Consensus Recommendations on the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization

April 2014 | Volume 13 | Issue 4 | Supplement Individual Articles | 44 | Copyright © April 2014


Danny Vleggaar MD,a Rebecca Fitzgerald MD,b Z. Paul Lorenc MD FACS,c J. Todd Andrews MD,d Kimberly Butterwick MD,e Jody Comstock MD,f C. William Hanke MD,g T. Gerald O’Daniel MD FACS,h Melanie D. Palm MD MBA,i Wendy E. Roberts MD,j Neil Sadick MD,k and Craig F. Teller MDl

aHead of Cosmetic Dermatology in Private Practice, Geneva, Switzerland
bDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
cLorenc Aesthetic Plastic Surgery Center, New York, NY, USA
dRiver Oaks, 3355 West Alabama, Houston, TX, USA
eDermatology/Cosmetic Laser Associates of La Jolla Inc., La Jolla, CA, USA
fSkin Spectrum, Tucson, AZ, USA
gDepartment of Dermatology, Saint Vincent Carmel Medical Center, Laser & Skin Surgery Center of Indiana, Carmel, IN, USA
h222 S. First Street, Louisville, KY, USA
iArt of Skin MD, Solana Beach, CA, USA
j35-280 Bob Hope Drive, Rancho Mirage, CA, USA
kSadick Dermatology, New York, NY, USA
lBellaire Dermatology Associates, 6565 W. Loop S, Bellaire, TX, USA

Patient Selection

As with all cosmetic procedures, it is important that there be clear communication between physician and patient (Table 1). In addition, patients should be well matched to the mechanism of action and clinical effects of the treatment.
  • Patients should have realistic treatment goals, be educated on aging-associated volume loss and the gradual nature of PLLA cosmetic benefits, and understand the need for multiple treatment sessions and periodic maintenance for an enduring effect.
  • Experience with facial augmentation has taught us that patients with very empty faces or those with a very elastotic outer skin envelope may be challenging to volumize, requiring a substantial amount of product, any product, to achieve a desirable result. This should be expected in this patient population and discussed prior to any filler treatment to prevent unnecessary frustration on the part of both the patient and the physician.
  • Patients are starting cosmetic treatments earlier than they have traditionally done. The 2012 American Society of Plastic Surgeons statistics revealed that 66% of cosmetic patients are now between the ages of 30 and 54, while only 26% are age 55 or older. This younger group often needs less product and fewer treatment sessions than the older group, and is gratifying to treat.33
  • Patients with permanent fillers, or active auto-immune or connective tissue disease (eg, multiple sclerosis, lupus) may be less predictable hosts.
  • Active granulomatous disease should be considered a contraindication to PLLA use.
  • Poly-L-Lactic Acid Preparation and Storage

    Recommendations on the preparation and storage of PLLA focus on ensuring complete and homogenous dispersion and hydration of PLLA in sterile water for injection (SWFI) or bacteriostatic water, in a volume that facilitates injection (Table 2).
  • Reconstitution/Dilution
    • Prior to reconstitution, tap the vial to ensure there is no powder sticking to the top of the vial or rubber stopper.
    • Use an antiseptic to clean the rubber stopper.
    • Add 7–8 mL SWFI or bacteriostatic water slowly to the powder.
      • Dilution in this volume range leads to:
        • Even PLLA distribution.
        • Easier injection, with reduced risk of needle blockage.
        • Decreased incidence of papules and nodules.
  • Hydration
    • Hydrate at room temperature for ≥24 hours.
      • Adequate powder hydration allows the avoidance of injecting dry PLLA microclumps, which will hydrate in vivo and potentially lead to nodule formation.
    • Do NOT shake the vial during hydration.
      • Shaking can result in the deposition of dry PLLA clumps on the vial wall.
  • Storage of reconstituted PLLA
    • Prior to use, reconstituted PLLA can be stored for up to:
      • 48 hours at room temperature.
      • 3–4 weeks in a refrigerator (4°C) [with bacteriostatic water]
  • Final Poly-L-Lactic Acid Preparation

    Final steps prior to injection should ensure a hygienic approach and a smooth injection process.
  • Patient/Clinician (Table 1)
    • Patients should wash their face with soap and water.
    • The clinician should wipe the areas for injection with chlorhexidine/alcohol immediately prior to injection to reduce risk of infection or biofilm formation.
  • PLLA preparation
    • Warm the PLLA solution to room temperature (if stored at 4°C).
    • Dilute to final injection volume.
      • For facial injections, a final dilution of 9 mL is recommended, and may be achieved by the addition of 1–2 mL lidocaine (with or without epinephrine).
      • For décolletage injections, a final dilution of 11–16 mL is recommended, and may be achieved by further dilution with addition al SWFI or bacteriostatic water and 1–2 mL lidocaine (with or without epinephrine).
    • Ensure product is evenly suspended by slowly rolling the vial; do not shake. Shaking can create foam, which may clog the needle.
  • Poly-L-Lactic Acid Injection and Aftercare

    Key factors in the utilization of PLLA include site selection (Table 1); injection depth, quantity, and frequency; and aftercare, as well as other practical considerations (Table 3).

    Injection Site Selection

    Injection sites associated with the most favorable outcomes are dynamically stable, with sufficient dermal thickness to allow a proper depth of injection.