Royal Prince Alfred Hospital Medical Centre, Newtown, Australia
Received: June 08, 2017; Published: June 15, 2017
Corresponding author: Andrew Korda AM, Royal Prince Alfred Hospital Medical Centre, Level 4, Room 404, 100 Carillon Avenue, Newtown, NSW 2042,
Australia
In the last twenty years, we have seen mesh used initially for
the treatment of urinary incontinence with great efficacy and for
pelvic organ prolapse, which in some women have had a negative
impact and unexpected morbidity. This has resulted in issuing of
warnings by regulatory authorities [1-5] the voluntary removal of
some of these products from the market, adverse publicity in the
media and an impending Senate Enquiry.
The inevitable outcome of this has been the concern women
have of the safety of mesh used for prolapse surgery and the
unfortunate consequence of questioning the benefits of the highly
effective midurethral sling products used for the treatment of stress
urinary incontinence. We were of the view that at this point of time
it would be useful to bring you up to date on the current state of
mesh products used of pelvic surgery.
In modern urogynaecology, the use of mesh has become popular
due to the work of Ulmsten who revolutionized incontinence
surgery using sub urethral slings [6]. In 2001, Weber et al published
a randomized trial comparing three techniques for anterior vaginal
repair. Using a definition of success as a reduction of prolapse of 2
cm above the hymeneal remnants, success rates were significantly
better in the group of patients in whom mesh was used. Based on
this study, gynecologists started to use mesh when they treated
pelvic organ prolapse. It was believed that mesh use improved
anatomical success rates [7].
Between 2003 and 2005, several mesh products were
introduced that used anchoring with mesh arms placed through
the obdurate foramen, the Perigee and Anterior Prolift. The first
was invented in Queensland, by two local Urogynaecologists. These
meshes seemed particularly effective, even in very difficult patients,
and we performed several audits which seemed promising [8-10].
By the time proper randomized controlled trials showed
the efficacy of such meshes in the anterior compartment [11],
especially in women with a highly abnormal pelvic floor [12]
the Anterior Prolife had been removed from the market due to
irregularities with the original FDA application. While we were
getting better at selecting patients most likely to benefit from mesh
[13], the accumulating information on risks associated with mesh
use effectively shut down the discussion.
It has become apparent that the restoration of structural
anatomy does not necessarily restore normal functional anatomy
as the reaction to the mesh creates a more rigid, non-pliable vagina
and does not reduce the urogenital hiatus, which is so essential
in maintaining normal functional anatomy. Additionally, the
restoration of normal anatomy does not necessarily result in the
reestablishment of normal vaginal, urinary or bowel function and
in some cases worsened the patient’s quality of life.
It became evident that in 7 percent of women further surgery
was needed to be undertaken to remove the eroded mesh; that
36 percent of patients who had mesh complained of dyspareunia;
and that in posterior compartment 3 percent of patients sustained
a rectal perforation, mesh erosion was reported to be around 14
percent and dyspareunia occurred in 16 percent [14]. Additionally,
Injury of the bladder, urethra, rectum and pelvic nerves arose from
the surgical technique used.
Furthermore, complications from mesh implant surgery
which do not arise from traditional surgical treatment options
are chronic and severe pain, more severe dyspareunia than after
traditional prolapsed surgery, hispareunia [15], mesh erosion,
mesh contraction and repeat surgery because of mesh erosion or
contraction. Finally, mesh certainly does not fix all cases of prolapse,
and our group has documented patterns of recurrence that in some
cases raise entirely novel technical issues [16].
We believe that, as always, patient selection and
individualisation of treatment is the key to optimal outcomes [17].
Hence it makes sense to use mesh only in women at high risk of
prolapse recurrence, that is, in those with previous failed surgery,
levator avulsion and, possibly, severe ballooning. However, this
is a moot point as long as those meshes that have been proven to
be effective are no longer available. The second best documented
mesh, the ‘Perigee’, was taken off the Australian market in 2016.
Newer products such as “Restorelle” and “Uphold” are anchored
in a different (and likely less effective) way, and as yetthere is very
limitedevidence on safety or efficacy [18]. As long as this is the
case it may be reasonable to limit mesh use to clinical trials. In the
meantime we are working on several alternatives to mesh. We have
been re-attaching avulsed levator ani to the pubic rami [19] and are
conducting two trials involving a reduction of the levator ani hiatus,
in an attempt to reduce recurrence rates by normalizing pelvic floor
functional anatomy [20]. All three trials are ongoing. So far we can
say that both methods seem to be effective in certain patients, but
neither is the ‘magic bullet’ that would allow us to cure all prolapse.
A randomized controlled multicenter trial is nearing completion
this year, and results should be available in 2018.
ISSN: 2574 -1241
