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Phillip Toozs-Hobson   I know a lot of women will have seen the recent news about mesh surgeries and may worry. There are several points that people may wish to consider. Firstly the majority of mesh procedures have been withdrawn by the companies for a considerable while (the first category of patients with problems) Secondly that there is clear guidance that transobturator tapes should not be used as first choice (second group of patients). Thirdly if you are considering surgery make sure that your surgeon can show you their results. Many established Urogynaecologists will use the BSUG database as recommended by NICE and NHSE. Also if you see someone about a mesh complication check they are on the list of centres on the RCOG list. This means they have signed up with their medical director, have an agreed MDT with colorectal and urology support. Finally they should report all mesh complications to the MHRA. The later is really really important as unless the MHRA have the reports they can't assess the problem. Primum non nocere.

Mr Philip Toozs-Hobson, Director of Urogynaecology and pelvic floor medicine at the
Birmingham Women's Hospital.

Toozscompany Ltd 20 April 2017

     
Dr Wael Agur   Mesh implants treatment brings unnecessary risks says study.
Dr Wael Agur, a consultant gynaecologist and lead clinician on the (ISD) study, said some of the results were surprising. The study only looked at hospital readmission within five years of treatment. But he warned that complications could present more than a decade later.

"It is a lifetime risk," he told BBC Scotland. "We know of patients who have developed complications 14 years later. This study is so important but it is just one piece of the puzzle. "The study looked at those who were readmitted to hospital after surgery but did not look at the severity of the complications nor the impact on quality of life."

Dr Wael Agur, Consultant Urogynaecologist, NHS University Hospital Crosshouse
BBC News - 21 December 2016
 
Prof Tom Joyce There are three major on-going crises with medical implants, metal-on-metal hips, PiP breast
implants and polypropylene mesh implants. Each case has raised questions over how these
implants are brought to market and how their performance within patients is monitored. There have
been government led investigations in many countries into problems associated with these implants.

A key issue is what is known as the ‘precautionary principle’; if there is a chance of harm by an item
then its use is stopped while the potential problem is investigated. We see this precautionary
approach in cars and in aircraft with thousands of vehicles brought back to be checked and planes
grounded while investigations are undertaken. Yet the same precautionary approach does not
appear to happen when there are concerns with medical implants. This should change. When major
concerns exist, implantation of specific medical devices should stop and evidence be gathered and
assessed so that an informed decision on benefits and risks can be made. Patient safety has to be
prioritised.

Prof Tom Joyce, Professor of Orthopaedic Engineering
School of Mechanical and Systems Engineering, Newcastle University
 
Michael T Margolis   Dear Minister Neil, I have been asked to provide a statement on the dangers of polyproylene
mesh implants used in transvaginal surgery for prolapse and urinary incontinence. I understand this
statement may be considered in the working group the Scottish Parliament has set up which is due
to meet on September 26 2013.


I am a US physician and surgeon specialising in female pelvic reconstructive surgery.
I am fellowship trained, subspecialty board certified and have been in practice since 1992
.
Click this link to read Michael T Margolis full letter
 
Mr Adam M Slater   "I met my first client who had been injured by these polypropylene mesh devices in 2007.
In my state, New Jersey, we now have more than 7,000 cases for which I am lead counsel.
With regard to these dangerous devices, the closest analogy to which that I can find is asbestos -
something that, for a long time, was thought to be a wonderful invention but which is now something
that everybody in the world now knows is something that you would not want to go anywhere near."

Mr Adam M Slater, Mazie Slater Katz & Freeman LLC
24 February 2015
     
Dr Elneil  

Dr Elneil is one of only two surgeons in England qualified to remove the mesh she said "she is inundated by women asking for help and believes there is grounds for the procedure to be banned. I used to see one or two a month who wanted the mesh taken out, and now it's more like five a week. My waiting list is full until October".

There was a huge uptake of this therapy well before we had all the evidence and the research into it so until we have that, which is now being done in retrospect, I think it’s very difficult to keep on using them unless patients specifically request them and they have been fully informed of the possible consequences, that’s quite critical."

"Obviously, for some patients, this surgery is of benefit - but for some women I see it is a personal tragedy.

"The perception is that the amount of women who have had problems is minimal, but for every woman affected that is one too many."

Dr Sohier Elneil, Consultant Urogynaecologist University College London Hospitals
Sky News 25 June 2015

     
  The industry has been crafty in imparting the idea that it is a simple operation and… sure enough it is but the complications are monumental. Especially when alternative pure tissue repairs are available.

The industry which supplies polypropylene devices and gadgets for Pelvic Organ Prolapse is but one arm of companies which have no qualms in abusing a principle which was designed to rely on an honour system. After all, what could be more important than saving lives, relieving suffering and be a worthy servant of the Hippocratic oath. But honesty, like lobbying, seems to have become a matter of negotiation and speculation, not of definition any longer. We have learned about meshes and their complications thanks to US courts which have been heavily imposing fines on the industry for lies and deceptions. The destruction of evidence through shredding of documents by Ethicon for a period of 5 years was one of the most despicable acts by any company dealing in human health. It reflected the nefarious nature of their policies of “profit at any cost”. Worse, they are setting up teaching centres where the practice of mesh use will be enshrined despite the condemnation of the public.

What must be highlighted and demanded of our legislators is to set a standard on what constitutes danger in a proposed operation. When must a device or procedure be declared dangerous? Is it 1%, is it 3% , is it 10 % when they risk having a severely painful, chronic and often irreversible outcome? Should the courts take over in deciding for the industry, for the trusting patient about to be deceived by a less than responsible surgeon? Should a patient be told unmistakably, in writing, what the risk is (as already recognized in the literature as 12-16% in hernia repairs) and allowed to make that decision for himself!?

To be sure, these companies could not have perpetrated their less than ethical deeds without the complicity of some members of the medical/surgical profession. That complicity is not a willing, genuine, insightful participation because the surgeon himself has not been provided with the accurate information to convey to a patient. When financial gain alone is the ultimate goal, truth can never be reliably included in an equation.

Common sense will prevail eventually. We are battling an industry with very deep pockets, deep enough to have enlisted the collusion of the legal, legislative, scientific community and government agencies in the same manner as the tobacco industry did for so long, not so long ago!

Fortunately, as Justice Brandeis once stated…. “The most important political office is that of the private citizen”, there will always be such a generous class.

R. Bendavid MD, FRCSC, FACS.

 
     
       
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