| Abstract: | 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. |
