Safety in immediate reconstitution of poly‐<scp>l</scp>‐lactic acid for facial biostimulation treatment

Bravo, Bruna Souza Félix; Carvalho, Raquel de Melo

doi:10.1111/jocd.13597

Cited by 9 publications

(6 citation statements)

References 11 publications

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“…6 , 8 Since then several studies have been conducted and very recently, two clinical studies further evidenced the safety and efficacy of PLLA in different conditions of reconstitution and with different injection techniques. 30 , 139 …”

Section: Discussionmentioning

confidence: 99%

“…To summarize, some practical means to avoid or limit nodule formation concern: a) the production preparation: reconstitution in sterile water for injection and good homogenization of the reconstituted product before administration; b) the volume of reconstitution: the reconstitution in higher volume was proposed and published in the American 7 and the European 8 PLLA experts’ recommendations; an improved safety and a decreased incidence of nodule formation were reached when PLLA was reconstituted in higher volume (7–9 mL with lidocaine versus 4–5 mL); 142 and c) Hydration time: a hydration time up to 48–72 hours was related to suspension quality and safety, but very recently, immediate injection together with high volume of reconstitution showed to be safe and leading to low adverse events and nodule formation rates. 30 , 139 These modifications consisting in immediate injection in high volume were finally approved by the FDA in 2021. The other practical means of key importance are: a) good selection of patients according to treatment aims; b) administration of the treatment by experienced and trained physicians; c) appropriate injection modalities (injection technique, depth of injection, volume injected according to the treated area and slow speed injection); d) to avoid overcorrection; and e) to proceed post-treatment massages.…”

Section: Discussionmentioning

confidence: 99%

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Collagen Stimulators in Body Applications: A Review Focused on Poly-L-Lactic Acid (PLLA)

Christen¹

2022

CCID

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The number of aesthetic procedures performed worldwide continues to grow together with an increase in the population seeking the restoration or preservation of a youthful appearance. Requests for non-surgical body rejuvenation are increasing. Patients are looking for safe and effective minimally invasive aesthetic procedures. Soft-tissue dermal fillers can meet these expectations. Based on the beneficial outcomes of these treatments in many facial areas, a new trend is developing to target body areas. Different dermal fillers are available and include collagen stimulators initially developed to restore facial volume. Furthermore, they are associated with long-lasting efficiency, a high level of patient satisfaction and a good safety profile, with mainly minor adverse events reported. In appropriate conditions of use, they are now used for body rejuvenation in clinical practice. Their use is expanding and allows addressing various issues including volume loss, skin laxity, cellulite, striae distensae and wrinkles. This review focuses on poly-L-lactic acid (PLLA), used in the first collagen stimulator and one of the most investigated in facial and in off-facial body applications. The available published data, although still limited, are presented by body area, neck and chest, buttocks, abdomen, upper arms, thighs, knees, and hands. Key features of the concerned zones and the main clinical signs affecting the body part as well as the injection modalities are provided along with the aesthetic results. This represents the state of the art on which to base further developments necessary for optimal and safe outcomes of treatment with the PLLA-based collagen stimulators and others in this class for body rejuvenation.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Collagen Stimulators in Body Applications: A Review Focused on Poly-L-Lactic Acid (PLLA)

Christen¹

2022

CCID

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“…Despite previous literature declaring that longer hydration times were necessary to reduce the risk of AEs, especially nodule formation, these authors claimed to have demonstrated the safety of immediate injection with recently reconstituted PLLA. 21 Their conclusion was founded on the following incidence rates of AEs, based on the number of patients (N = 26): Pain = 17/26 (65.38%); Bruising = 6/26 (23.08%); Nodule formation = 2/26 (7.70%); and by the following incidence rates based on the number of treatment sessions (N = 58): Pain = 17/58 (29.31%); Bruising = 6/58 (10.34%); Nodule = 2/58 (3.45%). Importantly, our sample demographics, interval between treatment sessions and average number of treatment sessions were similar to the Bravo & Carvalho (2020) study.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Cannula Safety in Injection of Poly-L-Lactic Acid

Nikolis¹,

Avelar²,

Enright³

2021

CCID

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Background and Objective Poly-L-lactic acid (PLLA) has been used in various medical applications for decades, including aesthetic ones. The use of a cannula technique in injecting PLLA has been proposed in order to lower the incidence rate of adverse events (AEs) following treatment. Such AEs include nodule formation, which may occur less frequently by fanning the product with a cannula, thus creating a more uniform product placement compared to that resulting from the use of a needle. Currently, however, there is a lack of comparative research regarding the safety of cannulas versus needles for PLLA injections, as the selection of either remains highly subjective. Therefore, the objective of our study was to investigate the safety of cannula use in the administration of PLLA, in order to report safety outcomes. Materials and Methods A single-center, retrospective chart review was conducted to examine the data of patients who had previously undergone treatment with PLLA in the form of Sculptra ® Aesthetic™ in the face and/or neck regions. Twenty-seven subject charts met eligibility. Descriptive data regarding treatment and follow-up visits were collected and analyzed. Results A total of seven AEs resulted from eighty-two treatment sessions (8.54%), with 6/27 patients having experienced at least one AE (22.22%). Mild bruising was the most commonly reported AE (57.14%). The majority of the AEs were mild and transient in nature, with one moderate AE being a nodule that was possibly related to a concomitant treatment. All AEs were resolved with follow-up care. Conclusion Mild AEs such as bruising, swelling and pain should be expected following the use of a cannula for PLLA injections. However, the incidence rates of AEs following treatment can remain low if proper product preparation and treatment techniques are utilized.

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“…Since its creation, Sculptra has undergone extensive research and is widely used [2,3]. In the past, doctors were instructed in some nations to reconstitute the bottle and wait 48 hours before using the product [4,5]. The most recent recommendation stated that a doctor might refill the vial with 5 ml of sterile water and utilize the particles right away after combining the sterile water and Sculptra particle.…”

Section: Introductionmentioning

confidence: 99%

New method to immediate reconstitute Sculptra to create a more homogenous mixture for immediate use in year 2023

Yu,

Lee,

Lee

et al. 2023

J Cosmet Med

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Background: To create a sterile, non-pyrogenic solution, Sculptra must first be reconstituted with 5 ml sterile water for injection. This reconstitution process has evolved, has become the norm, and has been recommended for use across the globe since it was marketed to the public for aesthetic reasons. The granuloma formation problem of Sculptra Aesthetic is troublesome to some injectors. It can appear anywhere that you injected and is erratic. According to some patients, the inappropriate mixing of Sculptra microparticles with sterile water or the inability of the microparticles to fully dissolve into the solution are to blame for the development of granulomas.Objective: This article aimed to demonstrate a new reconstitution method (with images) for mixing Sculptra with normal saline. Methods: In the new reconstitution method, we attached a 21G sterile needle to a sterile, single-use 5 ml syringe. Thereafter, we withdrew 2.5 ml normal saline into the 5 ml syringe. The 21G sterile needle was then introduced into the stopper of the vial, and we slowly added all normal saline into the vial. The vial was shaken vigorously to ensure the full hydration of the content. After shaking, the physician could then add any volume of normal saline. Results:A homogenous mixture of Sculptra can be achieved using this new reconstitution method. The mixture is ready to use after the immediate reconstitution of Sculptra. Conclusion:This novel reconstitution technique for Sculptra will result in less unpleasant treatment and less foam wastage on the part of the physician.

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Safety in immediate reconstitution of poly‐l‐lactic acid for facial biostimulation treatment

Cited by 9 publications

References 11 publications

Collagen Stimulators in Body Applications: A Review Focused on Poly-L-Lactic Acid (PLLA)

Collagen Stimulators in Body Applications: A Review Focused on Poly-L-Lactic Acid (PLLA)

Evaluation of Cannula Safety in Injection of Poly-L-Lactic Acid

New method to immediate reconstitute Sculptra to create a more homogenous mixture for immediate use in year 2023

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