Infection-Related Deaths Expose Deficiencies In FDA Oversight Of Medical Devices

Published: Nov 30, 2016

At first, Vincent Karst, 55, was recovering well from his open-heart surgery in March 2015.

He resumed the activities he enjoyed, such as visiting car shows and eating out. But some months later, his condition mysteriously deteriorated. By fall he was so short of breath, nauseated and overwhelmed by fatigue that he needed to be rehospitalized in York, Pennsylvania.

There, doctors diagnosed a new problem: a serious mycobacterial infection that was acquired during his surgery, according to his subsequent lawsuit. Aggressive treatment with antibiotics left him with partial hearing and vision loss.

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