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.
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.