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 = 9590) treated between 2000 and 2015 in 6 major regional hospitals in the Netherlands, we performed a health survey (response rate 64.7%). The presence of 18 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 = 1821), 20.7% reported ≥4 BII-associated symptoms vs 21.2% of non-exposed patients (risk ratio 0.98; 95% CI = 0.88 to 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 5 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 to 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 2, 2022 (NCT05400954).