Update of Novel Use of Polymethyl Methacrylate (PMMA) Microspheres in the Treatment of Infra-Orbital Rhytids

Research Article

Austin J Dermatolog. 2016; 3(5):1062.

Update of Novel Use of Polymethyl Methacrylate (PMMA) Microspheres in the Treatment of Infra-Orbital Rhytids

Mani N¹*, Mani M¹, Sauder D², Sauder MB³ and Bothwell MR4

¹La Jolla Cosmetic Laser Clinic and California Retinal Associates, San Diego, USA

²Department of Dermatology, University Hospital at Princeton, USA

³Boston, Massachusetts, USA

4Department of Surgery and Otolaryngology, University of California San Diego, USA

*Corresponding author: Nasrin Mani, La Jolla Cosmetic Laser Clinic, 7720 Fay Ave, La Jolla, CA 92037, USA

Received: October 03, 2016; Accepted: November 22, 2016; Published: November 23, 2016

Abstract

Introduction: Update and expansion of 2013 study investigating the use of Polymethyl Methacrylate (PMMA) microspheres injection for rhytids and infraorbital rejuvenation.

Methods: A retrospective case series of 395 patients for evaluation of longterm complications including lumpiness and granuloma from infraorbital PMMA injection performed in an outpatient cosmetic dermatology clinic by single senior provider (NM).

Results: With an additional 3-5 year for follow up from the original study, twenty-four (6.1%) of the 395 patients developed nodularity as a complication. Sixteen of the 395 (4%) presented later than 90 days. The average time to first sign of complication was 1.18 year with a range of 11 days to 3.8 years. Median time was .82 years or 9.8 months. Age, race, or prior blepharoplasty, facelift, or skin-type were not associated with increased complication risk. Twenty patients resolved with multiple steroid injections averaging 3.95 injections to resolution. Two were lost to follow up. Two have had ongoing injections with one of the two undergoing surgical resection of multiple infra-orbital and peri-oral granulomas.

Conclusion: Injection of permanent PMMA filler using a subdermal technique in the context of infra-orbital rejuvenation is possible with clinically significant cosmetic benefit. Complication rates are consistent with those previously reported for on and off-label indications. Since this is an off-label use of PMMA in the infra-orbits significant caution must be taken. Should this technique be utilized, it is recommended to do so using serial injections in the epi-periosteal plane with purposeful under correction.

Keywords: Infra-orbital; Rhytids; Polymethyl methacrylate (PMMA) microspheres; Rejuvenation; Filler

Introduction

Soft tissue fillers are continuing to increase in popularity throughout North America and worldwide as a means of wrinkle and fold reduction. A 3% increase in soft tissue fillers was noted in one year from 2013 to 2014 in the American Society of Plastic Surgery report 2014 [1]. Overall satisfaction using PMMA has been demonstrated as “satisfied or very satisfied” at 82% at 6 months, 78% at 12 months and 84% at 60 months by Cohen in the nasolabial fold [2]. Yet fillers are implants and essentially foreign bodies that can potentially trigger an inflammatory response in some individuals [3].

In 2013, this group’s first retrospective case series involving 289 subjects reported the use of serial PMMA (polymethyl methacrylate) microspheres injections for infra-orbital rejuvenation [4]. The data from the series demonstrated a nodular complication rate of 1.4%. Yet, the study was limited due to the 14-month follow-up period. Cohen et al reported 4- to 5-year complication rates with PMMA injections as 5 out of 69 patients with 6 late adverse complications in 272 rhytids injected (2.2%) developing “lumpiness” at 2-5 years. The rhytids treated were in the glabella, nasolabial folds, radial upper lip lines, and corners of the mouth [5]. A follow-up study in 2007 demonstrated that 10 of 145 patients (6.9%) developed “lumpiness” with 8 considered mild, 1 moderate and 1 severe [6]. This study aims to better characterize the complication rate of infraorbital PMMA injections with a follow-up similar to Cohen et al.

Materials and Methods

395 patients were re-evaluated for long-term efficacy and complications in an outpatient cosmetic dermatology clinic evaluated and treated by one senior provider (NM) for infraorbital rejuvenation with PMMA. The Microsoft ® Excel 2010 (Redmond, Washington, USA) from the prior study was used and updated to 2016 with numeric identifiers replacing patients identifying features to preserve anonymity. Data were then transferred into SPSS database version 23 (IBM Corporation, Armonk, NY, USA) for statistical analysis. Basic demographics data were analyzed with calculation of the frequency, mean, median, minimum, and maximum of variables. Due to the nonparametric type of data, chi-square analysis was performed to analyze independent variables and their influence on statistical outcomes.

Technique

The majority of patients were injected using the subdermal fanning/ threading technique described by Mani 2013 [4]. The authors would now recommend deep needle droplet injections in the epi-periosteal plane.

Results

The study is a retrospective case series of 395 patients that underwent 1-7 injections of PMMA filler bilaterally to the infra-orbital region from February 2009 to September 2015. The chart review was completed in May 2016. Three hundred fifty-six patients were female and 39 were male. The average age at first injection was 49 years old with standard deviation of 11.5 years. Patients’ race and skin type were diverse: Caucasian (262), Hispanic or South/Central American (54), and Middle Eastern (39), Asian (17), African American (4), other (19). Fitzpatrick skin type of patients varied from type 2 (1) type 3 (235), type 4 (154), type 5 (3) and type 6 (1). Age, race, or Fitzpatrick score were not significant contributors to complication.

As of May 2016, 24 nodular complications in the infra-orbital area or 6.1% were noted in the 395 patients. The average time to first sign of complication was 1.18 year with a range of .03 (11 days) to 3.8 years. Median time was .82 years or 9.8 months. Sixteen of the 24 (4%) had complications presenting later than 90 days as a technique reported by Cohen to confirm an immunological process. Per Cohen, granuloma surveillance events were divided into 2 groups based on time of onset. Early lesions were those symptoms that developed within 90 days of the last injections of implant material. These typically included ectopically placed implant material, either too superficial, misplaced laterally or simply excess implant material that becomes evident only after the procedure-induced swelling has subsided. In addition, many patients naive to injectable dermal fillers may report the ability to feel or palpate a normal implant. Thus, symptoms or findings appearing during this 90-day time interval were generally considered to be associated with the implantation procedure itself and were not believed to represent an immunologic process and not included as granulomas. Late lesions were those symptoms or findings that arose 90 days or longer after the last implant injections. After this period had elapsed, any changes that occurred were considered to be potentially because of a granulomatous process [2].

Forty-one or 10.4% had had prior blepharoplasty, which was not statically associated with an increase complication risk which was a change from prior report. Of the 24 patients who had complication, only 5 had blepharoplasty. Sixty or 15.2% had had prior facelift. Prior facelift was also not statistically associated with increased risk of nodule formation.

Six of the patients (1.5%) who underwent infra-orbital injection had nodular complication from PMMA filler elsewhere at other injection sites, predominately peri-oral. Other injection sites included: glabella, nasolabial, peri-oral, and temporal. This complication rate at sites other than infraorbital was consistent with Cohen’s 2006 findings (2.2% complication rate) [5].

Twenty patients resolved with multiple steroid injections averaging 3.95 injections of 0.1 to 0.5ml of 40mg/kg intralesionalkenalog. Of the remaining four: two were lost to follow up and two have had ongoing injections with one of the two undergoing surgical resection of multiple infra-orbital and peri-oral granulomas (Figure 1and 2).