Breast implant illness after reconstruction with silicone breast implants.

BACKGROUND 'Breast implant illness' (BII) is a constellation of non-specific constitutional, rheumatologic, mental and cognitive symptoms, reported increasingly by women carrying silicone breast implants (SBIs). The impact of BII on the well-being of breast cancer patients with SBI-based breast reconstructions is a subject of debate. METHODS In a multicenter cohort of breast cancer survivors (n = 9,590) treated between 2000 and 2015 in six major regional hospitals in the Netherlands, we performed a health survey (response rate 64.7%). The presence of eighteen BII-associated symptoms was compared between patients with and without SBIs in multivariable logistic regression models. In a latent class analysis (LCA), distinct symptom patterns were identified in the study population. RESULTS Median follow-up time was 13.7 (IQR, 6.8) years. Of all SBI-exposed patients (n = 1,821), 20.7% reported ≥4 BII-associated symptoms, vs 21.2% of non-exposed patients (Risk Ratio 0.98, 95% CI [0.88-1.09]). Joint pain, sicca, sleep impairment, morning stiffness and shoulder pain were reported most frequently. Patients with SBIs did not have a significantly increased risk of any of the individual BII-associated symptoms. The LCA identified five distinct symptom clusters. Patients with SBI-exposure had a lower risk of falling in the most severe symptom cluster (Odds Ratio 0.64, 95% CI [0.43-0.96]). The other symptom clusters were not significantly associated with SBI-exposure. CONCLUSIONS Our results indicate that breast cancer survivors with SBI-based reconstructions do not experience more BII-associated symptoms than breast cancer survivors without SBIs, challenging the notion of BII as a distinct clinical entity based on a generic silicone-induced biomechanical pathophysiological mechanism. TRIAL REGISTRATION This study was preregistered at ClinicalTrials.gov on June 2nd 2022 (NCT05400954).