Syringe lubricant and adverse reactions

Wambier, Carlos Gustavo; Ostroski, Tayza Katelline Danilau; Wambier, Sarah Perillo de Farias; Beltrame, Flávio Luís; M, Cappel; Maceira, Juan Piñeiro

doi:10.1111/ijd.13825

Cited by 6 publications

(4 citation statements)

References 3 publications

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“…There are several reports of Si granulomas after direct injection of dermal fillers or secondary leakage from Si breast implants [ 29 ]. Cases of sclerosing lipogranulomas resulting from syringe-lubricant-contaminated injections have also been reported [ 30 , 31 ]. The results of a recent study [ 32 ] indicated that submicron- and micron-sized Si oil droplets could increase the secretion of macrophage inflammatory protein-1α and proinflammatory cytokines—interleukin-6, interleukin-8, and tumor necrosis factor—in human peripheral blood mononuclear cells, indicating that Si oil droplets can potentially evoke early and late immune responses.…”

Section: Discussionmentioning

confidence: 99%

Determination of Hyaluronic Acid Dermal Filler Impurities Using SEM/EDS Analysis

Lee¹,

Rho

Yang

2023

Polymers

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Although hyaluronic acid (HA) filler injections are associated with various non-vascular inflammatory complications, the underlying mode of action remains unclear. The hyaluronic acid filler may not be sufficiently pure, leading to an immune response. The present study attempted to identify any impurities in hyaluronic acid fillers available on the market. Particles were counted after degrading hyaluronic acid filler with hyaluronidase. Particulate matter was subsequently observed using scanning electron microscopy, and the particle components were evaluated using energy-dispersive X-ray spectroscopy. Different quantities of impurity particles (>10 and 25 µm) were detected microscopically. Silicon and aluminum isotopes were also detected. Hyaluronic acid fillers were contaminated with these particles. The degree of contamination varied substantially among the tested filler products. These contaminant particles may evoke reactions in the patient’s body. Clinicians should be aware of this source of possible contamination and its effects.

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Section: Discussionmentioning

confidence: 99%

Determination of Hyaluronic Acid Dermal Filler Impurities Using SEM/EDS Analysis

Lee¹,

Rho

Yang

2023

Polymers

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“…Besides its likely role as an adjuvant to ocular inflammation and myodesopsia, silicone oil has been reported in association with autoimmune diseases, systemic embolism and sclerotic lipogranuloma [ 2 , 3 , 7 , 8 ]. A clinical entity resulting from breast silicone implants has long been acknowledged.…”

Section: Main Textmentioning

confidence: 99%

“…The injected subcutaneous silicone seems to migrate from the interstitial subcutaneous tissue into the general blood stream, resulting in a potentially fatal systemic silicone embolism [ 9 ]. Additionally, local sclerotic lipogranulomas might occur if injected in the fat tissue [ 7 ]. Another complication of dermal fillers includes pneumonitis, leading to respiratory failure [ 10 ].…”

Section: Main Textmentioning

confidence: 99%

The risks behind the widespread use of siliconized syringes in the healthcare practice

2021

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Injections are widely performed in the healthcare practice. Silicone has long been thought to be an inert and harmless material. Although used for decades in medical implants, including heart valves, breast implants, and as a tamponade for retinal detachment surgery, silicone oil might have deleterious effects. Agitation of the syringe to expel air at the moment of drug preparation not only leads to silicone oil release but also to therapeutic protein aggregation. Lab studies have shown that silicone oil microdroplets can act as an adjuvant to promote a break in immunological tolerance and induce antibody response. Similarly, recent studies have suggested a causal link between agitation of siliconized syringes and ocular inflammation after intravitreal injection. Systemically, silicone oil has been reported in association with autoimmune diseases and skin granuloma after either direct injection of dermal fillers or secondary leakage from silicone breast implant. However, it has not been established yet a potential link between the silicone oil released by the syringes and such relevant systemic adverse events. Few professionals are aware that agitation of a siliconized syringe might lead to silicone oil release, which, in turn, acts an adjuvant to an increased immunogenicity. We strongly recommend that every healthcare professional be aware of the use of silicone oil in the syringe manufacturing process, the factors that promote its release and the potential complications to the organism. Ultimately, we recommend that safer syringes be widely available.

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“…Another important issue involving the systemic effects of SO delivered directly into the subcutaneous space or into the bloodstream is the development skin granuloma, pulmonary emboli and autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld & Agmon-Levin 2011;Cohen et al 2017;Wambier et al 2018;Abrahams et al 2020). Although most of the previous adverse reactions associated with breast implants and dermal fillershave not been directly linked to the syringes, one should be aware that SO from any source might lead to harmful consequences.…”

Section: Introductionmentioning

confidence: 99%

Silicone oil‐free syringes, siliconized syringes and needles: quantitative assessment of silicone oil release with drugs used for intravitreal injection

Melo

Cruz

Agra

et al. 2021

Acta Ophthalmologica

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Purpose: This study aimed to quantify the amount of silicone oil (SO) released across a variety of syringe and needle models routinely used for intravitreal injection. Methods: The release of SO was assessed in eight models of syringes, two of which were reported to be 'SO-free', and eleven models of needles with unknown SO content. To evaluate SO release within the context of anti-VEGF therapeutics, syringes were evaluated using aflibercept, bevacizumab, buffer, ziv-aflibercept and formulation buffer. All syringe tests were performed with or without agitation by flicking for syringes. Needles were evaluated without agitation only. Samples were fluorescently labelled to identify SO, and triplicate measurements were collected using imaging flow cytometry. Results: Seven out of 8 syringe models showed a statistically significant increase in the SO particle count after agitation. The two SO-free syringe models (HSW Norm-Ject, Daikyo Crystal Zenith) released the least SO particles, with or without agitation, whereas the BD Ultra-Fine and Saldanha-Rodrigues syringes released the most. More SO was released when the syringes were prefilled with formulation buffer than with ziv-aflibercept. Syringes filled with aflibercept and bevacizumab had intermediate levels. Agitation increased the release of SO into each of the drug solutions. Silicone oil (SO) was detected in all needles. Conclusions: Agitation of the syringe by flicking leads to a substantial increase in the number of SO particles. Silicone oil (SO)-free syringes had the best performance, but physicians must also be aware that needles are siliconized and also contribute to the injection of SO into the vitreous.

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Syringe lubricant and adverse reactions

Cited by 6 publications

References 3 publications

Determination of Hyaluronic Acid Dermal Filler Impurities Using SEM/EDS Analysis

Determination of Hyaluronic Acid Dermal Filler Impurities Using SEM/EDS Analysis

The risks behind the widespread use of siliconized syringes in the healthcare practice

Silicone oil‐free syringes, siliconized syringes and needles: quantitative assessment of silicone oil release with drugs used for intravitreal injection

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