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Background The etiology of capsular contracture (CC), the most common complication following breast augmentation, remains unclear. Chronic, fibrotic inflammation resulting in excessive fibrosis has been proposed as a potential mechanism. Objectives In this study, we aimed to investigate the relation between biomarkers that are associated with inflammation and fibrosis and the severity of CC. Methods Fifty healthy females were categorized into 3 groups: females with no-to-mild CC (Baker 1-2; n = 15), females with severe CC (Baker 3-4; n = 20), and a control group awaiting breast augmentation (n = 15). We assessed 5 biomarkers (galectin-1 [Gal-1], interferon-β [INF-β], interferon-γ [INF-γ], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]) in breast implant capsules and serum samples. Results No significant differences in intracapsular cytokine levels were observed between the Baker 1-2 and the Baker 3-4 groups, as the levels were generally low and, in some cases, almost undetectable. In the blood samples, no significant differences in Gal-1, INF-γ, IL-6, or TNF-α levels were found within the 3 groups. We identified significantly increased levels of INF-β (P = .009) in the blood samples of females with severe CC, driven mainly by 3 extremely high values. Conclusions The cytokines assessed in this study did not reflect the degree of CC among females with silicone breast implants. However, 3 females with severe CC, who all had prolonged silicone exposure, showed extremely elevated levels of INF-β in their serum samples. This possible association between prolonged silicone exposure and systemic inflammation in some females should be further investigated. Level of Evidence: 3

Background: This study aims to describe a prospective clinical cohort of patients with silicone breast implants and suspected Breast Implant Illness (BII). Methods: Women were included in a specialized silicone outpatient clinic at Amsterdam UMC, the Netherlands. Baseline characteristics were collected including medical history, implant details, and symptoms. Experienced physicians categorized BII suspicion as high, moderate, or low, based on symptoms and after exclusion of other probable causes. Additionally, participants completed questionnaires assessing symptoms and daily life impact at baseline, 6 months, 1, 2, and 5 years. For this initial analysis, the results from the first three years of inclusions were collected. Results: Data from 353 women were collected from December 2020–December 2023. At baseline, the most reported symptoms were fatigue, arthralgia, myalgia, and morning stiffness, accompanied by local symptoms in 83.3% of patients. At the clinic, 112 women were categorized as having high suspicion of BII, 147 women as moderate, and 94 women as low. At follow-up, 182 women (51.6%) opted for explantation. Following explantation, women with a high or moderate suspicion of BII experienced more significant symptom improvement, accompanied by a decrease in anxiety and a greater sense of control over their illness, compared to women with a low suspicion of BII. Conclusions: Our study highlights a distinct interplay of systemic and local symptoms among women with suspicion of BII. Women with a high or moderate BII suspicion benefit significantly more from explantation than women with low suspicion. Experienced physicians are pivotal in effectively assessing and guiding this patient group, highlighting the need for tailored clinical approaches.

ObjectiveAn unknown portion of women with silicone breast implants (SBI) report development of systemic symptoms, recently named as ‘breast implant illness (BII)’. We aim to describe the symptoms and characteristics of women with SBI reporting these systemic symptoms and compare the clinical course of women who chose to keep their implants, to women who had their implants removed.DesignObservational cohort study.SettingSpecialised BII out-patient clinic at Amsterdam UMC, the Netherlands, from 2011 to 2020.ParticipantsAll women presenting to the BII clinic with SBI and systemic symptoms.Results467 women were included for baseline analyses and 398 women for follow-up. Most frequently reported systemic symptoms at baseline included fatigue (88%), arthralgia (71%), morning stiffness (59%), myalgia (48%), cognitive impairment (33%), peripheral neurological symptoms (30%) and lymphadenopathy (22%). Furthermore, 56% reported pre-existing allergies at baseline and positive antinuclear antibodies were observed in 23%. At follow-up with a median of 3.3 years (IQR 2–4), 152 women had their implants removed on clinical grounds. Symptoms improved significantly in 65 women (43%), improved moderately in 37 women (24%), did not change in 37 women (24%) and deteriorated in 13 women (9%). Women who underwent explantation showed more improvement of their systemic symptoms compared with women who did not (OR 2.9, 95% CI 1.3 to 6.2). Additionally, women who underwent explantation within 10 years after implantation improved significantly better than women who got the implants removed after 10 years (p=0.007). Lastly, local symptoms decreased from 75% to 34% after implant removal (p<0.0001).ConclusionMost women with SBI who developed systemic symptoms experienced improvement after explantation, especially when removed within 10 years after implantation. Early recognition of the pattern of systemic symptoms in women with SBI is important and implant removal should be considered.