Breast implant illness after reconstruction with silicone breast implants

Abstract

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).

Figure 1.

Flow diagram of inclusions and analyses. NKR = Netherlands Cancer Registry; MICE = multiple imputation by chained equations; SBI = silicone breast implant.

Figure 2.

Prevalence of breast implant illness-associated symptoms in the study population. Prevalence of severe, moderate, and mild breast implant illness-associated symptoms in breast cancer survivors who received silicone implant-based breast reconstruction (red) and breast cancer survivors who were never exposed to silicone breast implants (blue). *Scales used to measure these symptoms did not provide a rational criterion to distinguish a moderate symptom severity category.

Figure 3.

Breast implant illness-associated symptoms in breast cancer survivors with implant-based breast reconstruction compared with breast cancer survivors never exposed to silicone breast implants. (A) Risk of symptoms for women with SBI(s) versus all unexposed women. (B) Risk of symptoms for women with SBI(s) versus women who underwent simple mastectomy. (C) Risk of symptoms for women with SBI(s) versus women who underwent autologous breast reconstruction. (D) Risk of symptoms for women with SBI(s) versus women who underwent breast-conserving therapy. Multivariable logistic regression models (* modified Poisson regression models with robust standard error estimation) were constructed in imputed data and adjusted for age at study (category), time since surgery (category), socioeconomic status (continuous), education (category), employment (category), relationship (category), smoking (category), pack years (continuous), alcohol consumption (category), BMI (continuous), social media consumption (continuous), age at birth first child (category), children (category), Rosenberg self-esteem score (continuous), breast cancer stage (category), tumor differentiation grade (category), adjuvant endocrine therapy (dichotomous), adjuvant chemotherapy (dichotomous), adjuvant anti-her2 therapy (dichotomous), radiotherapy (dichotomous), contralateral breast cancer (dichotomous), genetic breast cancer (category), number of operations (category), and number of self-reported complications (category).

Figure 4.

Results of the latent class analysis. The X-axis shows the observed symptom clusters and the corresponding proportion of the study population that falls in the respective cluster. On the Z-axis individual symptoms that were used to identify the clusters have been plotted. The Y-axis gives, for every symptom cluster, the probability that a member of that cluster is suffering from an individual symptom. Each study participant falls in one cluster only.

Figure 5.

Secondary outcomes: breast-Q mean scores and health-related quality of life. Abbreviations: SBI = silicone breast implant-based reconstruction; SM = simple mastectomy; ABR = autologous breast reconstruction; BCT = breast-conserving therapy; HRQoL = health-related quality of life. Secondary outcomes: Breast-Q mean scores for breast cancer survivors according to surgical treatment and relative risks of impaired health-related quality of life in comparison groups versus breast cancer survivors with silicone implant-based breast reconstruction. (A) Pooled means and 95% confidence intervals of Breast-Q module scores per treatment group calculated in imputed data. (B) Relative risk (RR) of experiencing impaired health-related quality of life for breast cancer survivors in the unexposed groups compared with breast cancer survivors who received silicone implant-based breast reconstruction. Relative risks and 95% confidence intervals were calculated though a modified Poisson regression approach with robust standard error estimation in dichotomized Short Form-12 physical and mental component scores. Models were constructed in imputed data and adjusted for age at study (category), time since surgery (category), socioeconomic status (continuous), education (category), employment (category), relationship (category), smoking (category), pack years (continuous), alcohol consumption (category), BMI (continuous), social media consumption (continuous), age at birth first child (category), children (category), Rosenberg self-esteem score (continuous), breast cancer stage (category), tumor differentiation grade (category), adjuvant endocrine therapy (dichotomous), adjuvant chemotherapy (dichotomous), adjuvant anti-her2 therapy (dichotomous), radiotherapy (dichotomous), contralateral breast cancer (dichotomous), genetic breast cancer (category), number of operations (category), and number of self-reported complications (category).