Some Popular Medical Devices Escape FDA Scrutiny

Countless patients around the world depend on advanced medical devices to improve their quality of life. As the $110 billion medical device industry cranks out thousands of products every year, eye-opening reports continue to surface detailing faulty devices, repeat surgeries and massive recalls. The FDA argues patients need access to life-saving devices quickly. However, a speedy approval process means some risky devices are cleared without clinical testing, and once on the market receive limited oversight. You should know the risks and realities of medical devices before one is put in your body.

Fatally flawed approvals. »

Trek Bike Recall

The very popular Trek Bikes are the subject of a very important Consumer Product Safety Commission recall of Trek bicycles with front disc brakes and black or silver quick release levers on the front wheel hubs, model years 2000 through 2015.  At least three reported injury incidents have occurred to date, with one accident causing the rider to be paralyzed as a quadriplegic.  The accidents occur when the front wheel abruptly stops or completely comes off the bikes when the front disc brake assembly contacts the front wheel hub. 

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Blood Transfusion Gives the Gift of Food Allergies

Receiving a blood transfusion can mean the difference between life and death and is certainly a true gift given by countless well-meaning folks. However, in the case of a young Canadian boy, his blood transfusion also gave him a less welcome gift, food allergies. The eight year old boy had to be rushed to the Emergency Room with anaphylaxis, an allergic reaction to certain food that can be severe or deadly. The boy ate some healthy salmon a few weeks after his blood transfusion and suffered the reaction within a few minutes. Doctors reassured the family and sent the boy home with the advice he might want to carry injectable epinephrine just in case. Just days later, the boy ate chocolate and peanut butter together and had another allergic reaction. This boy had never suffered food allergies prior to the blood transfusion, and it is normally very rare that someone suddenly develop reactions to foods that have been consumed in the past without trouble. Therefore, doctors had the blood transfusion to blame in this not too common case.

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Black Tea and Kidney Failure

Chances are drinking tea has been growing on you lately given that, the market for tea in the United States has grown by more than four times in the past twenty or so years.  People are drinking twenty percent more tea than was consumed back in 2000.  America’s favorite kind is black tea, which accounts for more than half of all tea consumed in the country.  While this might seem healthy, it seems that once again too much of something is not always a good thing.  A man in Arkansas was storied to consume sixteen glasses of black tea every day, about a gallon total.   People are often encouraged to drink a gallon of water each day, and many would add some black tea to that to add a little flavor.  The Arkansas man, unfortunately, experienced kidney failure that was linked to his black tea habit.

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Listeria and Hummus

Once again we are sounding the alarms that more food-related listeria dangers are lurking out there. A very popular brand of hummus, Sabra, has had a U.S. Food and Drug Administration (FDA) recall of about thirty thousand cases due to the high possibility it contained listeria monocytogenes, organisms that can result in severe and even fatal infections. This is especially the case for young children, individuals with weakened immunity, diabetics, and elderly or otherwise frail people. Healthier individuals may also fall prey to listeria infection, resulting in symptoms such as nausea, diarrhea, abdominal pain, stiffness, bad headache, and significant fever. This can cause more severe or even fatal problems in the more at risk populations and the infection can cause miscarriages or stillbirths in pregnant patients. Listeria infection can also cause meningitis, so it is nothing to mess around with.

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