Evaluation of the Poly-L-Lactic Acid Implant for Treatment of the Nasolabial Fold: 3-Year Follow-Up Evaluation

Abstract

The search for an ideal filler for soft tissue augmentation still continues. Because aging changes are continuous, temporary fillers should be preferred against permanent ones. Since 1999, the poly-L-lactic acid filler (PLA) has been marketed in Europe as Newfill. As a synthetic biocompatible polymer, PLA originally was used in suture materials and screws. In 2004, the U.S. Food and Drug Administration approved PLA under the name of Sculptra for the treatment of human immunodeficiency virus-related facial lipoatrophy. This study aimed to evaluate a 3-year follow-up investigation into the effect of PLA implant injection for the treatment of sunken nasolabial folds. Between October 2003 and February 2004, 10 women with a median age of 54 years (range, 43-60 years) were injected with polylactic acid hydrogel (Newfill) in the nasolabial fold area for aesthetic reasons. All the patients underwent three injections: one injection per month for 3 months. Evaluation of the results based on clinical examination and photography was performed at each session, at 6 months, and then 36 months after the third session. Injectable PLA was able to correct nasolabial folds successfully with a more lasting result than absorbable fillers commonly used in clinical practice, such as hyaluronic acid and collagen. Careful and standardized photographic documentation is indispensable.

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

“…Therefore, injections into the dermis, particularly in thin dermis areas, such as upper lip, lower eyelids, glabella, and superficial wrinkles from the cheeks, are localizations with a high risk for any adverse event [35]. A rare complication due to the injection of PLLA is a foreign-bodyinduced granulomatous reaction, which can persist for several years [35,64]. This delayed hypersensitivity reaction to the product also can be associated with persisting itching, edema, and erythema [65].…”

Injectable poly-L-lactic acid for cosmetic enhancement: Learning from the European experience

“…Finally, a recently published small-scale European trial by Salles et al 30 assessed the use of injectable PLLA for the aesthetic correction of nasolabial folds. Each vial of PLLA was reconstituted in 5 mL of SWFI the night before injection.…”

Clinical data on injectable tissue fillers: a review

“…Also, aesthetic effects up to four years with injectable PLLA have been observed, while the claimed aesthetic effect is approximately two years [32]. Between 2008 and 2012, some studies have been published with longer follow-up periods, that is, three to four years [32][33][34][35][36]. The need for this development is illustrated by two studies [37,38] in which it was found that semi-permanent injectable fillers remain in the skin longer than the period claimed by the manufacturer: 18 and 23 months, respectively, while the claims were 12 months.…”

“…In 22 patients, palpable but non-visible subcutaneous micronodules were observed Not specified/not known [101] Prospective study (n = 116), 25 months follow-up Only 1 case of injection site bruising Treatment related [102] Prospective study (n = 10), 36 months follow-up Short-term complications Not specified/not known [34] Prospective study (n = 65), 36 months follow-up…”