Title: Mesh-Associated Pain Syndrome: Predictors for Continence and Prolapse Mesh Removal
Surgery in a Single Centre
Version: 2 Date: 28 Aug 2024
Reviewer's report:
Mesh-Associated Pain Syndrome: Predictors for Continence and Prolapse Mesh Removal
Surgery in a Single Centre
The authors should be congratulated on their work looking at possible predictors associated with
mesh pain syndrome.  This is a difficult study to undertake due to the multifactorial nature of
pain following any surgery.   If predictive factors were present that were associated with this
pain, it would be an important contribution to our literature. The following would need addressed
prior to being acceptable for publication.
Abstract:
1. Are the authors looking at “mesh types”  or specific surgical procedures using mesh? I do
not believe the authors are looking at mesh types (GoreTex, Mersilene, etc.) and this should be
made clear.
2. Rather than a purely retrospective, observational study, did the authors consider a case control
study? The numbers of MAPs removals compared to the number implanted is very small.
3. What does the “prevalence of mesh removal surgery averaging 85%” refer to? 85% of what?
Did all the patients enrolled not have mesh removed?
4. It needs to be clear that other complications (voiding dysfunction, bowel evacuation disorders,
vaginal exposures, etc,) were not the primary reason for mesh removal.
Introduction:
1. There is no mention of these conditions (chronic pelvic pain, dyspareunia, etc.)  in patients
undergoing native tissue repairs. This needs included for context. These conditions can occur
after any pelvic surgery.
2. Consistency needs to be present in regard to what is being studied.  Bringing up exposure and
erosion is fine as long as it is clear those are not reasons mesh was being removed in this study.
3. The FDA process which used a predicate device is the 510K process.
4. The FDA banned vaginal mesh kits despite the ongoing post market surveillance data showing
much more positive results.
5. The authors are quoting 2005 Cochrane data.  The 2017 update states “Mid#urethral sling
operations have been the most extensively researched surgical treatment for stress urinary
incontinence (SUI) in women and have a good safety profile. Irrespective of the routes traversed,
they are highly effective in the short and medium term, and accruing evidence demonstrates
their effectiveness in the long term. This review illustrates their positive impact on improving
the quality of life of women with SUI.” This should replace the 2005 data referenced.
6. The authors need to be clear who their population is – prolapse patients, incontinence patients,
or patients with both problems.  In other words, were there dually implanted patients?
7. There are studies showing at least a 30% rate of dyspareunia following a native tissue posterior
repair.  As above, this needs included in the introduction. Other prolapse and incontinence
surgeries are also associated with pain.
8.  A clear definition of MAPS needs to be provided.   Is this different or inclusive of levator
myalgia and guarding reflexes which may respond to physical therapy?
9. Did the patients undergo other therapies for their pain? Physical therapy? Trigger point or
Botox injections prior to surgical mesh removal?
10. Pain centralization needs addressed as these are long-term pain patients and the need for more
advanced pain therapy is needed. Any pain lasting over 6 months can lead to pain centralization.
Methodology:
1. As mentioned earlier, why not a case control study?
2. Was smoking looked at? This is a well-recognized risk factor for mesh complications.
3. Prior therapies should be recorded (physical therapy, trigger point injection, Botox).
4. A thorough description of the patient population is needed in the methodology.  Inclusion/
exclusion criteria need described.
5. Did all the patients included all have mesh removed? If so, where does the 85% number in
the abstract come from? This number does not appear in the results sections.
Results:
1. Are these consecutive patients? Were there any exclusions?
2. Line 256 states “out of the 273 women” – where does this number come from?
3. As stated earlier, mesh types is not what is reported. Different surgeries using pelvic mesh
are reported.
4. TVT is a trademarked name – Johnson and Johnson.  If this is true, the trademark logo should
be used. If they authors are referring to “retropubic procedures”, that terminology should be
used. Same is true of TVT-O (trademark) and transobturator procedures.
5. The figures and Tables are hard to follow and should be simplified.  The legends when present
are confusing. Examples -  Figure 1 should just show the actual patients where mesh was used,
not complicate it by combining it with a bar chart of patients who did not have mesh inserted.
There are two bar charts showing the same thing, one horizontal and one vertical. Is there a
reason this is duplicated?
6. Table 3 – “N years beginning of symptoms” could be worded “onset of MAPs in years.”
Likewise, “time to removal” in years is more clear than “N Years insertion-removal.”
7. The Mesh count bar graph is confusing. The CMC numbers do not add up to 335. In the “1”
category of meshes, CMC=254, PMC=77 but TMC=280? Perhaps these definitions need to be
defined more clearly for the reader to understand what is being reported and the significance.
8. Figure 2 bar chart is confusing. An example – No complications is reported at being present in
44.9% of patients and in 89.8% of “mesh retrieval prevalence in patients with complications?”
Did they have complications or not?
9. Figure 4- there are no legends. The colors should have a legend explaining them.
10. The remaining figures either need simplified or left out altogether and just given as negative
results in the text.   The data is too small to read and will not reproduce well in a journal and in
general, there are too many figures reporting data that showed no significance.
Discussion:
1. The number of implants (continence insertions well over 100,000) compared to the relatively
small number removed needs discussed.  The Cochrane report as well as others documenting
high patient satisfaction and low risk profiles is not represented in this discussion.
2. There should be a discussion of native tissue repairs and pelvic pain and dyspareunia.  These
conditions are not unique to mesh.
3. As stated in the Cochrane review, slings remain the most studied and reported on surgical
procedure in the history of incontinence surgery.  No other procedure has been put under the
microscope as much as slings. The failure rates and complications of other procedures needs
mentioned in relation to synthetic slings.