aesthetic surgery journal malar augmentation with a · 2017. 3. 31. · michigan. dr hurwitz is a...

Cosmetic Medicine

Aesthetic Surgery Journal33(3) 421 –430© 2013 The American Society for Aesthetic Plastic Surgery, Inc.Reprints and permission: http://www .sagepub.com/journalsPermissions.navDOI: 10.1177/1090820X13480015www.aestheticsurgeryjournal.com

Fullness and elevated projection of the malar area is con-sidered highly desirable for facial attractiveness, and these features are associated with youth.1 Recent studies exam-ining the aging face have demonstrated that facial soft tissues can suffer a loss of volume when subcutaneous fat redistributes or diminishes.2 The factors contributing to facial aging include reduced tissue elasticity, gravity, stress, and sun exposure. In addition, our understanding of facial aging has evolved, and it has been demonstrated that facial aging also includes a loss of soft tissue volume and erosion in bony landmarks.3-6 Many procedures for malar enhancement have been described, including

permanent implants, injection of autologous fat, and the use of various fillers.7,8

Surgical procedures for malar augmentation include placement of devices such as shaped silicone implants and fat grafting.7 However, there are disadvantages to these

Malar Augmentation With a Polymethylmethacrylate-Enhanced Filler: Assessment of a 12-Month Open-Label Pilot Study

Daniel C. Mills, MD; Steven Camp, MD; Scott Mosser, MD; Ayoub Sayeg, MD; Dennis Hurwitz, MD; and Daniel Ronel, MD

AbstractBackground: Most filler procedures in the United States are performed with hyaluronic acid (HA) derivatives. Artefill (Suneva Medical, Inc, San Diego, California), the only polymethylmethacrylate (PMMA)–enhanced dermal filler approved by the US Food and Drug Administration (FDA), has been well tolerated by patients for treatment of nasolabial folds and has a safety profile similar to other approved fillers.Objectives: The authors investigate the safety and efficacy of Artefill for malar augmentation.Methods: This prospective, multisite, open-label study included a total of 24 patients with age-related lipoatrophy. Only patients with mild to moderate lipoatrophy were considered candidates for treatment. Artefill was injected in the supraperiosteal layer of the malar region, at a maximum volume of 6 mL (3 mL/side). Touch-up injections were performed at weeks 4 and 6, up to a maximum total volume of 8.8 mL. Standardized assessments of results were made at 2, 6, and 12 months. Outcome measures included the Global Aesthetic Improvement Scale (GAIS), change in malar lipoatrophy grade, and patient satisfaction. Standardized photographs of each patient were collected.Results: Average patient age was 48 ± 5 years. Average volume of injections was 5.55 ± 1.87 mL. Based on both the patient- and physician-rated GAIS, 95.8% of study participants were reported as being “improved” or “very much improved.” The change in malar lipoatrophy grade was significantly improved from baseline to 1 year by 0.96 ± 0.98 (P < .0003). Patients also reported high levels of satisfaction, with 87.5% being “satisfied” or “very satisfied.” There were no reported adverse safety events in the study.Conclusions: Artefill demonstrated improvement in malar atrophy with a high level of patient satisfaction and an excellent safety profile. The absence of any adverse events in our study patients was notable, and we believe this is a result of the uniform nature of the PMMA particles in the Artefill and the strict and sterile manner in which this PMMA dermal filler is produced.

Level of Evidence: 4

Keywordsmalar fat pad, minimally invasive plastic surgery, cheek implant, fillers, cosmetic medicine

Accepted for publication October 30, 2012.

Scan this code with your smartphone to see the operative video. Need help? Visit www.aestheticsurgeryjournal.com.

422 Aesthetic Surgery Journal 33(3)

procedures, including invasiveness, infection, potential displacement of implants, and loss of sensation to the area.8,9 Fat grafting to increase fullness in the cheeks also requires a separate preliminary procedure to harvest the fat and carries the added risks of infection, resorption of the grafted material, asymmetry, and loss of sensation.8 Given these risks, many patients seek a minimally invasive nonsurgical procedure, such as filler injection, for malar augmentation.10

Ideally, dermal fillers should have low immunogenic-ity and a low incidence of adverse events (AE), be easy to inject, and cause minimal pain upon injection.11,12 Currently, many dermal filler options exist; these differ in origin (biologic or synthetic) and longevity (biode-gradable or permanent).12,13 Biodegradable fillers include hyaluronic acid (HA)–based and collagen-based fillers, both of which range in longevity from 3 to 9 months.12 Other available filler products include cal-cium hydroxylapatite (Radiesse/Radiance FN; BioForm Medical, San Mateo, California) and poly-L-lactic acid (Sculptra; Dermik Laboratories, Bridgewater, New Jersey), both of which have been reported to last up to 2 years.12,13

HA–based dermal fillers (including Restylane and Perlane [Medicis Aesthetics, Scottsdale, Arizona] and Juvéderm [Allergan, Santa Barbara, California]) do not require a pretreatment skin test and provide longer-lasting results compared with previously used, collagen-based dermal fillers. In a clinical study of Juvéderm, a smooth gel HA filler, the persistence of results (>6 months) com-pared to those with a bovine collagen–based dermal filler was preferred by the majority of treated patients.14 For Restylane SubQ, beneficial results were reported to persist up to 64 weeks in patients who received cheek augmenta-tion.15 A recent American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) patient survey reported that, “When asked to choose between treatments that had an immediate impact but lasted only 6 months versus treatment with a more gradual effect but lasted 2 years, the respondents chose the longer-lasting treatment 95% to 5% . . . when directly comparing cost of treatment to duration of results; the duration of the results was a more important factor in the treatment decision for 60% of the respond-ents.”16 The appreciation of patient-driven interest in longer-lasting injectable fillers deserves recognition and further study. Thus, the purpose of our study was to exam-ine the results of Artefill (Suneva Medical, Inc, San Diego, California), which is the only polymethylmethacrylate (PMMA)–enhanced dermal filler approved by the US Food and Drug Administration (FDA) and is believed to be

even longer lasting than other available fillers, for malar augmentation.

METHODS

Artefill is currently considered suitable for patients desir-ing mild to moderate cheek correction who demonstrate signs of facial aging in the malar area. Only patients with malar lipoatrophy grades 1 to 3 (on a scale of 1 to 5) were considered for treatment (scale range: grade 1 = mild flat-tening or shadowing of the malar regions, grade 5 = severe indentation of the malar regions, prominence of bony landmarks, and clear visibility of underlying muscu-lature; Table 1). Institutional Review Board approval for use of Artefill in the malar area as part of an “open-label” pilot study was obtained through Veritas (Saint-Laurent, Montreal, Canada). Each patient in the study was treated by 1 of 5 physician authors who participated in collecting patients (D.C.M., S.M., A.S., D.H., D.R.). The participating physicians performed the injections and follow-up visits.

Artefill is a gel suspension of 20% PMMA microspheres in 3.5% bovine collagen solution mixed with 0.3% lido-caine. The manufacture of the product includes strict con-trol of the particle size, to remain between 30 and 42 microns in a sterile environment.17 The product is supplied in sterile, prefilled, 1-mL syringes that do not require addi-tional mixing or hydration. Because it contains bovine collagen, patients must be skin tested 1 month before injection.13

We instructed all of our patients to avoid aspirin and nonsteroidal anti-inflammatory drugs for 1 week pretreat-ment to minimize the risk of bruising and swelling. Before treatment, all patients were photographed, and treatment sites were planned and marked. The treatment areas were outlined while the patient observed with a handheld mir-ror, to allow patient involvement in the treatment plan. Initial injections were 2 to 3 mL per cheek, as determined by the judgment of each individual physician injector on a case-by-case basis. As a part of the informed consent pro-cess, all patients in the study were told that Artefill was being used as a part of this pilot study to evaluate its effect on the malar area.

The importance of skin preparation with injectables has not been proven but is certainly worthy of attention to avoid the possibility of infections or possible introduction of biofilms into the deeper facial tissues.12 Alcohol cleans-ing is common, but we have added a chlorhexidine solu-tion in our practice. Reports exist suggesting that chlorhexidine has the benefit of a residual antibacterial

Dr Mills is a plastic surgeon in private practice in Laguna Beach, California. Dr Camp is a plastic surgeon in private practice in Fort Worth, Texas. Dr Mosser is a plastic surgeon in private practice in San Francisco, California. Dr Sayeg is a plastic surgeon in private practice in Troy, Michigan. Dr Hurwitz is a plastic surgeon in private practice in Pittsburgh, Pennsylvania. Dr Ronel, a plastic surgeon in private practice in Santa Fe, New Mexico, passed away on February 18, 2011.

Corresponding Author:Dr Daniel Mills, Aesthetic Plastic Surgical Institute, 31852 Pacific Coast Highway, Suite 401, Laguna Beach, CA 92651, USA. E-mail: [email protected]

Mills et al 423

effect that is not seen with alcohol.18 We also believe that it is important to stretch the skin during skin preparation to allow cleansing into the wrinkles. Application of the chlorhexidine solution was avoided near the periorbital area to prevent the potential for exposure keratitis.19

As we gained experience with the product, we noticed that it was much easier to inject when it had been hand-warmed for 5 minutes, and we incorporated this into our pretreatment protocol. Artefill was injected where the tear trough meets the zygomatic arch and deep to the malar fat pad just above the periosteum. A combination of crosshatching and fanning patterns was used to allow easier and more consistent delivery of the material and to minimize AE such as granuloma or nodularity. Once the treatment was complete, the areas were gently compressed and ice was applied if necessary. Patients were instructed to apply ice if swelling occurred and not to manipulate the area for several hours. Patients were evaluated immedi-ately after injection and at predetermined intervals of 2, 6, and 12 months. Additional injections were performed at the discretion of the investigator and by patient request at 4 or 6 weeks, up to a maximum total volume of 8.8 mL.

To achieve consistency among injecting practitioners in the study, all patients were evaluated using the same out-comes measures. These measures were investigator assess-ment of aesthetic results using the change in malar volume loss scale (Table 1), investigator assessment of aesthetic results using the Global Aesthetic Improvement Scale (GAIS; Table 2), patient assessment of aesthetic results using the GAIS, and patient satisfaction (N. Seretta, personal communication, 2010) (Table 3). To objectively document patient satisfaction, each patient completed a satisfaction

questionnaire, which measured the following: overall satisfaction, recommendation of aesthetic treatment to oth-ers, and the likeliness of recommending the study treatment to others. These variables were recorded at 8, 26, and 52 weeks posttreatment (Tables 4-6). During the study,

Table 1. Grades of Malar Lipoatrophy

Grades of Malar Lipoatrophy

1. Mild flattening or shadowing of the malar regions

2. Intermediate point between grade 1 and grade 3

3. Moderate concavity of the malar regions. Prominence of bony landmarks. May have visibility of underlying musculature

4. Intermediate point between grade 3 and grade 5

5. Severe indentation of the malar regions. Severe prominence of bony landmarks. Clear visibility of underlying musculature

Table 2. Global Aesthetic Improvement Scale

Global Aesthetic Improvement Scale

1 Very much improved

2 Improved

3 No improvement

4 Mild decrease

5 Worse

Table 3. Patient Satisfaction Scale

Patient Satisfaction Scale

0 Very satisfied

1 Satisfied

2 Neutral

3 Dissatisfied

4 Very dissatisfied

Table 4. Patient Satisfaction With Treatment (n = 24)

Question 1: Patient Satisfaction With Treatment

Week 8 (n = 23)

0 = Very satisfied 17 (73.9)

1 = Satisfied 5 (21.7)

2 = Somewhat satisfied 1 (4.3)

Missing, No. 1

Mean ± SD 0.30 ± 0.56

Median (P25, P75) 0.00 (0.00, 1.00)

Week 26 (n = 24)




3 = Dissatisfied 1 (4.2)

Mean ± SD 0.42 ± 0.83

Median (P25, P75) 0.00 (0.00, 0.50)

Week 52 (n = 24)




3 = Dissatisfied 1 (4.2)

Mean ± SD 0.46 ± 0.83

Median (P25, P75) 0.00 (0.00, 1.00)

Values are presented as No. (%) unless otherwise indicated. P25, 25th percentile; P75, 75th percentile.


standardized photographs of each patient were collected at 2, 6, and 12 months.

A video of the authors’ technique is available at www.aestheticsurgeryjournal.com. You may also use any smartphone to scan the code on the first page of this article to be taken directly to this video on www.youtube.com.

RESULTS

Of our 24 study patients, there were 23 women and 1 man. The average age of study participants was 48 ± 5.1 years (Table 7). In our series, the average volume of injections was 5.55 ± 1.87 mL, and the typical volumes of Artefill administered for malar augmentation were 2 to 3 mL per cheek. Some patients may require more. The results were immediately visible to patients after injection. The major-ity of patients required little or no recovery time and were able to resume most of their normal activities after the procedure. For the majority of patients, full correction was achieved in 1 visit. A small group of patients desired fur-ther augmentation and received touch-up injections at 4 or 6 weeks after the initial injections, at the discretion of the investigator.

Clinical results are shown in Figures 1 through 4.In our clinical practice, patients have reported that

Artefill treatment was less painful or no more painful than other fillers. Although this was not measured objectively in our study, we believe that Artefill treatment was well tolerated because of the 0.3% lidocaine included in the gel suspension. Generally, minimal or imperceptible swelling or bruising was observed after injection and at the first follow-up visit. Patient satisfaction was very high, with 87.5% of study patients reporting that they were satisfied or very satisfied at 52 weeks posttreatment (Table 4). Only 1 patient reported a decrease in fullness in her malar region (Figure 4). Her report was in contrast to the physician-rated assessments of her face, which reported an improvement in her GAIS and malar lipoatrophy grades. Overall, the majority of patients reported that they observed no resorption at 6 and 12 months. We also noticed that in some cases, patients continued to demon-strate slight increases in malar volume more than 2 months after the procedure. These patients reported even more enhanced malar projection at 6 months than at 2 months. This effect was deemed beneficial by both the patients and physicians.

DISCUSSION

Malar descent and loss of facial volume are common con-sequences of the aging process. Many authors now believe that volume deflation actually precedes gravitational descent in facial aging, and consequently, volume restora-tion has become an important component of aesthetic facial rejuvenation.2,20 Hyaluronic acid products have become increasingly popular because of the minimal downtime required after treatment.10 The perceived disad-vantage of temporary dermal fillers is the need for main-tenance injections, which incur additional discomfort, inconvenience, and cost. Therefore, a longer-lasting inject-able filler product may be considered a highly desirable treatment for patients seeking nonsurgical structural aug-mentation in the malar region.16

Artefill is a gel suspension composed of 20% PMMA microspheres, which are homogeneous 30 to 42 microns,

Table 5. Patient Recommendation of Aesthetic Treatment to Others (n = 24)

Question 2: Patient Recommendation of Aesthetic Treatments to Others No. (%)

Week 8 (n = 23)

Yes 23 (100)

Missing (no response) 1

Week 26 (n = 24)

Yes 22 (91.7)

No 2 (8.3)

Week 52 (n = 24)

Yes 22 (91.7)

No 2 (8.3)

Table 6. Subject Likeliness to Recommend Study Treatment (Artefill) (n = 23)

Question 3: Patient Likeliness to Recommend Study Treatment (Artefill)

Week 8 (n = 23)

0 = Very likely 22 (95.7)

1 = Somewhat likely 1 (4.3)

Mean ± SD 0.04 ± 0.21

Median (P25, P75) 0.00 (0.00, 0.00)

Week 26 (n = 22)



Mean ± SD 0.09 ± 0.29

Median (P25, P75) 0.00 (0.00, 0.00)

Week 52 (n = 22)



Mean ± SD 0.09 ± 0.29

Median (P25, P75) 0.00 (0.00, 0.00)


Mills et al 425

in 3.5% bovine collagen solution mixed with 0.3% lido-caine.12 Reports of other PMMA-enhanced dermal fillers suggest that this group of products may have durability over 5 years.21,22 The PMMA microspheres in Artefill are not absorbed by the body and therefore provide perma-nent support, which can be considered advantageous for the purpose of structural augmentation.16 This is in con-trast to other temporary dermal fillers such as Juvéderm, Restylane, or Sculptra, which consist of components that are eventually absorbed by the body.12,13,23

The most common AE associated with Artefill treatment are similar to those observed with other dermal fillers and include mild swelling and reddening at the treat-ment site. These side effects usually resolve within 24 hours.12,13 More serious AE such as the formation of inflam-matory nodules, vascular occlusion, and granulomas have

been reported with other fillers.24,25 To date, no serious AE of this type have been reported with Artefill.13 Occasionally, Artefill injection is associated with mild bruising that typi-cally disappears in 3 to 7 days. Less common side effects include rash and itching, persistent swelling or redness, and increased sensitivity at injection sites. A skin test is required before initial treatment to make sure the patient is not sen-sitive to bovine collagen, and the FDA recommends allow-ing 28 days to determine whether a patient has a sensitivity reaction.13 Artefill received FDA approval for nasolabial fold correction in 2006 and has demonstrated an impressive safety profile, but it should be used only by experienced practitioners because it is a longer-acting product and com-plications may be less forgiving.12,13 Current recommenda-tions also suggest avoiding use in patients susceptible to keloid formation or hypertrophic scarring.12

Figure 1. (A, D) This 43-year-old woman presented with grade 3 malar lipoatrophy and was seeking a fuller, more youthful appearance to her face. (B, E) Eight weeks after Artefill treatment, with a total of 4 mL injected into the right malar area and 3.2 mL injected into the left. (C, F) One year posttreatment, there is no evidence of resorption. No swelling, bruising, or lumps were observed immediately posttreatment or at 2, 6, or 12 months. This patient had also undergone botulinum toxin treatments approximately 3 months prior to and 10 months after treatment with Artefill, as well as dermal filler injections to her lips approximately 5 months after treatment with Artefill. No patient in this series underwent additional treatment in the midfacial area.


Again, Artefill contains highly uniform PMMA micro-spheres that are not absorbed by the body and allow for durable structural support to the malar area. Several other PMMA-enhanced products are available outside of the United States, and studies have demonstrated the persis-tence of results achieved with these products for more than 5 years.21,25,26 Although our study includes follow-up data for only 1 year, it is our belief that Artefill will dem-onstrate a longevity similar to that of the other previously studied PMMA-enhanced fillers. It is our plan to continue evaluating our patients for several more years to confirm that Artefill treatment is as durable as other PMMA-enhanced fillers. We have been encouraged by our 1-year data and believe that these early results have importance for documenting the safety and efficacy of the product at every stage.

In contrast to other PMMA-enhanced fillers, Artefill is the only product of this type with FDA approval. In Europe, a PMMA-enhanced product marketed by the same

manufacturer as Artecoll (Rofil Medical International, Breda, the Netherlands) is available. Although similarities exist between Artefill and other PMMA-enhanced prod-ucts, there are some distinct differences. Artefill is derived from a closed US bovine herd, is more consistent in parti-cle size, and has a larger particle size. The larger particle size decreases immunogenicity and digestion by mac-rophages (Table 8).13

Due to the permanent nature of PMMA and its potential to form palpable nodules, most authorities recommend that PMMA fillers should be placed in the deep dermis or, prefer-ably, the subdermis.13 Given our objectives to provide struc-tural support to the malar area and to minimize the risk for AE such as granuloma, we chose to inject Artefill in the supraperiosteal layer. Superficial placement may be associ-ated with pruritis, redness, and hypertrophic scarring.21,22,24,25 The safety of Artefill and the low incidence of severe AE such as granuloma formation have been reported.12,13 Delayed granuloma formation has been associated with Artecoll, but

Figure 2. (A, D) This 48-year-old woman presented with grade 1 lipoatrophy of the malar area. (B, E) Eight weeks after Artefill treatment, with 3.1 mL injected into the right malar area and 2.5 mL injected into the left. (C, F) One year posttreatment, the results are still evident. There was no evidence of nodularity at any point during follow-up. This patient underwent botulinum toxin treatments approximately 1 month prior, 6 months after, and 11 months after treatment with Artefill, as well as dermal filler injections to her lips and marionette lines approximately 5 months after and 10 months after treatment with Artefill. No patient in this series underwent additional treatment in the midfacial area.

Mills et al 427

not Artefill. The rate with Artecoll is quite low (0.01%) but can be troublesome because of its delayed appearance, often 6 to 24 months after injection.21,27 None of the patients in our

series developed any granuloma, but it is important to note that management of delayed granulomas with other PMMA-enhanced fillers has been described with repeated

Figure 3. (A, C) This 46-year-old woman presented with grade 1 malar atrophy. (B, D) One year after Artefill treatment, with 4 mL injected on each side of the patient’s malar area. This patient also reported having undergone filler injections to her lips at another clinic. No patient in this series underwent additional treatment in the midfacial area.


intralesional steroid injection at increasing concentrations over a 3- to 4-week interval.28 As stated earlier, beading and ridging complications (which are considered hypertropic scarring) are attributed to superficial placement of PMMA and may eventually require therapies, including laser or exci-sion.13 The lack of serious AE in our series indicates that Artefill is safe when used in the malar area and when proper technique and patient selection are applied.

Our clinical experience with Artefill for the purpose of cheek augmentation has been highly favorable. Our study demonstrates measured improvements in the aesthetics of the malar area, as measured by the GAIS and malar lipoat-rophy grading scales, and high levels of patient satisfac-tion. We have found that Artefill is well tolerated by patients with reproducible effects. As a result of their sat-isfaction with Artefill, many of our study patients have

referred other patients to our practice for this treatment. We have noted that patients treated with Artefill in this study have lasting results, with most patients noting lasting increased fullness 12 months after injection. Although 1 patient reported decreased fullness in the treatment area, our physician investigators did not see evidence of resorption in the malar area of any patient. In fact, several patients demonstrated a continued improvement in malar projection several months after injection. This was not expected, so we will continue to observe these patients, with planned follow-up for 5 years. It is important to note that the continued improvements in malar fullness that occurred 2 months after injection were slight and considered favorable in all patients in whom this effect was observed. However, this does pre-sent the possible problem of a late presentation of excessive volume correction. We have attempted to minimize this

Figure 4. (A, D) This 47-year-old woman presented with less malar projection on the left side of her face. (B, E) Eight weeks after Artefill treatment, with 3.2 mL injected into the right malar area and 5.6 mL into the left. This patient reported decreased fullness in her malar area despite receiving a relatively large volume of product. However, in contrast to the patient’s perception, the physician-rated Global Aesthetic Improvement Scale and malar lipoatrophy grade were considered improved. (C, F) One year posttreatment. This patient also received Artefill treatment in the nasolabial fold area approximately 5 months after Artefill treatment to her midface. No patient in this series underwent additional treatment in the midfacial area.

Mills et al 429

complication, but it will be interesting to see if this develops in patients as a possible late-presenting complication several years later.

The lasting effect of Artefill treatment and its lack of resorption make it attractive compared with fat grafting, which has a variable degree of permanence.29-31 Cheek implants can also present problems, as faces thin with aging and the implants become visible or impinge on the orbit. In contrast, Artefill adds volume to areas that atro-phy, and it contains collagen, which thickens the sur-rounding soft tissue. One potential drawback to Artefill is the fact that it cannot be easily removed; for this reason,

we chose to focus on patients with mild to moderate degrees of malar atrophy (grades 1-3), and we were care-ful not to perform any very large volume injections. The possibility of “overdone” volume additions to the face certainly exists, and by limiting the amount of our initial injections and performing no more than 8.8 mL, we believe that we limited the potential for excessive volume correction.

Limitations of this study include the subjective nature of the measurement scales and variability in the per-ceived degrees of change between the participating patients and investigators. Significant effort was taken to standardize all assessments during this multicenter, pro-spective study, but the design did not include blinded assessments of the treated patients and was therefore susceptible to bias. In addition, the number of associated ancillary treatments (such as skin resurfacing or surgical treatment) was not uniform among all patients. The abil-ity to measure volumetric changes with imaging studies would likely have been beneficial, but this was deemed prohibitively expensive.

CONCLUSIONS

Artefill is a PMMA-enhanced dermal filler for use in facial contour augmentation. It was FDA approved for use in the nasolabial area in 2006, and this study documented its use in the malar area as part of a pilot study examining its effect in the malar area. Patients who underwent cheek augmentation with Artefill reported minimal recovery time and little to no swelling or bruising immediately posttreatment, with no reported serious AE. Outcome measures in this study showed documented improvements in the aesthetics of the malar area and high patient satisfaction levels. In addition, because Artefill contains PMMA, which is not resorbed, we believe that the results of treatment will be more durable than those of other currently available fillers. We believe malar augmen-tation with Artefill may last for 5 years or more, and we plan to follow our patients to confirm this anticipated outcome. Therefore, Artefill is a possible alternative to traditional

Table 7. Demographics (n = 24)

Sex (n = 24)

Male 1 (4.2)

Female 23 (95.8)

Age, y (n = 24)

Mean ± SD 48.0 ± 5.1

Median (P25, P75) 47.6 (44.0, 50.3)

Min, Max 40.8, 60.8

Race (n = 21)

White 19 (90.5)

Other 2 (9.5)

Missing 3

Ethnicity (n = 20)

Hispanic or Latino 6 (30.0)

Not Hispanic or Latino 14 (70.0)

Missing 4


Table 8. Comparison of PMMA Fillers

Product Country of Origin Scanning Electron Microscope Analysis

Artefill (circa 2007) United States • Size: 30 to 50 microns, with negligible small sizes• Shape: smooth-surfaced microspheres with scant if any sediment• The only FDA-approved PMMA-enhanced dermal filler

Artecoll (circa 2005) Canada • Size: 30 to 50 microns, with negligible small size particles• Shape: smooth-surfaced microspheres, some slight surface irregularity, scant sediment

Artecoll (circa 2001) Europe • Size: 32 to 40 microns, but with variation in particle sizes• Shape: presence of nanoparticles on the surface of the microspheres, variation included some sub–20-micron particles and some sub–5-micron particles with sediment noted

Metacrill (circa 2006) Brazil • Size: 0.2 to 60 microns• Shape: variable with many irregular shapes, some nonspherical, jagged edges, poor surface

New Plastic (circa 2006) Brazil • Size: 0.2 to 70 microns• Shape: variable, with nonspherical and conjoined particles present

Courtesy of communication with Suneva Medical (San Diego, California) and adapted from Piacquadio et al.17 FDA, Food and Drug Administration; PMMA, polymethylmethacrylate.


fillers, since it is a convenient and longer-lasting option for patients seeking to restore facial volume and improve facial contours with nonsurgical filler.

Disclosures

Authors were given the option to buy stock in Suneva Medical. Dr Mills and Dr Hurwitz did not purchase the stock offered. Dr Mosser did not purchase the stock offered but does own stock in Suneva. Dr Sayeg was given stock in Suneva for a lecture series. As a writer but not a study participant, Dr Camp was not offered shares.

Funding

This study was funded by Suneva Medical, the manufacturer of the product discussed in this article. Suneva Medical pro-vided the product, paid the patients to return for their follow-up visit, and paid for the patients’ office visits. Suneva did not receive the article for review, nor did they provide editing or writing assistance. Suneva did provide data regard-ing the number of injections that have been performed. Suneva also collated the data for each visit, and its medical director provided statistical analysis for each of the visits.

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