HOUSE OF COMMONS APRIL 2022

For what it’s worth this is what I said:

The positives and negatives since Cumberlege

FOUR KEY POINTS

1. NICE GUIDELINE URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE IN WOMEN 2019

2. WORK OF THE PFHOG

3. IN PARLIAMENT / MEDIA

4. WOMEN’S HEALTH during covid was not prioritised. In fact it was demoted to the lowest possible category of care.

NICE GUIDELINE UI AND POP

Last updated June 2019.

We made recommendations for assessing and managing urinary incontinence and pelvic organ prolapse and covered complications associated with mesh surgery for these conditions.   We made the rarely used recommendation that a registry of procedures MUST  be set up. ( usually ‘offer’ ‘consider’ …) We recommended that implants such as mesh should be accompanied with a ‘passport’ for the patient to be able to show to any health care professional.

An Act of Parliament ensured that safety of patients was paramount as mesh had been paused and the Cumberlege report initially interviewed patients ( before even the doctors) in large numbers and as a result can be viewed as one of the biggest qualitative studies in this topic area.

In addition to Pelvic floor dysfunction December 2021

NHSEI set up the Pelvic Health Programme 2019

Pelvic Floor Health Oversight Group was set up in 2019 to improve the care pathways for women presenting with stress urinary incontinence (SUI), pelvic organ prolapse (POP) and rectal prolapse. PFHOG brings together clinical leaders and patient representatives to help examine the delivery of SUI/ POP treatment as well as advising regarding specialist centres for mesh removal, the creation on Pelvic Floor Registry by NHS Digital and improve SUIPOP patients experience of care. It’s work is linked to perinatal pelvic health pilots within maternity programme.”

The NHS Pelvic Floor Forum’ representatives of mesh injured are included in the patient centred meetings.

The Pelvic Health Programme consists of workstreams reporting to the oversight group. The workstreams are:

• Surgical practice and training.  

• Clinical guidance and standards.  

• GP awareness of post-operative problems and appropriate care pathways.  

• Support for women with post-operative problems.

• Reporting of consultant level outcomes data.

• Patients are represented at all levels.

We patients are paid by the NHS an attendance fee. Expert Advisor role 4 in line with NHSEI guidelines.

The Pelvic Health Programme involves clinicians and as mentioned patients. Representatives of the appropriate Royal Colleges are all in attendance. A huge amount of work has gone into this since we first sat on the NICE guideline and now all the team on the pelvic health forum. We have come so far already, NHSEI has done an amazing amount of work to get all this up and running, and during a pandemic.

In addition work has been implemented on the Perinatal Pelvic Health Projects led by Prof Jacqui Dunkley-Bent. About which Charlie Podgies spoke to the APPG in the past .

The Nine Mesh Centres are different to the pelvic floor centres.

Parliamentary Debate

The awareness of all this huge work is limited.  This was highlighted in the parliamentary debate which was full of inaccuracies and out of date facts. I sometimes think the focus is on retribution against surgeons rather than making things better for the future.

But not one MP mentioned the pandemic. They were all happy to clap the NHS on Thursday nights, but the reality is they are now blaming the NHS as if it’s one individual. Well done NHS for sorting so many vaccinations, hurrah the NHS has been caring for so many patients, but…. scream at the ‘NHS’ for not doing operations. There is no sense in that.

The accusation that surgeons are untrained in mesh removal is very unfair. The simple fact is that these ie mesh removals are new procedures so no-one on the planet has been formally trained. The surgeons use transferable skills from other complex pelvic surgeries. The surgeons, and I have spoken to many of them, in the centres of excellence (my phraseology) are caring people determined to make it happen. They are supported by amazing clinical nurse specialists and women’s health physiotherapists. They are hampered by the unprecedented worldwide pandemic. Let’s not forget that that has been in the 2 years since Cumberlege. The analogy of the no blame culture in the airline business was an example used at Westminster.

Scottish government fund patients to go to States for mesh removal

As for Scotland, the decision to fund patients to go to the States is frustrating. The worst part of that is that post surgery follow ups and complications, those patients will have to be seen in the UK by the specialists they could have seen in the first place.

The mesh injured are of course worthy beneficiaries of extra help, in addition the high number of women with pelvic floor issues also deserve a voice. Mesh successes. Mesh injured. Non mesh successes. Non mesh issues. All the many women awaiting diagnosis and treatment for Pelvic Organ Prolapse (POP)and Stress Urinary Incontinence(SUI). Let’s not forget that there are thousands who need help for SUI/POP

Misinformation

There is so much misinformation within the media.

Example 1. The pathway proposed by the Royal College of Obstetricians and Gynaecologists (RCOG) aims to outline the skills required of doctors working in specialist mesh removal centres, which were set up after a recommendation in the Cumberlege review into avoidable harm among patients injured by implanted pelvic mesh.

Surgical mesh: Proposed training pathway needs more patient input, say campaigners | The BMJ

This is not true. Patients were involved and the RCOG ensured credibility, transferability, dependability, and confirmability. Which is essential for rigorous qualitative research. The pathway proposed by the Royal College of Obstetricians and Gynaecologists (RCOG) aims to outline the skills required of doctors working in specialist mesh removal centres, which were set up after a recommendation in the Cumberlege review into avoidable harm among patients injured by implanted pelvic mesh.

Example 2. Specialist surgical mesh centres are not working, MPs are told | The BMJ

This is not true.  There are now NINE centres in England and one in Scotland.

Hurrah that patients with injuries due to mesh. They have been prioritised. That’s good. Now what about everyone else?

Example 3: RCN statement to UACC . BSUG responses in blue

We have attempted to provide comments from an RCOG/GMC/BSUG point of view for Gynaecological meshes but cannot comment on meshes inserted by colorectal surgeons (VMR) or general surgeons (hernia).

Example 4: The RCN are very pleased that the RCOG published a management training pathway for mesh complications, a much-needed piece of work and important tool in providing patients with confidence in the training and standard of care offered by specialists dealing with mesh complications.

Thank you and this has been very much supported by the GMC and specialist societies (BSUG/BAUS/PFS) as well as the Royal college of Surgeons while being led by the RCOG. 

Example 5: we could suggest a change, we would request a more proactive approach to prevent mesh complications in the first place with a new ‘UK Mesh Insertion Training Pathway’ to include insertion of all types of mesh procedures.

This already exists. The current curriculum identifies a pathway for training of current trainees through their ATSM (Advanced Training Skill Module) and SST (Subspecialty training) which are packages of training that current trainees have to undertake if they plan on undertaking this work as part of their consultant role. for abdominal mesh they have to undertake the Laparoscopic urogynaecology training. For continence mesh this would have been through the Vaginal surgery ATSM or SST but for the past 4 years no one has had any training in the use of vaginal mesh for continence as they have just not been performed. For Consultants there exists training packages run by the BSUG (Mentorship scheme) which requires that the same standards be achieved as expected of trainees.

 Example 6:  – detail a database of experienced and skilled surgeons who have completed specific mesh procedure training pathways, each including the long term risks of mesh and how to prevent complications in the first place.

A Database is not really a solution as skills are fluid and if a person’s job description changes, they may stop doing a particular procedure. This therefore needs to be managed through the Appraisal process where clinicians are expected to provide evidence of the work they undertake as part of their job plan and ONLY undertake such work where they can demonstrate ongoing competency. This is the responsibility of individual employing hospitals rather than something that can be managed centrally. This is more difficult to manage in the Independent sector, but with increased awareness I would be surprised if anyone undertakes a mesh insertion if it is not part of their clinical practice on the NHS as well. This may however be a piece of work for the Independent sector hospitals to undertake.

 Example 7  -Mesh is still being inserted throughout the UK today at large NHS teaching trusts, smaller district generals and in private hospitals by surgeons (all specialities) who currently do not have to complete any specialised mesh insertion training certification, provide the number of mesh procedures they perform on a national database, type of mesh procedure and record post-operative complication rates.

 The paused meshes are not being undertaken. This has been shown through the HES data and I am unsure where this information is coming from. NHS Digital have investigated this and found there have been coding errors resulting in this spurious information. The abdominal meshes on the other hand have never been paused so continue to be performed.

 Hospital Trusts and private hospitals where mesh insertion for POP/SUI is being undertaken are already required to submit details of the type of mesh procedure to the National Registry.

 Example 8 -This whole process should be externally monitored and checked with regular peer supervision and formal assessment. Patient safety is paramount and the evidence can only be achieved when long-term outcome data is collected accurately.

Couldn’t agree more. Patient Safety has to be the single biggest priority in conjunction with Patient Choice.

From a BAUS viewpoint: training in mesh is covered in the new special interest module in female and functional Urology which is approved for CCT and by the GMC

Mesh procedures are not performed at the moment although mesh in men for SUI is not covered by the restrictions is only performed exceptionally and in specialist centres following MDT approval

SUI procedures only performed by consultants with appropriate training in commissioned units although compliance needs to be checked

Postnatal care:

Postnatal care has long been patchy – even before the pandemic – partly due to a lack of education among healthcare professionals as well as the embarrassment and stigma that impedes mothers from reporting their issues in the first place. Covid simply exacerbated these underlying fissures, says Cornish: “We are facing a massive uphill battle, because cancer cases are going to be taking priority and so pelvic floor problems get pushed to the back of the queue again.”

For the most part, pregnant women are offered some education by the NHS about what to expect all the way through to delivery, but these classes are not uniform across the country. After birth, women are typically given a leaflet with instructions for exercises they can do to get their pelvic floor muscles back into shape (although pinpointing those muscles can be tricky). Meanwhile, postnatal care is largely the responsibility of community midwives. Around the six- to eight-week mark, a postnatal check on mother and baby is conducted by GPs.

Many campaigners cite France as a country with better pelvic healthcare. Mothers there are automatically prescribed multiple sessions of physio to “re-educate” their pelvic floor after delivery. But there is acknowledgment that postpartum care in the UK is ripe for improvement, and earlier this year NHS England announced the opening of 14 new pelvic health clinics, bringing together midwives, specialist doctors and physiotherapists to improve the prevention, identification and treatment of pelvic floor dysfunction.

Pain most common reason for mesh removal

The data: mesh procedures in UK = 600,000

up to 10 % have issues mainly pain = 60,000

up to 3% have mesh erosion = 1800

compared to half a million women on waiting list per RCOG

Large cohort study USA. in our study, the most common indication for mesh removal was pain.T

he most common type of mesh procedure removed was the sling,

and the most common type of sling removed was the TOT.

The most common typeof POP mesh removed was the anterior TVM.

Transvaginal sling revisions/removal had the least amount of surgical complications. Laparoscopic RP removal had the highest incidence of blood transfusion, anterior vaginal wall mesh removal had

the highest incidence of ureter injury, and posterior vaginal mesh removal had the highest incidence of rectal injury.

Overall, sling, TVM, and laparoscopic sacrocolpopexy mesh removal are safe procedures when per-formed by experienced surgeon

Among women undergoing midurethral mesh sling insertion, the rate of mesh sling removal at 9 years was estimated as 3.3%. These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence.

In summary we have made real progress. Cumberlege has highlighted mesh and therefore pelvic floor ie UI and POP .  As a result of the pause surgeons have had to review their practice to ensure other procedures can be undertaken instead. The training programmes for new specialists has been considerably delayed whilst this is put into place. Notwithstanding the delays of covid.  Work must now begin on recovery and waiting lists for women which until now have been low priority. Of course cancer care must take precedence in the covid situation.  Cancer must take priority over quality of life sufferers.

The fact that there has been a ‘buy in’ from all the surgeons. That a database of all clinical procedures on admission and patient reported outcomes (PROMS) will shortly be up and running is a massive improvement. Where substandard performance is taking place will be transparent and acted upon. Surgeons will be credentialled Patients everywhere can be assured that this will not happen again.