INTRODUCTION
Midfacial aging occurs in large part through bone resorption and volume loss of compartmentalized fat, both of which and can be ameliorated through soft tissue augmentation.1,2 Volume replacement in the cheek region is a necessary starting point for midfacial rejuvenation and contributes to an overall improved appearance, substantially impacting the adjacent periorbital area as well as other areas of the face.3
Dermal fillers are commonly used both on- and off-label to replenish volume in the midface through either a space-filling or biostimulatory mechanism of action. Space-filling hyaluronic acid (HA) is gradually absorbed for temporary results lasting 6-12 months.4 In contrast, biostimulatory fillers directly stimulate natural collagen production to create a new dermal matrix and include calcium hydroxylapatite (CaHA), poly-L lactic acid (PLLA), and polymethylmethacrylate-collagen gel (Bellafill [PMMA]; Suneva Medical Inc., San Diego, CA).4,5 Among the biostimulatory fillers, PMMA-collagen gel is unique; the microspheres are not absorbed by the body and are the only long lasting filler currently approved by the FDA.6 Upon injection, PMMA microspheres become encapsulated by newly deposited collagen fibers, mimicking the wound healing process.7 This ongoing collagenesis is the basis for the long-lasting correction observed with this filler.
In practice, patient satisfaction with PMMA-collagen gel long-term durability has been reported in the nasolabial folds out to 5 years.5 Although PMMA-collagen gel is FDA-approved for the correction of moderate to severe nasolabial folds and moderate to severe atrophic, distensible facial acne scars on the cheek, we demonstrated that PMMA-collagen gel is safe and effective for the correction of midfacial volume loss for up to 12 months.8 Revolumization of this off-label area with a long-lasting filler is particularly useful in that it can create enduring correction in an area where need for volume is not only consistent but central to a patient’s appearance; it creates a durable platform for addition of other modalities over time. Presented herein is an extension study to evaluate the safety and efficacy of this treatment in the midface out to 36 months.
Dermal fillers are commonly used both on- and off-label to replenish volume in the midface through either a space-filling or biostimulatory mechanism of action. Space-filling hyaluronic acid (HA) is gradually absorbed for temporary results lasting 6-12 months.4 In contrast, biostimulatory fillers directly stimulate natural collagen production to create a new dermal matrix and include calcium hydroxylapatite (CaHA), poly-L lactic acid (PLLA), and polymethylmethacrylate-collagen gel (Bellafill [PMMA]; Suneva Medical Inc., San Diego, CA).4,5 Among the biostimulatory fillers, PMMA-collagen gel is unique; the microspheres are not absorbed by the body and are the only long lasting filler currently approved by the FDA.6 Upon injection, PMMA microspheres become encapsulated by newly deposited collagen fibers, mimicking the wound healing process.7 This ongoing collagenesis is the basis for the long-lasting correction observed with this filler.
In practice, patient satisfaction with PMMA-collagen gel long-term durability has been reported in the nasolabial folds out to 5 years.5 Although PMMA-collagen gel is FDA-approved for the correction of moderate to severe nasolabial folds and moderate to severe atrophic, distensible facial acne scars on the cheek, we demonstrated that PMMA-collagen gel is safe and effective for the correction of midfacial volume loss for up to 12 months.8 Revolumization of this off-label area with a long-lasting filler is particularly useful in that it can create enduring correction in an area where need for volume is not only consistent but central to a patient’s appearance; it creates a durable platform for addition of other modalities over time. Presented herein is an extension study to evaluate the safety and efficacy of this treatment in the midface out to 36 months.
