Bellafill Dermal Filler

Bellafill

Dermal filler

PMMA collagen-based biostimulatory injectable 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.

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.

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.

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).

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