A 12-Month Study to Evaluate Safety and Efficacy of Polymethylmethacrylate-Collagen Gel for Correction of Midface Volume Loss Using a Blunt Cannula as Measured by 3-D Imaging.

BACKGROUND: Although polymethylmethacrylate (PMMA)-collagen gel is approved for correction of nasolabial folds, there are no reports characterizing safety and efficacy in the midface, an area where fillers are often used in clinical practice. OBJECTIVE: To determine the safety and efficacy of PMMA-collagen gel for long-term volume restoration in the midface. METHODS: In this prospective, single-center, 12-month study, 23 subjects with a pretreatment Midface Volume Deficit Scale (MFVDS) grade of 3, 4, or 5 were treated with PMMA-collagen gel. Efficacy was measured by the investigator and blinded reviewers using the MFVDS at 3, 6, and 12 months. Subject Global Aesthetic Improvement Scale (SGAIS) and physician GAIS (PGAIS) ratings were collected at 3, 6, and 12 months. RESULTS: Improvement in the MFVDS score from baseline was significant at all post-treatment time points (p < .0001). All subjects with baseline MFVDS grades of 5 (severe) or 4 (significant) had a grade of 0 (none) or 1 (minimal) at 12 months. Subject GAIS (SGAIS) and PGAIS ratings of improved or much improved were 100% at Month 3 and were maintained at 12 months (PGAIS = 100%, SGAIS = 91.3%). All adverse events were minor. CONCLUSION: Polymethylmethacrylate-collagen gel is safe and effective for long-lasting correction of midface volume deficit.

Postmarket Experience of Polymethylmethacrylate-Collagen Gel Dermal Filler.

BACKGROUND: This report synthesizes 12 years of postmarket surveillance data (PMSD) for polymethylmethacrylate (PMMA)-collagen gel dermal filler. OBJECTIVE: To present PMMA-collagen gel PMSD findings on real-world safety. METHODS: Postmarket surveillance data were collected from January 2007 to December 2018 and evaluated to determine the overall adverse event (AE) complaint rate, the nature of reported AEs, and whether the complaint included on-label, off-label, both, or unknown areas. RESULTS: In the 12 years examined, 754,229 PMMA-collagen gel syringes were distributed worldwide, and 839 product-related complaints (including those classified as unknown) resulted in an overall complaint rate of 0.11%. The 3 most frequent primary complaints in AE reports were lump/bump (309/839, 37%), nodule (152/839, 18%), and swelling (138/839, 16%). Histologically confirmed granuloma accounted for 17/839 complaints (2.0%; overall complaint rate of 0.002%), and histologically unconfirmed granuloma accounted for 66/839 complaints (8%; overall rate of 0.009%). There were 666 complaints representing AEs related to off-label injection in which the periocular area was most frequently represented. CONCLUSION: Although a limiting factor across all PMSD is voluntary reporting and resultant underrepresentation of AEs, the PMSD reported here are consistent with safety findings from US clinical studies in more than 1,500 patients with up to 5 years of follow-up.

Histologic Characterization of Polymethylmethacrylate Dermal Filler Biostimulatory Properties in Human Skin.

BACKGROUND: Little literature exits on the mechanism of action of implanted polymethylmethacrylate (PMMA) filler. OBJECTIVE: To characterize PMMA-induced dermal extracellular matrix production in the skin. MATERIALS AND METHODS: Single-center, open-label prospective study in healthy volunteers undergoing removal of redundant skin was injected intradermally and subdermally with PMMA dermal filler (Bellafill). Punch biopsies were harvested over a time course and evaluated for the deposition of collagen-3 and procollagen-1, proteoglycans and elastin using immunohistochemistry. Blinded histopathologic readings were performed by a dermatopathologist to characterize the nature of the dermal extracellular matrix findings. RESULTS: Normal inflammatory infiltrate was exhibited at all timepoints after PMMA injection with an influx of fibroblasts and new vasculature. Tissue proteoglycans were noted within the injectate beginning at Week 1 and persisted through the study end point. Increased collagen Type 3 was evident following the first week after injection, peaked at Month 2 and diminished through Months 3 through 6. Procollagen-1 was noted at Month 1 and continued to increase in intensity and organization through the study end point (6 months). Elastin staining was inconclusive. Polymethylmethacrylate microspheres remained within the initial injection area and became encapsulated within new collagen fibers. The growth and pattern of new connective tissue mimicked a normal wound healing response. CONCLUSION: Polymethylmethacrylate-collagen gel filler stimulates collagen-3 and procollagen-1 when injected into human skin. This combination of neocollagenesis followed by microencapsulation of PMMA microspheres in the new tissue provides for long-lasting results.

Polymethylmethacrylate Collagen Gel-Injectable Dermal Filler for Full Face Atrophic Acne Scar Correction.

BACKGROUND/OBJECTIVES: This trial evaluated the effectiveness and safety of Bellafill for full-face acne scar treatment. PATIENTS AND METHODS: In this open-label, nonrandomized, multicenter pilot study investigating the use of polymethylmethacrylate for full-face atrophic acne scar correction, 42 adult subjects with a mean age of 43 years were treated and assessed for safety and effectiveness at Months 4 and 7. There were no hypersensitivity reactions to pretreatment skin testing or during scar treatments. RESULTS: At 4 and 7 months after initial treatment, 92% and 95% of subjects, respectively, were responders with ≥1-point improvement on the 5-point Acne Scar Assessment Scale. Subjects reported very high levels of improvement on the Global Aesthetic Improvement Scale (GAIS), with 95% of subjects reporting "improved or better" at 4 months and 90% at 7 months. The outcome of the physician GAIS was also high with 92% of patients classified as "improved or better" at 4 months and 97% at 7 months. There were only 2 device-related adverse events, both mild events related to Bellafill skin test (bruising, ecchymosis). There were no serious adverse events in response to the treatment product in this short-term follow-up study. CONCLUSION: Polymethylmethacrylate is effective for treating full-face acne scarring. Clinicaltrials.gov #NCT02642627.

Treatment of Atrophic Facial Acne Scars With Microneedling Followed by Polymethylmethacrylate-Collagen Gel Dermal Filler.

BACKGROUND: Microneedling and soft-tissue filler injections have been used independently to improve acne scarring. The effectiveness of a combined approach using microneedling followed by polymethylmethacrylate (PMMA)-collagen gel has not been carefully studied. OBJECTIVE: The goal of this study was to assess the effectiveness and safety of microneedling alone versus microneedling followed by injection of PMMA-collagen gel filler for correction of atrophic facial acne scars. METHODS: We conducted a multicenter, open-label, randomized, prospective study on subjects with distensible atrophic acne scars in the face to determine whether microneedling with PMMA-collagen gel is a superior acne scar treatment over microneedling alone. Forty-four subjects received 3 microneedling treatments over a 12-week period followed by randomization to treatments with PMMA-collagen gel (treatment group) or no further treatment (control group). RESULTS: At 24 weeks, the treatment group achieved a statistically significant improvement in acne scores over microneedling alone. The improvement continued at 36 weeks. At 24 weeks, the treatment group showed a strong trend in improvement on the Physician Global Aesthetic Improvement Scale compared with microneedling alone.