Bellafill

Generic name: dermal filler
Company: Suneva Medical Inc.

Medically reviewed by Drugs.com. Last updated on Aug 11, 2021.

Treatment for: Correction of Nasolabial Folds and Acne Scars

What is Bellafill?

Bellafill is an FDA-approved dermal filler for permanent implantation into the skin for the correction of nasolabial folds, or smile lines. It can be used in both women and men. Bellafill is a non-resorbable dermal filler, unlike many other dermal fillers that are absorbed and require reinjection. Bellafill is also approved for the correction of moderate to severe facial acne scars on the cheeks in patients over the age of 21 years.

Bellafill is a combination of microsphere enhanced bovine collagen with the local anesthetic lidocaine. The microspheres are produced from a synthetic implant material called polymethylmethacrylate (PMMA) in accordance with FDA and USDA guidelines and are roughly 30 to 50 microns in size, barely visible to the naked eye. An allergy skin test is required prior to first use.

Bellafill should only be administered under the supervision of a licensed practitioner.

Bellafill Clinical Trials

A 12-month U.S. clinical trial in over 250 patients was completed in support of the approved uses for Bellafill. These trials evaluated the safety and effectiveness of Bellafill compared to another collagen control (Zyplast) for nasolabial folds. At the 6-month evaluation period, wrinkle correction with Bellafill persisted while patients treated with the collagen control returned to their pretreatment status. Wrinkle control effectiveness at one year was similar to 6 months. Safety was comparable among products. Bellafill was approved by the FDA in 2006.

In clinical trials for acne scars, the primary effectiveness endpoint was proven superior for subjects treated with Bellafill compared to a control at 6 months. A responder was defined as a subject who had 50% or more of treated acne scars improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). At 6 months, the response rate for Bellafill was 64% vs. 33% for control (p=.0005). Bellafill continued to show effectiveness by an unblinded assessment at 12 months (71%).

Do not use Bellafill in patients with:

• a positive reaction to the Bellafill allergy skin test
• a history of severe allergies, hypersensitivity, or anaphylaxis
• an allergy to the anesthetic (lidocaine) in Bellafill
• a history of allergies to any bovine collagen product
• a tendency for thick scar formation (hypertrophic scars) and/or excessive scar formations (keloid scars)
• current or planned desensitization injections to meat products
• Bellafill is contraindicated for use in lip augmentation and injection into the vermilion or wet mucosa of the lip.

Bellafill Side Effects

As with any injectable filler, temporary (< 24 hours) mild swe...