Evaluation of the in Vivo Effects of Various Laser, Light, or Ultrasound Modalities on Human Skin Treated with a Collagen and Polymethylmethacrylate Microsphere Dermal Filler Product

Background: Bellafill® is a soft tissue dermal filler composed of non-resorbable polymethylmethacrylate (PMMA) microspheres, suspended in a water-based carrier gel composed of 3.5% bovine collagen. It has been approved by the FDA for the correction of nasolabial folds and atrophic facial acne scars. Energy-based therapies are used for facial rejuvenation and treatment of acne scarring. However, little has been published about the effects of energy devices on previously placed PMMA. This prospective, in vivo clinical study evaluated the safety and histopathological effects of a number of different laser, light, and ultrasound treatment modalities on PMMA-collagen filler previously injected into human tissue.

Methods: Following a negative reaction to the bovine collagen skin test, the abdomen of one subject (with planned mini-abdominoplasty) was divided into a grid with 32 treatment sections. Seventeen treatment areas received subdermal injections of PMMA-collagen product (0.1-0.2 cc in each area). The subject was assessed for adverse events at each post-treatment office visit. Eighty days post-injection, 30 treatment sections were treated with laser, light, or ultrasound therapy (16 of the 17 PMMA-collagen treated areas, with two of those areas receiving a combination of therapies, and an additional 14 areas receiving laser therapy alone). One PMMA-collagen treated area was not exposed to any energy devices, and one remaining treatment area received no treatment of any kind, representing an internal control. Sixty days following energy device treatment, the tissue was excised in a planned mini-abdominoplasty procedure and sent for histological examination.

Results: The subject experienced no adverse events during the study. No histological changes in PMMA microspheres were observed in any treatment area. An expected lymphohistiocytic response was identified in all areas where PMMA microspheres were present.

Conclusion: Laser, light, and ultrasound treatments can safely be administered following a PMMA-collagen injection. Lasers Surg. Med. 48:811-819, 2016. © 2016 Wiley Periodicals, Inc.