dire, sometimes irreversible, complications as a result, including uri-
nary dysfunction, loss of sexual function, constipation and severe
pain.
The saga, which began in the 1990s, continues in 2016, playing out in
boardrooms and courtrooms across the country. Tens of thousands of
product liability lawsuits against mesh manufacturers like Johnson &
Johnson subsidiary Ethicon, Boston Scientific and Endo International
are pushing forward and hundreds of millions, if not billions, of dol-
lars have already changed hands as a result. In 2014, Endo said it
would pay about $830 million to settle more than 20,000 personal
injury lawsuits that alleged its vaginal mesh implants eroded in some
women and left them incontinent and in pain.
What remains to be seen is whether surgeons will continue to
implant vaginal mesh.
"What I'm afraid is going to happen is that 5 years from now we
won't have any of these (mesh) products around," says urologist Brian
A. Feagins, MD, medical director of the Texas Health Women's
Specialty Surgery Center in Dallas.
That would be fine with L. Lewis Wall, MD, a professor of obstetrics
and gynecology at Washington University School of Medicine in St.
Louis, who has petitioned the U.S. Food and Drug Administration to
recall all vaginal mesh products and ban further commercial sales.
The wide disparity in the 2 physicians' attitudes reflects the different
perceptions about what led to this epic problem, and about who's to
blame for the mesh mess.
Blame the FDA?
Some see the FDA as culpable, since it let vaginal mesh be brought to
market without clinical trials. Its 510(k) process is a pathway for
approval based on "predicate" devices — approved products that are
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