Assessment of Silicone Particle Migration Among Women Undergoing Removal or Revision of Silicone Breast Implants in the Netherlands

Dijkman, Henry; Slaats, Inca; Bult, Peter

doi:10.1001/jamanetworkopen.2021.25381

Cited by 31 publications

(27 citation statements)

References 34 publications

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“…Their contents were mixtures of various sized polymer compounds, many of which are smaller than the pores of the shell ( 6 ) and consequently bleeding occurrs ( 7 ). The latest generation of SBIs consists of a high cohesive gel but also in these latest types, gel bleed still occurs and will increase over time, due to biodegradation of the cohesive gel and the implant shell ( 8 – 10 ).…”

Section: Discussionmentioning

confidence: 99%

Case Report: Evidence of Migratory Silicone Particles Arising From Cohesive Silicone Breast Implants

Mustafá

Fleury

Dijkman

2022

Front. Glob. Womens Health

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BackgroundSilicone implants have been used since the 1960s for aesthetic purposes and breast reconstructions. During this period, many women have reported up to 40 similar symptoms, including fatigue, the emergence of autoimmune diseases, Raynaud Phenomenon, arthritis, arthralgias, and hair loss, among others. However, most of the time, these symptoms are neglected by doctors across different specialties and are most often considered a psychosomatic disease. Since 2017, many women suffering from the same complaints have formed social media groups to report their histories and subsequently describe the disease as Breast Implant Illness (BII). The phenomenon of gel bleed and silicone toxicity is known and accepted in literature, but silicone migration into the extracapsular space is still poorly demonstrated, due to the difficulty of monitoring its particles and access to patient data.MethodsThis work demonstrated the presence of silicone through pathological examination in post-explant breast capsules and in the synovial tissue of the right wrist, detected with special Modified Oil Red O (MORO) staining in a patient with a history of BII. The pathological results were compared to the breast MRI imaging files.ResultsThe MRI images show the permeability change of the implant shell diagnosed as a water-droplet signal. It was also possible to diagnose the gel bleeding as the silicone-induced granuloma of breast implant capsule (SIGBIC) in both implants. Silicone gel bleed and migration of silicone were detected with MORO staining in and outside the capsule and in the synovial tissue of the right wrist.ConclusionIn this case study, we showed that silicone migration is possible via cohesive silicone gel breast implant leakage. The accumulation of silicone in the synovial tissue of the right wrist suggests local silicone toxicity and defects.

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Section: Discussionmentioning

confidence: 99%

Case Report: Evidence of Migratory Silicone Particles Arising From Cohesive Silicone Breast Implants

Mustafá

Fleury

Dijkman

2022

Front. Glob. Womens Health

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“…Recent studies have shown that the newer generation of silicone gel implants degrade over time, with changes in color, clarity, and silicone cohesion [ 7 ]. These changes gradually increase the risk of silicone release following a rupture event, eventually resulting in no statistical difference in silicone leakage rates between the newer gel and older liquid silicone implants [ 7 , 8 ]. This may be an early indication that silicone leakage from breast implant rupture may not just be a problem of the past but an ongoing issue into the future.…”

Section: Discussionmentioning

confidence: 99%

Free Silicone With Giant Cell Reaction Can Enhance on Breast MRI

Miles¹,

Nguyen²

2022

Cureus

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BackgroundBreast augmentation with silicone implants is commonplace, and such implants have a risk of rupture which increases over time. Most implant ruptures are asymptomatic, and magnetic resonance imaging (MRI) is a recommended imaging modality for surveillance to detect these events. If a silicone leak enhances on MRI, it is currently categorized according to the Breast Imaging Reporting and Data System (BI-RADS) as category 4, which results in a recommendation for biopsy even when free silicone leakage is the most likely diagnosis. In this article, we present a case series that illustrates this issue with the BI-RADS system and propose an algorithmic approach that may allow some patients to be placed into BI-RADS category 3 and avoid biopsy. MethodologyEight cases of silicone breast implant rupture were identified at the University of Texas Medical Branch at Galveston over a five-year period. Two cases were excluded because MRI was not performed. The remaining six cases were evaluated for history and physical findings as well as mammogram, ultrasound, and MRI. All identified cases had been categorized as BI-RADS 4 and underwent biopsy. ResultsThe six cases in this series exhibited pre-biopsy radiographic findings that were most consistent with silicone implant rupture. The ruptures were proven by biopsy, and no evidence of malignancy was identified in any of the patients. ConclusionsFree silicone from breast implant rupture can present with enhancement on MRI. The two main categories of breast MRI enhancement, namely, mass and non-mass, include malignancies in their differential diagnoses and result in a BI-RADS category 4 designation. By correlating the findings with other imaging modalities, some of these patients can be classified as BI-RADS category 3 and biopsy can safely be avoided.

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“…The quantification of exposure via all these sources is not known and was therefore not considered in this review. However, it is known that today, human exposure to siloxanes through the environment [38], by cosmetic products [39], and medical devices [40] far exceeds that due to the additive E900 from food intake.…”

Section: Biological and Toxicological Effects Of Pdmsmentioning

confidence: 99%

Considerations on the Analysis of E-900 Food Additive: An NMR Perspective

Palacios-Jordan

Jané-Brunet

et al. 2022

Foods

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Food additives are in widespread use in the food industry to extend the shelf life of food, improve its organoleptic characteristics or facilitate industrial processing. Their use is not without controversy, which makes regulation and control crucial for food safety and public health. Among food additives, silicone-based antifoaming agents (polysiloxanes or E900) are difficult to analyze and quantify due to their polymeric nature. Currently, there is no official method of quantifying this additive in foods. In this context, nuclear magnetic resonance (NMR) is a quantitative method for speciation analysis of silicon compounds almost without known interferents. In this work, we describe the evolution of the regulation of the E900 additive, discuss different analytic methods quantifying polydimethylsiloxanes (PDMS), and propose a new method based on NMR suitable for analyzing the content of E900 in the form of PDMS in various types of food from dietary oils to marmalades and jellies, among others. The proposed method consists of a previous quantitative concentration of PDMS by liquid–liquid extraction and the monitoring of the quantification using a bis(trimethylsilyl)benzene (BTMSB) standard to control the variability, ranging within 2–7%, depending on the food. This simple, direct, and reproducible procedure for aqueous and lipidic foods may help to monitor and fill a gap in regulatory legislation regarding the E900 additive.

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Assessment of Silicone Particle Migration Among Women Undergoing Removal or Revision of Silicone Breast Implants in the Netherlands

Cited by 31 publications

References 34 publications

Case Report: Evidence of Migratory Silicone Particles Arising From Cohesive Silicone Breast Implants

Case Report: Evidence of Migratory Silicone Particles Arising From Cohesive Silicone Breast Implants

Free Silicone With Giant Cell Reaction Can Enhance on Breast MRI

Considerations on the Analysis of E-900 Food Additive: An NMR Perspective

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