The Effect of Study Design Biases on the Diagnostic Accuracy of Magnetic Resonance Imaging for Detecting Silicone Breast Implant Ruptures: A Meta-Analysis

Abstract

Background All silicone breast implant recipients are recommended by the US Food and Drug Administration to undergo serial screening to detect implant rupture with magnetic resonance imaging (MRI). We performed a systematic review of the literature to assess the quality of diagnostic accuracy studies utilizing MRI or ultrasound to detect silicone breast implant rupture and conducted a meta-analysis to examine the effect of study design biases on the estimation of MRI diagnostic accuracy measures. Method Studies investigating the diagnostic accuracy of MRI and ultrasound in evaluating ruptured silicone breast implants were identified using MEDLINE, EMBASE, ISI Web of Science, and Cochrane library databases. Two reviewers independently screened potential studies for inclusion and extracted data. Study design biases were assessed using the QUADAS tool and the STARDS checklist. Meta-analyses estimated the influence of biases on diagnostic odds ratios. Results Among 1175 identified articles, 21 met the inclusion criteria. Most studies using MRI (n= 10 of 16) and ultrasound (n=10 of 13) examined symptomatic subjects. Meta-analyses revealed that MRI studies evaluating symptomatic subjects had 14-fold higher diagnostic accuracy estimates compared to studies using an asymptomatic sample (RDOR 13.8; 95% CI 1.83–104.6) and 2-fold higher diagnostic accuracy estimates compared to studies using a screening sample (RDOR 1.89; 95% CI 0.05–75.7). Conclusion Many of the published studies utilizing MRI or ultrasound to detect silicone breast implant rupture are flawed with methodological biases. These methodological shortcomings may result in overestimated MRI diagnostic accuracy measures and should be interpreted with caution when applying the data to a screening population.

Reoperative Transaxillary Breast Surgery: Using the Axillary Incision to Treat Augmentation-related Complications

“…4, imaging may be useful. Despite the higher accuracy and efficacy of MRI in detecting collections, ultrasound may also be useful in directly locating the fluid [21][22][23].…”

Correlation between MRI results and intraoperative findings in patients with silicone breast implants

“…From their results, the authors concluded that rupture is a “relatively harmless condition, which only rarely progresses and gives rise to notable symptoms” 24. Song et al studied the diagnostic accuracy of MRI examination regarding breast implant rupture, and found that most studies using MRI and ultrasound examined symptomatic subjects and therefore had a 14-fold higher diagnostic accuracy than studies in asymptomatic subjects 25. This underlines the lack of proof that routine screening of patients with breast implants will result in correct detection of implant ruptures.…”

Diagnosing PIP breast implant failure: A prospective analysis of clinical and ultrasound accuracy

“…In a meta-analysis by Song et al, a pooled ultrasound sensitivity and specificity of 61% and 76%, respectively, was found. 16 However 66% of studies included in this meta-analysis were solely from symptomatic patients. Furthermore details regarding explantation were inconsistently reported.…”