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Bellafill Dermal Filler

Bellafill Dermal Filler

Bellafill

Dermal filler
  • U.S. FDA premarket approval (PMA) as a dermal filler for nasolabial folds and for moderate to severe, atrophic, distensible facial acne scars on the cheek in adults over 21 years.
  • CE Marked as a medical device in the European market (including approval noted in 2024), indicating conformity with EU Medical Device Regulation requirements.
  • Manufactured under Good Manufacturing Practice (GMP) and relevant medical device quality system standards for sterile injectable implants.
  • Supported by long Term post Approval clinical data demonstrating safety and effectiveness up to 5 years for nasolabial fold correction.
PMMA collagen-based biostimulatory injectable filler

Description

Bellafill is a long-lasting, PMMA (polymethylmethacrylate) microsphere and bovine collagen-based dermal filler designed for permanent implantation into the skin to correct nasolabial folds (smile lines) and moderate to severe, atrophic, distensible facial acne scars on the cheeks in adults over 21 years of age. The injectable gel consists of smooth, round PMMA microspheres suspended in a purified bovine collagen solution with lidocaine for comfort. The collagen component provides immediate, natural-looking volume to smooth wrinkles or acne scars, while the non-resorbable PMMA microspheres act as a scaffold that stimulates the body’s own collagen production for long-term correction. Bellafill has U.S. FDA PMA approval and clinical data demonstrating safety and effectiveness for up to 5 years in nasolabial folds, making it one of the longest-lasting dermal fillers available.

Bnefits

  • Provides immediate wrinkle and acne scar correction due to its collagen gel component.
  • Long-lasting results, with clinical data demonstrating effectiveness and safety for up to 5 years in nasolabial folds.
  • Biostimulatory effect: PMMA microspheres stimulate the body’s own collagen production for sustained structural support.
  • Indicated for both nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheeks in adults over 21.
  • Non-resorbable filler, reducing the need for frequent repeat treatments compared with temporary hyaluronic acid fillers.
  • Natural-looking results with soft tissue augmentation that integrates with the patient’s own collagen over time.
  • Extensively studied in multiple controlled clinical trials and long-term post-approval studies.
  • Contains lidocaine to improve comfort during injection.
  • Single in-office injectable procedure performed by trained medical professionals with minimal downtime for most patients.

Indications

  • Correction of nasolabial folds (smile lines) in adults over the age of 21 years.
  • Correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in adults over the age of 21 years.
  • Soft tissue augmentation where a long-lasting filler is appropriate and the patient desires a more durable alternative to temporary fillers, within the approved indications.

Composition

  • Active structural component: 20% non-resorbable polymethylmethacrylate (PMMA) microspheres, approximately 30–50 microns in diameter.
  • Carrier gel: 80% bovine collagen solution containing 3.5% purified bovine collagen.
  • Excipients within collagen solution: approximately 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and about 92.6% water for injection.
  • The suspension is isotonic and buffered, forming a smooth injectable gel containing evenly dispersed PMMA microspheres.

Formulation

  • Pharmaceutical form: Injectable dermal implant (suspension of PMMA microspheres in bovine collagen gel with lidocaine).
  • Strength per syringe: 20% PMMA microspheres and 80% bovine collagen solution containing 3.5% bovine collagen, 0.3% lidocaine hydrochloride, 2.7% phosphate buffer, 0.9% sodium chloride and water for injection.
  • Each prefilled syringe: 0.8 mL in a 1.0 mL sterile, single-use syringe.
  • Route of administration: Intradermal or subdermal injection into the skin in the treatment area by a qualified healthcare professional.
  • Drug/device class: Permanent/semi-permanent biostimulatory dermal filler (PMMA-based).

Packaging

  • Bellafill is supplied as prefilled, sterile, single-use glass syringes containing 0.8 mL of product, fitted with a Luer lock and packaged with appropriate sterile needles.
  • Syringes are provided in heat-sealed thermoformed trays within an outer carton.
  • Typical commercial presentation: carton containing 5 x 0.8 mL prefilled syringes, patient information labelling, and instructions for use.
  • Each carton and syringe are labelled with product name, lot number, expiry date, and storage conditions.

Usage

  • Bellafill is a prescription-only injectable dermal filler and must only be administered by appropriately trained and qualified healthcare professionals familiar with facial anatomy and the Bellafill prescribing information.
  • A Bellafill skin test (intradermal collagen sensitivity test) must be performed prior to treatment to assess for hypersensitivity to bovine collagen; patients with a positive reaction must not receive Bellafill.
  • Before treatment, obtain a complete medical history, including history of severe allergies, bovine collagen allergy, lidocaine allergy, bleeding disorders, autoimmune disease, abnormal scarring (keloids/hypertrophic scars), and any active skin conditions in the treatment area.
  • Use strict aseptic technique for all injections. Inspect the syringe; do not use if the product appears discoloured, cloudy, or contains particulate matter other than the expected PMMA microspheres in clear gel.
  • Inject Bellafill into the dermis or deep dermis at the appropriate depth recommended in the official instructions for use, avoiding intravascular injection and staying within the intended treatment plane.
  • For nasolabial folds and acne scars, use multiple small aliquots and linear threading or serial puncture techniques as directed in the instructions for use to achieve smooth, even correction.
  • Do not overcorrect; allow for the presence of initial collagen volume and subsequent collagen stimulation when assessing the amount to inject.
  • Massage the treated area gently if recommended by the product instructions to ensure even distribution and minimise lump formation.
  • Bellafill should not be injected into lips, eyelids, glabellar region, or any area not included in the approved indications.
  • Any unused portion of a syringe must be discarded; syringes are single-patient, single-use only and must not be resterilised or reused.
  • Advise patients about expected post-treatment effects (swelling, redness, bruising, tenderness) and provide aftercare instructions, including when to seek immediate medical attention (e.g., signs of infection, severe pain, vascular compromise, or persistent nodules).

Contraindications

  • Positive response to the Bellafill skin test or known hypersensitivity to bovine collagen.
  • History of severe allergies (e.g., anaphylaxis) or multiple severe allergies.
  • Known allergy or hypersensitivity to lidocaine or other amide-type local anaesthetics.
  • Patients with bleeding disorders or those taking anticoagulant/antiplatelet therapy where the risk of injection-related bleeding or haematoma is unacceptable, unless carefully assessed and managed by the prescriber.
  • Patients prone to keloid formation or hypertrophic scarring.
  • Presence of active infection, inflammation, acne, or dermatologic disease in the intended treatment area.
  • Use in patients under 21 years of age.
  • Injection into the lips, vermilion border, eyelids, glabella, or any non-approved anatomical site.
  • Use in patients with significant immune-compromising conditions without careful risk–benefit assessment by a specialist.

Adverse Effects

  • Very common, usually transient injection-site reactions: redness, swelling, pain, tenderness, bruising, itching, firmness, and lumps or bumps at the treated sites.
  • Temporary induration, palpable nodules, or papules in the treated area, which may persist for weeks or months in some cases.
  • Discoloration or erythema at the injection site.
  • Hypersensitivity reactions, including prolonged redness, swelling, itching or rash, particularly in patients with collagen sensitivity.
  • Infrequent granuloma formation at or near the injection site, which may present as persistent nodules and may require medical management (e.g., corticosteroids or other interventions).
  • Infection at the injection site if aseptic technique is not properly followed or if post-treatment care is inadequate.
  • Vascular complications (rare): inadvertent intravascular injection may result in tissue ischemia or necrosis, requiring urgent medical intervention.
  • As with any dermal filler, there is a risk of asymmetry, overcorrection, undercorrection, or contour irregularities requiring further management.

Storage Conditions

  • Store at controlled room temperature as specified in the official product labelling (typically around 15–25°C).
  • Do not freeze.
  • Store in the original carton and sealed tray until use to protect from light and maintain sterility.
  • Do not use after the expiry date printed on the carton and syringe label.
  • Keep out of the sight and reach of children.
  • Discard opened, unused syringes and expired product in accordance with local regulations for medical sharps and pharmaceutical waste.

Duration

Correction from Bellafill has been demonstrated in clinical studies to be maintained for up to 5 years in nasolabial folds, with many patients experiencing long-lasting improvement. Individual duration and need for touch-up treatments vary based on indication, injection technique, and patient factors.

Onset

Immediate visible improvement is typically seen due to the bovine collagen gel providing instant volume, with further refinement and sustained correction developing over months as new collagen forms around the PMMA microspheres.

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