FDA, Vaginal Prolapse Repairs and Implications
Marja Sprock, M.D.
On July 13th, the FDA issued an updated warning against
the use of vaginally implanted meshes. This was based on
the perceived high number of reported complications for
this biomedical device used to treat severe and often
recurrent vaginal prolapse. The repair without the use
of an artificial material, be it polypropylene or
derived from animal sources, does not get reported,
since it does not involve FDA regulated material.
The pelvic prolapse surgeon network has drafted a letter
to the FDA that I cosigned, to put some of the
accusations against mesh material used in the vagina in
The goal of the letter, which has already received over
400 pelvic floor surgeon signatures is to express our
opinions and concerns to the FDA, since the July update
fails to convey an accurate reflection of the vaginally
placed mesh for prolapse repair and is not consistent
with the current literature and experience. In broader
every prolapse option involves risks and benefits.
In actuality, a lot of people, including other
physicians start laughing when I tell them: "I fix
vaginas"; reality is, it is an art and you need to know
what you are doing. A lot of weight is put on a vagina,
it has to withstand a lot of forces, and we do not like
it too wide or too small, not too deep and not too
superficial and keep on going. Once your entire vagina
or parts of it start hanging down and put pressure on
your back or make it difficult to empty your bladder or
rectum, or you are up the whole night going to the
bathroom, you'd like some relief.
small shelves to hold up a bladder or small bowel are
great for some people, however they create discharge,
are less than romantic to take out right before
intercourse and sometimes do not even hold the large
prolapsed vagina anymore.
Vaginal repair of prolapse without a mesh
is definitely an option, however for the descent of
vaginal tissue to the opening of the vagina or through
the opening, not very realistic. Support is severely
defective and the past has shown us, a lot of these
"native tissue repairs", or in other words use your
existent defective tissue repairs, do not work, last or
make sex impossible or painful or cause pelvic pain. The
same problems you could get with mesh repairs. Again
vaginal prolapse repair is an art, it is for the
Laparoscopic, robotic or abdominal sacrocolpopexy
is our "gold standard"
for vaginal prolapse repair. It
uses the same mesh material; however the mesh is
introduced through the abdomen and not the vagina.
Research shows this approach has the lowest failure
rate, however there are also mesh erosion problems (mesh
showing itself without vaginal tissue covering)and the bowel could get stuck to
the mesh, often requiring another invasive surgery. Also
for a lot of women this approach is not an option, since
the surgery is more involved and takes longer. If you
are a healthy 55 year old with your bladder protruding
through your vagina, it is probably a great surgery for
you, but not if you are the same age, have severe
diabetes mellitus and had a quadruple bypass. However
you may still not desire a pessary, but want your vagina
surgically fixed. A vaginally placed mesh may be the
best option for you,-let us not prevent this from
happening. Another option, the only prolapse surgery
that I refuse to do, is to close off the vagina. The
published rate of complications for the
is close to 33% and I refuse to take away/close a
vagina, if I can fix the problem in the same amount of
time with a mesh and much lower rate of complications.
The vaginal prolapse surgeon consortium is fighting for
women with the data from the literature to support us,
that there is a place for the vaginally inserted mesh.
Other repairs of the severely descended vagina all come
with their potential problems also, there is no free
Pelvic Organ Prolapse Repairs and
Their Potential Complications
Women need their options, severely prolapsed vaginas
interfere with quality of life, do not take away a good
option to repair a vagina for the right woman in the
right surgeons hands.
A high rate of satisfaction is noted for patients
undergoing vaginally placed mesh repairs, in the hands
of well-trained pelvic floor surgeons,
as quoted from the evidence based response from Pelvic
Surgeons to the FDA Safety Communication.
Yesterday I saw Ruth, a 78 year old active lady in the
clinic, 6 months after vaginal insertion of a mesh to
fix her bladder and top of vagina prolapse through her
vaginal opening. Ruth is doing great and has a normal
well-functioning and supported vagina. When asked if she
read some of the articles that had come out regarding
the FDA mesh warning, she said sure, "means little to
me. You told me it was no 100% guarantee and told me
about possible problems and I accepted that. To
interview some people with problems, means little to me,
it is sad, but will happen with any surgery, I am great
My next patient Mary, another 78 year old, used to have
her vagina hanging out for 1.5 inches and came for her 2
year checkup. Mary wrote me a little testimonial: "This
surgery has improved my quality of life and all my
check-ups have been excellent. This prolapse caused a
lot of stress on me and my recovery was quick and easy.
Thanks, Mary R”.
Not every vaginal prolapse needs repair, not every
prolapse repair needs mesh and not every mesh repair can
be done laparoscopically or robotically. The experienced
vaginal surgeons are speaking up for women to keep the
option of repairing a severely prolapsed vagina with
vaginally placed mesh open.
There are possible complications with any surgery, any
surgeon claiming there are none, has either not done
enough of them, is never in the operating room or is
Severely prolapsed vaginas are debilitating and
interfere with the quality of life of many women, a
vaginally placed mesh in the right surgeon's hands
could be the best choice for some of us, let us not give
up this option.
Remember there is no free lunch; any surgery has its
risks and benefits.
Marja Sprock, MD, FACOG, is fellowship trained in
urogynecology by David Richardson at Henry Ford Hospital
in Detroit, has more than 10 years of experience in
pelvic floor prolapse repairs and is up-to-date on new
and minimally invasive techniques.
Please call for an
appointment at 321-806-3929,
send us a
note or visit us online at