In this study, we compared one hundred patients with autoimmune/inflammatory syndrome induced by adjuvants (ASIA) due to silicone implant incompatibility syndrome diagnosed in 2014 in Maastricht, the Netherlands, with one hundred historical patients with adjuvant breast disease diagnosed in the Baylor College of Medicine, Houston, USA, between 1985 and 1992. Similarities and differences between these two cohorts were identified to determine whether the spectrum of silicone-related disease changed during the last 30 years. Patients with complaints possibly due to silicone-filled breast implants were prospectively examined in the Reinaert Clinic, Maastricht, the Netherlands between January 2014 and October 2014. All patients were evaluated for the fulfilment of ASIA criteria. Results were compared to results of the Baylor College cohort and 18 other reviewed historical cohorts. Clinical manifestations between the Maastricht and Baylor College cohorts were comparable. Fatigue was observed in 98 current patients and in 95 historical patients. Arthralgia was observed in 91 versus 81 historical patients. Myalgia was observed in 54 versus 91 patients. Cognitive impairment was observed in 78 versus 81 patients, pyrexia was observed in 64 versus 52 patients, sicca complaints in 73 versus 72 patients and severe neurological manifestations in 20 versus 32 patients. From the 54 patients who underwent removal of their silicone breast implant, 50 % (n = 27) of the patients experienced improvement of complaints after explantation of the implant. Also, in the 18 reviewed historical cohorts, similar clinical manifestations were described. Our findings suggest that no major changes were present in the observed clinical manifestations between the Maastricht and Baylor College cohorts. Also, despite changes in the principal constituents of the silicone implants during the past fifty years, silicone remained an adjuvant that may ‘bleed’ and subsequently may be a chronic stimulus to the immune system resulting in similar clinical manifestations as observed in the Maastricht cohort, the Baylor College cohort and 18 other large cohorts of patients. We therefore conclude that silicone-related disease has not changed during the last 30 years.

In this review, we present a critical review of the existing literature reflecting the results of explantation of silicone breast implants in patients with silicone-related complaints and/or autoimmune diseases. A literature search was performed to discuss the following issues: which clinical manifestations and autoimmune diseases improve after explantation, and what is the course of these complaints after explantation. Next, we reviewed studies in which the effect of explantation on laboratory findings observed in patients with silicone breast implants was studied, and lastly, we reviewed studies that described the effect of reconstruction of the breast with a new implant or autologous tissue after explantation. We calculated from the literature that explantation of the silicone breast improved silicone-related complaints in 75 % of the patients (469 of 622). In patients with autoimmune diseases, however, improvement was only infrequently observed without additional therapy with immunosuppressive therapy, i.e., in 16 % of the patients (3 of 18). The effect of explantation did not influence autoantibody testing such as ANA. We discuss several possibilities which could clarify why patients improve after explantation. Firstly, the inflammatory response could be reduced after explantation. Secondly, explantation of the implants may remove a nociceptive stimulus, which may be the causative factor for many complaints. Options for reconstruction of the explanted breast are autologous tissue and/or water-/hydrocellulose-filled breast implant. Unfortunately, in very few studies attention was paid to reconstructive possibilities. Therefore, no adequate conclusion regarding this issue could be drawn. In conclusion, explantation is useful for improvement of silicone-related complaints in 75 % of the patients, whereas in patients who developed autoimmune diseases improvement is only observed when explantation is combined with immunosuppressive therapy. In a patient with silicone-related complaints in which explantation is considered, the patient should be counseled for the different options of reconstruction after explantation.

SBIs are associated in a proportion of patients with complaints such as fatigue, cognitive impairment, arthralgias, myalgias, pyrexia, dry eyes and dry mouth. Silicones can migrate from the implant through the body and can induce a chronic inflammatory process. Explantation of SBI results in the majority of patients in an amelioration of the symptoms.

Background Millions of women have silicone breast implants (SBI). Some report a pattern of systemic complaints, also referred to as ASIA syndrome. However, the association between these complaints and breast implants remains uncertain. Objectives This study aimed to evaluate the prevalence of complaints in women with breast implants and healthy controls, and to compare their health-related quality of life (HRQoL). Methods Four groups of subjects were requested to fill in a general and a diagnostic questionnaire, and the Short Form 36. Group 1 was recruited from the Dutch foundation for breast implant illness (BII). Two groups were recruited from Dutch hospitals, where they were augmented or reconstructed with SBI (group 2) or saline-filled and hydrogel implants (group 3). A control group without breast implants was recruited from friends of subjects from group 2 and 3. Results In total, 238 women completed the questionnaires. ASIA manifestations appeared in the majority of the respondents (72.3-98.8%), with a latency period of 0-35 years. Adjusted for age, smoking, and comorbidities, typical symptoms only occurred significantly more frequent in group 1. The presence of a chronic disease was an independent predictor for ASIA syndrome. HRQoL was lower in women with SBI than in women without breast implants. Conclusions The adjusted prevalence of BII manifestations is not significantly higher in women with SBI compared to women without implants. The findings of this study suggest that results on BII are subject to selection bias. Further studies are needed to prove an association between self-reported complaints and SBI.

The development of autoimmunity and/or autoimmune diseases is multifactorial. Vitamin D is one of the factors that might play a role. We postulated that both the presence of adjuvants and insufficient levels of vitamin D may result in the development of autoimmunity in patients with autoimmune/inflammatory syndrome induced by adjuvants (ASIA) in relation to silicone implant incompatibility. We measured vitamin D levels in 135 patients with ASIA in relation to silicone implant incompatibility and related findings to the presence of autoantibodies that are commonly used to diagnose systemic autoimmune diseases. Furthermore, we systematically reviewed the literature regarding vitamin D deficiency as a risk factor for the development of autoantibodies. Vitamin D measurements were available for analysis in 131 of 135 patients with ASIA in relation to SIIS. Twenty-three patients (18%) tested positive for autoantibodies, from which 18 patients (78%) had either a vitamin D deficiency or insufficiency (median vitamin D level 60.5 mmol/L), whereas five patients (22%) had sufficient vitamin D levels. The risk to develop autoantibodies was significantly increased in vitamin D deficient and/or insufficient patients [RR 3.14; 95% CI, 1.24–7.95; p = 0.009]. Reviewed literature suggested an association between vitamin D levels and the presence and/or titer levels of autoantibodies in different autoimmune diseases. From our current study and from our review of the literature, we conclude that vitamin D deficiency is related to the presence of autoantibodies. Whether vitamin D supplementation results in a decrease of autoimmunity needs to be studied prospectively.