F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women [The New York Times]
Boston Scientific Corporation (BSX)
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Source: The New York Times
F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women - The New York Times The Food and Drug Administration on Tuesday ordered the two remaining medical device companies selling surgical mesh It was the most severe action the F.D.A. has taken in the protracted legal and medical battles over vaginal mesh, a synthetic product that has been implanted in millions of women to strengthen weakened pelvic muscles that can cause the bladder, the uterus and other organs to sag into the vaginal area. The number of serious complications from the device has increased significantly over the years, prompting the F.D.A. to ask manufacturers to submit more evidence that the devices were safe and would benefit patients. In announcing its decision on Tuesday, the F.D.A. said that the two manufacturers, Boston Scientific and Coloplast, had not demonstrated a reasonable assurance of safety and effectiveness for the devices. “In order for these mesh devices to stay on the market, we dete
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