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PLURYAL VOLUME LIDO (1x1ml)

PLURYAL VOLUME LIDO (1x1ml)

Pluryal

Aesthetic / cosmetic injectable
  • CE Marked injectable medical device for intradermal and subcutaneous use in aesthetic and reconstructive indications.
  • Manufactured under an ISO 13485 Certified quality management system for medical devices.
  • Produced in compliance with Good Manufacturing Practice (GMP) standards for sterile injectable products.
  • Prepared under clean Room conditions with strict control of bioburden and pyrogen levels.
  • Low residual BDDE (≤ 2 ppm) and controlled protein and endotoxin levels in line with international safety specifications for HA dermal fillers.
  • Part of the Pluryal dermal filler range developed according to the P.R.E.M.I.U.M Design Concept, focusing on purity, rheology, elasticity and safety.
Volumising hyaluronic acid dermal filler with lidocaine

Description

PLURYAL VOLUME LIDO (1x1ml) is a sterile, biodegradable, viscoelastic, clear and transparent monophasic cross-linked hyaluronic acid dermal filler with 0.3% lidocaine, manufactured by MD Skin Solutions. With an HA concentration of 23 mg/ml (2.3%) cross-linked using BDDE, it is designed as a volumising filler for restoration of facial structures in the deep dermis and subcutis. It corrects deep wrinkles and folds, increases facial and lip volume, and remodels facial contours, and can also be used in reconstructive indications such as facial lipoatrophy, debilitating scars and morphological asymmetry. Typical treatment areas include the cheeks, lips, nose, mandibular line, chin and dorsum of the hands. Results are immediate and natural-looking, with a recommended treatment frequency of approximately every 12–16 months.

Bnefits

  • Volumises and restores facial structures in the deep dermis and subcutis.
  • Corrects deep wrinkles and folds while reshaping facial contours.
  • Boosts cheek and lip volume for a fuller, more youthful appearance.
  • Allows non-surgical reshaping of the nose and correction of the mandibular line and chin.
  • Can be used to rejuvenate the dorsum of the hands by restoring volume and smoothing contours.
  • Contains 0.3% lidocaine to reduce pain associated with injection and improve patient comfort.
  • Monophasic, homogeneous HA gel for smooth injection, uniform distribution and predictable results.
  • High G' (≈ 400,000 mPa) providing strong lifting and structural support where deep volume is required.
  • Non-animal origin HA with low residual BDDE and endotoxin levels for enhanced safety and biocompatibility.
  • Longer-lasting effect relative to more superficial fillers, with recommended re-treatment every 12–16 months depending on indication and patient factors.

Indications

  • Aesthetic purpose: correction of deep wrinkles and folds.
  • Aesthetic purpose: increase or restoration of facial volume and remodelling of facial contours.
  • Volumisation and contouring of the cheeks and cheekbones.
  • Enhancement and volume restoration of the lips.
  • Non-surgical reshaping of the nose (nasal correction).
  • Correction and definition of the mandibular line and chin remodelling.
  • Volume restoration and rejuvenation of the dorsum of the hands.
  • Medical reconstructive purpose: correction of facial lipoatrophy.
  • Medical reconstructive purpose: treatment of debilitating scars or morphological asymmetry.

Composition

  • Monophasic cross-linked sodium hyaluronate (hyaluronic acid) 23 mg/ml (2.3%), obtained from Streptococcus equi bacteria.
  • Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anaesthetic to reduce injection pain.
  • Cross-linking agent: BDDE (1,4-Butanediol Diglycidyl Ether), cross-linking grade BDDE ++++.
  • Residual BDDE: ≤ 2 ppm.
  • Proteins: trace.
  • Residual endotoxins: < 5 EU/ml.
  • G' factor: approximately 400,000 mPa (elastic modulus).
  • Molecular weight of HA: approximately 3 million Daltons.
  • Physiologic phosphate buffer and sodium chloride (NaCl).

Formulation

  • Sterile, biodegradable, viscoelastic, clear, transparent and isotonic injectable gel implant.
  • Monophasic, homogenised cross-linked HA gel for deep volumising indications.
  • Hyaluronic acid concentration: 23 mg/ml (2.3%).
  • Lidocaine hydrochloride concentration: 0.3%.
  • Non-animal origin HA produced by bacterial fermentation and purified.
  • Formulated in a physiologic phosphate buffer with NaCl for intradermal and subcutaneous injection.

Packaging

  • Box containing 1 x 1 ml pre-filled glass syringe of PLURYAL VOLUME LIDO gel.
  • 2 x 27G 1/2" Terumo ultra-thin wall needles (CE 0197).
  • Package insert (Instructions for Use).
  • 2 traceability labels (for patient and clinic records).
  • Single-patient, single-use sterile packaging with batch number and expiry date printed on the carton.

Usage

  • PLURYAL VOLUME LIDO is a medical device for medical use and must only be administered by appropriately trained and qualified healthcare or aesthetic professionals with specific training in soft tissue augmentation techniques.
  • Prior to treatment, take a complete medical history, assess facial anatomy and volume deficits, identify aesthetic or reconstructive indications (cheeks, lips, nose, mandibular line, chin, dorsum of hands) and rule out contraindications. Obtain informed consent and document baseline appearance.
  • Cleanse and disinfect the treatment area thoroughly. Topical anaesthetic may be used according to clinic protocol, although the product contains 0.3% lidocaine for analgesia.
  • Open the sterile blister, attach one of the supplied 27G 1/2" Terumo ultra-thin wall needles to the pre-filled 1 ml syringe using aseptic technique and expel any air bubbles before injection.
  • Recommended injection level: deep dermis or subcutis, depending on the treatment area and desired volumising effect.
  • Use suitable injection techniques such as linear threading (retrograde or anterograde), fanning, depot/bolus injections, cross-hatching or supraperiosteal boluses in areas like cheekbones, mandibular angle, chin or nasal dorsum, following manufacturer recommendations and practitioner training.
  • Indicated areas include: cheeks and cheekbones, lips, nose, mandibular line, chin and dorsum of hands. Adjust volume per injection point and distribution to match anatomical needs and patient goals.
  • Inject slowly with minimal, controlled pressure, aspirating where appropriate and continuously monitoring for pain, blanching or other signs of vascular compromise. If such signs occur, stop immediately and follow established emergency protocols for filler complications.
  • After injection, gently mould or massage the treated areas if necessary to shape contours and ensure even distribution, avoiding excessive pressure that might displace product or compromise perfusion.
  • Recommended frequency of use is approximately every 12–16 months; some patients may benefit from earlier touch-ups (e.g. 9–12 months) depending on metabolism, lifestyle, treated area and desired level of correction.
  • Provide post-treatment advice: avoid makeup on treated areas for several hours; avoid intense heat (sauna, steam room), extreme cold, vigorous exercise and alcohol for at least 24 hours; protect treated areas from sun and UV exposure using broad-spectrum sunscreen.
  • Instruct patients to report any persistent or worsening pain, marked redness, blanching, skin discolouration, nodules, signs of infection or visual disturbances without delay.
  • Refer to the official PLURYAL VOLUME LIDO Instructions for Use and professional product literature for comprehensive, up-to-date information on indications, techniques, precautions and management of adverse events.

Contraindications

  • Hypersensitivity or allergy to hyaluronic acid, lidocaine or any component of the formulation (including BDDE or excipients such as phosphate buffer and NaCl).
  • History of severe allergic reactions or anaphylaxis, particularly to amide-type local anaesthetics (e.g. lidocaine).
  • Presence of active infection, inflammation or skin disease at or near the intended injection sites (e.g. bacterial infection, herpes simplex, dermatitis).
  • Autoimmune diseases or immunodeficiency conditions where injectable HA fillers may be inadvisable, unless assessed and cleared by a specialist.
  • Known tendency to hypertrophic or keloid scarring in the proposed treatment area.
  • Bleeding disorders or current significant anticoagulant/antiplatelet therapy that increases bleeding risk, unless evaluated and approved by a prescribing clinician.
  • Pregnancy and breastfeeding (commonly listed as contraindications or strong precautions for elective aesthetic injectable treatments).
  • Previous permanent or semi-permanent fillers in the same area where interaction or irregularity may occur, unless carefully evaluated by an experienced injector.
  • Any other contraindications or warnings specified in the official PLURYAL VOLUME LIDO Instructions for Use and local regulatory or professional guidelines.

Adverse Effects

  • Common transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, warmth, itching, bruising or slight bleeding.
  • Temporary nodules, papules or lumps at injection points, usually resolving as swelling subsides and the product integrates; persistent nodules require clinical evaluation.
  • Temporary asymmetry or overcorrection immediately after treatment, generally improving as oedema decreases or with minor corrective treatment at follow-up.
  • Local hypersensitivity or inflammatory reactions, potentially presenting as prolonged redness, swelling or induration.
  • Infection at injection sites if aseptic technique is not strictly followed; may require appropriate antimicrobial therapy and medical follow-up.
  • Very rare but serious complications associated with all dermal fillers, including inadvertent intravascular injection leading to vascular occlusion, ischaemia, tissue necrosis or, in high-risk areas, visual disturbances or blindness; these events require immediate recognition and management according to established filler complication protocols.
  • Any other adverse events mentioned in the official PLURYAL VOLUME LIDO Instructions for Use should be considered and monitored by the treating practitioner.

Storage Conditions

  • Store at controlled room temperature as indicated on the packaging, typically between 2°C and 25°C.
  • Protect from direct sunlight and extremes of temperature; do not freeze.
  • Keep the syringe in its original blister and outer carton until use to maintain sterility and product integrity.
  • Do not use if the packaging, blister, syringe or needles are damaged or if sterility appears compromised.
  • Do not use after the expiry date printed on the packaging.
  • Discard any unused product remaining in the syringe after treatment; PLURYAL VOLUME LIDO is intended for single-patient, single-use only.

Duration

According to product guidance, treatments are typically repeated every 12\u201316 months for volume and structural restoration; in practice, duration of effect commonly falls within a 9\u201316 month range depending on the treated area, injected volume, technique, patient metabolism and lifestyle.

Onset

Volumising and contouring effects are usually immediate after injection due to the HA gel implant, with final appearance stabilising over the following days as transient swelling and redness subside and the product integrates into surrounding tissues.

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