Patients with pelvic organ prolapse present with varying
symptom states. Treatment is guided by
the patient’s degree of symptoms and functional defects. The recent controversy fueled by the trial
lawyer escalation of FDA committee reports has left many confused as to
appropriate treatment options for these patients. Before providing my opinion on the use of
mesh I want to stress that we offer non-surgical and surgical treatment for
symptomatic pelvic organ prolapse with or without the use of mesh. The approach is individualized dependent upon
the patient’s symptoms, anatomic defect, surgical history and the patient’s personal
opinions.
I have used mesh for select patients for 11
years and have been very pleased with the results. In my opinion mesh augmented surgery has revolutionized the
care of women with pelvic organ prolapse for the better. Of course it certainly is not appropriate for every
patient with pelvic organ prolapse. No
procedure is for this matter. However
for the many women suffering from debilitating symptoms as a result of
prolapsing pelvic organs that I have treated with transvaginal mesh; it was a
lifeline. For every woman with a mesh complication there
are 20 women who are extremely pleased and much better off than prior to
surgery.
There is a huge discrepancy between what the FDA said and
what trial lawyers would like you to believe.
For the most part basically what the FDA said was that physicians
placing mesh should be well trained, patients informed of the risks associated
with mesh, and appropriate studies be performed on mesh products before coming
to market. They did not say that all
mesh is bad, the products should not be used and should be recalled. Most of the complications listed with mesh
augmented surgeries are not unique to mesh surgeries and can occur with
procedures that are not augmented with mesh.
The only complication listed that is unique to mesh augmented procedures
is the risk of mesh erosion.
With proper
placement of mesh, the erosion rate is less than 4%. The reoperation rate for recurrence of prolapse when mesh
is not used is known to be 30-40%. More than 99% of mesh erosions are exposures in the vagina that can be
treated in the office or with a same day surgical procedure. On the other hand, recurrence
would require a complete redo of the
surgery. Given this, erosions are not a reason to discard mesh. To be fair, mesh erosions into visceral
organs like the bladder or rectum would be more complicated, but these are extremely
rare.
The first decade of the 21st century was a period
of rapid evolution in the care of women with pelvic organ prolapse. Most of the
issues that have occurred are a function of how rapidly this area of medicine
has changed. Most gynecologists in
practice at the start of this revolution had no history or training in the use
of transvaginal mesh. Researchers and
developers needed time to perfect better delivery systems. The mesh products utilized required closer
inspection and thought. Changes such as
larger pore sizes and lower mesh loads have dramatically impacted tissue ingrowth and
decreased mesh exposures.
Without a doubt, placement of transvaginal mesh for pelvic
organ prolapse should be used cautiously by experienced surgeons with extensive
training in pelvic surgery. With 11
years of experience with pelvic floor surgery and the use of mesh
transvaginally, I’ve had the advantage of personally performing many surgeries. I’ve performed repairs with and without mesh,
with sacrospinous ligament fixation, with site specific mesh repair, abdominal
sacrocolpopexy, laparoscopic sacrocolpopexy and transvaginal mesh kit repairs. Every approach or procedure has a place and
time. No two patients are the same and
care must be individualized. No one
surgical approach will fit all.
When
needed, I am a believer in the use of transvaginal mesh . An unbiased view of the data supports using
mesh in the appropriate patient.
Moreover, I’ve seen it with my own eyes.
The use of mesh provides good anatomic repair without narrowing or
shortening of the vagina which is common with the old imbrication repairs that
most gynecologists were taught. It
provides an efficient, fast and complete repair for even the very elderly. It is durable and safe. It works.
Melvin Ashford, MD