Department of Plastic, Reconstructive and Hand Surgery, VU University Medical Centre, De Boelelaan 1117, PO Box 7057, 1007 MB, Amsterdam, The Netherlands,
Eur Radiol. 2014 Jun;24(6):1167-75. doi: 10.1007/s00330-014-3119-8. Epub 2014 Mar 6.
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.
2010 年，由于 Poly Implant Prothèse（PIP）硅胶乳房植入物的召回，大量无症状的植入物女性接受了磁共振成像（MRI）筛查。本研究旨在评估 MRI 筛查在检测破裂和囊外硅胶渗漏中的准确性和观察者间变异性。
前瞻性研究纳入了 107 名 214 例 PIP 植入物女性，这些女性在接受 MRI 检查之前进行了乳房假体取出术。2013 年，两名放射科医生在对先前的 MRI 结果或手术结果不知情的情况下，独立重新评估了所有的 MRI 检查。采用结构化方案描述 MRI 结果。离体检查结果作为参考标准。
在 214 个取出的假体中，208 个假体的两位放射科医生独立对假体的状况达成一致意见。在 6 个不一致的病例中（2.6%），但随后达成了共识。MRI 检查的灵敏度为 93%，特异性为 93%，阳性预测值为 77%，阴性预测值为 98%。观察者间的一致性极好（kappa 值为 0.92）。
MRI 对诊断硅胶乳房植入物破裂具有很高的准确性。考虑到观察者间一致性的高 kappa 值，MRI 似乎是一种一致的诊断测试。一个简单、统一的分类系统可以改善放射科医生和整形外科医生之间的沟通。
MRI 对诊断硅胶乳房植入物破裂具有很高的准确性。MRI 似乎是一种一致性好的诊断测试，观察者间一致性极好。一个简单、统一的分类系统可以改善放射科医生和整形外科医生之间的沟通。对假体破裂的观察者间一致性高于对囊外渗漏的一致性。
