Silicone breast implants (SBIs) have been used since the 1960s for breast augmentation and reconstruction. Over the years, there have been great controversies about its biocompatibility and toxicity. Significantly, in 1995, Brautbar et al. proposed that silicones were not inert and could induce cell death and have mutagenic effects as a result of gel bleed and migration of silicone molecules (1–3). Some women with the most recent generation of cohesive SBIs have reported similar clinical complaints known as Breast Implant Illness (BII). BII is characterized by a set of 40 symptoms including, but not limited to, fatigue, arthralgia, autoimmune disease, and hair loss. However, these symptoms are often considered a psychosomatic disease. On 27 October, 2021 the FDA took several new actions to strengthen breast implant risk communication and issued a black box warning. Such warnings alert physicians and the general population that breast implants are not lifelong devices, there is an increased chance of complications (BII), and that SBIs have been associated with anaplastic large cell lymphoma (BIA-ALCL) and systemic symptoms (4).

This case report aimed to alert the medical community about the real migration of silicone particles to tissues, which is therefore associated with their deleterious cytotoxic effects.

Currently, there is a lack of standardization for BII diagnosis. No validated tests can infer silicone bleed and impact patient management. The diagnosis of silicone bleed is possible with special histological staining, such as Modified Oil Red O (MORO), associated with MRI or ultrasound to perform the diagnosis of gel bleed, rupture, or migration in the patient. We demonstrated that we can perform screening and diagnosis for patients suffering from BII.

Silicone is an artificial molecule that is not present in the environment. The first attempts to apply silicones subcutaneously began as early as the late 1940s, and at that time, studies by Rowe and co-workers suggested that silicones were physiologically inert and presented no health risks.

Silicone in SBIs is usually straight chains of polydimethylsiloxanes (PDMS). PDMS fluids come in various viscosities from water-like liquids to non-pourable fluids, and all of them are essentially water-insoluble (hydrophobic). 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).

The result of silicones bleeding from the SBI is that they are able to trigger an immune response. Furthermore, due to biodegradation by enzymes and hydrolysis, the silicones are degraded to cyclic siloxanes leading to toxicity and further rupture (9, 11, 12).

The increase in the number of silicones in tissues is often associated with an increase in the numbers of macrophages, fibroblasts, giant cells, and contractile myofibroblast (13, 14), all of which are related with several symptoms of BII (15). Further, the surface and texture of silicone breast implants can impact the immune system (16). In our study, we have used MORO stain to show silicone migration in tissues–synovia, blood vessels, and nerve bundles, via the specific staining of silicone polymers (5).

We also describe the correlation of the MRI findings to histology, regardless of no evident intracapsular rupture. The MRI accurately showed gel bleed and therefore MRI could be used as a marker for gel bleed and silicone migration. When silicone-induced granuloma of breast implant capsule (SIGBIC) is present, the nonspecific symptoms reported by patients should be valorized by the clinician using MRI to further diagnose BII.

In many patients who have complaints about their breast implants, removal (explanting) of the SBI leads to a considerable decline in complaints in a lot of patients, a strong indicator of a causative relation (17, 18).

Accordingly, in our patient, there was a significant improvement in reported symptoms after explantation, such as muscle contractures, arthralgias, shortness of breath, urticaria, fatigue, and arthritis. However, at present (2021), pain and paresthesia persist in the wrists, especially on the right, as well as the persistence of immunological markers and Raynaud Phenomenon.

Silicone breast implant toxicity is a cause for concern toward the unborn child because silicone molecules can pass the placenta and miscarriages occur (15), supported by increasing scientific evidence (19). It is of great importance there is a more intensified discussion for the diagnosis of BII, silicone gel bleed, and migration in the medical community.

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.

Ethical review and approval was not required for the study on human participants in accordance with the local legislation and institutional requirements. The patients/participants provided their written informed consent to participate in this study. Written informed consent was obtained from the individual for the publication of any potentially identifiable images or data included in this article.

All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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