Unexplained Systemic Symptoms in Women With Silicone Breast Implants: A Descriptive Cohort Study

Background: An unknown portion of women with silicone breast implants (SBI) report development of systemic symptoms, known as Breast Implant Illness (BII). This study aimed to describe the pattern of symptoms in a cohort of these women and evaluate the effect of implant removal.  Methods: Data were collected from women who visited a specialized BII outpatient clinic in the Netherlands between 2011 and 2018. Additionally, women were interviewed with follow-up questions by phone between 2016-2020. The effect of implant removal was evaluated and symptoms were compared to women who did not had their implants removed. Findings: 467 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 (ANA) were observed in 23%. At follow-up with a median of 3·3 years (IQR 2-4), 152 women had their implants removed. 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 to women who did not (OR 2·9, 95% CI 1·3 – 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 complaints decreased from 75% to 34% after implant removal (p<0·0001). Interpretation: Most 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. Funding Information: None. Declaration of Interests: We declare no competing interests. Ethics Approval Statement: This study was reviewed by the Ethical Review Board of the Amsterdam UMC, VU University Medical Center Amsterdam (reference number: 2021.0200). It was determined that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and necessity for written informed consent was waived. All data were processed anonymously.