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OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. KEY POINTS: 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.
Assuntos
Implantes de Mama/efeitos adversos , Imageamento por Ressonância Magnética/métodos , Imageamento por Ressonância Magnética/normas , Falha de Prótese/efeitos adversos , Géis de Silicone/efeitos adversos , Adulto , Implantes de Mama/estatística & dados numéricos , Feminino , Humanos , Variações Dependentes do Observador , Valor Preditivo dos Testes , Estudos Prospectivos , Padrões de Referência , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Adulto JovemRESUMO
STUDY DESIGN: It is a longitudinal pilot study. OBJECTIVES: To investigate the feasibility of a low-cost and widely used fitness tracker with step count and heart rate data to monitor daily physical activity in wheelchair users with spinal cord injury (SCI). SETTING: Dutch community. METHODS: Six participants with SCI who were in training for a handbike event were recruited. They were asked to wear a Fitbit Charge 2® 24 h a day for at least 2 weeks and were questioned about the utility and user-friendliness of this device. RESULTS: Five out of six participants managed to wear the device nonstop for 2 weeks, and continued to wear the device after this initial period. Most participants were enthusiastic about the direct feedback provided by the tracker and reported the data to be accurate. Data collected during more than 2 months of three participants and during 8 months on one of them showed the possibility of detecting training days and observing interpersonal and intrapersonal variation in daily physical activity level. CONCLUSIONS: A commercially available, low-cost, self-monitoring multi-sensor wrist device or a fitness tracker like the Fitbit Charge 2® can be a promising instrument to monitor daily activity levels among wheelchair users with SCI. The free commercial dashboard and log data clearly show trends of variations in physical activity and increases in heart rate, which are of value to both researchers and clinicians interested in identifying training schedules of wheelchair athletes.
RESUMO
BACKGROUND: Since their introduction, the safety of silicone breast implants has been under debate. Although an association with systemic diseases was never established, women continuously blamed implants for their unexplained systemic symptoms. In 2011, a pattern of symptoms caused by systemic reactions to adjuvants (e.g. vaccines, silicone) was identified: 'autoimmune syndrome induced by adjuvants' (ASIA). Our aim was to collect a cohort of women with silicone breast implants and unexplained systemic symptoms to identify a possible pattern and compare this with ASIA. METHODS: Women with silicone breast implants and unexplained systemic symptoms were invited through national media to visit a special outpatient clinic in Amsterdam. All were examined by experienced consultant physicians and interviewed. Chest X-ray and laboratory tests were performed. RESULTS: Between March 2012 and 2013, 80 women were included, of which 75% reported pre-existent allergies. After a symptom-free period of years, a pattern of systemic symptoms developed, which included fatique, neurasthenia, myalgia, arthralgia and morning stiffness in more than 65% of women. All had at least two major ASIA criteria and 79% fulfilled ≥ 3 typical clinical ASIA manifestations. After explantation, 36 out of 52 women experienced a significant reduction of symptoms. CONCLUSIONS: After excluding alternative explanations, a clear pattern of signs and symptoms was recognised. Most women had pre-existent allergies, suggesting that intolerance to silicone or other substances in the implants might cause their symptoms. In 69% of women, explantation of implants reduced symptoms. Therefore, physicians should recognise this pattern and consider referring patients for explantation.