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FDA to consider approval of personalized DNA testing kit to determine disease risk

Genetic test maker 23andMe has applied for Food and Drug Administration (FDA) approval of a saliva-based DNA test that would enable consumers to look at their genetic code for information about their ancestry and what diseases they may develop in the years to come. Such personalized kits have caught flack for claiming to help users detect if they are likely to develop diseases such as breast cancer, heart disease and Alzheimer’s disease. Geneticists say that how DNA variations lead to certain diseases is still poorly understood and that tests that claim to predict these risks is not reliable. But the ... Read More

Man sues maker of surgical mesh

A Texas man is suing the manufacturer of the surgical mesh used to repair his hernia, alleging the device was defective and caused infections. The lawsuit was filed against C.R. Bard, maker of surgical mesh and other medical devices. The man claims that shortly after surgery his pain became worse and his surgical site became infected. He underwent a second surgery, where surgeons found that the problem stemmed from the mesh dislodging and eroding. Surgical mesh is a woven fabric used for chest wall reconstruction, strengthening tissues, providing for support for internal organs, and treating surgical or traumatic wounds. The fabric ... Read More