Research articles

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 interes.t

Animal studies prove mesh implants cure the problem but they cannot  show the devastating quality of life complications  mesh can cause.

Other problems with trials are that the questionnaires are designed to not capture worsening or new onset of problems.

Or they include short term trials like the York report .

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 that there 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. 

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.

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)

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.

Risk is 12%

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

Risk is 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.

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 is 75.1%

We are still trying to verify this from the Serbian report author. He says risk is 75% but when you dig deeper to the study to which he alludes we cannot find the 75% figure – the study is written in French though which makes it tricky!  We include – but want to highlight that we are not yet 100% happy that this is verified.

Review accepts risk can be as high as 75.1% yet still says mesh is the gold standard treatment.
Review accepts risk can be as high as 75.1% yet still says mesh is the gold standard treatment.

A review, supported with a Serbian Ministry of Education, Science and Technological Development grant, includes a study which shows the complication rate is up to 75.1% for TVT slings and up to 31.3% for transobturatory midurethral slings.

Despite this sky high risk,  this review concludes by saying: “Improvements in the treatment of stress urinary incontinence are remarkable, and polypropylene slings have met the criteria for the gold standard of treatment.”

Risk 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.

Risk 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 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 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%

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.”

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.

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.

 

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.

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

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