Magnetic Resonance Imaging To Monitor The Integrity Of Silicone Gel-Filled Breast Implants

This evidence review addresses the use of magnetic resonance imaging (MRI) to monitor the integrity of silicone gel-filled breast implants (hereafter, referred to as silicone implants). For individuals who have suspected rupture of silicone breast implants who receive screening with MRI, the evidence includes diagnostic accuracy studies and systematic reviews. Relevant outcomes are test validity, morbid events, and treatment-related morbidity. The available literature on MRI for the detection of suspected rupture of silicone breast implants shows reasonable clinical validity, with high sensitivity and specificity when compared with the more invasive procedure of surgical explantation. While there is no direct evidence on the clinical utility of MRI for detecting suspected rupture, there is evidence for the clinical utility of confirming rupture prior to the explantation of an implant. Because other noninvasive techniques such as clinical examination, mammography, or ultrasonography have technical limitations and lower sensitivities and specificities, an MRI may be the most appropriate noninvasive diagnostic technique to confirm rupture. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. For individuals who are asymptomatic with silicone breast implants who receive screening with MRI, the evidence includes diagnostic accuracy studies and systematic reviews. Relevant outcomes are test validity, morbid events, and treatment-related morbidity. Studies of MRI screening for silent rupture in asymptomatic women with silicone implants have demonstrated reasonably high sensitivity and specificity compared with surgical explantation. However, the studies have generally been conducted in select populations (eg, women who want implants removed), and the data lack screening populations. None of the systematic reviews conducted pooled analyses that focused on asymptomatic women. Moreover, the clinical utility of MRI screening for silent rupture is unclear, ie, complications that may result from asymptomatic leakage of silicone are not well-characterized. The evidence is insufficient to determine the effects of the technology on health outcomes. <a id="