has been estimated that 50% of women by the age of 50 will have some degree of
pelvic organ prolapse (POP) and at least 10% by the age of 80 will require
surgery. POP has always been considered a difficult problem to manage and in a
significant percentage of patients the prolapse surgery has a tendency to
urogynaecologists took the view that failure was due to the poor quality of the
patient’s tissues and therefore looked for a substitute for conventional
vaginal repair. A synthetic mesh
therefore seemed the ideal material.
There are many different types of meshes used in POP surgery
(biological, absorbable synthetic, non-absorbable and composite). Nearly all of the meshes used for POP
repairs are non-absorbable synthetic i.e. lightweight monofilament
polypropylene. Ideal mesh
properties for POP surgery should result in minimal infection, minimal
inflammatory reaction and avoidance of excessive fibrosis.
has been used for repair of prolapse (vaginal vault prolapse,
rectocele/enterocele and cystocele) for many years. It has been proven to be
the most successful repair for vaginal vault prolapse and is considered
standard of care.
from the expertise of the surgeons, there are inherent problems associated with
the mesh. The mesh can create
intense inflammatory reaction in the tissues and this leads to oxidation and
degradation of polypropylene mesh, which then causes inflammation and
contraction. In Examination of our experience with LVMR here @ Bristolsurgery.com has shown that the vast majority of the mesh related complications occur using polyester mesh. It seems to be extremely rare using Titanium coated light weight polypropelene mesh and absorbable sutures e.g., PDS.
considered the standard of care, complications can still occur including:
Mesh erosion (see below) and extrusion
through the vagina
Erosion into viscera such as the
bladder or bowel (see below)
Obstruction of the urethra
Injury to nerves
the last decade it was popular to place the mesh vaginally using kits. As with
any new technology there is learning curves both surgically and with the
technology itself and together these can lead to complications.
kits were developed by industry who then “trained” many surgeons to do the
procedures which resulted in many inexperienced surgeons doing them and
complications ensued. This led to an FDA notification in late 2008 informing
patients of the potential complications and that surgeons have had the proper
training and experience to do the procedures. In spite of this warning the use
of mesh for POP increased, the FDA receiving nearly 3,000 reports of adverse
events. In 2011, the FDA issued an
even stronger warning. It led to improvements in surgical technique and mesh
technology, which together decreased complications. The FDA also issued a set of recommendations for surgeons.
Obtain special training for every mesh placement
procedure, and be aware of the risks.
Watch for adverse events, specifically erosion and
Check for complications related to the implantation,
specifically bowel, bladder and blood vessel perforations.
Inform every patient that the implantation of mesh is
permanent, and that certain problems may require revision surgery that may or
may not fix the complication.
In January 2012, the FDA issued postmarket surveillance study
orders – called 522 orders– to all manufacturers of urogynecologic surgical
mesh products. After the FDA issued the orders, some mesh manufacturers quietly
withdrew their products from the market.
In June 2012, Johnson & Johnson’s Ethicon unit stopped
selling four of its GynecareR mesh products after more than 600
women filed lawsuits against the mesh manufacturer.
one must separate use of mesh for urinary stress incontinence (ie. TVT tape)
which has shown huge benefit and in the right surgeons hands very low risk of
0.1% tape erosion rate. If there
are higher complications relating to TVT you must seriously question the
competence of the surgeon.
is no data in support of using trans-vaginal synthetic mesh for posterior and
apical vaginal repairs. My
impression is that for the anterior vaginal repair, experienced surgeons in
very rare high-risk patients who are fully informed may use the synthetic mesh.
Skilled laparoscopic surgeons argue (and I am one) that the laparoscopic
approach (ie. laparoscopic sacrocolpopexy) is the gold standard but beware that
the mesh still has potential risks, even if reduced.
has been proven and shown to have higher cure rates than using the patients own
tissue that has already failed, however again it takes a specialist with extra
years of training and an expertise in vaginal reconstruction to decide on its
appropriate use. The mesh itself DOES NOT cause the complication, how the body
reacts to it and how it is placed are the primary causes of complications. It
also is important to note that NO surgery is free of risk of complications
whether mesh is used or not.
ventral mesh rectopexy and sacrocolpopexy are operations that have a long
learning curve (calculated at 90 cases when functional outcomes are examined)
and therefore associated with a higher chance of complications and less
experience with recognition and management of complications related to the new
procedure. Surgeons may also feel embarrassed or simply do not explain to the
patient that they have only done a small number of these procedures.
surgeons should discuss in detail the procedure, complications (short and
long-term), potential benefits, his/her experience with the procedures to date,
where they trained in the technique and whether a colleague will assist or be
present in the theatre.