International guidelines for groin hernia management, 1/12/2018

[Good intentions]

Here is an interesting (to me anyway) old Topic about the Guidelines. Post #18513 especially, two posts above this one. Dr. Bendavid is one of the few surgeons who actually did focused work on trying to understand why mesh causes pain.

https://file.scirp.org/pdf/IJCM_2014072117033945.pdf

[Good intentions]

The HerniaSurge group is no longer available to the public. But they do have a Facebook page.

They don’t really need to be active now though, because they have the European Hernia Society doing the work now. Bard and Johnson and Johnson got an excellent return on their investment. Well-done, revenues growing, stockholders happy…

http://herniasurge.com/

https://www.facebook.com/herniasurge/

https://www.europeanherniasociety.eu/science/summary-international-guidelines-groin-hernia-management

• This reply was modified 2 years, 10 months ago by  Good intentions.

[Good intentions]

Here is a more reasoned response, a rebuttal, to the Guidelines. I hope that it is okay for approval. It is from the HerniaLetter site that I had posted in a different topic. It’s not as extreme as some of his writing, but seems relevant. If the Professor Emeritus and Chair of Surgery at Harvard is involved, one would think that it’s worth considering.

A proper debate requires a look at both sides. If an idea is good it will get stronger with more discussion.

Rebuttal to the “International Guidelines”
By R. Bendavid MD | June 25, 2018 | 1

The original “rebuttal” (of 2500 words) as suggested by the invited guest-editor was rejected by Drs Miserez, Fitzgibbons and Montgomery, Editors. The following is the version which was shortened to 1011 words and still rejected by the same editors of HERNIA.

The release of the proposed “International Guidelines for Groin Hernia Management in Adults” will no doubt instigate a gamut of responses. The document will be a testament to a considerable effort on the part of the steering and working committees but, regrettably, the outcome falls far too short of the exegesis which it purports to be.

In response to this attempt at an “International Guidelines”, the Boston Consensus Group was formed which expressed a deep concern about the methods leading up to the conclusions and how these translated into recommendations. This group gathered in Boston at the behest of Josef Fischer, emeritus professor and chair of surgery at Harvard. There were ten people involved and an additional nine who were not listed, nor were they actually present because of their delicate positions within the AHS, EHS and the steering/working committees of the said guidelines! These unlisted members did register objections to aspects of the guidelines to the steering committee and were rebuffed without further consideration by the leadership of HerniaSurge. We must respect the wish of these unlisted members to remain incognito as it is not anyone’s aim to create a state of subversion within the sister societies. The situation whereby members of societies seek anonymity reflects upon an unsavory political nature which these societies have evolved into and promulgated.

Because of the limitations of space and time we will simply list the major objections to the HerniaSurge recommendations which the Boston Consensus Group felt were academically pertinent and significant. The following grievances must be looked at constructively and not as a gratuitous attempt to disconcert or confuse those members who labored at it.

1. The EHS-HerniaSurge does not have a data base to corroborate any recommendations. As famed pharmacologist and teacher, Mark Nickerson once stated … ”If it cannot be measured, I am not interested”!

2. The search for publications which use RCTs and Metanalyses may be dubious retrospectively. Many of the articles did not have the statistical power for the intended conclusions. Ioannidis, Barbour and Steen have warned us about the unreliability, fabrications and retractions of articles which have become instruments of lobbies. (1,2,3). Most reliable instead would have been Random Registered Trials (Registered Clinical Trials) and Propensity Score Matching which would depend on the availability of a very large data base. Consistency and transparency of a clearly defined, pre-specified primary outcome would improve by accuracy by 10-60% (4).

3. The elimination of pure tissue repairs is a blot which tarnishes the history of hernia surgery. Only twenty years ago, such names as Stoppa, Nyhus, Shouldice, Schumpelick, Flament, Berliner etc. reported recurrence rates of less than 1-2%! Pure tissue would have been an ideal recommendation whenever meshes are removed because of a chronic pain syndrome! Where is the wisdom of removing a mesh and replacing with another albeit lighter mesh?!

4. A major objection to the Guidelines is the recommendation of mesh, laparoscopically for all women! This recommendation would never be accepted by many surgeons. It is a recommendation which, in the eyes of five national hernia societies which expressed themselves in Cancun at the annual AHS meeting, has stripped much of the credibility in the Guidelines. Certainly, such a recommendation is far from being compatible with the findings of the Shouldice Hospital and the data base Herniamed, both bodies having each 400 000 case histories in their records.

5. It is safe to say that the issue of mesh being used on everyone aged 18 years and older has been most controversial and has been generously rejected by everyone but the members of the steering and working committees of the EHS-HerniaSurge. Mesh complications become more evident with time and we have recorded complications as late as 20 years later. The Shouldice Hospital as well as Herniamed easily confirm this serious objection on each of our part.

6. The experience of a surgeon is a major contributory factor in many surgical endeavours. Is it wise to eliminate it altogether to impose a Guideline which does not have approval of an immensely knowledgeable surgical public?

7. It must be clarified unconditionally that Guidelines are not immutable laws. The appearance of a recommendation may be translated as a commandment by licensing bodies and may put (as it has already been in Nevada) many surgeons at risk unless the individual surgeon toes the mesh line! That would be unfortunate.

8. The most worrisome aspect of the Guidelines is that it exonerates all manufacturers of meshes and devices from any fault, wrongdoing, inadequate research and testing before marketing, responsibility, or any obligation towards surgeons and patients. The industry would hide behind a security screen and claim (as they already have) that mesh is safe, does not degrade so that any problems lie with the incompetence of the surgeon! These are well hackneyed tactics which have been used in court proceedings. Another court defense by the industry is the fact that the industry only supplies what the surgeons are demanding!

It is our hope that HerniaSurge will lend an ear in the hope of reconsidering many of the ill-conceived recommendations. The evidence is there, it is available, let us include it!

References:

1. Ioannidis John. Why most published research findings are false. PLoS Medicine 2005; 2(8):e124. doi10.1371/journal.pmed.0020124. (10/19/2010).

2. Barbour, V et al. An Unbiased Scientific Record Should Be Everyone’s Agenda. PLoS Medicine. 2009;6(2). doi: 10.1371/journal.pmed. 1000038.http://wwwncbi.nlm.nih.gov/pmc/articles/PMC2646782 (last accessed 10/19/2010).

3. Steen, R. Grant. Retractions in the scientific literature: Do authors Deliberately commit Research fraud? Medical Ethics: Nov 15-2010:doi:10.1136/jme.2010.038125.

4. Christopher W. Jones, Lukas G. Keil, Lukas G. Keil, et al. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Medicine201513:282. DOI: 1186/s12916-015-0520-3.

5. Jones CW, Keil Lo, Holland WC, Caughey MC, Platts-Mills TF. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Med, 2015 Nov 18; 13:282.

[Good intentions]

I got flagged as Unapproved again. Not sure what is going on, nothing seems to be getting through.

https://thehernialetter.org/category/issue-one/

[Good intentions]

Here are are some alternative views about The Guidelines, and guidelines in general. They are from a new publication that I just came across. Well worth reading all of the articles. I am a little bit shocked at the bluntness, but Dr. Bendavid is, apparently, one of the founders of the Americas Hernia Society, so his opinion would seem worth considering. Incredible how far apart the perspectives have become.

I was unaware of this document when I created this topic and in my comments up to now. But somehow I have ended up with a similar opinion to Dr. Bendavid’s (although not as extreme), getting there from a different direction.

https://thehernialetter.org/category/issue-one/

https://thehernialetter.org/issue-two/the-problem-of-guidelines-in-modern-medicine/

“The HerniaSurge-International Guidelines for Adult Hernias: A Willful and Deceitful Document.

The virtues, which transcend any document, particularly International Guidelines, must include ethics, integrity and transparency. There cannot be a whiff of favouritism, collusion, cronyism, lobbyism, conspiracy or complicity. With such demanding criteria, the HerniaSurge International Guidelines sponsored and supported financially by Ethicon, Bard and the European Hernia Society (EHS) have failed dismally! The AHS on the other hand, never really had a significant role other than to acquiesce. The same objections applied to those “sister societies” which are not hernia societies at all but endoscopic societies and whose influence in recommendations in hernia surgery can only be spurious at best and contentious.”

[Good intentions]

Here is another article promoting the Guidelines. The HerniaSurge group seems to be taking control of the narrative, pushing the results of their big review effort out to the world at large, via a variety of professional publications. They also seem to be speaking for “everyone”. Kind of fascinating.

https://www.karger.com/Article/FullText/487278#ref11

” By developing evidence-based guidelines and recommendations, the international hernia societies aim to improve the outcome of inguinal hernia repair due to standardization of care. ”

I notice in this article that the authors have distilled recommended repair procedures down to just three techniques, using mesh. But make zero mention of any differences in the materials used. All mesh polymers, materials (naturally derived or synthetic), and knit or weave patterns are still just considered as “mesh”. Despite the efforts of the device makers to distinguish their materials from their competitors.

It also makes one wonder about where the 100-plus other techniques came from. Even if all surgeons accept and follow these Guidelines, how will things be different? Will they lock in the bad or the good?

“From a total of more than 100 different repair techniques for inguinal and femoral hernias, classified as tissue repair, open mesh repair, and laparo-endoscopic mesh repair, the new International Guidelines of the Hernia-Surge Group only recommend the totally extraperitoneal patch plasty (TEP), transabdominal preperitoneal patch plasty (TAPP), and Lichtenstein techniques.”

[drtowfigh]

In an ideal world, that would work.

The reality is that industry needs expert surgeons to provide them with their expertise as they develop new products. Such a collaboration should not be hindered. Also, surgeons enjoy the collaboration, as they have an opportunity to help influence the direction of their specialty.

Plus, it’s expensive to develop guidelines.

[Good intentions]

I’ve had this positive thought recently – maybe by banding together around a common set of guidelines the community of surgeons will realize that they have the power to change what’s happening, through their coordinated efforts. Instead of looking outside for guidance and direction, e.g. to the device makers for new products, maybe they’ll look to each other and work together to refocus on better healthcare. Hopefully the Guidelines will be reviewed on a regular and very frequent basis, but without the influence of the monetary support.

[drtowfigh]

[USER=”2029″]Good intentions[/USER] that was actually nicely put. Thank you.

The unfortunate reality is that we don’t have Level 1 or Level 2 evidence to support guideline recommendations for mesh-related complications in these Guidelines.

We barely have any Level 3 evidence.

It’s incumbent on us surgeons to get that data out. We are doing it piecemeal. The numbers are low.

Just providing the surgoen’s Viewpoint…

Also, to address the J&J website: I believe that’s a marketing plan by J&J. The goal of the surgeons was to get the publishing in a peer reviewed journal.

[Good intentions]

I apologize in advance for any offense the following causes. I tried to rewrite it many times and the same thoughts come out. I don’t find any real guidance in the Guidelines that would have helped my surgeon avoid causing me four years plus of pain and suffering. He would say the same things to get me to accept the surgery, and do the same things to me, and I would end up in the same condition afterward. Three years after I had my surgery, at the time of publication, and nothing is different. I don’t find anything useful here that would prevent any person from ending up like me, or any surgeon from creating my problems.

It is a very impressive piece of work.

Still, recurrence rates are described as the main focus, with chronic pain the second. It was well-documented that chronic pain was the new prevalent problem by 2018 but they don’t acknowledge it. They should be touting the success of mesh to reduce recurrence rates and refocusing on chronic pain.

“The main goal of these guidelines is to improve patient outcomes, specifically to decrease recurrence rates and reduce chronic pain, the most frequent problems following groin hernia repair.”

And the choices will be more limited as surgeons only learn to use “mesh”, in any of its many forms.

“Surgical treatment should be tailored to the surgeon’s expertise, patient- and hernia-related characteristics and local/national resources. ”

In essence, the Guidelines are a minimum, a review of the state-of-the-art and the past, the least a surgeon should know, actually reinforcing the fact that nobody has a solution for the new chronic pain problem.

This statement below seems to absolve “mesh” as a material cause for pain, with the old saw that “everyone is different”. It takes the focus off of the materials, but doesn’t give any guidance on how to avoid problems. It, in essence, discounts the whole of the massive document. All of that work done and the result is:

“Thus HerniaSurge recommends that surgeons be acquainted with the fact that every specific device has its specific risk pattern, which is strongly affected by the surgical procedure and the patient’s biology.”

Ethicon’s (Johnson & Johnson) statement and presence on the front page of the web site isn’t really a good look either. Would they be involved if “mesh” was not? It seems unlikely. Are the organizers influenced, consciously or not, by the realization that Ethicon’s support goes away if mesh is not the preferred choice of repair? Is the HerniaSurge group required to put Ethicon’s sales pitch on their front page?

“Shaping the future of surgery.”

[drtowfigh]

Just to provide some clarity, since I personally know all the authors of HerniaSurge and am familiar with what they went through to get these guidelines published:

– this is a multi-continent effort to update and add to the European Hernia Society guidelines. I believe 3 surgeons were from the US.
– the amount of time and effort that went into this was enormous: years of planning and research, multiple meetings. The surgeons literally sat all in a room, like the United Nations of surgeons, for weeks, painstakingly going through point after point.
– it is costly to make such a valiant effort. Just the travel and accommodations alone can be costly, not to mention the loss of time, effort, and income at the surgeons’ practice.
– most of the surgeons were Europeans. The professors there tend to have a very close relationship with Industry as compared to the US, where our relationship is held more at arm’s length. So, it’s not surprising that most of these experts have a relationship it’s Industry.
– Most expert surgeons spend their time teaching others in courses, etc. these are mostly funded but indistry—there are just very few federally or non-industry-funded courses. And surgeons attending these courses won’t be able to afford paying for the entire course themselves without industry support. As an example, I believe the recent Hernia Compact course cost $50,000, and that’s with all the instructors, including myself, spending their day teaching for free. We taught 20 surgeons.
– the experts are truly well respected and the guidelines are each supported with referenced evidence at high levels. I don’t believe that their relationship with Industry affected their interpretation of the evidence.

[pinto]

Jnomesh, I agree but did not intend to support the great hold that mesh has had on IH medical practice. As Dr. Kang mentioned elsewhere how mesh popularity came as a simplified method for most surgeons. The same happens in any field: simplicity yet effective practice enables wide application by practitioners. Unfortunately mesh has not yet been fully perfected, but it can be a functional option. It is not a new idea but I believe was entertained by some surgeons in the 19th century. My purpose was to try to add a little balance to the debate about mesh and even mesh makers: Doubtless mesh is absolutely necessary in some cases–it may be the only option. I fully recognize also certain medical practice and faulty design of mesh have tragically victimized some patients. Such of course demands pure tissue repair but as you pinpoint non-mesh approaches are getting pushed aside by the dominance of mesh in medical practice.

[Jnomesh]

Pinto you are right that mesh has a place in the repair for certain types of hernias. And non mesh surgeons in specific cases use mesh when needed.
However, instead of using mesh in certain situations it has become the golden standard and 99% of surgeons use mesh whether it is indicated for special situations or just a typical repair. This is wrong and reduced patient choice and care.
When the majority of surgeons say that don’t do non mesh repairs or aren’t confident in sold them because they just don’t do them often-it is a severe problem. The playing field is not balanced it is extremely tilted towards the use of mesh forbjer is repair

[pinto]

Another way of looking at this is by necessity. Some herniae are so large that mesh might be the only option for treatment. My understanding is that pure tissue repair surgeons resort to mesh for such extreme cases. So mesh is life-saving in this regard, and the mesh makers would be making great contributions to society for funding such research.
But looking more broadly, mesh seems to have a spotty history because clearly some mesh have been failures, even the mesh makers would agree. So the quest is to find the golden mesh. Due to known failures, GoodIntentions rightfully questions medical practice and as well research funded by the mesh makers. I myself was disappointed to see this financial tie-up, but then again the extreme cases occur and the research must be done. Unfortunately, mainstream science is biased toward mainstream approaches. This likely stunts the growth of pure tissue repair.

[Good intentions]

I just noticed this and really don’t know what to think about it. Johnson & Johnson and Bard have funded the creation of the new “group” called Hernia Surge. They have a web site, supported by Johnson & Johnson/Ethicon. On the web site are links to the “International” guidelines for groin hernia management, which recommend that mesh is the most appropriate repair method. And, on the very first page, they have a symbol of a piece of mesh as their logo. Weird.

Feel free to correct me if that’s not a representation of a piece of mesh.

[Good intentions]

Didn’t make it. “Unapproved”. Probably too many links. Here’s the start of it…

http://herniasurge.com/

[Good intentions]

Here’s the Hernia Surge web site. Kind of an odd name for a branding exercise…Hernia Surge. Supported by Ethicon, AKA Johnson & Johnson, who also started the “International Hernia Registry”, which they are using in their marketing literature to sell mesh products, even though no study results have been posted, links below.

http://herniasurge.com/

I wonder how things would be if the Hernia Surge group had determined that tissue repair was the most appropriate repair method for most hernias. You can’t deny the conflict of interest no matter how honorable the people involved. Sorry to be so cynical, but I work in these large corporations and understand what goes on. It’s in the news these days, with Boeing, Purdue Pharma, Monsanto, etc. as examples. All around us.

https://clinicaltrials.gov/ct2/show/NCT00622583

https://clinicaltrials.gov/ct2/show/record/NCT00622583

https://clinicaltrials.gov/ct2/show/results/NCT00622583

https://www.ethicon.com/na/products/hernia-mesh-and-fixation/hernia-mesh/ultrapro-advanced

[Good intentions]

The study was funded by Bard and Johnson & Johnson.

“Disclosures

All HerniaSurge members are active in the scientific community. An additional course was given to all involved members to guarantee unbiased literature searches and review.

The guidelines are the property of HerniaSurge and they were financed through grants by Bard and Johnson & Johnson. The sponsor had no direct or indirect influence on the methodology or the content of the guidelines.

TA, FB, TB, RB, KB, PC, ADB, HE, RFO, LNJ, IK, JK, LL, DL, MLO, AM, HN, PN, MP, MM, WR, DS, RSA, NS, RSI, MSI, SS, MSM, HT, ST, BJH, GVR, NVV, DW and AW report grants for meeting expenses related to the submitted work from Johnson & Johnson and Bard, during the conduct of the study.”

[Good intentions]

Here is what is essentially a summary of that huge document, by two of the authors involved.

https://www.karger.com/Article/FullText/487278

[Good intentions]

It’s full of information but seems to start in the middle instead of the beginning. Everything is referenced to the 2009 European Hernia Society guidelines, which are firmly “pro-mesh”. Almost like the experts were dropped on to the planet in 2009 and assumed that mesh repair was the established method and tissue repair was the new unproven method. Very strange to read.

There is even a “statement”, (the point of the publication seems to be to boil everything down to firm statements), that says:

kQ06.b

“The use of open non-mesh repair in specific patients or types (e.g. young males with lateral hernia L1 and L2) of ingunial hernia as an acceptable alternative to a mesh technique has not been adequately investigated so far.”

I am sure that somebody in the discussion had to have said “we never really investigated whether mesh repair was better than tissue repair”.