The Diagnosis of Silicone Breast-Implant Rupture

Abstract

In Brief The objective was to evaluate the usefulness of clinical examination in the evaluation of breast-implant integrity, using the diagnosis at magnetic resonance imaging (MRI) as the “gold standard.” Fifty-five women with 109 implants underwent a breast examination either just before or shortly after an MRI examination. Twenty-four of 109 implants were clinically diagnosed with possible rupture or rupture. Eighteen of the 24 implants were ruptured according to the MRI examination (75%). Eighty-five implants were clinically classified as intact, and 43 of these were actually ruptured at MRI (51%). The sensitivity of the clinical examination for diagnosing rupture was thus 30% and the specificity 88%. The positive predictive value of a clinical diagnosis of rupture was 75%, and the negative predictive value was 49%. In this study, we found that when a clinical examination is used as the sole diagnostic tool to identify implant rupture, neither the sensitivity nor the specificity is acceptable. Of 55 women with 109 breast implants undergoing breast examination in proximity to MRI, 24 were clinically diagnosed as ruptured, whereas 43 were confirmed as ruptured on MRI. Sensitivity of clinical exam for diagnosis of rupture was 30% and specificity was 88%, both deemed unacceptable.