplied as a colorless, transparent gel placed in a sterile, disposable syringe, with a graduated scale and Luer-Lock type connection.

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Indications

It is intended to fill and irrigate the intimate area in women (vaginal vestibule, vaginal entrance, vaginal walls, clitoris and G-spot) for the treatment of atrophic vaginitis and vulvodynia, dehydration, dryness, dyspareunia and sexual dysfunction.

Composition 

• Cross-linked hyaluronic acid 20 mg/ml,
• Sterile saline solution

Action

Involves increasing the volume of the epidermal tissue and dermis, based on the natural ability to hydrophilic water molecules in an amount far exceeding their mass.

This allows to fill the intradermal space and integrate into the intercellular matrix. This hydration and restoration of tissue volume makes the use of the product in various areas of the female genitalia an effective therapy for each of the indications suggested above.

The cross-linking of the hyaluronic acid contained in the product makes the filling effect more stable and long-lasting.

Area of application

• Female genitalia and their surrounding areas.

Administration

• Intradermally,
• Recommended needle/cannula size: 27G x 1/2'' (needle).
• Recommended technique of administration: "dot by dot".

Packaging

1 ampoule syringe with a capacity of 1 ml,

2 27G x 0.4 x13mm needles.

Contraindications

The medical device mesofiller must not be used:

In periorbital injections (eyelids, orbits),
In injections into blood vessels,
For breast augmentation or implantation into bones, tendons, ligaments or muscles.

The medical device mesofiller must not be administered to patients:

• With an established tendency to hypertrophic or keloid scars or with pigmentation disorders,
• With previous active autoimmune diseases or undergoing immunotherapy,
• With multiple severe allergies or active inflammatory conditions,
• With coagulation disorders,
• With confirmed hypersensitivity to hyaluronic acid.
• This product must not be used in pregnant or breastfeeding women or in persons under eighteen years of age.

MEDICAL WARNING

The mesofiller medical device may only be used for subcutaneous or intradermal injections and may not be injected intravascularly.

There is a potential risk of accidental injection of material into blood vessels during the procedure.
In rare cases, vascular occlusion, abscess, necrosis or embolic phenomenon may occur. To verify that the needle is not in a blood vessel during normal use of this product, it should be gently aspirated with a syringe before proceeding to injection.

It is packaged for use in only one patient in the same session.
It  is supplied sterile and disposable and must not be re-sterilized. Do not reuse.
Use It  immediately after opening the blister and dispose of the syringe immediately after use, even if the entire contents have not been used.
Do not use the product after the expiration date on the package.
Do not use it with other injectable products and do not mix it with other preparations before use.
Do not use it if there are areas of redness, swelling or change in pigmentation on the skin. Do not use mesofiller medical device in inflammatory conditions, during infections or fever.
Patients taking medications that slow blood clotting (such as aspirin) may experience petechiae or marked bleeding around the injection site. Patients being treated with anticoagulants should, after consulting with their doctor, refrain from taking them
taking them for at least 14 days before receiving injections of mesofiller medical device.
Keep the product out of the reach of children.

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The products are intended for professional use.