Sculptra Injections
Initially injectable PLLA was marketed in Europe as NewFill and was associated with a range of challenges that centered upon subcutaneous papules and nodules. According to Lowe, these most probably arose as the result of too concentrated a dilution, too large a volume of injection, inappropriate areas for injection and injections that were too superficial.
Originally the vial containing 150 mg of PLLA freeze-dried powder with excipients was diluted in 3 ml of sterile water. Current recommendations call for dilution with 5 ml or greater of dilutent. Many authors recommend 4 ml of sterile water or bacteriostatic saline and 1 ml of 2% lidocaine with epinephrine (which may reduce post-injection bruising). Some authors, including Vleggaar and Bauer, and Lam et al recommend greater dilutions (8-12 ml), in areas such as the hands and neck. The lyophilized powder should be reconstituted no less than 2 hours prior to injection, but most users now recommend 12-24 hours prior to use. Just before withdrawal from the vial PLLA needs to be vigorously shaken, and then again, in the syringe just prior to injection. Injection with a 1 cc luer-lok syringe and a 25 gauge 1 in needle affords excellent control. Smaller gauge needles are prone to blockage with the particulate material.
Topical anesthesia should be applied 20-30 minutes prior to treatment. Areas most frequently and successfully treated are the hollow of the cheek, nasolabial and prejowl folds, malar area, suborbital and temporal areas. The lips and nose are to be avoided. Unlike many ‘immediate’ fillers, PLLA is not injected directly into a fold to achieve correction, but rather in a matrix-like cross-hatching pattern. The pattern of injection is much like a scaffold or that of rebar in reinforced concrete, where an interlocking network is created as a foundation. PLLA is injected subcutaneously - not in the dermis - by means of a reverse threading technique, where the needle is passed at a 45-degree angle through the skin and then fully inserted in the subcutaneous plane parallel to the surface. The injection then places the PLLA upon withdrawal, usually in amounts of 0.1-0.2 cc per pass. In the temple and above the malar ridge it is injected in submuscular, small depot-like deposits of 0.05 ml. A fanning pattern of injection has been recommended by some, however, a single entry point for multiple passes increases the chance of too much material being deposited in a single area, leading to nodule formation. In the subocular hollow, a successful technique for those comfortable injecting in the periorbital region is a reverse threading injection of small amounts (0.05-0.1 ml) beneath the orbicularis oculi and along the periosteum of the orbital rim.
Vigorous massage for 5 minutes to all injected areas immediately post-injection is important to assure proper dispersion in order to optimize results and avoid nodule formation. Patients should be instructed to massage daily for 1 week post treatment. The application of cold packs post injection is useful to limit bruising. Most patients require one vial per treatment session, and some, especially with significant lipoatrophy, require two vials. Injection sessions should be scheduled 4-6 weeks apart so that adequate time elapses to see volume enhancement. Three treatment sessions are often required to reach full correction.