deemed to be essentially similar in form and function to new prod-
ucts. The predicate product in this case? The mesh used to repair her-
nias.
Dr. Wall, who calls the FDA approval process "terribly flawed," says
the fact that hernia mesh was viewed as a legitimate predicate is
absurd. "They took material used in vascular grafting and said it's
already been used in the body, therefore we can use it in the vagina,"
he says. "As if a vascular graft and a vaginal graft were the same thing,
or as if the interior abdomen wall is the same as the vagina. You don't
need to be a rocket scientist to appreciate that they're different struc-
tures with different functions."
Vaginal mesh is now facing increased federal scrutiny. The FDA has
relabeled it from a moderate device to a class III high-risk device. This
past January, the FDA took the unusual step of giving manufacturers
30 months to submit documentation "to support the safety and effec-
tiveness of surgical mesh for the transvaginal repair of POP." Are
these measures too little, too late?
"FDA-bashing is a fun pastime for a lot of people," says Steve Xu, MD,
co-author of a recent study on the FDA's regulation of women's health
devices (osmag.net/uhc6tv). "But it's important to remember that it
has immense responsibility and limited resources."
Dr. Xu and co-author Jessica Walter, MD, both residents at the
Northwestern University Feinberg School of Medicine in Chicago,
found "significant weaknesses in pre-approval and post-approval regu-
lation" when they examined the approval process for 18 high-risk
obstetrics and gynecology devices approved between 2000 and 2015.
While high-risk implant devices require the most scrutiny, the
researchers note that the FDA is mandated to take the least burden-
some approach.
"When you have a device that's placed permanently in the body,
3 8 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • A U G U S T 2 0 1 6
