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Mesh complications & treatments

It 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 fail. 

Most 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.

Mesh 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.

Apart 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.

Although considered the standard of care, complications can still occur including:

Infection

Mesh erosion (see below) and extrusion through the vagina

Erosion into viscera such as the bladder or bowel (see below)

Recto-vaginal fistula

Obstruction of the urethra

Injury to nerves


During 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. 

These 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 infection.

·      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.

However, 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.

There 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.

Mesh 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.

Laparoscopic 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. 

Your 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.



Salvage surgery

What to ask your Urogynaecologist or Surgeon
How to deal with complications post LVMRectopexy

Trans-vaginal & TVT Mesh

Reporting mesh complications to the MHRA
MHRA position on vaginal mesh for POP
DOH statement on vaginal mesh & tapes
Problems with TVT
FDA - POP & Mesh problems

Most surgeons do not have the experience or expertise in the treatment of mesh complications. Maximize your surgical benefits by choosing the right surgeon with the most experience.  

Here in Bristol we have operated on >100 patients with vaginal mesh complications post gynecolological mesh (Prolift, Farnsworth Total Pelvic Floor Repair, Prolift and many more) insertion and following ventral mesh rectopexy, including our own.  Many had undergone repeated failed trans-vaginal attempts by urogynaecologists at correcting the problem.  All were successfully managed using laparoscopic techniques, which allows removal of all mesh material (see left) and the anatomy restored using either a biologic implant or absorbable sutures.  In all cases function and QoL was restored. 

The surgery requires a high degree of competence and “concentration and hard work” but it needs to be performed thoroughly to ensure that the patient achieves the best result.  Many of the patients have had had multiple surgeries for prolapse and many meshes and sometimes different types of meshes were implanted in the same individual.  These women have already suffered and need to be managed with utmost care and empathy.

If you have been told that your vaginal mesh or erosion post ventral mesh rectopexy cannot be removed or if you have already had a mesh revision by another surgeon and still suffer from symptoms (dyspareunia, pelvic pain, discharge, extrusion-visible mesh) of a vaginal mesh implant, Mr Dixon his associates @ Bristolsurgery.com can usually help. 




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SPIRE Hospital, Bristol. 
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Contact: Claire Trenberth - 0117 9804051
claire.TRENBERTH@spirehealthcare.com
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