Bellafill® Dermal Filler

Bellafill’s tiny, polymethyl methacrylate (PMMA) microspheres are suspended within a base of smooth collagen gel. Once injected, the collagen gel immediately reduces the look of smile lines. Over time, your body uses the microspheres in Bellafill to create a “scaffold” onto which your own natural collagen can develop. This collagen forms a foundation that adds volume to wrinkles, reducing their appearance – and giving you natural-looking results that feel soft and smooth for up to 5 years.

• Natural looking results that last
  The only dermal filler FDA approved to be a safe and effective for up to 5 years.
• Instant results
  Starts working immediately, and continues to add volume over time.
• Happy patients
  83% satisfaction after 5 years.

Are there other dermal fillers on the market with FDA approval to treat acne scars?
No, Bellafill® is the only FDA-approved dermal filler, on the market, for the correction of atrophic (pitted), distensible facial acne scars on the cheek. No other dermal filler on the market is approved for the treatment of acne scars.

What is Bellafill®‘s indication for use?
Bellafill® is the only dermal filler FDA approved for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. It is also the only dermal filler established safe and effective for nasolabial fold correction through 5 years.

How long does Bellafill® last?
Satisfaction and effectiveness for the correction of nasolabial folds have been established over 5 years. Effectiveness for the correction of acne scars has been proven over 12 months.

Is there a current demand for effective acne scar treatments?
Yes. Millions of Americans suffer from acne and billions of dollars are spent each year on treatments. Furthermore, a significant number of acne sufferers go on to develop devastating scarring. Physician and patient market research shows relatively low satisfaction with many available treatments with patients having to make trade-offs between efficacy, longevity, safety, downtime, and cost. Now with Bellafill®, acne scar sufferers have a new treatment choice that is proven to be safe and effective with minimal to no downtime.

What kind of research has been done to determine acne scar effectiveness?
A pivotal, randomized, double-blinded, placebo-controlled study was conducted to evaluate the effectiveness and safety of Bellafill® for treating moderate to severe, atrophic, distensible facial acne scars on the cheek. Subjects were randomized to Bellafill® vs. saline injections. Bellafill® was found to be a safe and effective treatment when compared to control-treated subjects.

This study maintained a high threshold for success: the primary effectiveness endpoint defined a responder as a subject who had 50 percent or more treated acne scars and improve by two or more points on a validated 4-point Acne Scar Rating Scale (ASRS). This six-month endpoint was met with statistical significance and, as a secondary endpoint, continued to show improvement at nine and 12 months when assessed by the un-blinded investigator. Subjects blinded to treatment also reported successful outcomes and demonstrated improvement in their global appearance after treatment with Bellafill®.

When did Bellafill® receive FDA approval for the treatment of acne scars?
Bellafill® received FDA approval for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years in December 2014.