Title: Understanding Risk: a substitute for Information?
The use of mesh for the management of stress urinary incontinence and
pelvic organ prolapse (POP) has caused more controversy in modern times
than any other intervention. It is estimated that 10% of women will
require surgery for POP over their lifetime. The Olsen paper of 1997
(Olsen et al. Obstet Gynecol 1997; 89[4], 501-506) highlighted the
risk of recurrence at approximately 30% following native tissue vaginal
repair which fuelled the need for a more robust treatment. Analogies
were drawn between POP and hernias, and it was extrapolated that the
success (Lichtensein. Herniorrhaphy 1987; Am.J.Surg , 153, (6)
553-559) of mesh in prevention of hernia recurrence could be applied to
the use of mesh for POP too. This was followed by widespread diffusion
into clinical practice without robust evidence of efficacy.
The PROSPECT trial was a pragmatic parallel-group multicentre trial of
women having surgery for POP comparing native tissue repairs with mesh
augmented repairs (inlay and mesh kits) and biological mesh (grafts). It
found no difference in outcomes at 2 years and all complications were
similar in the groups except mesh complications which was 12% (Glazener
et al. Lancet 2017;389: 381-392).
Chronic pain is the commonest cause of referral following mesh surgery
and women are choosing to have mesh removed in the hope of symptom
improvement. Pain can manifest as dyspareunia, obturator neuralgia,
pudendal neuralgia, back pain and nonspecific pain. This study by Reid
et al, is a secondary analysis of the data from PROSPECT, and the
authors analyse pain and other complications based on the type of
repair.
It is interesting that the complications reported in all groups were
relatively low and similar in the different groups. As part of this
trial, it would be the most experienced surgeons performing cases, but a
nuance we must not forget is that unit’s enrolling would likely be those
where a urogynecologist was the surgeon. The issue of training arises
repeatedly in the Cumberlege report (First Do No Harm.
https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf.
Accessed 12.06.21) and this study is possibly a reflection of the fact
that when undertaken by the specialists’ adverse events are low. Pelvic
floor surgery as a subspecialty has in the past been dumbed down and was
felt to be the domain of the generalist. This may explain some of the
problems encountered with the use of mesh, but I would propose that
pelvic floor surgery is the remit and prowess of the urogynaecologist.
There is no problem that surgery cannot make worse. This study confirms
that all surgeries have a risk of de novo dyspareunia and vaginal pain,
but this is much greater with mesh kits when compared to native tissue
repair, mesh inlays or grafts. Given that the use of mesh does not
improve outcomes however, the added risk of mesh complications is
difficult to justify hence the NICE recommendation to use vaginal POP
mesh only in the context of research is welcomed by the
Urogynaecologists and it is important that lessons learnt from the
Cumberlege Report are not forgotten.