U.S. health regulators ordered two medical device companies to stop selling surgical mesh used in pelvic repair surgeries after saying there isn’t enough evidence that the product embroiled in thousands of lawsuits is safe or effective.
The Food and Drug Administration told Boston Scientific Corp. and the Danish company Coloplast A/S “to stop selling and distributing their products in the U.S. immediately.” They were the last two companies selling surgical mesh for use during minimally invasive repair of pelvic organ prolapse, a common condition in women that develops when the muscles holding in the bladder and uterus weaken and the ...
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