Generic Name and Formulations:
Polymethylmetacrylate microspheres 20%, bovine collagen solution 80%; per syringe; dermal implant; contains lidocaine HCl 0.3%.
Suneva Medical, Inc.
Indications for BELLAFILL:
Correction of nasolabial folds and moderate-to-severe, atrophic, distensible facial acne scars on the cheek.
See full labeling. Inject slowly with least amount of pressure necessary. >21yrs: Individualize. Max 3.5mL per treatment site; max total 8.9mL. May require 1–2 touch-up implantations at ≥2 week intervals to achieve desired effect.
Positive response to required skin test. History of anaphylaxis or presence of multiple severe allergies. Lidocaine hypersensitivity. Bovine collagen allergy (eg, injectable collagen, collagen implants, hemostatic sponges, collagen-based sutures). Undergoing desensitization injections to meat products. Bleeding disorders. Use in lip augmentation and injection into the vermilion or wet mucosa of the lip. Known susceptibility to keloid formation or hypertrophic scarring.
Should only be used by trained and experienced healthcare practitioners. Must administer the Bellafill skin test for a 4-week period and evaluate prior to inj. Patients with positive skin test or 2 equivocal skin tests, or abnormal baseline anti-bovine collagen serum IgG level results: do not consider for treatment. Obtain patient's complete medical history prior to initiation. Avoid intravascular inj; discontinue immediately if changes in vision, signs of stroke, blanching of skin or unusual pain during or shortly after procedure occurs. Risk of infection. Defer if active inflammatory process or infection is present at specific sites. Possible risk of an inflammatory reaction at implant site if laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after Bellafill treatment or if product is given before skin has healed completely after such a procedure. Advise patients to avoid excessive sun, UV-lamp exposure, extreme cold weather. Use in non-dermal spaces, thin or flaccid skin, or for ice pick or sinus tract scars: not studied. Non-distensible atrophic acne scars, connective tissue disorder: not established. Patients (<21yrs), pregnancy, nursing mothers: not established.
Use within 6 months of collagen, botulinum toxin, other wrinkle therapies: not studied. Concomitant immunosuppressants: not established. Concomitant thrombolytics, anticoagulants, platelet aggregation inhibitors within 3 weeks prior to Bellafill: not studied. Do not mix with other products prior to implantation.
Inj site reactions (eg, lumps/bumps, persistent swelling or redness, pain, bruising, rash, itching, discoloration), increased sensitivity, granulomas, hyperpigmentation, keloids, hypertrophic scars; rare: vision impairment, blindness, cerebral ischemia/hemorrhage, stroke, skin necrosis, facial structure damage.
Single-use syringe—1 (w. needles)