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But even small mesh devices have an unacceptable complication rate, he says, in the range of 5 to 15%. "These lattice products have never been necessary," he said, noting that there is another surgical procedure that uses a patient's own tissue.
Disputes over the safety of the pelvic mesh lasted more than a decade. Until Tuesday, the F.D.A. He had never formally asked for the products to be taken off the market, but he had issued several warnings about the devices. The agency said earlier that it has received more than 10,000 serious injury complaints and nearly 80 deaths since last year.
Women who have had the devices in place and do not have problems with them should not take any action other than continuing to see their doctors regularly, "said Ms. Kotz, Director of the Women's Affairs Division. spokesman, said.
It is estimated that nearly 10 million women worldwide have received mesh implants to treat weakened pelvic muscles and relieve urinary incontinence. About 10 to 15% have suffered complications, requiring in some cases removal of the mesh.
In the light of litigation, warnings and complaints from women about severe pain and bleeding from mesh implants, some manufacturers, including Johnson & Johnson, have voluntarily stopped selling them.
More than 100,000 people filed lawsuits against major manufacturers in federal and state courts. Although some of the figures relating to the institution were high, the women complained that the lawyers took a large part of the institution 's money. Documents reviewed by the New York Times and interviews indicated that the average settlement for each woman was less than $ 60,000.
"If this had happened at the very beginning of the litigation, we might have seen a higher settlement value," said Elizabeth Chamblee Burch, a law professor at the University of Georgia and litigation expert with a pelvic mesh. . "It could help with the remaining cases. The plaintiffs themselves see it as a huge victory and a victory they would like to have won much earlier. "
In recent years, pelvic mesh sales have declined as companies stop selling devices and increase litigation costs. According to some estimates, between 2010 and 2017, sales in the United States amounted to approximately $ 600 million.
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