Clinical Experience with PEGylated Hyaluronic Acid Fillers: A 3-year Retrospective Study

Rauso, Raffaele; Nicoletti, Giovanni Francesco; Bove, Pierfrancesco; Rauso, Giuseppe Mario; Fragola, Romolo; Giudice, Giovanni; Zerbinati, Nicola

doi:10.3889/oamjms.2021.6457

Cited by 4 publications

(11 citation statements)

References 20 publications

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“…Results concerning the ability of PEGylated hyaluronic acid gel to modulate human immune functions suggest that they carry a very low risk of immune-mediated adverse effects, particularly granulomatous reactions and associated cellulitic processes [ 15 ]. In this study, we observed a significant decrease in the overall local inflammatory infiltrate, which reached a frequency significantly lower than before the administration of Neauvia PEGylated fillers.…”

Section: Resultsmentioning

confidence: 99%

“…The decrease in the number of antigen-recognizing T lymphocytes (CD4+), cytotoxic T lymphocytes (CD8+), and CD68+ innate immune cells suggests that PEGylated hyaluronic acid gel fillers are not recognized as a foreign body. Cross-linking agents in PEGylated hyaluronic acid gel fillers might have contributed to the high biocompatibility of the incorporated product, which reduces the risk of adverse events related to the immune response, such as the formation of granulomas [ 15 ]. An important feature of polyethylene glycol and hyaluronic acid is that they create a matrix with a scaffold structure, a sort of 3D molecular scaffold, that has better integration with the host tissue, gaining a long-lasting effect and better resistance to thermal and mechanical stress.…”

Section: Resultsmentioning

confidence: 99%

“…The technology of hyaluronic acid cross-linking using PEG also guarantees a long duration of the administered hydrogel due to greater resistance to physiological degradation [ 14 ]. To date, there have been no reports of granulomas and delayed inflammatory reactions that have been described after the use of PEG cross-linked fillers [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

“…Jeong et al [ 16 ] demonstrated that PEGylated hyaluronic acid (PEG-HA) fillers, in vitro, have an high biosafety and [ 17 ] reduce immune cell recruitment, the production of reactive oxygen species (ROS), and the expression (mRNA) of proinflammatory cytokines such as tumor necrosis factor (TNF) α and interleukin (IL) 8, both at rest and in stimulation conditions [ 17 ]. These findings suggest that PEGylated hyaluronic acid fillers carry a very low risk of immune-mediated adverse effects, particularly granulomatous reaction and associated cellulitic processes, and even induce an anti-inflammatory phenotype in immune cells, which may contribute to the beneficial effects of PEG-HA [ 15 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records

Kubik¹,

Gallo

Tanda

et al. 2023

Gels

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The aim of this study was to test the effect of hyaluronic acid cross-linked with polyethylene glycol containing micronized portions of calcium hydroxyapatite (Neauvia Stimulate) on both local tissue and systemic consequences, which are crucial from the perspective of long-term safety, in patients suffering from Hashimoto’s disease. This most common autoimmune disease is a frequently mentioned contraindication to the use of fillers based on hyaluronic acid as well as biostimulants based on calcium hydroxyapatite. Broad-spectrum aspects of histopathology were analyzed to identify key features of inflammatory infiltration before the procedure and 5, 21, and 150 days after the procedure. A statistically significant effect on the reduction of the intensity of the inflammatory infiltration in the tissue in relation to the state before the procedure was demonstrated, combined with a reduction in the occurrence of both antigen-recognizing (CD4) and cytotoxic (CD8) T lymphocytes. With complete statistical certainty, it was demonstrated that the treatment with Neauvia Stimulate had no effect on the levels of these antibodies. All this corresponds with the risk analysis that showed no alarming symptoms during the time of observation. The choice of hyaluronic acid fillers cross-linked with polyethylene glycol should be considered justified and safe in the case of patients suffering from Hashimoto’s disease.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records

Kubik¹,

Gallo

Tanda

et al. 2023

Gels

Self Cite

View full text Add to dashboard Cite

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“…No adverse events were observed apart from minimal bruising and swelling, which were mostly resolved within 24h of injection. PEGDE-HAs are a relatively recent introduction to the esthetic field and published clinical data are only just starting to appear [14]. A 3-year retrospective study of clinical experience with PEGDE-HAs for a range of treatment indications reported long-term results with no safety concerns, including no nodules, granulomas, or foreign body reactions [14].…”

Section: Discussionmentioning

confidence: 99%

Case Report: Lip Augmentation with Injection of a Novel PEG-crosslinked Hyaluronic Acid Hydrogel

Edwards

2023

Open Access Maced J Med Sci

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BACKGROUND: Lip augmentation with hyaluronic acid (HA) hydrogels is one of the most common esthetic procedures worldwide, but requires products with an optimal balance of elasticity and cohesivity to volumize while integrating with the surrounding tissue. This case report describes the results of lip augmentation with a novel, 24 mg/mL HA hydrogel cross-linked with poly (ethylene glycol) diglycidyl (PEGDE-HA 24), and supplemented with l-proline and glycine to limit post-injection swelling. METHODS: In three separate treatment sessions (Weeks 0, 2, and 10), a 29-year-old woman requesting lip augmentation was injected with PEGDE-HA 24 as multiple superficial injections using a tenting technique. Photographs were taken before treatment and at 2-weeks, 1-month, and 5-months after the initial injection. The subject provided post-treatment updates on her experience with the hydrogel in terms of the results achieved and any adverse events experienced. RESULTS: A total of 1.0 mL PEGDE-HA 24 was injected: treatment session 1 (0.3 mL); session 2 (0.4 mL); and session 3 (0.3 mL). The day after each injection the subject reported that her lips were sensitive, but not painful. The level of post-injection bruising and swelling diminished with each subsequent injection and healed rapidly. No other adverse events were reported. The subject was very satisfied with the results describing them as attractive and natural looking for up to 5 months. CONCLUSIONS: This case report demonstrated that 1 mL of PEGDE-HA 24 was effective and well tolerated for volume augmentation of the lip. The subject was very satisfied with her experience of the hydrogel and natural-looking results were achieved.

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Are We Overlooking Harms of BDDE-Cross-Linked Dermal Fillers? A Scoping Review

Wojtkiewicz,

Stachura,

Roszkowski

et al. 2024

Aesth Plast Surg

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Abstract1,4-Butanediol ether (BDDE) is widely used as a cross-linker for hyaluronic acid in dermal fillers. The purpose of this scoping review was to determine the state of knowledge about the behaviour of cross-linked substances and safety of BDDE application. The rationale behind the review came from the clinical experience of the corresponding author, who noticed adverse reactions after BDDE-linked hyaluronan application. The scoping review was conducted according to PRISMA-ScR guidelines. Out of 399 articles, 52 met the inclusion criteria. Data on study design, sample/population, aims, methodology, outcomes and funding were extracted. Results were charted according to 6 subtopics: rheological properties, hydrogel stability, BDDE toxicity, immunogenicity, tissue interactions and clinical studies. In vitro, cross-linked hydrogels were characterized as effective fillers in terms of viscosity and elasticity; however, previously uncharacterized by-products of the cross-linking reaction were found. Most in vivo studies reported increased dermis regeneration, vascularization and anti-inflammatory cytokine release after implantation of BDDE-cross-linked substances. In clinical studies, BDDE was shown to sensitize subjects to 1,6-hexanediol ether and other substances found in epoxy resin systems. Occupational dermatitis and hypersensitivity reactions were documented. Our review shows that BDDE may have long-term adverse effects, which are overlooked in the safety assessment of fillers. Reviews on BDDE conducted so far have mostly been sponsored by the industry, potentially leading to incomplete reporting of adverse effects. A review of the occurrence of allergic reactions after commercial dermal filler use and analysis of possibly harmful by-products of BDDE hyaluronan degradation are needed.Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

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Clinical Experience with PEGylated Hyaluronic Acid Fillers: A 3-year Retrospective Study

Cited by 4 publications

References 20 publications

Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records

Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records

Case Report: Lip Augmentation with Injection of a Novel PEG-crosslinked Hyaluronic Acid Hydrogel

Are We Overlooking Harms of BDDE-Cross-Linked Dermal Fillers? A Scoping Review

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