Research articles

Pinned posts:

The MHRA 1 to 3% complications is a myth if you look at this paper:

National audit of incontinence surgery in the United Kingdom This is a study from 2009 of SUI mesh headed up by Jonathan Duckett

Only 5 adverse event reports made to the MHRA in 2008-9 .

10% of over 500 surgeons surveyed had erosion

47% patients developed urge incontinence or urgency

29% reported bladder perforations

2% needed emergency abdominal surgery-laparotomy

16% had emergency readmissions to hospital

Persistent subrapubic Pain Reported by 16%

 

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SERNIP in the UK, the fore runner to NICE, upgrades the TVT incontinence mesh from C to A  following complaints by J&J that remaining at C will affect sales SERNIP upgrades TVT from C to A

In Jan 1998 the TVT is C. By October 1999, the TVT is still rated as C pending results of RCTs. Just three months later in January 2000 The TVT is upgraded to A – with no long term large scale RCTs.

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In 2017 the MHRA conduct a review of papers into reaction of Polpropylene implants in animals. Animals cant talk of pain or loss of sex life – different end points in research – so is not useful. Additionally, it is not a thorough look at all of the evidence, known as an RCT, so is  low quality evidence. MHRA review of Mesh – Poplypropylene review of biocompatibility McGuire et al

Head of J&J Alex Gorsky, CEO, says you dont need to get it 100% right, when you hit 60% hit go

Hernia mesh used in horses causes complications for up to 60%

Hernia mesh paper by Bendavid and Iakoviev – Shows 37% risk of complications. Pain is the game changer  Bendavid and Iakoviev Revival Pure Tissue

BJOG 2019 – Two views on TVT mesh. One for by Christopher Maher and one against by Wael Agur

March 2019 FDA say implant materials can cause allergic reactions

FOI to UCLH shows alternative provision during Suzy Elneil’s suspended service have very little experience FOI Response_Mesh Removals_26.04.2019

Oxford mesh complications paper Mesh related complications sacrocolopexy-oxford-2005-to-2017 (1)

Ethicon fudge figures! See p 50 of this  documentDuring a product liability hearing, Ethicon’s medical director, Piet Hinoul, admitted a third of TVT slings fail.yet officially reported the success rate as more than 90%. TVT court paperwork 1:3 fail

Incontinence and prolapse mesh is  approved on the back of a mesh sling that was withdrawn in 1996

BMJ article traces the flawed piggy back system of approval which means that all pelvic mesh on the market today can be traced back to the Protogen sling – which was withdrawn amid safety concerns.

 

Surgeons must meet 6 criteria if mesh is to “unsuspended”

Link to the criteria in this letter from RCOG

BSUG CRITICISE THIS

Jackie Doyle Price announcement

Criteria to lift the SUI mesh suspension
Criteria to lift the SUI mesh suspension

 

Ester study

Ester study looks set to be used to get mesh back into mainstream use as regular treatment option as it has been for 20 years. Ester Study
NICE guidelines 2019 say Ester has been looked at even though the study has not been peer reviewed and published! See p175 of stakeholder comments
Ester p175 of NICE stakeholder comments replying to the question of why they didn’t use the Keltie study, which shows risk of complications from a mesh sling for incontinence is at least 9.8%

June 2019 BMJ paper says there is no long term evidence on efficacy or complications of SUI mesh

2019 paper says minority suffering

Urology News publishes an article by Tamsin Greenwell that down plays suffering. “It has become clear that whilst mesh surgery for SUI offers a simple, effective treatment for the majority of women, a small but significant number suffer life-changing complications.”

In 2011 MHRA knew of concerns and did nothing

In 2011 the MHRA did nothing to protect patients despite

1 Increased number of women reporting complications

2 Concerns mesh was approved without enough clinical data

3 Surgeons implanting without adequate training MHRA not fit for purpose p14

Vaginal prolapse mesh in N Ireland

Vaginal mesh for prolapse has not been used in N Ireland for some years according to this link.
“The differences in complications mean that vaginally placed mesh is no longer recommended by NICE in the treatment of pelvic organ prolapse. It has not been used in Northern Ireland for several years.”

Mesh removal reduces pain

This 2016 paper by Scottish medics says following mesh removal 75% of women have reduced pain and 50% remain continent.

In 2007 J&J destroyed mesh records

In 2014, a judge found that Johnson and Johnson lost or destroyed thousands of documents and computer files dating back to 2007 for prolapse and TVT  meshes. However, instead of saying it was done deliberately she said it was negligently done.

Being a mesh specialist centre in the UK does not guarantee competency

Click the letter link below. Being a specialist mesh centre only means it ticks boxes for staff within the team. It does not guarantee they can successfully remove mesh or indeed have any experience of doing so. RCOG BSUG  mesh specialist centres does not guarantee competency

Here is the link to the letter on the BSUG website 

BSUG Database is not fit for purpose because…

In 2012 BSUG accepted the new international 5 code ICS/IUGA mesh complication code generator system. Surgeons can then report specific types of problems and how long it took for them to appear.  BUT…this information has never been analysed and published by BSUG. Why?

To work, a database must be independent from surgeon societies.

Here is BSUG’s first national report from 2008 to 2017 which shows that only a third of surgeons reported. BSUG National Report – Stress Incontinence Surgery in the UK (2008-2017)

The 5-code system. You  can only log one type of pain. You can’t list multiple pain eg you can only log one choise of pain in sex, provoked pain, asymptomatic, during physical activities and spontaneous – as we know women have all sorts of pain and you need to be able to tick multiples NOBODY IS PROPERLY RECORDING PAIN
TVTO is 2.3% risk
TVT is 2.8%.
Yet surgeons say TVTO has higher complications!
 
Go to page 19 to see  68.3% surgeons didn’t answer this basic question on how many women had complications after a TVT
 
TVT Graft complication  2.8% risk                   No =                       8251
                                                                                   Yes =                       239
                                                                                   Unanswered =        18,275
                                                                                   TOTAL WOMEN      26,765
 
Go to page 24 to see how 66% surgeons didn’t answer this basic question on how many had complications after a TVTO or a TOT
 
TVTO / TOT Graft complication  2.3% risk     No =                       3235
                                                                                    Yes =                       77
                                                                                   Unanswered =        6,099
                                                                                   TOTAL WOMEN      9,411

Postcode lottery on  risk warnings

Here is a BSUG leaflet that hospitals used to be able to down load and then cherry pick which risks they warned women about BSUG SUI patiient info leaflet

 

Auto immune disease are rife in mesh support groups

Elsevier Scientific community accepts for first time that plastic can act as an adjuvant for auto immune diseases like fibromyalgia and also allergies, IBS, chronic fatigue.

Surgeons don’t bother reporting medical device problems. They don’t see the point

CTV Canada has blind spot on medical device safety

In 2017, a total of  22 Canadian physicians of varying specialty, region, organisation and career stage perceived Adverse Medical Device Event AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Their  “behaviour is reinforced by limited healthcare system capacity and industry responsiveness.”

Gagliardi et al Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices

 

BSUG take 4 years to come up with results of its 2014 audit

BSUG audit of SUI mesh from 2013. It took 5 years to publish its data

BSUG dissolved its database in October 2014 just two months after the deadline for its audit

The March 2018 BSUG newsletter announces the arrival of these audit results but by June 2018 they are still not online.

Companies House show the BSUG database was dissolved on October 14, 2014. Two months after the deadline to submit to the BSUG audit. Background to the BSUG database

Failing system: Consultants cannot add a mesh complication to the BSUG database if the original mesh operation was carried out by another surgeon. They have to gain the patient’s consent to contact the original surgeon. Which means a vast number of complications will not be logged. Recording Mesh Graft Complication Surgery on the BSUG Database

Oxford release a disparaging report that says mesh complications are more likely psychological issues

Natalia Price, Simon Jackson et al publish paper Sep 2018 that says “Patients may attribute highly diverse symptoms due to mesh insertion, including chronic pelvic pain, chronic fatigue, fibromyalgia and pain distant from the pelvis. There is limited evidence to support the causality of mesh in these distant symptoms. Patients may also have psychological morbidity rooted in anxieties about long- term harm from mesh”

Conflicts of interest in medicine

Fiona Godlee, editor of the British Medical Journal, said in this article: “We don’t let judges or journalists take money from the people they are judging or reporting on: we shouldn’t let doctors do this either. Paid opinion leaders are a blot on medicine’s integrity, and we should make them a thing of the past.

 

BAUS response to NHS England interim working group report from 2015

BAUS response includes many ideas to strengthen up protection for women and also develop more robust reporting systems.

UK trials “new mesh” since 2016

New mesh” has been trialled in England and Northern Ireland since 2016. They are trialling it as they admit shrinkage with the polypropylene mesh is a problem.

“The sling being studied is DynaMesh®SIS soft, made of polyvinylidene fluoride (PVDF) which has improved biocompatibility with tissues, meaning reduced scar formation and less mesh shrinkage.”

It is poly so is still plastic and still introduces a foreign body into a clean, contaminated field using large hooks and inserted blindly.

There are 11 centres. It is currently in use in four.  Norwich (main research centre), Antrim and Belfast in the UK and Munich in Germany.

It will be introduced in London, Cambridge, Wirral, Solihull, Huntingdon and Kilmarnock in the UK and Wurzbug in Germany.

Classic short term follow up of one year then, then for a further year by postal questionnaire. Clinical follow up is at 3 and 12 months post operatively and as required if any concerns.

 

Vue Trial where are the results

This article describes the VUE trial, but does not show any results despite being published in 2016 . The Vue Trial began recruiting in 2013 across 40 centres. Six month and 12 month reviews were done. We are now in May 2018.. Not even one year results have been published. Five years on it should’ve published full results by February 2018.

ncbi.nlm.nih.gov/pmc/articles/P .

Vaginal tumour

Study shows tumour like reaction inside the vagina following a polypropylene TVT sling.

Ward Hilton study Burch vs TVT

Karen Ward and Paul Hilton carried out the largest RCT of old fashioned Burch vs TVT mesh in 2002 and found they are similar in efficiency. The study measured if it stopped women leaking. Even in secondary outcomes it is not clear if they measured new onset of pain or UTIs. WARD AND HILTON 2002 BMJ

Also, they took funding from J&J for this study.

Updated here in 2008 Ward_et_al-2008-BJOG_3A_An_International_Journal_of_Obstetrics_Gynaecology

KS Olah 2003 Had the Ward Hilton study not been published it is likely that the Vaginal Colposuspension would have become the gold standard as per this paper. Or laparoscopic Burch colpo would have become gold standard. Instead mesh took off and surgeons lost their traditional skills

 

Back to the future with Colposuspension

This paper by Jan et al  says there is a rise in the traditional Burch colposuspension operation to fix SUI with the rise in concerns of mesh risks. Great news. The downside is the surgeon leaves in a “failed” TVT,  leaving in the plastic, while hitching up a woman’s insides.

 

SCENIHIR says mesh should only be used for moderate to severe cases

SCENIHIR says incontinence mesh was acceptable to use but only for moderate to severe cases Sadly we see it has been sued carte blanche for years.

For prolapse mesh it says it should only be used in secondary surgery , not primary. This hasn’t been happening either.
For failed primary surgery in complex cases its use should be limited but women should be properly counselled for both on risks & benefits & evidence should be collected systematically. This didn’t happen.

Mesh removal study

This 2018 study by Kowalik et al says women were happy with their TVT mesh removal surgery even if  92% were still incontinent. That is because this is the least of women’s worries if it means they can get rid of or vastly reduce the debilitating pain.

Professor Carl Heneghan gives his overview of the Government’s mesh audit

This is a “seriously difficult report to understand” and there are “several limitations” that need to be taken account of.

The costs the NHS are considerable, despite the fact that the costs we have outlined underestimate the true costs to the NHS.

The actual costs, however, to women are not revealed by this report. There is no information on quality of life and no information on long-term morbidity. The report does, however, tell us that the long-term complications persist and worsens over time.

Here a link to private earning potential for surgeons. According to this link surgeons can make 1/3 as much again on top of their NHS wage, from private practice.

International surgeon societies shame BSUG for failing to report mesh incidents to their database AS LONG AGO AS 2010

The ICS IUGA meeting in Canada calls out BSUG for failing to report to their databases as per NICE guidelines. Read it here in pdf format ICS call out BSUG for not reporting to their database:

In 2003 this report said the TVT needed unbiased research

Scroll to near the bottom for the conclusion in this report which says there should be unbiased trials of more than five years on the TVT (tension free vaginal tape).  It also says research is needed on possible long-term complications of TVT. When did this happen? It didn’t Health Technology Assessment of tension free vaginal tape

In 2003 they knew TVT mesh tapes could result in women losing sex lives

This study by Yeni et al says the TVT sling for stress incontinence can result in women losing or suffering a reduced sex life. It advises that women should be counselled about this accordingly. Nobody is.

In 2003 a Swiss surgeon expressed concern

Professor Bernhard Schuessler, of Lucerne, wrote to the BMJ to express concern about the Ward and Hilton study comparing TVT to colposuspension. He said the scientific community and hence patients expectations could be misled by improperly planned studies.

In 1995 Sir Ian Chalmers talks of bias in studies

Sir Ian Chalmers writes on bias. Readers of trial reports should be wary of  pitfalls, and investigators must improve their design, execution, and reporting of trials.

In 2005 study says TVT trials should be interpreted cautiously

Michelle et al Much of the data are from non‐peer‐reviewed small case series often ‘published’ as abstracts. As a result, the conclusions should be interpreted cautiously.

Plastic should not be implanted in the body

Three independent reports by chemist Chris DeArmitt, a consultant to Fortune 100 who writes in the Cambs Times that plastic cups have more protective additives than surgical mesh.

Phantom Plastics – Mostyn Law – PP Mesh Design Report Final CD 2018

Boston Scientific Expert Rebuttal Report v2018 redacted (2)

US Marlex® PP versus China Sourced Resin v2018 (1)

BSUG ask about £20,000 funding by J&J for its database in 2010

In a BSUG meeting members minute that they want to ask J&J for funding for their database BSUGCommitteeMeetingMinutesJan2010

£20K plea from J&J for BSUG database

In a BSUG newsletter from 2017 they admit being a mesh centre is not a sign of competence. It just means they meet set criteria

Mesh centres are not neccessarily competent
Mesh centres are not necessarily competent
Number of consultant O&G & urology surgeons potentially implanting mesh in the UK is 5,208. If you add in trainee O&G it comes to more than 7,000 
RCOG
1,835 obstetricians and gynaecologist members in the UK
1,550  in England , 65  in Northern Ireland , 150 in Scotland and 70 in Wales. 
 
NHS Obs & Gynae workforce:
Consultants 44.4%, 2,686
Speciality doctors 24.8% 1,500
TOTAL = 4,126
Less than half are members of RCOG
Trainees 30.7% 1,850
If you add in trainees total O&G workforce is 6,044
BAUS 
1,083 urologists who are members of BAUS in the UK
44 in Republic of Ireland
93.8% of urologists are members of BAUS

MHRA patient safety alert

The MHRA issue this patient safety alert  in 2014 to highlight THE SHOCKING LACK OF AUDIT FOR ALL MEDICAL DEVICES. Read their patient safety alert here MHRA Safe from harm? psa-med-dev-0414

When reporting problems (not just mesh) 82.3% of doctors did not record manufacture name. A total of 65% did not record product name, while 68.1% did not record apparent causes of a patient problem. Around 40% did not record outcomes because it was wrongly coded including death or serious harm. In this document the MHRA austerity measures are outlined.

In 2012 MHRA say in Parliament that post market scrutiny of medical devices  is left to manufacturers like this is OK. It is like leaving a bunch of kids to mark their own exam papers. It is not OK

Lord Porter of Spalding asks a question in the House of Lords in December 2017 on stats from the MHRA on mesh insertion and mesh risk.

Transparimed  call for transparency in clinical trials data

Sling The Mesh survey

Sling The Mesh survey of 544 women shows the devastating complications of mesh implants. More than half suffer UTIs, 8 out of 10 find it painful to walk or sit, 7. out of 10 lose their sex lives, a third have had to give up work, while 1 in 5 have had to reduce their  working hours to cope.. Sling The Mesh Survey

Key points to survey are here SLING THE MESH SURVEY – key points

Foreign body reaction to implants can be “devastating says this study.

Mesh risk is AT LEAST 10%

Landmark study by Keltie & Elneil et al shows mesh for incontinence carries a risk of 9.8%. The study looked at more than 92,000 women over an eight year period. It is published in Nature, the world’s most respected medical journal. A story outlining the study is in the Cambs Times.

Delayed perforation of bowel by TVT after a year

A woman was seemingly fine until a TVT mesh tape, the most commonly used mesh kit, perforated her bowel. Surgeons in the NHS are only paid to Risks can be life changing and irreversible . Study by Allison et al

Mesh risk is 34%

Bilal Farhan et al say risk of mesh complications from vaginal prolpase mesh is 35% That is one in three women suffering life altering complications. Overall, 21% women underwent mesh-related reoperation.. The rate of mesh-related complication was 34%, while ; 30% had mesh extrusion into the vagina and 1% had mesh erosion into the bladder or rectum.

 

Looking at studies from 2005 to 2012 Mesh erosion up to 33% & average shrinkage of 25-30%

1. A mesh erosion rate of up to 33%

2. Pain of up to 40% in TVTO & 24.4% in prolapse

3. Loss of sex life 9.1%

4. Retraction of tissues surrounding the mesh with average shrinkage 25–30% in surgery on rats. It may reach 40% of the initial surface of the implant. One study found  19.6% reduction in the length of mesh.

“It is important not to fall prey to industry-driven treatment options, but to follow evidence-based medicine.

“It is important to cautiously analyse results of various published studies in the literature”

Mesh risk is 40%

Fabian et al say the risk of suffering after a sling for incontinence four out of ten women. Problems include

pain, erosion, failure to fix the problem, De Novo urgency, bleeding, post operative voiding dysfunction, bladder perforation, abcess, haematoma.

Complications of mesh slings 40%

Mini sling trial Failure 90%

Hilton et al Manchester and Newcastle run a trial that shows terrible fail results.

90% of mesh slings failed
Only 10% Cured
38% had ReOps

GyneIdeas of Glasgow was the manufacturer for the Minitape in this trial, which received funding from Mpathy Medical, later bought out by Coloplast.

This is the substantial equivalent notification for this sling. It has been approved cos it is found to be substantially equivalent to hernia mesh, TVT and other regular mid urethral slings. Yet the Single Incision Mini Sling is a very different concept. https://www.accessdata.fda.gov/cdrh_docs/pdf2/K023898.pdf

Here is Companies House information for GyneIdeas It was dissolved in 2014 https://beta.companieshouse.gov.uk/company/02803959/officers

Complications don’t show

This study by Yeng, Raz et al says major complications of midurethral slings are more common than appear in literature. Devastating complications involving urethral and bladder perforations can present with mild urinary symptoms and thus are likely under‐diagnosed and under‐reported. Most of these cases need to be managed with additional reconstructive surgery. Neurourol. Urodynam. https://onlinelibrary.wiley.com/doi/abs/10.1002/nau.20357

German surgeons unimpressed by mesh

German study by Hampel says German surgeons “remain unimpressed.” that the traditional surgery skills to fix prolapse and SUI have been lost to mesh – without evidence to back it up – as it has been pushed as the cheap quick fix. But at what cost?

European Urology Burch vs slings. An example of p hacking aka research cheating –  where figures are massaged to fit desired outcomes. In this case, in 2002, Ward & Hilton compared the old fashioned Burch operation to mid urethral mesh slings (MUS) and found they were about the same in effectiveness. However in 2017 Fatteh et al looked at the same study and concluded MUS were better. How? By looking at secondary outcomes instead of primary –  changing goal posts. They also included a study that was not a true comparison of an open Burch colposuspension vs mesh in a study by Valpas.

The Valpas study added mesh into the Burch operation all done via keyhole rather than open surgery, which has more adverse events – so of course a MUS would come out as better by comparison.

The MHRA admit that there are austerity measures in the medical device department.

BJOG The Humpty Dumpty theory by Paul Hilton

The problem with research

Early trials used animals who cannot speak of pain or loss of sex life.
Early trials used animals who cannot speak of pain or loss of sex life.

Many studies are short term, or the early studies were on animals that can’t speak of pain or lost sex lives. Many report authors have conflicts of interest.

Animal studies proved mesh implants cured the problem but they did not show the devastating quality of life complications  mesh can cause.

There is p hacking which is medical speak for research fraud where figures are massaged to fit desired outcomes by amending trial protocol.

Other problems with trials are that the questionnaires are designed to not capture worsening or new onset of problems – in other words they do not properly ask about a woman’s quality of life after a mesh operation – so this is not captured in any of the data. Many women on Sling The Mesh would show as a success in Quality of Life questionnaires as they are “cured”. So a woman could be in a wheelchair, having had a number of mesh removals and in terrible pain, but if the mesh has fixed eg her incontinence and she no longer has to wear pads then in trial terms she is deemed a success.

Many include short term trials like the York report .

The Nilsson TVT study One of the worst is a study by Nilsson, called the 17 year follow up. It used just 90 women but this dropped to 56 at the end of the 17 years and 12 of those were interviewed over the phone. Eleven women died. The oldest to be implanted was 87 when she had a TVT fitted. The average age is 54 and women would not have been so sexually active so the dyspareunia risk would not have been so obvious. The two leading trial authors were paid Ethicon consultants. Yet still this study is used to “prove” mesh is safe globally. It was used on the Oxford Hospital linkbut has been removed in 2018. Here on the Gynecare link 17 years follow up (2)

Another big problem is that the Randomised Controlled trials (RCTs) compare one type of mesh to another as oppose to mesh vs a natural tissue repair. This means  results may well show a TVT sling is a better treatment option than a TVTO sling for incontinence but if more trials were done comparing plastic fix to a patient’s own tissue fix we would have a better selection of studies to deem if mesh genuinely was better than native tissue for being both a safe and effective treatment option.

There is currently a crisis of confidence in evidence base. There are 40,000 clinical trials – how do you find the useful unbiased ones?  Ethics, regulation, research bodies and conflicts of interests are a concern across the entire medical device and pharmaceutical  industry.

Another problem is poor auditing of problems experienced by women. For example in the Single Incision Mini Sling (SIMS) trials,  the questionnaire shows that medics do not fully allow women to report their quality of life complications. Read the story here. 

This article from 2009 by Robert Freeman shows that only 3% of 120,000 women given mesh are recorded anywhere so  it is clear to see nobody is properly monitoring how the product is faring. He also says reviews are poor quality and do not provide meaningful results.

Anzjog Journal Transvaginal mesh let’s not repeat the mistakes of the past

Yeng, Raz et al Mesh risks are devastating and happen more frequently than appear in the literature

The MHRA and the NHS quote a figure of mesh risk as being as low as 1 to 3%,. To calculate that risk they have used figures for pain and erosion but not for dyspareunia. They say risk of dyspareunia (painful sex / lost sex life) is as high as 13.5%. The following research shows a range of very different figures. The reality, of course, is that nobody knows the true scale of the mesh disaster because there is poor auditing of outcomes and less than 40% of surgeons report to the main BSUG database. also they did not incude the risk of dyspareunia (loss of sex life) to help keep the figure low. In the York report the dyspareunia risk is shown as 14.3% (they wrongly put it at 13.5% but the fact remains, this risk was not included in their calculations; See page 4 of the York Report).

Guardian. There are lies, there are dam lies and there are statistics. John Carlisle’s review into falsified trials.

Study of consent process here. 

You Tube. Aggressive marketing of drugs and devices is a real issue – and it’s more than just a free lunch.

Conflicts of interest mean studies have high risk of bias.
Conflicts of interest mean studies have high risk of bias.

BJOG The rise and fall of vaginal mesh

IUJ The patient is the one who has most to lose in this debate

EJOG Prolapse surgery worsens sex life concerns

History of slings – a critical analysis Mesh Ulmsten and Petros_evolution of TVT (1)

WARNINGS:

Mesh kits do not make ethical sense – 2009

Before the advent of mesh kits, there was little commercial interest in gynaecologic surgery aside from the sale of sutures or catheters, but now there are operation-specific kits, huge profits are on the table. Almost everything you need to operate – except good clinical judgment and technical skill – is right there, fresh out of the box.Wall and Brown in 2009 

Study says plastic mesh for prolapse repair should be abandoned – the report was in 2004

Milani et al say. Dyspareunia increased by 20%. and 13% had vaginal erosion of the mesh.  “Although this study shows good anatomical results with the use of prolene mesh for prolapse repair, there was a high rate of morbidity.”

Caution required for vaginal mesh – 2007 report

A warning was issued in this journal in 2007 – but it was ignored. Many products are used despite limited scrutiny or long term efficacy checks

Mesh can shrink by 20 – 75%

Stanek et al talks about what can lead to complications. The paper reports that “Within a year of the procedure, a mesh positioned evenly underneath the urethra may shrink up to 20-30% after the implantation, whereas if it is wrongly positioned and folded, it may shrink up to 75% of its volume. The above mechanisms may lead to obstruction in the urine flow and consequently to the erosion of the urethra.”

Stanek pdf This includes a paper by Trabucco AF, Witkowski P. Nowa beznapięciowa taśma w leczeniu wysiłkowego nietrzymania moczu. In: Rechberger T, editor. Nowe trendy w uroginekologii. Lublin: Akademia Medyczna w Lublinie; 2005. pp. 308–322.

Two thirds surgeons don’t report mesh removals

Duckett et al says only 27% of surgeons report all of their mesh removals to the MHRA database. Reason? It is not mandatory to do so. Black holes in data collection. Rather handily Duckett also found that Miniarc mini slings don’t work despite funding from its maker AMS

BMJ Urbach et al says surgeons don’t report adverse events with medical devices because they don’t see the point. Except by not recording problems nobody gets to see the true risk rate.

Risk: all mesh 10%

A study of explanted meshes shows that the average rate of problems of ALL types of mesh be it prolapse, incontinence and hernia is 10% . This study about Degradation of Polypropylene in Vivo says it averages out that 1 in1 0 people have to have their mesh removed because of complications.

Mesh can slice  urethra up to 11 years later

Swedish study follows women with mesh complications and shows problems can cut in early or as late as 11 years. In this case slicing through a woman’s urethra.

 

Vaginal pain risk from mesh shrinking: prolapse

A study be Feiner et al of prolapse mesh says vaginal mesh contraction is a serious complication after prolapse repair with armed polypropylene mesh.

 

Vaginal pain risk from mesh shrinking: prolapse and incontinence mesh

Donald Ostergard wrote in 2010 that scar tissue causes mesh contraction to less than 50% of the implanted size, which results in dyspareunia and tension on the pelvic mesh attachments. Such contraction may cause pelvic pain and subsequent erosion into adjacent organs. An individual response in fibrosis also exists, with some individuals being “high responders.”

Manufacturers need encouragement to develop meshes that are inert and incorporate without contraction along with routine clinical tests to detect “high responders” to avoid complications. Polypropylene is not inert within the human body.

 

Incontinence mesh risk is 12%

New study by Chapple et al in European Urology says complications are 12% which is one in eight women suffering.

 

Risk:  incontinence mesh 30% to 40%

Surgeon Firouz Daneshgari from the  Department of Urology, Case Western Reserve University,  Cleveland,  US says: “Almost two decades after the introduction of TVT and midurethral slings into clinical practice, and by any modern industrial standards of quality, a 30–40% rate of adverse events is simply unacceptable.

“Whether or not this is due to changes in names or mechanisms of action is not relevant.

If cars had this many safety concerns they would be recalled.
If cars had this many safety concerns they would be recalled.

“Can any of us imagine what would happen if one-third of all cars, computers, food packages, or any other commodity we purchase would fail or result in recalls?

“Moreover, it is unlikely that the manufacturer would remain in business after such recalls and failures.

“In either a single-institution case series or multi institution, we impose an adverse event on at least one third of our patients. In the Serati et al. report, up to 30 per cent of patients developed de novo urgency.

“Similarly, results of two of the largest RCTs involving midurethral slings revealed a nearly 42 per cent rate of side effects. One can attempt to tease out the differences in types of adverse events, but the big picture remains the same.”

The Serati et al study (30% de novo urgency) to says : “The 10-yr results of this study seem to demonstrate that TVT is a highly
effective option for the treatment of female SUI, recording a very high cure rate with low complications after a 10-yr follow-up.”

The  Brubaker study (42% adverse events) to which Daneshgari refers..

Chang and Lee say it is only prolapse mesh that is a problem and “skewed” media reports are saying incontinence mesh aka mid urethral slings like TVT, TVTO and TOT are a risk. They also claim women are only making a fuss as they are attracted by “big pay outs”

Chang & Lee claim media reports are "skewed" and women are making a fuss as are attracted by big pay outs.
Chang & Lee claim media reports are “skewed” and women are making a fuss as are attracted by big pay outs.

Of women suffering problems 77% were severe

In the American Journal of Obstetrics and Gynaecology AJOG, a study by Abbot et al , shows 347 patients sought help for synthetic mesh-related complications.

30% had dyspareunia aka lost or reduced sex lives,  42.7% of the patients had mesh erosion and 34.6%  had pelvic pain. It says 77% had a grade 3 or 4 (severe) complication.

Mesh 60% 77 % mesh complications requiring further surgery (1)

 

Risk: incontinence mesh is 42%

A report headed by Linda BRUBAKER, 2012 shows adverse episodes occur for up to 42% of women following a mesh sling implant for incontinence.

Would you gamble with your health if you knew the risks could be this high?
Would you gamble with your health if you knew the risks could be this high?

It says 20% of those are serious. Yet the authors say mesh is still acceptable to use. How high must the complication rate be?

There are 11 authors and only five declare “No Conflict of Interest” The other six are all MDs except for Yan XU who has a Master’s degree.

Among the non-declared conflicts of interest (COI), Gary Lemack received $136 832 in 2013-2015. To check his COI visit this site. This paper claims pain beyond six weeks was 2.3% which seems unlikely.

This same TOMUS study is followed up after 5 years and miraculously the adverse events suddenly fall to 10% Smell a rat? We do! Also in this study the efficacy says it is only 51.3% which means a failure rate of 48.7% 

Brubaker says 35% removal risk

Brubaker et al  who was involved in the TOMUS study of 2012, said in 1997 that mesh removal risk was as high as 35%

Risk of prolapse mesh is 36%

Schimpf et al found erosion risk for prolapse mesh is  36% of women but said re-operation rates were low. It is abundantly clear from this study that researchers are only seeing that the initial prolapse problem has been fixed. They are not looking at problems for more than a third of patients. Erosion is where the mesh cuts into nerves, organs, tissues and causes exruciating lifelong pain.

Risk of prolapse mesh problems is 34%

Knoedler et al show one in five women need re operation after prolapse mesh. A total of 34% had mesh poking through/extruding through vaginal walls and 16% say they were very unsatisfied with the operation.

Risk of prolapse mesh cutting into tissue 15.6%

Iglesia et al This study showed erosion, a medical term for the mesh slicing into tissue, nerves, muscle, vaginal walls, is one in six women.

Risk of incontinence mesh is 27.6%

A report by Sue Ross1, Selphee Tang1, Misha Eliasziw, Doug Lier, Isabelle Girard1, Erin Brennand1, Lorel Dederer, Philip Jacobs, Magali Robert says the risks are nearly one in three women who suffer complications.

Risks are much higher than the 1 to 3% quoted by medics globally. It is Russian roulette as to whether a woman will suffer or not.
Risks are much higher than the 1 to 3% quoted by medics globally. It is Russian roulette as to whether a woman will suffer or not.

The report says 27.6% of women suffer complications following a TVT and 21.8% for a TOT..

Both versions are plastic mesh slings and both support the urethra but are just inserted differently.

Authors said: “Serious adverse events and tape effectiveness did not differ between groups at 5 years.” truth is all mesh has serious risk regardles of whether it is TVT, TVTO or TOT.

Risk of incontinence mesh is 15% and plastic degrades

Risk of a negative outcome after a mesh implant for incontinence is around 15%.

This report is on degradation of polypropylene in vivo: A microscopic analysis of meshes explanted from patients by Vladimir V. Iakovlev, Scott A. Guelcher and Robert Bendavid. They say Mesh degrades and can turn brittle inside the body. See the full report on this link Iakovlev_Bendavid et_al-2015-Journal_of_Biomedical_Materials_Research_Part_B-_Applied_Biomaterials

Risk of reduced or lost sex life is 26.5%

Studies suggest 1 in 4 women lose or have reduced sex life because of mesh which puts a huge strain on relationships.
Studies suggest 1 in 4 women lose or have reduced sex life because of mesh which puts a huge strain on relationships.

A table of studies to show loss or reduction of sexual function. The worst is by Mazouni et al. (2004) which says 26.5% have reduced sexual dysfunction – that is one in four women. A terribly high risk rate.

Risk of reduced or lost of sex life is 14.3%

Marszalek et al. 2007. said in this report: “Our investigations showed that the influence of the TVT procedure on female sexual function is evident, but of low impact, and in general will not be of relevance.”

Risk of Urinary Tract Infection is 22%

This review by Daniel Rapoport,  Howard Fenster, and Jamie E. Wright quotes a figure of 22.3% risk of suffering painful UTIs after having TVT mesh and 19.7% risk of urinary retention.

Many women who have a mesh implant suffer chronic urinary tract infections.
Many women who have a mesh implant suffer chronic urinary tract infections.

It says: “The various tape procedures offer an innovative approach to the treatment of urinary stress incontinence and offer good clinical results in the hands of the well-trained, experienced surgeon.

Nonetheless, there are complications that have been noted in the literature and in our experience. Some complications can be very difficult to treat, such as post-op pelvic discomfort and voiding dysfunction, and patients should be aware of these complications prior to surgery.”

Mesh benefits do not outweigh risks

A study by Tom Margolis looks at Polypropylene mesh benefits do not outweigh the risks

Single incision mini tape study

Hilton et al. This study of 60 women between 2002 and 2006 shows this trial, done under local anaesthesia, resulted in 12 (20%) experienced mesh complications, half of which were considered to be serious adverse events requiring exit from the study. At 2 years following Minitape™ insertion, six women (10%) were defined as cured. This is a terrible complications and cure rate!

TVT Secur seven out of ten failure rate

Promises broken. In our experience, the TVT SECUR device definitely
did not stand the test of time, with a 31% success rate after a 4.5-yr of follow-up. It should not be considered a valuable option for SUI management unless supplementary data is provided regarding its long-term outcome. The lifecycle of the TVT Secur is here in this report. Removed from market in 2013.

This 2010 study in European Urology says failure is 42% over three years TVT Secur terrible results

However this 2009 TVT Secur study from the UK from a two year period from 2007 to 2009 says it is safe with low complication rates. TVT secur good results in UK – doesnt tally

 

Prolapse repair with mesh has a 47% risk of developing another prolapse

Withagen et al say a repair with mesh runs high risk of getting a prolapse in a new compartment. It is a 13 Centre Dutch rct study – 47% of mesh patients had prolapse in other compartment vs 17% with non mesh repair.

Pain risk 31% No long term follow ups.

A review by Ackerman and  Raz says that most reports do not follow up women after the one year mark. Mesh complications can take months or years to cut in. This report reckons chronic pain risk could be as high as 31%.

Risk of bladder perforation up to 31%

Training surgeons to use mesh is difficult as they cannot see what they’re doing. It is a bit like touch typing. Or trying to fix a car’s fan belt without lifting the bonnet.

Mesh implants are over used which means the skills to perform a traditional surgical fix are being lost.
Mesh implants are over used which means the skills to perform a traditional surgical fix are being lost.

Hilton and Rose said: “Whilst seductively simple in concept, mid-urethral tape procedures are not without risk.

“Their inherently “blind” nature makes them difficult to teach. The “learning curve” to independent practice may be longer than previously considered.”

Biased medics and small trial numbers

Some of the authors/surgeons involved in producing studies have conflicts of interests which means they have received payments in kind from the medical device manufacturers.

Conflicts of interest mean studies are at a high risk of bias.
Conflicts of interest mean studies are at a high risk of bias.

An example is this study from May 2017. The author says there is no link between surgical mesh and autoimmune conditions like fibromylagia or cancer. Yet the surgeon’s work that he bases his conclusion on, has had  industry payments. Here is the study and the link to his industry payments.

Or this example. Surgeon Vincent Lucente bragged in 2007 that he encouraged an American surgeon society to remove the word “experimental” from its literature about a new prolapse mesh kit by Ethicon because it would scare people off. At the time he was the highest paid trainer of other surgeons by Ethicon. He still has conflicts of interest today, click here to see how much. He still today speaks of how he has a passion for pelvic mesh surgery. At $318,485.63 it doesn’t take a genius to work out why.

See this Conflicts of interest list in the USA. See this Voluntary conflicts of interest list in the UK – however, because it is voluntary it will mean many WILL NOT list their COI here.

Sling The Mesh Campaign. Image: Michelle Deyna-Hayward.
Sling The Mesh Campaign. Image: Michelle Deyna-Hayward.

Some have sponsorship or research grants. This means their reports are at risk of bias.

The Cochrane Review looked at 81 mesh trials and found only two were at low risk of bias. A total of 13 were high risk and in the other 66, bias was unclear. Read the story here.

Other trials use woefully low patient numbers making it difficult to capture a clear picture of risk

Hospital Episode Statistics (HES)

Many mesh injured women survive on a cocktail of pain killers.
Many mesh injured women survive on a cocktail of pain killers.

Some studies use HES which only give numbers of women admitted to hospital for their mesh problems. This ignores a whole army of patients suffering who never go into hospital because they are told their pain has nothing to do with their mesh implant.

Or they simply go back and forth to GPs for pain killers.. Their story is never captured in the HES data.

Don’t believe the hype

A report published in the Lancet gives the impression that it follows women for 18 years from 1997 to 2016 . It doesn’t. It only follows women for up to five years but takes statistics from an 18 year period.

The statistics used are called Hospital Episode Statistics HES. These figures are of women who go into hospital for a mesh complications so it doesn’t tell the story of women going to their GP for pain killers. Nor does it tell the story of women going for repeat antibiotics for urinary infections. HES data will be a vastly under reported set of figures for mesh complications.

A study in Denmark by Nilsson said it followed women for 17 years. It picked 90 women who had a mesh implant. Of those, only 70 women agreed to a final interview and most were done over the telephone at the end of the 17 year period. It claims one woman had a mesh exposure and no other complications occurred. Two of the medics involved in this study had financial interests with the mesh manufacturers. Yet Oxford Pelvic Floor Centre rely on this study to tell women that mesh is safe.

Nilsson study at 11 years says no COI

Nilsson study at 17 years.There are COI

 

Synthetic slings not safe

Doctors A. Lenore Ackerman and Shlomo Raz  say synthetic slings are not safe.

This review says mesh erosion (including exposure, extrusion and perforation) varies widely from 0–33%. The average incidence of graft erosion is 10.3%. Other studies say it is 0–7.3%. Yet another study shows it is 0–21% for POP surgeries. If nothing else this review – which looks at a range of literature already out there proves nobody knows the true scale of this disaster

Acceptable morbidity

Many studies say mesh has acceptable morbidity or that the benefits outweigh the risks.
Many studies say mesh has acceptable morbidity or that the benefits outweigh the risks.

This study says of mesh for Stress Urinary Incontinence SUI  that: “current data suggest that the use of non autologous durable materials in surgery has well-established benefits but significant risks” but ends with the line, mesh has “acceptable morbidity.” Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence.

Mesh triggers autoimmune disease

We see hundreds of women in support groups globally suffering auto immune diseases like fibromyalgia and lichens schlerosis. This study was carried out in 2017 by Bilal Chughtai which says there is no link between mesh and auto immune conditions – yet interestingly Mr Chughtai received around $140,000 in payments in the year before this study was published.

Evidence destroyed

USA attorney Mike Papantonio speaks to a lawyer who has called for a criminal investigation into Johnson and Johnson after it was found thousands of documents were destroyed and hard drives wiped clean with information on relating to mesh implants watch from 2.20

Pitfalls of mesh

Although mesh insertion seems like an easy procedure, treating mesh complications involves complex procedures. Surgeons are not properly informing patients about mesh risk. Worse, complications are under-reported.. Even with complete mesh removal, more than 30 per cent of patients may be permanently disabled.

Polymers are toxic and plastic degrades

Osgtergard Degradation, effects of heat and infection of plastic. Risks were known before the giants starting marketing mesh slings.

Some reports recognise the plastic mesh material can cause problems

The Definitive User’s Guide and Databook by Clive Maier, Theresa Calafut shows that polymers are potentially toxic substances that should not be used in medical devices. See 10.4., 10.5 and 10.6. Beware of anything with the word poly in it as it may mean plastic.

Polypropylene plastic used to make mesh implants can leach toxins and break down under body heat once implanted. This study shows chemicals with unknown toxicity form when polypropylene plastic is heated – study by .Reingruber, E, M Himmelsbach, C Sauer and W Buchberger. 2010. 

This study by Taylor from 2018 says polypropylene can suffer stress corosion failure which leads to mesh problems.

The plastic creates inflammatory response that continues years after implantation

AJOG  In women with complications, mesh induces a proinflammatory response that persists years after implantation. Removed meshes show degradation; and pain is consistent with fibrosis

They knew the risks but sold it anyway

Donald Ostergard says Many properties of polypropylene mesh, causing complications for patients,  were published in the literature prior to the marketing of most currently used mesh configurations and mesh kits. These factors were not properly taken into account before selling these products.

No long term follow ups

A review by Ackerman and  Raz says that most reports due not follow up women after the one year mark. Mesh complications can take months or years to cut in. Study reckons complication of chronic pain could be as high as 31%.

EU upgrades mesh risk

Mesh to be upgraded to a higher risk medical device in the EU by 2020. See pages 469/70.

FDA says the implanting hooks are high risk

American watchdog body, the FDA, upgrades the trocars (hooks) to implant vaginal mesh implants, to a higher risk device.

Prospect

PROSPECT study says a vaginal repair for prolapse with mesh or graft material did not improve women’s outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short term, but more than one in ten women had a mesh complication.

The implantation of any mesh for the treatment of prolapse via the vaginal route should be only considered in complex cases in particular after failed primary repair.

 

Testimony of Ethicon employees

Watch employees give evidence in mesh trials here. Link courtesy of leading lawyers Mazie, Slater, Katz and Freeman.

Ethicon co sponsor a study, published in a prestigious American medical journal, to show prolapse mesh in a favourable light..  Trial document shows this here.

A good resource with many links to research papers is at Mesh Problems. Others can be found by scrolling down this page.

http://meshcomplications.com/files/2014/09/Mesh-deicisions-4264934-4287872.pdf

Back to the future

Time honoured incontinence fixes like Burch colposuspension are making a come back as more women opt out of mesh sling operations. Social awareness of mesh sling complications play a part in this.

Mesh degrades under heat

Donald Ostergard “Many properties of polypropylene mesh that are causative in producing the complications that our patients are experiencing were published in the literature prior to the marketing of most currently used mesh configurations and mesh kits. ”

Surgical practice driven by commercial interest

Report by Wall and Brown looks at what happens when commercial interest drives surgery 2009
Report by Wall and Brown looks at what happens when commercial interest drives surgery 2009

 

Vaginal Support Device Study by Carey and Slack

Emerging problems with mesh:

http://ec.europa.eu/health/scientific_committees/emerging/docs/surgical_co_christensen.pdf

K Baessler.  Mesh is a good fix as in anatomical outcomes but pelvic floor symptoms are scarcely reported in reviewed trials, so how does anybody really know quality of life after a mesh implant?

Abbott Most women who seek management of synthetic mesh complications after POP or SUI surgery have severe complications that require surgical intervention. A significant proportion require more than one surgical procedure. 305 of them have lost sex lives and 42.7% had erosion.

Ethicon release brochure with risks of mesh but those risks are not included in UK patient information leaflets See P6. Risks of exposure, infection, pain, foreign body reaction, fistula, urinary tract obstruction

TVT Secur was not getting good results in the studies but Douglas Tincello, of Leicester,  wanted to run a trial on it . Short-term 93.5% success..Long term only 40% patients cured & 42% failed. It was quietly taken off the market in 2012.

PeterAngelos  To uphold professionalism, surgeons must be driven by altruistic motives rather than self-interest. They must not allow the lure of the new and potential for financial benefit to influence their assessment of whether an innovative procedure truly benefits the patient.”

https://assets.documentcloud.org/documents/3924306/Mesh-Doc-2.pdf?fref=gc

https://assets.documentcloud.org/documents/3923201/Mesh-DOC-1.pdf?fref=gc

What even is this device – the Vaginal Support Device used for 4 weeks to support Prosima mesh.

European Association of Urology Mesh slings in an era of uncertainy by Chapple, Raz, Brubaker and Zimmern. Beyond the current, passionate debates for or against synthetic material, there is limited knowledge about the long-term integration of these devices into the vaginal wall near vital adjacent organs and the risks and benefits of the devices’ added strength versus native tissue repair.

Serious irreversible complications

Vaginal mesh kits - how serious are the complications asks this study.
Vaginal mesh kits – how serious are the complications asks this study

Lee et al on Researchgate transvaginal mesh – how serious are the complications and are they reversible. We say serious and no mostly not reversible. sadly.

Kokanali et al Women’s pain and complications not taken seriously even in the studies! In this one it says mesh erosion following vaginal sling procedures is a frustrating complication with relatively low incidence.

Dunn et al Women describe a feeling of hopelessness and abandonment after suffering mech complications in this Researchgate article.

Steep learning curve & while surgeon practices women are injured

Hilton & Rose It is a steep learning curve to teach how to insert mid urethral slings “Whilst seductively simple in concept, mid-urethral tape procedures are not without risk; their inherently “blind” nature makes them difficult to teach. The “learning curve” to independent practice may be longer than previously considered.”

Surgeons globally are slowly waking up to the fact that mesh has high risks.
Surgeons globally are slowly waking up to the fact that mesh has high risks.

Jason Cooper says mesh erosion is easy to fix – yet few surgeons can successfully remove the plastic implants once they’ve embedded into a woman’s pelvic tissue after 6 weeks. He also says as time goes on surgical skill will improve to implant these devices – yet they have been around 20 years and still srugical skill hasnt improved and all the time women are injured.

Rogowski et al found an ongoing reduction in the mesh size – they found it can shrink up to 53%.

https://www.ncbi.nlm.nih.gov/labs/articles/23749240/

Mesh erosion and pain with mesh vs native tissue

The true incidence of complications is not known, as less than 25% of patients return with their sling problems to the same surgeon. Under reporting is a major issue  Lise Hanne Christensen, Herlev Hospital,  University of Copenhagen and Thomas Bjarnsholt, of University of Copenhagen

Mesh erosion is anything from 0 to 33%

This study by Shah, Badlani et al gives widely varying figures for mesh erosion.

Surgeons dont see point of reporting problems

BMJ study – Gagliardi Urbach et al. Participants perceived Adverse Medical Device Event (ADME) reporting as unnecessary, not possible or futile. Physicians were not motivated to report AMDEs because they viewed them as an expected or unavoidable part of practice that they themselves could manage by switching to different devices or by developing work-around strategies to continue using problematic devices. Device industry factors (no feedback to reports of AMDEs, little impact on device improvement) and healthcare system capacity (lack of systems for AMDE reporting, lack of patient monitoring for AMDEs, poor patient record of devices used, purchasing contracts constrain device choice) reinforced individual physician views and behaviour. As a result, some physicians used devices that were less than ideal for a given patient or with which they were unfamiliar, potentially leading to poor patient outcomes.

No patient information leaflets for five years

Welsh women not given patient information leaflets for prolapse operations using mesh from 2006 to 2011. How is this fully informed consent?

38% women leave a study by Hilton to have reops yet it does not warn of this in the conclusion

NICE In 2014 a court ruling said that CCGs cannot refuse to give treatment or ignore NICE guidelines just because they don’t like them .

Linda Cardozo says in 2000 that slings need more randomised controlled trials and follow up for 5 years. In 2018 this is still not happening and most follow up is less than two years

In 2003 a Health Technology Assessment said long term efficacy and risks of TVT were not known HTA report. Further research suggestions include unbiased assessments of longer term performance from follow-up of controlled trials or population-based registries; more data from methodologically sound RCTs using standard outcome measures; a surveillance system to detect longer term complications, if any, associated with the use of tape; and rigorous evaluation before extending the use of TVT to women who are currently managed non-surgically NONE OF THIS WAS DONE

 

Mesh Removals

Barski et al There has been no randomised trials on mesh complications. See the tables of risk in this full version

Dr_Linda_Cardoza_cv

Treatment shifting from secondary (hospitals) to primary (GP surgeries) Mesh Surgical care for SUI PROTOCOL

The changing face of incontinence surgery report

Managing  mesh complications

Our response to this report is that if it is so difficult removing and you can only do partials, then why are surgeons implanting something that can  not be fully removed Cundiff and Slack_et_al-2018-BJOG_Managing mesh complications

Patients are guinea pigs

BMJ Article by Mary Madden who asked the MHRA should they have stricter controls on medical devices? The MHRA said: “We think that requiring pharmaceutical-style clinical trials for medical devices would be disproportionate. There is a limit to what extent devices can be assessed pre-market. Unlike medicines, it is not feasible to accurately predict the likelihood or time to failure for new medical devices via pre-market studies. In practice, such studies of sufficient size and diversity are either impractical or so onerous that they would block the product’s development process.” Thus admitting patients are the human guinea pigs

Ethics Approval

A document by the Bradford Institute for Health Research on ethics approval in the UK. Approval is key to

  • Ensuring that the Study is managed, monitored and reported as agreed in the Protocol.
  • Ensuring that no Participant is recruited to the Study until the PI is satisfied that all relevant regulatory permissions and approvals have been obtained.

Trial of mini slings at St Mary’s, Manchester, shows 20% failure rate within one month.

Only 10% were cured at the end of 2 yrs. loads dropped out to to get other stress incontinence surgery. Unclear why it wasn’t terminated earlier with such a high failure at 1 month. In conclusion, 20% of the 60 patients who took part in the trial, had mesh complications.
BUT
They also confirm that:
They call the 20% mesh complications the 12 women who had tape complications. Some were apparently resolved by trimming or suturing. The exposed mesh & alarmingly that’s at 1 month stage (20% mesh complications).
But then 23 out of 60 patients ie 38% , left the study to have other surgical procedures for SUI . The mesh failed. Technically that’s also a complication to be reported to the MHRA as a surgical reoperation/revision  was needed. So the complication rate should be over 30s
41 women exited the trial prematurely OUT of 60 ?1
Some refused to come back & participate.
Only 19 women completed the 2 yr follow up period.
So why wasn’t this trial terminated?

Handley “unreasonable adverse attention”

This article talks of an unreasonable amount of adverse attention to the current gold standard for treating SUI, the mid urethral sling.

Treatments for SUI depends on surgeon opinion

No consensus exists among surgeons for recurrent SUI. However, many surgeons say they would put another mesh sling in if the first one fails!

Oxford audit shows a third of women need to self catheterise after TVT mesh tape

Audit by Natalia Price and Simon Jackson claims TVT is a good treatment option and used this as an audit so mesh was used routinely in hospitals circa 2003. But it shows on page 7 that a third of women, 27% , have to self catheterise afterwards. Also 57.9 % had this mesh as primary surgery while 41.6% had it for failed previous Sui surgery in this audit.

Mini Slings failed for nine out of ten women in Manchester

UK experimental mesh trials resulted in serious complications for women. 90% mesh tape failed at St Marys Manchester & Royal Victoria Hosp Newcastle. Only 10% Cured. 38% had ReOps. There are not enough Drs with skills to remove.

Sling The Mesh sets out its required Terms of Reference for the Baroness Cumberlege review. TERMS OF REFERENCE for Baroness Cumberlege Review June 2018.

The TOR as set out by Baroness Cumberlege review team. Draft terms of reference for discussion 1 by Baroness Cumberlege 

TERMS OF REFERENCE for Baroness Cumberlege Review

Evidence process  TOR evidence process

 

Kim et al Key hole Sacrocolpopexy risks.

In the conclusion it says  this has acceptable risk at a rate of 1 in 10 suffering mesh erosion yet in Calman tables that is high risk!

Boston Scientific encourage doctors to NOT quote mesh removal in operations but instead call it foreign body removal to keep complication rates low Boston Scientific coding – 

 

Gender bias in medicine

Carey et al This study from 2017 looks at a range of women’s medicines and devices, including mesh and says: “historical precedence has described a generation of morbidity and mortality associated with unrecognised sex- and gender-specific adverse events that continue to affect individuals today. Although significant advances have been made to recognise and prevent additional gender bias in future drug and device trials, continued scrutiny and vigilance should be practiced among manufacturers and researchers as novel sex- and gender-specific adverse events continue to occur.”

 

2011 How do British urogynaecologists deal with failed  mid urethral slings? I think everyone needs to work out what “failed” means. Does it mean it is no longer fixing the problem or does it means it has failed because it is  causing chronic pain, loss of sex life, chronic UTI?

 

BAUS publish its outcomes from mesh surgery for SUI. They say they have good short term outcomes – at three months,. What about at 6 months, a year, two years, three years, five years etc…The survey pretty much means nothing. BAUS REPORT 2018

Mesh removals

Favors et al If a TVT has been sitting laterally it can create similar  pain at the obturator site as a TVTO

 

8 out of 10 failed mesh slings – surgeons just put another mesh on top

DOUG TINCELLO FROM LEICESTER SAYS 8 OUT OF 10 WOMEN WITH A FAILED SLING GET ANOTHER MESH SLING JUST PUT IN ON TOP

This 2017 study says 78% of the UK surgeons surveyed just leave the old tape in place & put another on top if it fails.. Which is why UK removal rates aren’t an indication of the true complication rates for sling tapes..No wonder they are panicking.

TOP 5 QUOTES TO MAKE YOUR EYES ROLL:
1. This is “a consequence of training and experience rather than an actual preference. It appeared that many respondents were unable to offer alternative procedures because they had not received training in procedures such as Burch colposuspension or autolgoous sling.”

2. “This is an important finding not only for future research plans, but also as a training and clinical governance issue, bearing in mind the increasing concerns about Mid Urethral Tape complications, how they are managed, and the possibility of providing women with alternative choices.”

3. “From the patients’ perspective, the variability and inconsistency of surgeons’ responses in general is a finding that will generate considerable concern, particularly given that this survey was only sent to those with specific training and a declared interest in pelvic floor dysfunction.

4. “Patients hope and expect that doctors know what they are talking about and that treatments offered are the most suitable/effective. However, it is clear from the data that the treatments women may be offered may depend largely upon the discipline and training of the surgeon, and that the choice of treatments offered depends upon the surgeon’s skills, experience and opinion rather than any evidence.

5. “This highlights the importance of comprehensive and appropriate training, in addition to the need for research addressing the specific issue of failed continence surgery, to avoid and reduce the variability in patient choice that is currently present and to provide greater consistency of care provision.”

This article reckons mesh removal rates for mesh slings are 3.3% yet Keltie et al found risk of an overnight stay with a serious complication to be  9..8% then the Guardian working on HES data found it to be 6.5%. So who is correct?

JAMA study Mesh complications are more than just removal

Paper  by Ipek Gurol-Urganci Dolan et al says mesh removal rate is 3.3% and 6.8% have some kind of re-operation within 9 years. At Sling The Mesh we say removals or re operations are only a small chapter in the story behind the mesh disaster. JAMA long term study of mesh

A survey in 2017 in STM shows 70% of women have not had mesh removals yet are suffering irreversible, life changing pain, infections and lost sex lives.

JAMA also shows that it doesn’t matter if surgeons implants large volumes of mesh or do not insert much – complications rates remain the same. See the tables in the link in pdf format here: JAMA long term study of mesh 

https://jamanetwork.com/journals/jama/article-abstract/2708113

 

MHRA & the CE mark are a waste of time

Committee meeting minutes from 2011 and 2012. On page 4 of the 2012 minutes it says: If a device is causing havoc but functioning normally it can only be removed from the market if the device itself is not performing properly or was unsafe.”

Committee on the safety of devices 7 July 2011 adverse reporting tapes

Committee of safety of medical devices 2012

 

In 2003 a committee said TVT was rushed into NHS use exposing thousands of women to harm

In 2003 the Health Technology Assessment HTA programme admits TVT was brought into widespread use before its safety was known. “This approach exposed thousands of women to an incompletely evaluated procedure in a poorly controlled way.”
The committee said there should be unbiased trials of more than five years on the TVT (tension free vaginal tape) for incontinence. They called for research on long-term complications. See p71.
A break down of key points:
● Research is needed on possible long-term
complications of TVT; this would provide either
reassurance of safety or earlier warning of
unanticipated adverse effects.
● If the indications for TVT are likely to be
broadened to include women who are currently
managed conservatively, this should be formally
evaluated, ideally in an RCT, before widespread
adoption.
● As new evidence about the effectiveness, safety
and costs of TVT emerges, this should be
incorporated in updated cost-effectiveness
analyses.
● Evidence of efficacy from case
series led to the rapid, widespread adoption of
TVT before its relative effectiveness (its place
within NHS care) and long-term safety were
known. Although current evidence suggests that
TVT probably is effective and safe, this
approach exposed thousands of women to an
incompletely evaluated procedure in a poorly
controlled way.
● Future research to evaluate new
procedures of this type could avoid this by
earlier and wider use of pragmatic RCTs and
rigorously organised population-based
registries.
They based mesh views on  case series evidence, which is Level 4 out of 5 on the scale of evidence. Five being the lowest quality. So basically, rubbish quality evidence. See this link for explanation on evidence types. https://www.orthobullets.com/basic-scie…/…/level-of-evidence

Mesh complications from the ICS and IUGA

Three versions of this document on complications from mesh written by the International Continence Society with the International Uro Gynaecologist Association uploaded to their page in 2010

Is industry making mint out of a little understood condition?

Overactive bladder OAB condition that not many understand, have no idea how to diagnoses and limited treatments. Many have side effects such as cognitive function which can lead to falls in elderly women. Barking up the wrong tree, a presentation
1 in 5 women give up anitmuscarinic medication because of side affects.
This Nursing Times article explains the medication and a bit more about urinary incontinence.

In 2013 surgeons say medical devices are a problem

SURGICAL PROBLEMS ONLY COME TO LIGHT AFTER MEDIA OUTRAGE: In 2013 the Association of Surgeons of Great Britain & Ireland say that medical devices surgery is a problem and risks go unrecognised & unreported until too late and often only after a media storm.

Instructions for Use for TVT

If you were given these risks would you go ahead with this operation? This is the ADVERSE REACTIONS  AS QUOTED BY THE GYNECARE TVT IFU https://hostedvl106.quosavl.com/qb/

• Punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel, may occur and may require surgical repair.
Fistula. As with any implant, a foreign body response may occur. This response could result in extrusion, erosion, exposure, fistula formation and/or inflammation.
Mesh extrusion, exposure, or erosion into the vagina or other structures or organs.
• As with all surgical procedures, there is a risk of infection.
As with all foreign bodies, PROLENE Mesh may potentiate an existing infection. •
 Over correction, i.e., too much tension applied to the tape may cause temporary or permanent lower urinary tract obstruction. •
 Acute and/or chronic pain •
Voiding dysfunction •
Pain with intercourse which in some patients may not resolve. •
Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur. •
 Recurrence of incontinence •
Bleeding including hemorrhage, or hematoma. •
One or more revision surgeries may be necessary to treat these adverse reactions. •
PROLENE Mesh is a permanent implant that integrates into the tissue. In cases in which the PROLENE Mesh needs to be removed in part or whole, significant dissection may be required.
OTHER ADVERSE REACTIONS • Seroma • Urge incontinence • Urinary frequency • Urinary retention • Adhesion formation • Atypical vaginal discharge • Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse. •
 Death

Allergies can trigger IC and Odema

ICA Allergic reactions can make Interstitial Cystitis worse according to this research

Lee et al Are allergies triggering IC?

Web MD Plastic chemicals linked to allergies

 

1,038 problems but only 5 reported

There were 1,038 women readmitted to hospital within 30 days of surgery in 2008-9. The Royal College of Obstetrics and Gynaecology were aware of this in its 2012 report but only 5 problems were reported to the MHRA Yellow Card.

Dynamesh

This trial, led by Mark Slack and 2019 President of RCOG Eddie Morris, is based from Norfolk and Norwich hospital but is on hold during the suspension. The patient consent form has zero details on what women are signing up for and does not warn of risks. The trial focuses on efficacy of PVDF and compares erosion rates  to Polypropylene. Look at the archive link.

The trial paperwork admits shrinkage is a problem with polypropylene mesh, so that is why they invented their new shiny Dynamesh.

“The sling being studied is DynaMesh®SIS soft, made of polyvinylidene fluoride (PVDF) which has improved biocompatibility with tissues, meaning reduced scar formation and less mesh shrinkage.”

It appears N Ireland held a pre trial of Dynamesh?

 

 

Is Botox the solution?

In 2012 Tincello, Slack, Tooz Hobson et al say  a third of  women achieve continence after botox injections in a blind trial of 240 women. The downside is a third of women who had botox had UTIs and one in six had to self catheterise.

TVTO removal

Tamsin Greenwell and Alfred Cutner of UCLH write about the first ever laparoscopic and vaginal TVTO removal

Conflicts of interest

Many surgeons take funding from industry. It is a stain on medicine. The biggest back hander I have seen to date is Boston Scientific giving Roger Goldberg $4 million. Roger then talks at a conference saying there is still a place for prolapse mesh. Here is his COI on CMS open data. 

 

Robotic Surgery and conflicts of interest

 Out of 458 studies, with 2,253 authors, half had one or more author with undeclared COI
https://www.ncbi.nlm.nih.gov/pubmed/…Accurate conflict of interest (COI) statements are important, as a known COI may invalidate study results due to the potential risk of bias.
:
To determine the accuracy of self-declared COI statements in robotic studies and identify risk factors for undeclared payments. Under reporting of complications with robotic surgery
https://onlinelibrary.wiley.com/doi/abs/10.1111/jhq.12036

Jekyll and Hyde

Swati Jah reckons the TVT is Dr Jekyll and the TVTO is Mr Hyde in this BJOG opinion piece. We say they both have horrendous life altering complications. In STM 46% have TVT and 26% have TVTO.
Mesh types in Sling The Mesh

It’s Russian Roulette! Not Smoking hysterectomy and prolapse surgery

This paper from 2018 reckons smoking, hysterectomy and prolapse surgery puts women at higher risk of needing mesh revision surgery. Not true! Patient experience shows it is Russian Roulette risk. This commentary says more studies are needed to f ind out who is at risk but we say it is a waste of time as you cannot predict who will suffer.

 

Men’s mesh slings

Will this be the next scandal? The MASTER study  looks at Artificial Urinary Sphincter cure rate of 82% vs male sling 63%. Why risk mesh problems at such a low cure rate? The trial’s ethics approval are terrible. It says there are no risks posed to patients. It only follows up for two years. The trial focuses on efficiency and cost effectiveness.  Quality of life and sexual function is included , but will be looking at it in relation to the incontinence problems and questions are likely to be confusing for that reason. The male sling costs  £6,000. NHS cost of £4,000 plus device cost of £2,000. The artificial urinary sphincter costs £9,000. NHS costs of £4,500 plus device cost £4,500.

1. Information leaflet
Discomfort and bruising in your perineum, scrotum and groins. Between 1 in 2 & 1 in 10 patients. Failure to produce any significant
improvement in your leakage Between 1 in 2 & 1 in 10 patients

GPs guide to mesh

Here is a link produced via e-learning for doctors to learn about mesh

JAPAN

  1. 2018 study: Mesh is supposedly low risk and successful outcomes It’s easier to show improvement , after mesh surgery if patients are inactive or low active sexually, before, so even 1 sexual episode after is 100% improvement. In this study 79 of 237 patients didn’t complete sexual function study =  2/3 of missing data!.

2. 2017 study: This Tissue Fixation System study only looks at long term success. It doesn’t look at long term pain or sexual dysfunction. Also it only cured 52% of women for SUI after 5 years and 79% of women with prolapse after 5yrs.

Conflicts of interest in medicine

Doc Dollar COI site https://projects.propublica.org/docdollars/doctors/pid/103796

The safety and effectiveness of the Uphold™ Lite Vaginal Support Systems compared to conventional surgical repair for pelvic organ prolapse have not been demonstrated in RCTs. In the United States, substantial equivalence of the Uphold Vaginal Support Systems to synthetic mesh has been demonstrated through bench top testing.

CMS Open Data of $4.8 Million from 2013 to 2017

Surgeon who takes $4.8million from mesh makers from 2013 to 2017 tells a conference in Australasia there’s still a role for vaginal prolapse

International Urological Journal article says a database should be used to log mesh complications – you dont say! This should have happened since 1997!

 

Science research should not be hidden behind pay walls

Patient safety campaign groups should be able to freely access studies in the spirit of transparency. So here is some:

Free Research https://citationsy.com/

and

https://sci-hub.se/

 

 

STM 2019 STM survey 2019

 

IUGA Mesh Complications down played

This document shows medics chatting honestly about mesh complications in 2010  https://www.ics.org/Documents/ViewDocumentVersions.aspx?DocumentID=671
Some background on TVT inventor Ulf Ulmsten in the BMJ
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