FAQs Questions? We have answers.
What is Bellafill®?
Bellafill® is a smooth, collagen-based dermal filler with polymethyl methacrylate (PMMA) microspheres. The collagen gel in Bellafill® provides immediate volume and lift to correct wrinkles and acne scars. Once injected, these microspheres stay in place and create a base that provides structural support for smoother-looking skin.
How long does it last?
The effectiveness and patient satisfaction rates of Bellafill® have been established through 5 years when used to correct nasolabial folds, and 12 months when used to correct acne scars.13
What are the microspheres in Bellafill® made of?
The microspheres are made of polymethyl methacrylate (PMMA), a biocompatible material that has been safely used in medical implants and other devices for more than 65 years.
How does it work?
The collagen in Bellafill® provides immediate volume and lift for results that you can enjoy as soon as you leave the office. Over time, the collagen is reabsorbed while the PMMA microspheres are left behind. They create a supportive base that allows more of your own collagen to develop, resulting in smoother-looking skin in the long term.
Where and how is Bellafill® available for purchase?
Bellafill® is only available through physicians. Use our Find a Provider tool to find a qualified provider near you.
Will it work for me?
In a clinical trial, Bellafill® was shown to work equally well on both male and female patients with a variety of skin types.12 If you have a history of severe allergies, have a known allergy to bovine collagen, are allergic to lidocaine, have a bleeding disorder, or are prone to thick or excessive scar formation, let your doctor know prior to your treatment.
Is it safe?
Bellafill® has been proven safe through 5 years in the largest and longest prospective dermal filler study ever completed.12 In short, yes!
When will I see results?
Bellafill® replaces lost volume in the skin below the indentation for correction that is both immediate and lasting.
What’s the downtime?
You can return to your normal activities right away. However, you may experience some temporary swelling, redness, pain, bruising, lumps or bumps, itching, and discoloration at the treatment site. Keep in mind that these symptoms are usually temporary, resolving within 1 to 7 days.
Who can receive treatment with Bellafill®?
To be eligible for Bellafill®, patients must be 21 or older and receive the required skin test prior to treatment. In clinical studies, Bellafill® was shown to work in both men and women with a variety of skin types. If you have a history of severe allergies, are allergic to bovine collagen, are allergic to lidocaine, have a bleeding disorder, or are prone to irregular scarring, let your doctor know prior to your treatment. For a full list of contraindications, contact your doctor or check out our Instructions for Use.
How much does Bellafill® cost?
The cost of Bellafill® varies depending on how many syringes your doctor recommends. During your consultation, your doctor can personalize a treatment plan that fits your budget and time.
How long has Bellafill® been available in the U.S.?
Bellafill® was approved by the FDA to treat nasolabial folds in October 2006, under the trade name ArteFill®. In December 2014, Bellafill® was approved by the FDA for the correction of certain types of moderate to severe acne scars in patients over 21.
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Important Safety Information
Bellafill® is indicated 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. Patients who have had a positive reaction to the Bellafill® Skin Test, have a history of severe allergies, have known bovine collagen allergies, are allergic to lidocaine, have bleeding disorders or are prone to thick scar formation and/or excessive scarring should not receive Bellafill®. The safety of Bellafill® for use during pregnancy, breastfeeding, or in patients under 21 has not been established. You may experience temporary swelling, redness, pain, bruising, lumps/bumps, itching, and discoloration at the treatment site. These side effects are usually transient and typically resolve within 1–7 days. You may experience lumps/bumps/papules that may occur more than one month after injection and that may persist. Less common side effects include rash and itching more than 48 hours after treatment, persistent swelling or redness, lumps/bumps, acne, and increased sensitivity at treatment sites. Infrequently, granulomas may occur and may be treated by your licensed physician provider. Be sure to call your licensed provider immediately if you notice any unusual skin reactions around the treatment area. Based on the 5-year Post-Approval Study on nasolabial folds with 1,008 patients, long-term safety of Bellafill® for up to 5 years has been established.
References
1. Gottfried Lemperle, et. al., ArteFill® Permanent Injectable for Soft Tissue Augmentation: I. Mechanism of Action and Injection Techniques., Aesthetic Plast Surg. 2010 Jun;34(3):264–72. 2. Bellafill® [Instructions for Use]. San Diego, CA: Suneva Medical, Inc.; 2015. 3. Jacob CI, Dover JS, Kaminer MS. Acne scarring: A classification system and review of treatment options. J Am Acad Dermatol; July 2001; 109-117. 4. Data on file. Suneva Medical, Inc. 5. Haneke et al. Polymethyl Methacrylate Microspheres in Collagen. Semin Cutan Med Surg 23:227-232,2004. 6. Cohen et al. Artecoll: A Long-Lasting Injectable Wrinkle Filler Material: Report of a Controlled, Randomized, Multicenter Clinical Trial of 251 Subjects. Plast. Reconstr. Surg. 114: 964,2004. 7. American Academy of Dermatology, http://www.aad.org/media-resources/stats-and-facts/conditions/acne#.Uc2hG_nvt8F. 8. Journal of Plastic, Reconstructive and Aesthetic Surgery, 2008, http://www.sciencedirect.com/science/article/pii/S1748681508003951. 9. Formula PR Independent Study, 2013. 10. Suneva Medical AAD Advisory Board, August 2015, data on file. 11. Keep in mind each patient is unique and your results may vary. 12. Cohen et al. Five-Year Safety and Satisfaction Study of PMMA-Collagen in the Correction of Nasolabial Folds. Dermatol Surg. 2015 Dec;41 Suppl 1:S302-13. 13. Karnik et al. A double-blind, randomized, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic facial acne scars. J Am Acad Dermatol. 2014 Jul;71(1):77-83.