Decrease of reported adverse events to injectable polylactic acid after recommending an increased dilution: 8‐year results from the Injectable Filler Safety study

Roßner, Florian; Roßner, Mathias; Hartmann, Vanessa; Erdmann, R.; Wiest, Luitgard; Rzany, Berthold

doi:10.1111/j.1473-2165.2009.00417.x

Cited by 36 publications

(33 citation statements)

References 19 publications

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“…The safety profile of PLLA has improved dramatically over recent years with increased experience in product preparation, in selection of injection area and in injection modalities. In particular a decreased risk of adverse reactions with an increased dilution was noted in several clinical trials and in the Injectable Filler Safety Study [26]. …”

Section: Discussionmentioning

confidence: 99%

Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients

et al. 2014

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BackgroundFacial lipoatrophy is a frequently reported condition associated with use of antiretroviral (ARV) drugs. Poly-L-lactic acid (PLLA) acid has been used to correct facial lipoatrophy in people with HIV since 2004 both in Europe and the United States. The objective of this study was to establish, in real life conditions and in a large sample, the safety of PLLA (New Fill®, Valeant US, Sinclair Pharma Paris, France) to correct facial lipoatrophy among HIV-positive patients.MethodsA longitudinal study was conducted between 2005 and 2008 in France. Data from 4,112 treatment courses (n = 4,112 patients) and 15,665 injections sessions (1 to 5 injection sessions per treatment course) were gathered by 200 physicians trained in the use of PLLA.ResultsThe average age of patients (88.3% males) treated for lipoatrophy was 47.1 ± 8.1 years (Mean ± SD); 91.2% of patients had been receiving ARV treatment for 10.9 (±4.2) years; CD4 T-cell count was 535 ± 266 cells/mm3. The duration of facial lipoatrophy was 5 ± 2.8 years and the severity was such that 47.3% of patients required five injection sessions of PLLA and 81.9% of the sessions required two vials of the preparation. The final visit, scheduled two months after the last injection session, was attended by 66.0% of patients (n = 2,713). 48 treatment courses (2.8%) were discontinued due to adverse events (AEs). The overall incidence of AEs per course was 18.8%. Immediate AEs, bleeding (3.4%), bruising (2.3%), pain (2.0%), redness at injection site (1.6%), and swelling of the face (0.7%), occurred in 15.4% of courses and 7.0% of sessions (usually during the first session). Non-immediate AEs, mainly nodules (5.7%), inflammation (0.7%), granuloma (0.3%), discolouration (0.2%), and skin hypertrophy (0.1%), occurred in 6.7% of courses. Non-immediate AEs occurred within a time ranging from 21 days (inflammation) to 101 days (granuloma) and all but three of the 13 cases of granuloma resolved. Product efficacy was rated satisfactory by 95% of the patients and physicians.ConclusionsThis study demonstrated, in real-life conditions and on a large sample, that PLLA injections were feasible, efficient, and safe when performed by trained physicians.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2334-14-474) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients

et al. 2014

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“…The safety and efficacy of PLLA for soft-tissue augmentation are well established, with over 20 studies in more than 4000 patients [17][18][19][20]. However, several treatment sessions are required for optimal facial volume restoration, and the main concern about PLLA injection is the delayed effect of nonvisible palpable nodules and visible papules.…”

Section: Poly-l-lactic Acidmentioning

confidence: 97%

“…According to a blinded evaluator, 77 % of subjects at week 8 and 59 % of subjects at week 24 following upper and lower lip injections were considered to have a one-grade or greater change on the 5-point Medicis Lip Fullness Scale. For subjects receiving additional injections for correction of perioral rhytides, there was a statistically significant and clinically meaningful improvement in perioral rhytides as assessed by the blinded evaluator at weeks [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]. No serious adverse events occurred.…”

Section: Restylane ò Silkmentioning

confidence: 99%

Dermal Fillers: An Update

2015

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Injection of dermal fillers is the second most frequent nonsurgical cosmetic procedure performed in the USA. Dermal fillers are an option in the treatment of volume deficiency, scars, and rhytides; facial sculpting; facial contouring; and augmentation of specific anatomical sites such as the lips. The number of injectable dermal fillers available on the market increases yearly. Dermatologists and cosmetic surgeons should regularly review treatment options to provide patients with safe and effective filler options. This paper extensively reviews the properties of the available fillers, such as their rheology, longevity, and adverse effects, and how these properties affect the choice of filler agent for a particular patient or a particular site. Also, trends in dermal filler injections are discussed.

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“…Even with increased dilution of poly-l-lactic acid, the study concluded that adverse events still occur and advised that poly-l-lactic acid continue to be monitored for safety. 44 The other study on the Berlin Injectable Filler Safety registry characterized adverse reactions to DermaLive (Dermatech, Paris, France), a fixed combination of hydroxyethylmethacrylate and ethylmethacrylate with hyaluronic acid. The study identified 30 patients who were treated with this filler.…”

Section: Adverse Event Reportingmentioning

confidence: 99%

Facial Soft-Tissue Fillers conference: Assessing the State of the Science

Hanke

Rohrich

Busso

et al. 2011

Journal of the American Academy of Dermatology

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Decrease of reported adverse events to injectable polylactic acid after recommending an increased dilution: 8‐year results from the Injectable Filler Safety study

Abstract: PLA is an injectable filler substance that may cause subcutaneous nodules in treated patients. Our data support a decreased risk of adverse reactions with an increased dilution. However, nodule formation still appears to be a characteristic feature of PLA.

Cited by 36 publications

References 19 publications

Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients

Safety of poly-L-lactic acid (New-Fill®) in the treatment of facial lipoatrophy: a large observational study among HIV-positive patients

Dermal Fillers: An Update

Facial Soft-Tissue Fillers conference: Assessing the State of the Science

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