Objectives Injectable poly-l-lactic acid (PLLA; Sculptra®) is widely used throughout Europe and the USA to restore volume in depressed areas of the face by stimulating neocollagenesis. Injectable PLLA was previously marketed as New-Fill™, which was often injected incorrectly and at too high a concentration, resulting in some physicians losing confidence in this product. Today, Sculptra® is still regarded with a degree of scepticism by some physicians, due to direct or indirect experience with New-Fill. Sculptra®, both in formulation and use, is vastly superior to New-Fill and clinical experience with this product dispels the myths associated with the earlier types of injectable PLLA.
Results PLLA is a very safe, biodegradable compound that has been used in a wide range of medical devices for the last 30 years. In injectable form a good safety profile has been proven; however, when the device is overconcentrated, localized overstimulation of the fibroblasts can result in the formation of small lumps (subcutaneous papules), which are non-pathological but nevertheless palpable by the patient. Physicians must also be trained in the injection of this device, as incorrect injection technique can cause device-related adverse events.
Conclusion New product guidelines have ensured that problems with PLLA concentration have been countered, and tried and tested injection techniques have been shown to ameliorate device-related adverse events, both of which are dispelling the myths associated with modern injectable PLLA.