Hyamax® Contour Filler

Hyamax® Contour is a high viscosity dermal filler designed to treat body rhytides and lipoatrophy by injection into the skin. Hyamax® Contour is a long-lasting filler for deep injection with minimal discomfort as it penetrates the skin to augment the injected area.

Indication: Deep mid-dermis augmentation and injection

Application areas: Body rhytides and lipoatrophy, cheeks

Hyamax® Contour is a high viscosity, sterile, colorless, clear, viscoelastic, biodegradable and non-pyrogenic gel supplied in a disposable glass syringe.
Hyamax® Contour consists of a biofermented hyaluronan soft tissue filler gel suspended in a physiological pH7 buffer.
Hyamax® Contour is supplied in a disposable glass syringe with a Luer lock fitting. The syringe is equipped with a plunger stopper, finger grip and plunger rod and is packaged in a blister with two sterile needles.

Intended use

Hyamax® Contour is an injectable solution for the treatment of facial rhytids, lipoatrophy and augmentation for mid-to-deep skin grafting.

Signs

Hyamax® Contour is a dermal filler used to enhance facial tissue in the mid to deep dermis. On average, the implant lasts between 6 and 12 months, depending on lifestyle, depth and location of injection.

Contraindications

Injections in the eye lines (eye circles, eyelids)
Injections into blood vessels
Patients suffering from untreated epilepsy
Pregnant or lactating women
Patients under 18 years of age
Patients prone to hypertrophic scarring
Patients with known hypersensitivity to HA
Patients suffering from porphyria
Injections in inflamed and/or infected areas such as acne, herpes, etc.
Concurrent laser therapy, intense pulsed light, chemical peels or dermabrasion
Presence of a significant inflammatory response to the superficial layer
Coagulation deficiency or undergoing anticoagulant therapy
Overcorrection
Patients with unattainable expectations
Hypersensitivity or allergic reactions have been reported rarely, including edema, sensitivity, and rarely acneiform papules in the surrounding tissues. In specific cases, treatments include systemic steroids, systemic antibiotics, and intravenous administration of medications. Rare cases of granuloma formation, superficial necrosis, and urticaria have been reported with this type of product. Patients who experienced this type of reaction should not have retreated.

Precautions

The correct injection technique is crucial for the final treatment outcome.
Individual differences affect the final treatment outcome.
If additional Hyamax® Contour implants are required, the minimum interval is 2 to 4 weeks.
Clean the area to be treated with alcohol or another suitable antiseptic solution.
As with all skin procedures, Hyamax® Contour implants carry a risk of infection.
Safety The safety of Hyamax® Contour has not been established during pregnancy, in nursing women or in patients under 18 years of age.
Hyamax® Contour should not be used in patients prone to keloid or hypertrophic scar formation.
Hyamax® Contour should never be used for breast augmentation or implants in bone, tendon, ligament or muscle.
Due to the lack of sufficient clinical data on the tolerability profile of Hyamax® Contour in patients with a history of past or current autoimmune disease, multiple allergies or anaphylactic shock; skin care professionals are strongly advised to use this product with discretion and on a case-by-case basis, carefully considering the nature of the disease.
If you are taking aspirin, nonsteroidal anti-inflammatory drugs, or high doses of vitamin E supplements prior to treatment, be aware that bruising and bleeding at the injection site may increase.
It is strongly recommended that you do not apply any makeup or touch the treated area for 12 hours after the injection.
Hyamax® Contour should be used with caution in patients receiving immunosuppressive therapy or using agents that reduce coagulation.
After treatment, the patient should minimize exposure of the treated area to UV lamps, excessive sunlight, and extreme cold until any initial reaction has resolved.
After treatment with Hyamax® Contour, patients should not receive laser therapy, chemical peels, or any other procedure based on an active skin response.
Patients who have had a severe allergic reaction should not receive Hyamax® Contour treatments.
Hyamax® Contour should not be injected too deeply or too superficially.
After injection, used syringes and needles should be disposed of as medical waste in accordance with local and state requirements.
Clinical research confirms that the first injection of Hyamax® Contour is safe. Repeated injections of the same type of filler in the same area have been reported to have no increased risk of adverse reactions.

Warning

Hyamax® Contour is for single use only.
Do not use if the package is open or damaged.
Do not re-sterilize Hyamax® Contour as this may cause damage or alteration of the product.
Avoid intravascular injection.
Do not use Hyamax® Contour with other fillers.