F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women – Smart Media Magazine

F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women


The disputes over the safety of pelvic mesh have gone on for more than a decade. Until Tuesday, the F.D.A. had never formally demanded that the products be taken off the market, but it had issued several warnings about the devices. The agency said earlier that it had received reports of more than 10,000 complaints of serious injury and nearly 80 deaths as of last year.

Women who have already had the devices implanted and are not having problems with them should not take any action, other than to continue regular doctor visits, Ms. Kotz, the F.D.A. spokeswoman, said.

It has been estimated that nearly 10 million women worldwide have received mesh implants to treat weakening pelvic muscles and alleviate urinary incontinence. Roughly 10 to 15 percent have suffered complications, in some cases requiring the mesh to be removed.

In light of the litigation, warnings and complaints from women about severe pain and bleeding from mesh implants, some manufacturers, including Johnson & Johnson, had voluntarily stopped selling them.

More than 100,000 people filed claims against the major manufacturers in federal and state courts. Although some of the settlement figures have been large, women have complained that lawyers have taken a lot of the settlement 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 outset of the litigation, we might have seen higher settlement values,” said Elizabeth Chamblee Burch, a law professor at the University of Georgia and an expert in pelvic mesh litigation. “It could help with the remaining cases. The plaintiffs themselves see this as a pretty huge victory and a victory that they wish had come a lot sooner.”

In recent years, sales of the pelvic mesh had declined as companies stopped selling the devices and the costs of litigation mounted. From 2010 to 2017, sales in the United States amounted to about $600 million, according to some estimates.



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