Bellafill Safety Information

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

What is it? Bellafill is an injectable facial implant (dermal filler) made from cow tissue (bovine collagen) and non-absorbable polymethylmethacrylate beads (PMMA microspheres) that provide structural support to the skin. It also contains a very small amount of a local anesthetic (lidocaine). Lidocaine helps to reduce the pain of the injection.

How does it work? A doctor (dermatologist or plastic surgeon) injects Bellafill into the facial tissue underneath the wrinkle and/or acne scar just above the skin’s fat layer. Bellafill is double-acting. First, both the collagen, a gel-like solution, and the PMMA beads provide immediate volume and lift to correct wrinkles and/or acne scars. Second, the PMMA beads remain in place and provide long-term structural support to the skin.

When is it used? Bellafill may be used in patients to smooth moderate to severe smile lines (nasolabial folds) and in patients over the age of 21 to improve the appearance of acne scars.

What will it accomplish? Bellafill helps increase the volume of patients’ wrinkles and acne scars to smooth moderate to severe smile lines (nasolabial folds) and acne scars. In the current clinical study, patients needed one or two injections to improve their acne scar appearance. The effect lasted for more than 12 months.

Side-effects of Bellafill include:

  • lumps at the injection site
  • redness
  • swelling
  • pain
  • tenderness
  • itching

When should it not be used?
Bellafill should not be used in:

  • Patients showing a positive response to the required Bellafill Skin Test.
  • Patients with severe allergies (for example, a history of severe hypersensitivity [anaphylaxis] or a history or presence of multiple severe allergies).
  • Patients allergic to lidocaine or cow tissue products, including but not limited to, injectable and implantable collagen, collagen sponges, and collagen-based sutures. These patients are likely to be hypersensitive to Bellafill.
  • Patients undergoing or planning to undergo injections to reduce allergies to meat products.
  • Patients with bleeding disorders.
  • Patients undergoing or planning to undergo lip enlargement (augmentation) and injection into the red pigment (vermilion) or the wet mucus membrane (mucosa) of the lip.
  • Patients with known susceptibility to excessive scarring (keloids) or thick scarring (hypertrophic scars).

Additional Links:

 Summary of Safety and Effectiveness Data and labeling 

Soft Tissue Fillers (Dermal Fillers)

American Society of Plastic Surgeons - Dermal Fillers (Illustrated)