FDA Public Health
Warning: Vaginal Mesh Use
In October 2008 the FDA
issued a notification regarding complications associated
with transvaginal placement of surgical mesh in repair
of pelvic organ prolapse and stress urinary
This is a mouthful,
however it relates to the frequently used polypropylene
or xenograft (animal or human tissue) pieces of
material, to strengthen the weakened vaginal wall.
The FDA describes the
problems they have encountered on their website.
The main problem is
exposure of the mesh, which means, some part of the mesh
is not covered by vaginal tissue. Dependent on the
material used, this mesh exposure can be removed or
delayed healing awaited with the help of vaginal
estrogen. Vaginal estrogen is used to prevent the
complication of mesh extrusion also.
I agree that mesh
extrusion can be encountered by every surgeon using
vaginal mesh implants. A significant amount of women
prefer a mesh extrusion over their vaginal organs
hanging out. The mesh, not being covered by vaginal
tissue is often treatable in the office, or with a small
Remember not everybody
with pelvic organ prolapse will need surgery, there are
other treatment options. Also not everyone requiring
surgery will need transvaginal mesh placement.
The FDA describes
problems with pain, recurrence of prolapse, urinary
problems and perforation of organs during insertion.
Even though it is
stated in the medical community that “the only surgeon
who has never had a complication does not operate”, it
is well known that experience with the procedure
diminishes the risk of complications.
Sometimes vaginal scar
formation can not be controlled, however most patients
who had pain after mesh placement that were referred to
me, had their mesh placed too tight, by inexperienced
surgeons. The good news is, I was able to relieve all of
them from their pain and their prolapse has not
It needs to be
remembered that transvaginal mesh placement is not the
best procedure for all and some women may be better off
with a laparoscopic sacrocolpopexy ( the use of mesh
with the help of a scope placed through the belly
button) or a vaginal repair without mesh.
It needs to be
emphasized that the use of mesh is permanent and as with
any procedure there are downsides.
The general failure
rate of pelvic organ prolapse repair is 30%. It has been
scientifically proven that the use of mesh for a
condition of prolapse called cystocele (bladder
prolapse), diminishes the rate of recurrence.
What to do if you have
pelvic organ prolapse and your surgeon has discussed the
use of mesh? The FDA website describes questions that
you should ask your surgeon pertaining to the need for
the mesh, experience of the surgeon and how the surgeon
will deal with possible complications.
The best recommendation
I can give to you is to go on the FDA website and choose
your surgeon wisely. Ask questions and make sure your
surgeon is an urogynecologist or gynecologist/urologist
with extensive experience with the use of vaginal mesh.
If you are postmenopausal use your vaginal estrogen as
Dr. Sprock is
fellowship trained in urogynecology and has an extensive
experience in the use of mesh. She is at the forefront
of development of new techniques for vaginal prolapse
repair and has worked closely with industry in the
development of some mesh products, to improve the
outcome. She continues to improve techniques and
products and has instructed hundreds of surgeons in the
safe use of vaginal meshes to improve the outcome of
pelvic organ prolapse repair.
come for a consultation to Central Florida
UroGynecology, which is located just off of
US 1 in Rockledge, on 1009 Harvin Way, Suite
110, the building with the red roof. The
phone number is 321-806-3929.
We offer a
friendly professional atmosphere to treat
all your urogynecologic and cosmetic
gynecologic needs. Treatments offered range
from exercises, nerve stimulation,
medication, diet instruction to surgical
contact us at 321-806-3929 today.