Poly-L-lactic acid
Poly-L-lactic acid
Another well-studied product is poly-L-lactic acid (PLLA), or Sculptra® Aesthetic (Galderma Laboratories, Fort Worth, TX), which is a biodegradable and biostimulatory filler. The first use of PLLA for hand rejuvenation was described in 27 patients by Radaelli in 2006.31 A 150 mg vial of PPLA was diluted with 0.5 mL of 3% mepivacaine, and sterile water to achieve a volume of 5 to 8 mL, typically using higher concentrations in the first session. The dilution is made 12 hours before injection and stored at room temperature. With each treatment, a maximum of 2 mL of the 5- to 8-mL solution was used per hand. Injections were made with a 2.5-mL syringe and 25- to 27- G needle, entering the skin parallel to the metacarpal bones, although at times in various directions. With each injection, volumes of 0.05 to 0.1 mL of product were placed into the deep subcutaneous tissue. During the procedure, patients were kept in a Trendelenburg position in order to decrease venous pressure. Immediately following treatment, each hand was massaged for 15 minutes, and the patient was encouraged to continue massage at home at least twice a day for 3 days. Patients receiving PLLA had a measurable decrease in the visibility of veins and tendons, in addition to an improvement in patient and investigator satisfaction scores. In the study, patients required between 3 and 6 sessions about 1 month apart. One patient developed a nontender, nonvisible palpable deep nodule noticed at the last follow-up visit. PLLA with dilutions of 5, 6, and 7 mL were used at the first, second, and last session. Raedelli believed the nodule was likely due to errors in injection and massage done during the first two sessions.
In a 2008 study, Sadick et al. treated 26 patients with PLLA.32 A 367.5 mg vial was reconstituted with an 8- to 10-mL mixture of sterile water and 1% lidocaine. Using a 1- or 3-mL syringe attached to a 25-G 1.5-in needle, the product was introduced into the deep subcutaneous space using a tenting maneuver. One half vial, or 5 mL, was used per hand. Apart from massage done immediately postinjection, patients were ask to massage for 5 minutes at a time, 5 times per day, for a total of 5 days (“5–5–5” rule). Patients
received an average of 2.38 treatments 1 to 2 months apart. No papules or nodules were reported.
Eight patients had their hands treated with PLLA by Palm et al.33 A 367.5 mg vial of PLLA was reconstituted with 1 mL of 1% lidocaine (with or without epinephrine) and 5 mL of bacteriostatic water the day before treatment. The day of treatment, a Vortex Genie (Scientific Industries, Inc., Bohemia, NY) was used to agitate the product. Then, 1.5 mL of agitated product and 1.5 mL of bacteriostatic water were drawn into a 3-mL syringe. The final reconstituted product should equal 12 mL, with 6 mL used per hand. Using a 25-G, 1.5-in syringe, product was injected into the subcutaneous tissue plane in a retrograde fanning technique. Subjects were instructed to perform vigorous massage and keep to the “5–5–5” rule. Patients received an average of 2.5 treatments. One of the eight (12.5%) patients who received PLLA to the hands developed a nodule; this patient had been treated once with a 9 mL dilution.
When treating off the face with this product, one approach is to reconstitute 1 vial of PLLA overnight with 1 mL of 1% lidocaine and 7 mL of bacteriostatic water. Though the manufacturer recommends sterile water for reconstitution, the vast majority of physicians utilize preserved (bacteriostatic) water, as the preservative decreases patient discomfort during cosmetic injections.34 The reconstituted product is agitated with the Vortex Genie mixing device immediately prior to injection, and then 1.5 mL is withdrawn into a 3-mL syringe. Next, another 1.5 mL of bacteriostatic water is withdrawn into the syringe resulting in a combined total volume of 3 mL. This step is repeated until a final total of 16 mL is mixed and withdrawn into the syringes. A 16 mL dilution cannot be done at the outset, as the vial can only hold up to 10 mL of diluent. Half of the PLLA vial (or 8 mL) is used per hand. The length of correction with PLLA has been reported to last 18 to 24 months, but requires multiple treatments spaced 4 to 6 weeks apart.18
Besides developing edema, ecchymoses, and hematomas, PLLA can lead to the formation of nodules.35 Because of this, and the availability of other filler agents, PLLA should be used with caution for hand augmentation. A 10-year retrospective review by Park et al. published in 2012 identified 15 patients who developed foreign-body granulomas.36 Four patients had been treated with PMMA, three with CaHA, three with HA, two with PLLA, and two with “other” material. Subjects had been symptomatic from 1 month to 9 years, with 12 of the 15 having symptoms for more than 1 year. Four patients (two with PMMA, two with other filler) had sensory dysfunction, and four (two with other, one with PMMA, one with CaHA) developed hand stiffness.
In their article, Park et al. recommended an algorithm for dealing with nodule formation. First, the authors started an antibiotic trial consisting of a second-generation cephalosporin combined with a third-generation macrolide. If the nodule persisted despite antibiotics, hyaluronidase was used for HA fillers, excision for CaHA, and
intralesional triamcinolone for other types of filler. Excision was reserved as an intervention of last resort.
For those who use PLLA, there are techniques that can decrease nodule formation: using dilutions greater than 5 mL (16 mL is advised), using smaller volumes, not overcorrecting, spacing treatments at least 4 weeks apart, reconstituting the product the night prior, and performing massage after treatment.21 Although the Sculptra product insert recommends reconstitution with 5 mL of sterile water at least 2 hours before treatment, dilutions less than 5 mL are associated with an increased risk of nodule formation.32