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PROFHILO STRUCTURA IBSA (1 x 2 ml)

PROFHILO STRUCTURA IBSA (1 x 2 ml)

Profhilo

Injectable aesthetic medical device
  • CE Marked Class III injectable hyaluronic acid medical device for intradermal/subcutaneous use in facial adipose tissue restoration and lipolifting.
  • Manufactured using IBSA’s NAHYCO Hybrid Technology to produce stabilised hybrid cooperative complexes of high and low Molecular Weight hyaluronic acid without chemical cross Linking agents such as BDDE.
  • Produced under IBSA Group’s pharmaceutical and medical device quality systems in compliance with applicable EU Medical Device Regulation and relevant ISO/EN standards for sterile injectable devices.
Hyaluronic acid lipolifting bioremodeling injectable for adipose tissue restoration

Description

PROFHILO STRUCTURA IBSA (1 x 2 ml) is a Class III CE-marked injectable hyaluronic acid medical device from IBSA Derma specifically developed for lipolifting and deep structural rejuvenation of the face. Each pre-filled 2 ml syringe contains 90 mg of ultrapure hyaluronic acid in the form of hybrid cooperative complexes (HCC) of high- and low-molecular-weight HA (45 mg H-HA + 45 mg L-HA), created using IBSA’s patented NAHYCO thermal technology. PROFHILO STRUCTURA is indicated for facial treatment with the specific intended use of restoring adipose tissue and improving deep laxity, targeting age-related fat atrophy and contour changes. Injected into superficial subcutaneous fat compartments with cannula-based techniques, it provides deep hydration, structural support and regeneration of facial fat tissue, improving firmness, elasticity, contour definition and overall skin texture while stimulating collagen and elastin production. The formulation is thermally stabilised, free from BDDE and other chemical cross-linking agents, and designed for excellent biocompatibility and tissue integration.

Bnefits

  • High concentration of ultrapure hyaluronic acid: 90 mg HA in a 2 ml pre-filled syringe (45 mg high-molecular-weight HA + 45 mg low-molecular-weight HA), one of the highest HA contents available for an injectable biorestructuring device.
  • Developed using NAHYCO hybrid technology to form stabilised hybrid cooperative complexes (HCC) of high- and low-molecular-weight HA via a patented thermal process, without BDDE or other chemical cross-linkers.
  • Specifically indicated for lipolifting and restoration of facial adipose tissue, addressing deep structural ageing changes such as midface hollows, contour loss and deep laxity.
  • Provides deep hydration and structural support, regenerating superficial fat compartments and improving firmness, elasticity and overall tissue tone.
  • Improves skin texture and reduces the appearance of wrinkles and deep slackness while preserving a natural look, rather than producing a traditional filler-type volumising effect.
  • Acts at the level of subcutaneous fat to restore volume and support, while also enhancing the quality and compactness of overlying skin.
  • Demonstrates excellent biocompatibility and tolerance due to the absence of chemical modification and the use of ultrapure, biofermented hyaluronic acid.
  • Supported by clinical and observational studies showing effective restoration of lateral cheek fat compartments, improved midface contours and maintained benefits over several months with a good safety profile.

Indications

  • Facial treatment for restoration of adipose tissue (lipolifting) to address age-related loss of subcutaneous fat and deep laxity.
  • Correction of pronounced hollows, midface volume loss and altered facial contours caused by atrophy of superficial fat compartments.
  • Improvement of deep structural slackness and descent of tissues ("sinkers" and "saggers" phenotypes) in the lateral cheek and midface region.
  • Deep rejuvenation and hydration of facial tissues where a regenerative, adipose-focused injectable is preferred over conventional volumising fillers.
  • Adjunctive treatment in dermal tissue repair processes, such as certain acne scars or contour defects, in line with the device’s instructions for use and clinician assessment.

Composition

  • Hyaluronic acid sodium salt 4.5% – 90 mg per 2 ml as hybrid cooperative complexes of:
  • • Low molecular weight hyaluronic acid (L-HA, 80–100 kDa) – 45 mg/2 ml.
  • • High molecular weight hyaluronic acid (H-HA, 1100–1400 kDa) – 45 mg/2 ml.
  • Sodium chloride.
  • Phosphate buffer salts (e.g. sodium phosphate).
  • Water for injections.

Formulation

  • Sterile, apyrogenic, viscoelastic injectable gel of hyaluronic acid sodium salt based on hybrid cooperative complexes (HCC) of high- and low-molecular-weight HA.
  • Total HA concentration 4.5% (90 mg/2 ml), comprising 45 mg H-HA and 45 mg L-HA in each pre-filled 2 ml syringe.
  • Thermally stabilised using NAHYCO technology (sodium hyaluronate hybrid complexes) without the use of BDDE or other chemical cross-linking agents, improving resistance to enzymatic degradation while maintaining flow and cohesivity.
  • Formulated to be injected into superficial fat compartments (intradermal/subcutaneous) to restore adipose tissue and provide deep firmness and structural support.
  • Supplied as a single-use, ready-to-use pre-filled 2 ml glass syringe for use exclusively by qualified medical professionals.

Packaging

  • Primary box contains:
  • • 1 x 2 ml pre-filled, ready-to-use glass syringe of PROFHILO STRUCTURA (4.5% – 45 mg H-HA + 45 mg L-HA/2 ml).
  • • 1 x product leaflet (Instructions for Use / patient information).
  • • 2 x implant / traceability cards for medical records and patient documentation.
  • Secondary box contains:
  • • 1 x TSK 22G x 50 mm cannula.
  • • 1 x TSK 21G x 25 mm pre-bore (pilot) needle.
  • • 1 x TSK 25G x 38 mm cannula.
  • • 1 x TSK 23G x 19 mm pre-bore (pilot) needle.
  • All components provided in sterile packaging within an outer carton marked as a Class III medical device.

Usage

  • PROFHILO STRUCTURA is a Class III medical device strictly for medical use and must only be administered by qualified healthcare professionals with appropriate training in facial anatomy and cannula-based injectable techniques.
  • Before use, verify that the outer carton and sterile blister are intact and that the product is within the labelled expiry date. Do not use if packaging is damaged or if the gel appears cloudy, discoloured or contains visible particles.
  • Perform a full medical history and facial assessment to determine suitability, focusing on patterns of fat loss (e.g. lateral cheek hollows, midface sinking or sagging) and overall skin quality.
  • Under aseptic conditions, remove the syringe from its blister and attach the recommended TSK cannula (e.g. 22G x 50 mm or 25G x 38 mm) using the corresponding pre-bore needle entry point, as per training and manufacturer guidance.
  • PROFHILO STRUCTURA is injected into the superficial fat compartments of the face using retrograde cannula techniques. Common approaches include treating the preauricular area and zygomatic arch for sinkers and saggers, respecting anatomical safety zones and avoiding major vessels.
  • Typical treatment protocol (according to clinical studies and manufacturer guidance) consists of two Profhilo Structura sessions of 2 ml each, spaced approximately 4 weeks (30 days) apart, with product distributed between both hemifaces (e.g. 1 ml per side).
  • Injection depth should target the intended fat compartments rather than the dermis alone; avoid intravascular, intramuscular or intradermal-only injection when adipose restoration is the objective.
  • Following injection, gentle moulding may be performed if required, avoiding aggressive massage or excessive pressure.
  • Advise the patient to avoid makeup on the treated area for several hours post procedure and to refrain from intense physical exercise, extreme temperatures (saunas, steam rooms, hot baths), and direct UV or sunbed exposure for a few days.
  • Instruct the patient to report any unusual pain, blanching, prolonged redness, swelling, nodules or other concerning symptoms promptly.
  • Single-use only: any remaining product in the syringe after the procedure must be discarded. Do not resterilise or reuse the syringe or cannula. Dispose of all sharps in approved containers in accordance with local regulations.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid or any excipients in the formulation (e.g. sodium chloride, phosphate buffer components).
  • Presence of active skin or subcutaneous infection, inflammation, or disease at or near the intended injection sites (e.g. bacterial infection, herpes simplex, severe dermatitis).
  • History of severe allergy or anaphylactic reactions to injectable biomaterials.
  • Pregnancy or breastfeeding, as adequate safety data are not available and treatment is generally not recommended during these periods.
  • Patients with uncontrolled systemic diseases, coagulation disorders or those receiving high-dose anticoagulant/antiplatelet therapy without prior medical evaluation of bleeding risk.
  • Autoimmune diseases or immunosuppressive therapy, unless the treating physician determines that potential benefits outweigh risks.
  • Do not inject into blood vessels, muscles, nerves, bony structures, mammary tissue, or areas containing permanent fillers or implants where interactions and safety cannot be ensured.
  • Not recommended in patients with unrealistic expectations or in those unable or unwilling to comply with post-treatment care or follow-up.

Adverse Effects

  • Typical transient injection-related reactions at cannula entry points such as erythema (redness), mild to moderate pain or tenderness, oedema (swelling), ecchymosis or bruising and small haematomas.
  • Localised discomfort or tightness and temporary irregularities in treated areas due to gel placement and tissue oedema, which generally resolve within days to a few weeks.
  • Occasional prolonged swelling, induration or inflammatory reactions in the treated fat compartments, which usually respond to conservative management but should be evaluated by the treating clinician.
  • As with all injectable HA devices, rare but potentially serious complications include infection, abscess formation, vascular compromise or embolisation leading to tissue ischaemia or necrosis if inadvertently injected intravascularly or if significant vascular compression occurs.
  • Very rare hypersensitivity or delayed inflammatory responses to hyaluronic acid or other components; clinicians must be prepared to recognise and manage allergic reactions and other adverse events according to local emergency protocols.

Storage Conditions

  • Store the unopened pre-filled syringe in its original blister and outer carton at controlled room temperature as specified on the packaging, typically between 2 °C and 25 °C.
  • Protect from direct sunlight, moisture and excessive heat. Do not freeze.
  • Do not use after the expiry date stated on the carton and syringe label.
  • Once the sterile blister is opened, use the syringe immediately and discard any unused product; do not reseal, resterilise or reuse.
  • Keep out of the reach and sight of children.

Duration

Clinical protocols and observational studies commonly use an initial course of two Profhilo Structura sessions of 2 ml each, spaced approximately 4 weeks apart. Improvements in adipose compartment volume, midface contours, skin firmness and wrinkle scores are typically maintained for at least 3\u20136 months after the final session, with many practitioners recommending maintenance treatments at intervals of roughly 6\u201312 months depending on patient age, degree of volume loss and clinical response.

Onset

Increases in soft tissue thickness and improvements in contour and firmness can often be observed immediately after injection due to the gel presence and tissue integration, with progressive regenerative effects on adipose tissue and overlying skin developing over the following weeks. Significant improvements in clinical scales (e.g. facial volume loss and wrinkle severity) are typically evident after the first session and maintained or enhanced 1\u20133 months after completion of the two-session protocol.

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