It is our consensus that types 2 and 3 (microporous,
<
10 microns, mono- and multifilament) and type 4
(submicronic and monofilament) are not appropriate for
use in this clinical context.
When considering risk factors for mesh materials, it is
important to consider the following important issues:
1. Overall surface area of the material used (which is
greater for POP than for SUI)
2. Mesh design (eg, physical characteristics of the mesh,
size of the pore as a predisposing factor to infection—in
particular with a pore size of
<
75 microns)
3. Material (biocompatibility, long-term stability, flexibili-
ty, elasticity, etc.)
The factors influencing the surgical outcomes are as
follows:
1. Indication for which the material is used
2. Overall surface area of the material used (lower overall
surface area for SUI than for POP)
3. Material characteristics (polymer used, physical char-
acteristics of the mesh, size of the pores, surface area,
biocompatibility, long-term stability, compliance)
4. Route of implantation (eg, vaginal or transabdominal)
5. Patient characteristics (eg, somatic inflammatory disease,
obesity, smoking)
6. Associated procedures (eg, hysterectomy)
7. Surgeon experience
There is a lack of both preclinical and real-life practice
clinical data. Whilst there are randomised controlled
studies, the majority are limited in terms of the number
of recruited individuals and duration of follow-up, and they
do not evaluate differences in product design.
It is clear that:
1. The risk of use of a mesh increases with its surface area
and, thereby, its increasing density.
2. In this context, a clear distinction should be drawn
between the tape used for synthetic MUSs and the larger
amount of mesh used to treat POP. A significantly greater
amount of mesh is implanted in patients with POP than
in those with SUI.
3. Surgeons should be adequately experienced in the
management of SUI and POP, and should have all the
therapeutic options available (or be able to refer to
colleagues if required). Patients should be appropriately
assessed and counselled prior to making a decision to
undergo surgery, regarding the experience of the
surgeon and results of the proposed technique.
4. There is higher mesh-associated morbidity when treat-
ing patients with POP as compared with using synthetic
MUSs for SUI.
5. The efficacy and use of synthetic MUSs for SUI is evident,
and it can be recommended for use in clinical practice,
whilst acknowledging the limitations of existing long-
term data and under-reporting of other studies relating
to long-term follow-up in real-life clinical practice.
6. Synthetic MUSs are now the most widely used surgical
approach for SUI with well-established success rates and
safety profile. The efficacy is higher than colposuspen-
sion and comparable with autologous slings, but with
lesser morbidity compared with colposuspension. Mor-
bidity is uncommon, but may occur either at the time of
implantation (eg, bladder perforation or vascular/bowel
injury) or subsequently (eg, tape exposure, pain, or
erosion into the urinary tract). Existing data do not allow
reliable quantification of tape-specific long-term risks,
but it may be 4%
[57].
7. Vaginally implanted mesh for POP is associated with
increased risks. Its use should be restricted to the special
group of patients defined according to established
evidence-based clinical guidelines or in the context of
ethics committee-approved clinical research. Its use
should also be restricted to expert individuals working in
specialised departments. Whilst the risk associated with
the transabdominal insertion of mesh for POP is
considered more acceptable, its use should also be
restricted to specialist practice.
8. Based on the available scientific evidence, the SCENIHR
[21]recommends the following:
(a) Implantation of any mesh for the treatment of POP
via the vaginal route should only be considered in
complex cases, in particular after failed primary
repair surgery.
(b) Owing to increased risks associated with the use of
synthetic mesh for POP repair via a transvaginal
route, this option should only be used when other
surgical procedures have already failed or are
expected to fail.
(c) The amount of mesh should be limited for all
procedures where possible. However, there is a need
for further improvement in the composition and
design of syntheticmesh, inparticular for POP surgery.
(d) A certification system for surgeons should be
introduced based on existing international guide-
lines and established in cooperation with the
relevant European Surgical Associations.
(e) Appropriate patient selection and counselling are of
paramount importance for the optimal outcome for
all surgical procedures, particularly for the indica-
tions discussed. This should be based on the results
of further clinical evidence, which should be
collected in a systematic fashion for all these devices.
9. Therapy should only be instituted in accordance with
EAU guidelines and with full informed consent of all
patients.
5.
Treatment of SUI in men
Physiotherapy is considered to be better than no treatment
at all, as it is suggested that patients should not undergo
surgery for stress SUI for at least 6 mo and preferably not
before 1 yr after initial surgery. In addition, it is important to
exclude the presence of an anastomotic stenosis and
bladder dysfunction in cases of postradical prostatectomy
prior to considering any corrective surgery.
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