Late-Onset Infections and Granuloma Formation after Facial Polylactic Acid (New-Fill) Injections in Women Who Are Heavy Smokers

Sir: I read with interest the article entitled “Late-Onset Infections and Granuloma Formation after Facial Polylactic Acid (New-Fill) Injections in Women Who Are Heavy Smokers” by Goldan et al. (Plast Reconstr Surg. 2008;121:336e–338e). The authors reported four patients with infection and granuloma formation after receiving New-Fill injections 2 to 6 months before admission. I would like to clarify several issues concerning the use of injectable poly-L-lactic acid, which is marketed both as New-Fill and as Sculptra in Europe, and as Sculptra in the United States, Canada, Australia, and Brazil. My comments are based on my experience with Sculptra, which is approved in the United States for the treatment of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.1 It is currently under review by the U.S. Food and Drug Administration for volume restoration and/or correction of wrinkles and folds such as nasolabial lines or folds. The description of infection and palpable nodules “under the skin or the lip vermilion” in these patients suggests that some or all patients received injections in the lip and/or perioral regions, a practice not advisable or recommended by the manufacturer.2 Injectable poly-L-lactic acid should be injected into the deep dermis or subcutaneous layer, taking special care in areas of thin skin.1,2 Injectable poly-L-lactic acid, when correctly and appropriately administered, has been shown to have a good safety profile.2,3 Adverse events often are associated with inappropriate reconstitution, injection volumes, and injection technique2; increased awareness of the appropriate use of injectable poly-L-lactic acid by trained and experienced physicians has resulted in a low incidence of adverse events.2,3 An adverse reaction such as nodule formation is a well-known effect of soft-tissue augmentation,4 and the risk with injectable poly-L-lactic acid may be reduced by appropriate reconstitution, injection, and postprocedure techniques.1 In the present cases, no information is provided about previous augmentation procedures, injection technique (site and depth), or the dilution of injectable poly-L-lactic acid used, making it difficult to draw definitive conclusions about the patients’ conditions. In my clinical experience, greater dilutions (6 to 10 ml) of injectable poly-L-lactic acid are preferable to the 5 ml of diluent per vial recommended by the manufacturer.1 Needle size is important in preventing clusters of injectable poly-L-lactic acid after injection: 26-gauge needles should be used.1 Furthermore, it is unclear whether any of these patients received multiple product injections, and if so, whether sufficient intervals were allowed between treatments to prevent overcorrection, given the gradual increase in volume over weeks to months associated with the product’s demonstrated clinical performance.3 The authors also note that the patients were generally healthy except for being heavy smokers. It is known that smoking results in numerous harmful cutaneous effects, including poor wound healing, increased pathogenic oral bacterial colonization, and enhanced bacterial binding to oral epithelial cells.5 Smoking status may therefore have contributed to development of infection at the injection site and should be taken into account in assessing risk versus benefit for any patients desiring surgical and noninvasive facial rejuvenation, regardless of the injectable product used. Babak Azizzadeh, M.D. The Center for Facial and Nasal Plastic Surgery 8670 Wilshire Boulevard, Suite 200 Beverly Hills, Calif. 90211 [email protected] DISCLOSURES Editorial support for this letter was provided by Dermik Laboratories, a business of Sanofi-Aventis U.S. LLC. The opinions expressed in the current letter are those of the author. The author received no honoraria or other form of financial support related to the development of this letter.

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