MRI screening for silicone breast implant rupture: accuracy, inter- and intraobserver variability using explantation results as reference standard
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The recall of Poly Implant Prothèse (PIP) silicone breast implants in 2010 resulted in large numbers of asymptomatic women with implants who underwent magnetic resonance imaging (MRI) screening. This study’s aim was to assess the accuracy and interobserver variability of MRI screening in the detection of rupture and extracapsular silicone leakage.
A prospective study included 107 women with 214 PIP implants who underwent explantation preceded by MRI. In 2013, two radiologists blinded for previous MRI findings or outcome at surgery, independently re-evaluated all MRI examinations. A structured protocol described the MRI findings. The ex vivo findings served as reference standard.
In 208 of the 214 explanted prostheses, radiologists agreed independently about the condition of the implants. In five of the six cases they disagreed (2.6 %), but subsequently reached consensus. A sensitivity of 93 %, specificity of 93 %, positive predictive value of 77 % and negative predictive value of 98 % was found. The interobserver agreement was excellent (kappa value of 0.92).
MRI has a high accuracy in diagnosing rupture in silicone breast implants. Considering the high kappa value of interobserver agreement, MRI appears to be a consistent diagnostic test. A simple, uniform classification, may improve communication between radiologist and plastic surgeon.
• MRI has a high accuracy in diagnosing rupture in silicone breast implants.
• MRI appears to be a consistent diagnostic test with excellent interobserver agreement.
• A simple, uniform classification system, improves communication between radiologist and plastic surgeon.
• The interobserver agreement on implant rupture is higher than on extracapsular leakage.
KeywordsMagnetic resonance imaging (MRI) Silicone breast implants Accuracy Interobserver variability Intraobserver variability
The scientific guarantor of this publication is R.A. Manoliu. The authors of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article. The authors state that this work has not received any funding. No complex statistical methods were necessary for this paper. Institutional Review Board approval was not required because all MRIs were made during normal follow-up procedure after the recall procedure at the Jan van Goyen Medical Centre in Amsterdam; all information was anonymous and is not traceable to individual patients. Written informed consent was not required for this study because all MRIs were made during normal follow-up procedure after the recall procedure at the Jan van Goyen Clinic in Amsterdam; all information was anonymous and is not traceable to individual patients. Some study subjects or cohorts have been previously reported in Plastic Reconstructive Surgery [18, 19, 37]. This study, however, had a new purpose: to evaluate all MRI images made in 2011 by two independent radiologists to assess accuracy, as well as interobserver and intraobserver agreement. This current study was recently performed in 2013. The two radiologists evaluated all images from 2011 according to a new structured protocol, which was different from the 2011 round, reported earlier. Methodology: prospective, cross sectional study/prognostic study, performed at one institution.
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