Research articles

Hold the front page:

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.

European Urology 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

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.

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 include short term trials like the York report .

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 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. 

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)

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.”

Two thirds surgeons dont 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 says it averages out that 1 in1 0 people have to have their mesh removed because of complications.

Risk:  incontinence mesh 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 to which Daneshgari refers is here.

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.

The median number of treatments for mesh complications was two.

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

 

Risk: incontinence mesh is 42%

A report headed by Linda BRUBAKER, 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% 

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 exrutiating lifelong pain.

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.

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.”

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.

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 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.

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. 

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

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?

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