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First Do No Harm: Complications and Complaints will Change Pelvic Floor Surgery Using Mesh Implants in 2015

Special Reports

by Christine Landon, Consultant Urogynaecologist and Pelvic Floor surgeon. MB ChB, MD FRCOG

Introduction
In a plenary session of the Scottish parliament on the 26th of June 2014 Alex Neil the Scottish cabinet minister for social justice gave a ministerial statement on the use of polypropylene (plastic) mesh devices in pelvic floor surgery.

He described hearing of the “horrendous” complications suffered by some women after vaginal mesh surgery for incontinence and prolapse.

He related that traditional surgical methods without mesh had high failure rates of 25% or more and that the medicines and health care products regulatory agency (MHRA) had previously reported complication rates for mesh procedures of only 1-2.6%.

He was now concerned as to the real incidence of serious complications and that many might be going unreported.

Mr Neil confirmed that he was asking all Scottish health boards to suspend the use of vaginal mesh pending an independent inquiry. Procedures involving mesh would be only be allowed if they were part of a clinical trial.

An independent review would be set up to look into the possible under estimation of complications.

What had happened to cause such an unprecedented parliamentary situation?
A small group of Scottish women who had suffered severe complications following surgery using polypropylene mesh for urinary incontinence and prolapse had raised a petition (PE01517) on behalf of the Scottish mesh survivors – Hear our voice campaign, urging action to suspend mesh procedures and regulate their use.

Alex Neil had noted that the American food and drug administration (FDA) had reclassified mesh surgery for prolapse from moderate to high risk and that the
European device directive which had originally classified vaginal mesh as moderate or 2b risk was to increase it.

What are these complications and what is the real incidence?
All adverse events regarding mesh implants should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) who can remove devices from the market on sufficient evidence of complications. They rely on events being correctly and fully reported. This may not be happening. The true rate of complications is unknown

Complications of vaginal surgery using mesh implants
There are over 100 procedures described in the medical literature that are designed to cure urinary stress incontinence or pelvic organ prolapse in women which perhaps suggests how difficult it is to achieve good results. In the 1990’s the colposuspension was the gold standard procedure for urinary stress incontinence with cure rates of up to 85%.

This surgery however required internal suturing through a significant incision across the lower abdomen so a search was on to provide a minimally invasive procedure that was not only relatively straight forward to perform but also had a short learning curve, good cure rates, a short recovery time, low risk and low cost.

A procedure that seemed to meet these criteria known as the tension-free vaginal tape (TVT) was eventually developed by Professor Ulf Ulmsten and colleagues at Uppsala university in Sweden. He carried out clinical trials for his device that involved using trocar needles to insert a small net tape made of polypropylene plastic under the urethra of incontinent women.

This tape became fixed by tissue adherence behind the pubic bone (retro pubic approach) to form a support which prevented the urethra from opening during physical activity and thereby curing incontinence in over 80% of women treated.

Randomised controlled trials subsequently showed the TVT or sub urethral tape, also known as a mid urethral sling (MUS) to be equivalent to the colposuspension in effectiveness yet only 3 small incisions were required, morbidity was low and recovery was rapid.

Response to the new procedure was enthusiastic.
Johnson and Johnson developed the device in 1996 and following in the wake of this seemingly brilliant innovation in pelvic floor surgery many other medical device companies began producing similar devices and special kits to enable easy insertion of a mesh tape beneath the urethra. The research that went into many of these copycat devices was however somewhat variable.

The method originally involved inserting quite large needles behind the pubic bone to position the tape. Organs in the pelvis such as bladder, blood vessels and
bowel were at risk of possible perforation. This prompted the development of a technique whereby the tape would be fixed more laterally and would not enter the pelvis.

By 2003 Professor Jean De Leval from the University of Liege in Belgium had developed a method whereby a mesh tape would be fixed via attachments to lateral pelvic tissues including the obturator membrane and muscles in the groin and inner thigh. This would lessen the risk of damage to organs behind the pubic bone.

“We have developed a novel surgical treatment of urinary incontinence, the transobturator inside- out tension-free urethral suspension, which uses specifically designed surgical tools, and in which a synthetic tape is passed from underneath the urethra, through the obturator foramen, towards the thigh folds, without entering the pelvic region at any time during the procedure”.

“The procedure was carried out in 107 consecutive patients (mean age: 62 years) using the same operative protocol in all case subjects. The operative time was 14 min and no bladder or urethral injuries and no vascular (hematoma or bleeding) or neurological complications were encountered.”
                                                                                                                                                                                                            Jean de Leval 2003
This became known as the TVT-O (Obturator approach tape) also supported and then manufactured by Johnson and Johnson

The mid urethral sling tapes soon became the gold standard procedure for urinary stress incontinence and have remained so until now.

Encouraged by the success of tapes for incontinence and the grade 1 level evidence for the success of polypropylene mesh reinforced hernia repairs in reducing recurrence, polypropylene mesh inserted vaginally began to be developed for vaginal wall prolapse repairs.

High recurrence rates for prolapse in women after native tissue repairs had long been a problem reaching 25 to 30 % in some studies. Polypropylene mesh reinforcement to support the vagina, bladder and rectum via the more minimally invasive vaginal route seemed to be a promising way forward for restorative longevity and successful outcomes for many women.

Mesh had in fact been used for sometime to elevate and attach the vagina when weakened following childbirth or hysterectomy by to the back of the pelvis through an abdominal incision (Abdominal approach sacrocolpopexy).

Later, laparoscopic techniques were developed with good results but very long learning curves. Complications relating to mesh within the abdominal cavity had been reported such as organ damage, bowel obstruction and serious infection at the site of the mesh attachment to the sacrum resulting in spinal complications.

Trans vaginal mesh repairs were therefore welcomed as providing potentially easy surgical access, short recovery times and long term success.

As with the tapes many medical device companies developed similar but individually different pre prepared kits to allow shaped polypropylene mesh to be inserted and fixed into position through vaginal and small external incisions.

Mesh began to be used regularly worldwide for prolapse repairs with the aim of permanently restoring bladder and bowel function, relieving symptoms of a protruding bulge and reducing discomfort.

Clinical trials from the developers of the original trans vaginal mesh procedures showed good initial results but problems began to occur.

It should be emphasised at this point that many women electing to have pelvic floor surgery using mesh reinforcement were reported to have a successful outcomes and that over a million of women throughout the world have been treated for distressing incontinence and prolapse using these techniques.

However, some women particularly in the USA began reporting serious problems and complications following polypropylene implants and some also began to seek significant compensation through litigation.

The problems became increasingly significant. Class actions against trans vaginal mesh companies were started in the USA and many mesh kits were withdrawn from the market following FDA action requesting follow data for mesh implant procedure from medical device companies.

Women’s complaints frequently related to distressing vaginal or thigh and leg pain, bladder problems and sexual difficulties.

So what went wrong?
As with all surgical procedures particularly with those involving the insertion of material foreign to the human body, there will be complications.

Some complications following vaginal mesh surgery are now known to be particularly problematic and may lead to litigation.

These complications include chronic pain, infection, mesh erosion and exposure, mesh contraction or shrinkage, mal positioning of the mesh, bladder dysfunction and damage to adjacent structures.

Pain.
Pain may occur after any vaginal mesh implant and may be due to mesh exposure or contraction, erosion, nerve damage, scarring or tension effects within pelvic tissues.

In many cases pain resolves a few days after surgery but it may last for weeks or months and require revisional surgery including removal. Obturator approach tapes can cause significant pain in the groin, thigh or leg. This may be due to damage or irritation of the obturator nerve or muscles. Many surgeons choose not to insert obturator tapes into the thigh area particularly in young women and those keen on sports reserving these for women where a retro pubic approach may be challenging.

Mesh exposure and erosion.
Mesh exposure (or extrusion) where mesh is directly visible or palpable within the vagina may be recognized shortly after surgery or many years later.

Exposure may be limited to a small area such as a few fibres or the entire sub urethral portion of a tape may be visible and present with pain, discomfort or
unpleasant discharge from the vagina. An exposed mesh may also be felt during sexual intercourse by the patient or their partner and can cause bladder problems.

Obturator tape exposures may a occur in the lateral lower vagina and may be due to operator error with failure to recognize buttonholing of the tape through the vagina.

Exposure is more likely to occur if skin is of poor quality due to the menopause or other health issues. Smoking is known to adversely affect healing.

Larger exposures will not heal and need surgical management as soon as they are recognized as patients often find this problem very distressing.

The exposed part of the mesh may be excised. Simple over sewing of epithelium over exposed mesh without excision is often unsuccessful as epithelialization
may have already occurred beneath the mesh or there may be chronic low grade bacterial colonization of the exposed mesh affecting healing.

Mesh that is obviously infected may need antibiotics and complete or partial removal. Excising exposed portions of sub urethral mesh may lead to loss of mesh integrity and effectiveness so that urinary incontinence may reoccur.

Obturator approach tapes can cause significant pain in the groin, thigh or leg. This may be due to damage or irritation of the obturator nerve or muscles. Many
surgeons choose not to insert obturator tapes into the thigh area particularly in young women and those keen on sports.

Damage to adjacent structures.
Insertion of vaginal mesh may cause direct damage to the bladder urethra or bowel. Surgeons are advised to examine the bladder cystoscopically after mesh
insertion particularly if damage to bladder integrity is suspected.

Mesh penetrating the bladder must be removed. Failure to recognize mesh within the bladder at the time of surgery may lead to severe problems such as pain, chronic infections, stone formation, haematuria, fistula formation and incontinence.

Inadvertent insertion of mesh into bowel is potentially life threatening due to possible leakage of bowel contents causing overwhelming infection and organ failure. Immediate assistance from a colorectal colleague may be required.

If bowel damage has occurred it may be advisable not to proceed with mesh insertion due to an increased risk of infection and fistulation.

Damage to blood vessels can cause severe haemorrhage or haematoma formation. Transfusion and reoperation may be required.

Malpositioning of a suburethral tape. The tape is too tight
A sub urethral tape should be under no tension, a tight tape will lead to bladder emptying problems and pain.

If it is suspected then action can be taken to loosen the tape. This can only be carried within the first 7 to 10 days after which tissue adherence to the tape will not allow adjustment. Many surgeons advise taking this action sooner rather than later particularly if the patient is unable to void at all.

If a voiding problem remains unrecognised the patient may suffer with marked frequency, urgency and incontinence. This may be compounded by recurrent urinary infections and cystitis symptoms. If this does not resolve then action is required to incise and release the tape in order to restore voiding function and urinary flow through the urethra but removal of the sub urethral portion of the tape may be required.

Any revision of the tape may lead to recurrence of urinary incontinence and the requirement for further surgery.

The mesh is in the wrong place.
A tape may be situated at the bladder neck rather than in the mid urethral position. This may be due to operator error or the tape may have become dislodged in the post operative period.

Patients may present with pain, urgency, poor bladder emptying, sexual difficulties and chronic infection

Mesh may also erode into bladder bowel or urethra over a period of time.

Mesh contraction, shrinkage or retraction.
In some patients polypropylene mesh is known to contract or shrink. This can cause severe vaginal pain due to tension on vaginal tissues and nerves or alteration of the vaginal anatomy such as narrowing. Sexual function can be markedly affected. There is often tenderness over lateral mesh fixation straps.
Surgical intervention may be required to divide contracted fixation straps or remove contracted mesh. The exact cause and reason for a variable contraction
response within the tissues of some patients and not others is not fully known.

Infection.
This can be reduced by the use of antibiotic prophylaxis at the time of surgery and attention to technique and operative sterility. The type of mesh or tape is extremely important. A type 1 mesh is advised as the pore size and type of weave optimisizes the ability of defensive cells such as macrophages to eliminate bacteria and produce uniform adherence.

Recurrent urinary tract infection should prompt investigation for mesh problems.

Bladder over activity may follow vaginal mesh surgery causing urinary frequency, urgency and urge incontinence. If there is outflow obstruction it may resolve after tape release but medication or further intervention may be required.

What is the real incidence of these complications?
Various authorities and regulatory bodies have recently examined the literature to clarify this.

The York Report was commissioned by the MHRA and produced by the University of York. An analysis of all data from systematic reviews published in the last 10
years was undertaken with results as follows.

For mid urethral slings
post operative pain 0-1.9%
erosion/exposure 0-5.8 %
deterioration in sexual function 1.9-13%
need for reoperation 0.5-6%

For trans vaginal mesh
pain after 6 months 5.5%
erosion/exposure 6.5%
problems with sexual function 15.3 %
reoperation 4%
organ perforation 2.1%

There was a wide variance in complication rates suggesting that other factors, such as surgical skill or individual patient characteristics were playing a significant role in an individual woman’s likelihood of experiencing significant problems.

The MHRA executive summary from their recent report states that there appears to be no evidence that vaginal mesh implants are unsafe and that 10 year data indicates significant long-term benefits in the majority of women undergoing these procedures (13,500 women per year in England).

They noted the NICE guidelines data which had shown that up to one year, vaginal mesh implants for incontinence had a peri-operative complication rate of 1-12% but was up to 6.5% if mesh is used for prolapse.

Although the data regarding vaginal mesh implants for prolapse is less clear NICE guidance had also reported that vaginal mesh implants offered significant
improvements in failure rates compared with surgical repairs undertaken without mesh.

The MHRA therefore concluded that -
The overall benefits appeared to outweigh the risks and that whilst some women have experienced distressing and severe effects, the current evidence shows that when these products are “used correctly” they can help alleviate the very distressing symptoms of incontinence and prolapse.

The Scottish pelvic floor network has issued a statement reinforcing the advice from the Royal College of Obstetricians and Gynaecologists (RCOG) and the British Society of Urogynaecology (BSUG) to adhere to the NICE guidelines in the management of stress urinary incontinence and prolapse which specify that all suitable treatment options be offered to women undergoing and consenting to surgery.

NICE interventional procedure guidance states that - The evidence suggests that surgical repair of vaginal wall prolapse using mesh may be more efficacious than traditional surgical repair of vaginal wall prolapse without mesh but that risk of complications that can cause significant morbidity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

Clinicians wishing to undertake surgical repair of vaginal wall prolapse using mesh should take the following actions. Inform the clinical governance leads in their Trusts.

Ensure that patients understand that there is uncertainty about the long-term results and there is a risk of complications, including sexual dysfunction and erosion into the vagina, which would require additional procedures. They should provide them with clear written information. In addition, the use of the Institute's information for patients ('Understanding NICE guidance') is recommended.

Audit and review clinical outcomes of all patients having surgical repair of vaginal wall prolapse using mesh and that - This is a technically challenging procedure that should only be carried out by gynaecologists with special expertise in the surgical management of pelvic organ prolapse. Specific training is required when trocar introducer systems are used for the insertion of mesh.

A case series using non-absorbable synthetic mesh reported new sexual problems in 36%.

Mandatory reporting of complications to the MRHA has been proposed and all surgeons are recommended to audit their outcomes. The use of the national registry for all incontinence and prolapse procedures is also supported.

Litigation
Failure to select the correct patient, failure to inform and consent, surgical failure, device failure, failure to listen, failure to explain, failure to act, failure to refer

There are clearly a number of factors leading to the controversies besetting vaginal mesh implants and the complications that some women have suffered.

These seem to centre not only around the patient selection and possible lack of surgical experience or inadequate training leading to poor technique and sub optimal surgical standards for some women but also the inherent properties of plastic mesh and the human tissue response to it in some patients.

Surgeons may be taking on procedures that appear to be straightforward and that are marketed to them and presented in handy kit form but that are in reality technically challenging to get absolutely right.

There is evidence in the literature that good results can be achieved by well trained surgeons with a high volume of cases. Mesh surgery requires good anatomical knowledge, precise tissue dissection and accurate placement to avoid problems and there is a significant learning curve.

Careful Patient selection is vital and the marketing of mesh devices to all surgeons who might be able to do the procedure due to commercial pressures is unwise. Training courses including mentoring by experienced surgeons and assessed competency certification for mesh procedures may help.

Failure to follow up and examine women carefully after mesh surgery must be avoided as should a paucity of knowledge regarding the management of complications.

Referral to a revisional surgeon should be considered before the problem becomes chronic and difficult to manage. A head in the sand approach to complications
will always lead to problems.

Failure to listen to patients causes frustration and anger. If problems occur they must be explained. The message is always communicate…communicate communicate…but also individual physicians do now have a duty of candour.

Controversies should be discussed as patients will not be thankful later if they are not.

The FDA has recently issued a safety communication update stating that -
Serious complications associated with the insertion of synthetic mesh for pelvic organ prolapse are not rare and that mesh contraction could cause significant problems.

Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 and reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

IUGA position statement
The International Urogynecological Association (IUGA) supports the use of mid-urethral slings (MUS) as one of the options for the surgical management of female stress urinary incontinence.

Conclusion
Pelvic organ prolapse and incontinence may occur in up to 50% of childbearing women and the need for surgery is common.

Recent studies have shown surgeon experience to be one of the most significant predictors of successful outcome and there is evidence in the literature for good results for synthetic mesh procedures carried out by fully trained surgeons with a high volume practice. In carefully selected and counselled patients it may be the best option for incontinence or when prolapse is severe and recurrent.

The incidence of complications varies with operative experience and there is a learning curve that requires further study. The perfect mesh is not available.

Some complications can be very difficult to treat, such as pelvic pain and voiding dysfunction, and patients should be referred early for expert advice and be made fully aware of these complications prior to surgery.

In June 2013 a jury delivered its verdict in the J&J Prolift Mesh Trial, Class action. New Jersey.

After a month-long trial nine jurors awarded $7.76 million in punitive damages to the plaintiff a 47-yearold nurse from South Dakota who complained of chronic debilitating pain.

The jury ruled that J&J did not defectively design the mesh and did not make fraudulent misrepresentations to the surgeon.

The legal team argued that J&J had known about problems with the Prolift mesh but failed to adequately warn about potential problems and risks in their literature and instructions for use.

The jury awarded $3.35 million in compensation for loss of earnings, medical expenses and husband’s loss of companionship. Punitive damages brought the total award to over $11 million.

This was the first of over 2,000 cases listed in the New Jersey courts against Ethicon and J&J.

Johnson & Johnson announced that it would be appealing against the verdict, the share price did not fall. 

Since then in the USA and as of June 10, 2015, trans vaginal mesh plaintiffs have won twelve trials for and the defendants have won three.

It is now clear that the Scottish women who have courageously brought their anguish and highlighted their problems to the public and medical profession will make a significant change to the way that all pelvic surgery using polypropylene mesh is carried out in Europe including who carries it out on whom and how it is monitored.

On 12 May 2015 the Scottish petition committee agreed to write to the European Commission's Scientific Committee on Emerging and Newly Identified Health Risks, the Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology.

If the number of signatures reaches 100,000 the petition will be considered for debate in the House of commons.

…I will not be ashamed to say “I know not” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.
                                                                                                                                                                                    From the Hippocratic covenant
                                                                                                                                                                                             Primum non nocere