Prompted by a spike in reported complications, the Food and Drug Administration
has released an updated advisory regarding the risks of surgical mesh
implanted in women to strengthen vaginal tissue. This is a significant
update given that manufacturers estimate that 100,000 women were treated
for pelvic organ prolapse with surgical mesh last year, with 75,000 of
those implanted vaginally.
The FDA report states that a review of industry literature and the adverse
event reports has shown little evidence that the device, which is implanted
vaginally or abdominally, improves pelvic organ prolapse, where a woman’s
uterus, bladder, or rectum can slip out of place.
Instead, the review found that vaginal implantation exposes patients to
a number of serious risks.
Specifically, the review found that erosion of mesh through the vagina
is the most common and consistently reported mesh-related complication
from transvaginal POP surgeries using mesh. Mesh erosion can require multiple
surgeries to repair and can be debilitating for some women. In some cases,
even multiple surgeries will not resolve the complication.
As detailed by the
Los Angeles Times, the FDA first alerted doctors to the risks associated with the mesh in
2008, citing over a thousand manufacturer reports of complications between
2005-2007. The FDA recommended doctors receive specialized training in
mesh placement, and warn patients of complications they identified as
serious but “rare.”
Since then, complaints of serious complications associated with prolapse
repair have jumped five-fold, causing the FDA to reexamine its position.
As we have previously discussed on this blog, medical devices are often
approved by the FDA without clinical trial data requirements. Manufacturers
who demonstrate their products are “substantially similar”
to other products on the market are frequently given clearance to sell
the device without undergoing a stringent review process. Under this system,
vaginal mesh devices were approved for use in treating incontinence in
1996, and for pelvic organ prolapse in 2002.