Preoperative lymph-node staging of invasive urothelial bladder cancer with 18F-fluorodeoxyglucose positron emission tomography/computed axial tomography and magnetic resonance imaging: correlation with histopathology.

OBJECTIVE: The treatment and prognosis of bladder cancer are based on the depth of primary tumour invasion and the presence of metastases. A highly accurate preoperative tumour, node, metastasis (TNM) staging is critical to proper patient management and treatment. This study retrospectively investigated the value of ¹8F-fluorodeoxyglucose (FDG) positron emission tomography/computed axial tomography (¹8F-FDG PET/CT) and magnetic resonance imaging (MRI) for preoperative N staging of bladder cancer. Material and methods. From June 2006 to January 2008, 48 consecutive patients diagnosed with bladder cancer were referred to preoperative staging including MRI and ¹8F-FDG PET/CT. Eighteen out of 48 patients underwent radical cystoprostatectomy including removal of lymph nodes for histology, and were included in the study. Values of ¹8F-FDG PET/CT and MRI for regional N staging were compared to histopathology findings, the gold standard. Results. ¹8F-FDG PET/CT and MRI were performed in 18 patients. The specificities for detection of lymph-node metastases for MRI and ¹8F-FDG PET/CT were 80% (n = 15) and 93.33% (n = 15), respectively. The negative predictive values were 80% (n = 15) and 87.5% (n = 16) for MRI and ¹8F-FDG PET/CT, respectively. The differences in specificity and negative predictive values were not statistically significant. Conclusions. No significant statistical difference between ¹8F-FDG PET/CT and MRI for preoperative N staging of urothelial bladder cancer was found in the study. However, the trend of the data indicates an advantage of ¹8F-FDG PET/CT over MRI. Larger prospective studies are needed to elucidate the role of ¹8F-FDG PET/CT in N staging of bladder cancer.

Regulatory measures for implementing new medical devices. Recalling Boneloc.

Through the past decades, new medical devices have been introduced at an increasing pace at the urge primarily of manufacturers, clinicians, and patients. Whereas it is mandatory to assess and approve new pharmaceuticals before their widespread use is allowed, innovations in medical devices generally have not been subject to the same restrictions. The European Community's program on completion of the Internal Market has generated a series of three Directives regulating the safety, reliability, and marketing of practically all non-pharmaceutical medical products. Once CE-marked, devices are available throughout the Union, an area constituted of nearly half a billion citizens after the expansion to 25 Member States. Before the European Union Directives were implemented, Boneloc was introduced to commercial distribution in the beginning of the nineties as a new and promising bone cement to be utilized in joint arthroplasty prostheses. While promptly gaining wide acceptance in most of the Nordic countries, Boneloc was after few years and about 5,500 implanted Scandinavian patients withdrawn from the market abruptly because of inferior fixation properties. Utilizing Boneloc as a test case, the present study critically examined whether a comparable incident could occur after the implementation of the European Union Directives and what strategies can be applied to avoid equivalent future misconduct.