Hölmich Lisbet R, Vejborg Ilse, Conrad Carsten, Sletting Susanne, McLaughlin Joseph K
Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100 Copenhagen, Denmark.
Eur J Radiol. 2005 Feb;53(2):213-25. doi: 10.1016/j.ejrad.2004.03.012.
The aim of this study was to evaluate the accuracy of Magnetic Resonance Imaging (MRI) as performed according to a strict study protocol in diagnosing rupture of silicone breast implants.
The study population consisted of 64 women with 118 implants, who had participated in either one or two study MRI examinations, aiming at determining the prevalence and incidence of silent implant rupture, respectively, and who subsequently underwent explantation. Implant rupture status was determined by four independent readers and a consensus diagnosis of either rupture (intracapsular or extracapsular), possible rupture or intact implant was then obtained. Strict predetermined rupture criteria were applied as described in this report and findings at surgery were abstracted in a standardised manner and results compared.
At MRI, 66 implants were diagnosed as ruptured, nine as possibly ruptured and 43 as intact. Among the ruptured implants, 27 were categorized as extracapsular. At surgery, on average 297 days after the MRI, 65 of the 66 rupture diagnoses were confirmed, as were 20 of the cases with extracapsular silicone. Eight of the nine possibly ruptured implants were in fact ruptured at surgery. Thirty-four of the 43 intact implants were described as intact at surgery. When categorising possible ruptures as ruptures, there were one false positive and nine false negative rupture diagnoses at MRI yielding an accuracy of 92%, a sensitivity of 89%, and a specificity of 97%. Correspondingly, the predictive value of a positive MRI examination was 99% and the predictive value of a negative MRI examination was 79%.
We conclude that MRI is highly accurate for identification of silicone breast implant rupture, with a high sensitivity and specificity when evaluation of images are based on presence of well-defined rupture criteria.
本研究旨在评估按照严格研究方案进行的磁共振成像（MRI）在诊断硅胶乳房植入物破裂方面的准确性。
研究对象为64名女性的118个植入物，她们分别参加了一次或两次研究性MRI检查，目的分别是确定无症状植入物破裂的患病率和发病率，随后均接受了取出手术。由四名独立阅片者确定植入物破裂状态，然后得出关于破裂（囊内或囊外）、可能破裂或植入物完整的共识诊断。采用本报告中所述的严格预定破裂标准，并以标准化方式提取手术结果并进行比较。
在MRI检查中，66个植入物被诊断为破裂，9个可能破裂，43个完整。在破裂的植入物中，27个被归类为囊外破裂。在MRI检查平均297天后进行手术，66个破裂诊断中有65个得到证实，20个囊外硅胶病例也得到证实。9个可能破裂的植入物中有8个在手术中实际破裂。43个完整的植入物中有34个在手术中被描述为完整。将可能破裂归类为破裂时，MRI检查有1例假阳性和9例假阴性破裂诊断，准确率为92%，敏感性为89%，特异性为97%。相应地，MRI检查阳性的预测值为99%，阴性的预测值为79%。
我们得出结论，当基于明确的破裂标准评估图像时，MRI在识别硅胶乳房植入物破裂方面具有高度准确性，具有高敏感性和特异性。
