MaiLi Extreme with Lidocaine (4 x 1 ml)
MaiLi
Medical device – dermal fillerCross-linked hyaluronic acid (HA) volumizing filler
Certifications
- CE Marked medical device (CE 2797) under European regulations for hyaluronic acid dermal fillers.
- Manufactured according to quality and safety standards required for injectable HA fillers and in compliance with relevant medical device directives.
- Supported by clinical data demonstrating efficacy and safety, including documented volume restoration, injectability characteristics and patient satisfaction in randomized controlled studies.
- CE Marked medical device (CE 2797) under European regulations for hyaluronic acid dermal fillers.
- Manufactured according to quality and safety standards required for injectable HA fillers and in compliance with relevant medical device directives.
- Supported by clinical data demonstrating efficacy and safety, including documented volume restoration, injectability characteristics and patient satisfaction in randomized controlled studies.
Cross-linked hyaluronic acid (HA) volumizing filler
Description
MaiLi Extreme with Lidocaine (4 x 1 ml) is the most powerful dermal filler in the MaiLi range by Sinclair Pharma, formulated using patented OxiFree™ technology. The filler contains high-concentration cross-linked hyaluronic acid and lidocaine to provide powerful volumizing, sculpting, and profile-balancing effects while preserving natural facial movement and expression. Supplied as four 1 ml pre-filled syringes (each with needle), MaiLi Extreme is intended for deep volumetric enhancement of facial structures — for example cheeks, chin, jawline — as well as for reconstruction in cases of volume loss (e.g. lipoatrophy). The gel’s spring-like elasticity and high projection power allow for restoration or creation of facial volume with fewer syringes compared to some alternative HA fillers.
Bnefits
- High volumizing power — ideal for cheeks, chin, jawline and overall profile balancing.
- Strong projection capability enabling sculpting, contouring and deep volume restoration.
- Long-lasting results: many patients experience up to 12 months of effect (sometimes longer) depending on area and individual metabolism.
- Contains lidocaine (3 mg/ml) to improve injection comfort and reduce treatment-related pain.
- OxiFree™ technology preserves long HA molecular chains — producing a supple, elastic gel that moves naturally with facial expression and reduces stiffness.
- Requires less volume compared to some traditional HA fillers for similar outcomes — improves cost-effectiveness and reduces overfilling risk.
Indications
- Sculpting and defining facial contours — cheeks, chin, jawline, and overall profile balancing.
- Restoration or augmentation of facial volume lost due to aging, lipoatrophy (e.g. HIV-associated) or weight loss.
- Facial reconstruction of structural defects or volume deficits from congenital, medical or traumatic origin.
- Deep volumetric enhancement for patients seeking more pronounced facial reshaping or definition.
- General aesthetic facial rejuvenation in areas requiring significant projection and structural support.
Composition
- Cross-linked hyaluronic acid (HA): 24 mg/ml
- Lidocaine hydrochloride: 3 mg/ml (0.3%)
- Crosslinking agent: 1,4-Butanediol Diglycidyl Ether (BDDE)
- Physiological buffer and sterile water for injection — to maintain pH and tonicity
- Sterile, pyrogen-free viscoelastic HA gel
Formulation
- Sterile, pre-filled 1 ml syringes containing cross-linked HA gel with lidocaine
- Concentration: 24 mg/ml HA, 3 mg/ml lidocaine
- Intended for deep dermal, subcutaneous or supra-periosteal injection depending on treatment area and indication
- Single-use syringes; treatment to be performed by trained medical professionals experienced in facial anatomy and filler injections
Packaging
- Box containing 4 × 1 ml pre-filled syringes
- Needles included (typically 27G, ½ inch or as per distributor specification)
- Each syringe individually packaged in sterile blister or sterile syringe packaging for aseptic delivery
- Includes instructions for use, batch/lot number and expiry date, per CE-mark / regulatory requirements
Usage
- To be administered only by qualified and trained medical professionals (dermatologists, plastic surgeons, or aesthetic physicians) familiar with facial anatomy and injectable fillers.
- Injection depth depends on treatment area — typically deep dermis, subcutaneous fat layer or supra-periosteal plane for max volumizing effect.
- Use aseptic technique; cleanse skin thoroughly; avoid injection into or too close to blood vessels.
- Inject slowly, in small aliquots; observe tissue response; avoid high-pressure bolus injection to minimise risk of complications.
- After injection, gentle massage may be performed to distribute gel evenly, per official instructions for use.
- Advise patient on standard aftercare: avoid intense heat/cold, massage, strenuous exercise, or facial treatments for the period recommended in the product leaflet; monitor for early adverse reactions.
- Record batch/lot number in patient records for traceability.
Contraindications
- Known hypersensitivity to hyaluronic acid, lidocaine, BDDE or any excipient in the formulation
- Active skin infection, inflammation or dermatological disease at injection site
- Patients with bleeding disorders, or on anticoagulant/antiplatelet therapy (unless risk assessed acceptable by clinician)
- History of severe allergic reactions or anaphylaxis, especially to local anaesthetics (lidocaine) or HA fillers
- Pregnancy and breastfeeding (unless supported by local regulations and clinician judgment)
- Injections into or near areas previously treated with permanent fillers, unless carefully evaluated for compatibility
- Unrealistic expectations or inadequate psychological suitability for aesthetic filler treatment
Adverse Effects
- Local: redness, swelling, bruising, tenderness, itching, pain, transient lumps or nodules at injection site
- Transient firmness or asymmetry immediately post-injection (due to swelling or product settling)
- Risk of infection if aseptic technique is not strictly observed — may lead to abscess or biofilm formation
- Delayed inflammatory reactions (e.g. prolonged swelling, erythema, induration, granulomas) in rare cases
- Risk of vascular occlusion or embolisation if inadvertently injected into or too near a blood vessel — may lead to blanching, severe pain, tissue ischemia or necrosis; in high-risk zones, rare but serious complications such as visual disturbances or vision loss may occur
- Allergic reaction to lidocaine: local or systemic symptoms, e.g. itching, rash, dizziness, more rarely systemic allergic response
Storage Conditions
- Store at recommended temperature (typically between 2 °C and 25 °C) — consult product label for exact range
- Keep syringes in original, sealed packaging until use to maintain sterility
- Do not freeze, expose to excessive heat or direct sunlight
- Use by expiry date printed on packaging
- Dispose of any unused product, used syringes and needles as per medical sharps waste regulations
Duration
Single treatment session; volumizing and contouring effects visible immediately. Effect duration commonly around 12 months, though may vary based on area treated, volume used, and patient metabolism.
Onset
Immediate visible change in volume and contour; final appearance stabilises over several days as swelling resolves and gel integrates into tissue.
