Good intentions
Forum Replies Created
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The body adapts to injury. The necrotic tissue gets replaced, the new collagen reforms to stronger collagen, healing happens. The initial tension is worth considering but it’s the results that matter.
In a way you are just following the logical path to the “tension-free” mesh repair concept. Which was/is a good idea to develop, but the prosthetic materials on the market today have new problems. The medical device makers have stopped trying to improve the concept (the revenue stream is very solid, the litigation has been priced in, there is no true device regulation), so here we are – lots of words, but no progress from the mesh suppliers. The meshes are all essentially the same as they were many decades ago.
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Here is my thread about healing from mesh removal. Probably not really part of the topic that you intended but it does give an idea of how long the body can continue to adjust after surgery. I should update it soon, The last few months have been very good. Over five and half years since removal at the end of 2017.
https://herniatalk.com/forums/topic/healing-from-mesh-removal-surgery/
If the direct link takes people somewhere strange put this in the search box – “Healing from mesh removal surgery”.
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Still no word at all from EHS/HerniaSurge. Ten chapters being updated in the “International guidelines for groin hernia management”. The group said their work was almost done at the end of 2022. What could be causing the delay?
They should at least tell which ten chapters are outdated. It makes a person wonder about the professionalism of this huge organization. They have roped in many other national hernia repair societies and now they are all left hanging. How can any patient be confident in their surgeon if they say that they are following the Guidelines, which have been defined as outdated?
https://europeanherniasociety.eu/guidelines/international-guidelines-for-groin-hernia-management-2/
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The guidelines were developed by The HerniaSurge Group and have been endorsed by all five continental hernia societies, the International Endo Hernia Society and the European Association for Endoscopic Surgery. The guidelines were published in 2018 in the Journal Hernia. Ten chapters are in the process of being updated.
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The web site that I had been using to keep track of litigation seems to be slipping. I found another that seems to be up-to-date.
https://www.millerandzois.com/products-liability/hernia-mesh-case-value/
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August 16, 2023: The Bard MDL has been frustratingly quiet in August. The MDL did add 191 new cases last month, increasing the total case count for the 3rd largest MDL in the country to added to 20,126 lawsuits.August 10, 2023: The pivotal 3rd bellwether test trial is on track to begin on October 16, 2023 in the case of Stinson v. C.R. Bard, et al. (2:18-cv-01022). In preparation for that upcoming trial, the MDL Judge recently issued an Order setting last-minute discovery deadlines related to the plaintiff’s post-operative treatment last month. The order gives the parties until August 14, 2023, to complete supplemental fact depositions and until September 27 to finish additional expert depositions. The short time frame of these deadlines suggests that the judge is committed to going to trial in October without further delays.
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Here’s another one. BD’s (Bard) Ventrio ST, used by Dr. Reinhorn of Boston Hernia, in his TREPP procedure.
By the literature it would be an “off-label” usage since it is specified for ventral hernias.
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I’ve had that problem too. One work-around is to put the title of the Topic in the post and let the reader use it in the Search Forums box. It’s clunky but it will get them there.
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I tried to find something about where Medvedev had his hernia repaired but can’t. It is incredible though how much was written about the fact that he was going to have hernia surgery. Page after page of internet articles about it.
He apparently has made a very fast recovery. Which does not actually tell much. I was playing high level soccer at one month after my mesh implantation. It will be interesting to see how he does in the long term. Dai Greene also was back to training soon after his mesh implantation but had to have the mesh removed eventually. If anyone can find more about the details of Medvedev’s procedure they would be good to know. Thanks for the post William Bryant.
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The Herniamed group is interesting in that they say that they developed the registry to collect information about all types of hernia repair but have an image of mesh as the background on their homepage along with free advertisement for the big mesh makers (“Sponsors”). Kind of hard to believe that there is not some inherent bias in the effort, realized or not. It seems very similar to the EHS web page, which also uses an image of mesh as their background. They just can’t resist promoting mesh, in what seems a disingenuous way. A person can understand showing the sponsors but using the mesh as a logo for the group shows a lack of objectivity. What is the real goal?
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To improve the results and quality of hernia surgery, the non-profit organisation Herniamed was founded. This is a network of surgeons who have a particular interest in hernia surgery. The cornerstone of the Herniamed project is an internet-based quality assurance study (registry) into which all hospitals and private surgery practices can enter data, free of charge and using a scientifically corroborated standard, on the hernia operations performed by them. The results of treatment are followed up for up to ten years so that any problems occurring later can be reliably identified. Based on these findings, experts can then devise the best treatment options for patients.
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Everybody has flaws. If you focus on the flaws you miss the good stuff.
The Discussion section of the paper is very relevant even today. When I was studying the situation back in 2014 I thought to myself that “there is no way that this could be continuing. The errors must have been solved by now”. It is now nine years later and nothing has really changed at all, except for more lawsuits. The new products are just small variations on old products, and copies of competitors products. No product has been identified as bad enough to be removed from the market. Laparoscopy is growing, making mesh problems even more difficult to solve. The studies keep coming back with the same approximate 15% percentage for pain problems.
The paper is worth reading because it shows that today’s problems were recognized and well-defined almost a decade ago.
I wonder what happened to the Mesh Retrieval Registry. Maybe Dr. Koch knows. He is a co-author.
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A “Mesh Retrieval Registry” has been set up by the present surgeons and pathologist and several colleagues have volunteered to participate for an in-depth study of the “Mesh-Pain” problems. A protocol will be addressed to all who would be willing to participate and contribute. Reports of such a surveillance are sure to find their way, on time, in the surgical literature. For a certain, very small segment of the surgical population, prostheses may be here to stay and it then behooves all of us to understand their pathophysiology. The next step will be the correlation of histology/pathology to the clinical presentation and severity of pain. This is presently being done and will form the basis of a later publication.
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Thank you Mark T. for reading through the full paper and sharing what you found. It’s surprising that there is so little analysis of the physical differences between the two products. The reason that one product might be better than another product. It’s brand name versus brand name. One company’s stuff competing with another company’s stuff, and they are essentially identical. Marketing and price point make the sale.
This seems to be the only difference that they could distinguish. And it looks like pure marketing hype. They just repeated what they read from the brochure.
“conforms even more to the contours of the groin region in comparison to other 3D meshes”
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Sounds like they followed the basic Lichtenstein instructions. Here’s a video from Dr. Chen of the Lichtenstein Amid Hernia Clinic at UCLA with his recommendations and how it’s done. He talks a lot about handing the nerves.
Also a link to the Medtronic product page.
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Just to round the thread out, here are the two product pages, and the MAUDE database link. Put Dextile in the brand name on the MAUDE page and you’ll see that it is now in a race with 3D Max (type 3DMax as one word to see MAUDE results). More market share = more reports and more lawsuits.
https://www.medtronic.com/covidien/en-us/products/hernia-repair/dextile-anatomical-mesh.html
https://www.bd.com/en-us/products-and-solutions/products/product-families/3dmax-mesh#overview
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
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Thank you Mark T.
So it looks like one of those purchasing department decisions, maybe because the new product came in at a low price to get some market share. Was there a statement or two at the beginning describing what, exactly, the purpose of the study was, and why it was undertaken? “Hey, Purchasing changed our mesh, let’s compare it to the old stuff” seems like the only reason. Besides being the “first” to compare the new 3D product to 3D Max.
Disturbing also, as usual, to see the rationalizing used to try to show that the mesh is not the cause of any problems. Objectivity is hard. Not real recurrences, the surgeon’s weren’t skilled… If they are going to report “not all” they should report the actual number. If they don’t have it then they don’t know.
” As described in the results section, not all recurrences were “true” recurrences but also lipomas, although these lipomas may have formed in the interim, others have described recurrences due to missed lipomas [23]. This would suggest that these particular recurrences are not necessarily related to the mesh but to the technical execution of the surgery.”
And they describe major flaws in the study. But publish anyway. And, indirectly promote the idea that lap mesh has low pain rates, by including the percentages in the discussion. Hernia Journal does not seem to be a scientific journal at all. More of a hernia repair promotion magazine. Supposedly peer-reviewed but it doesn’t really seem that way.
The Journal is also associated with the EHS.
https://www.springer.com/journal/10029/aims-and-scope
“Hernia is a rigorously peer reviewed journal that regularly publishes specific topical issues and collections in addition to original articles, and is affiliated with the European Hernia Society (EHS), with the Asia-Pacific Hernia Society (APHS), and with the American Hernia Society (AHS).
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Not a good sign for progress. Just reporting that a new product is just as bad as an old product. -
That is an interesting question, especially since you often read of ligation of the hernia sac for indirect hernias. I found a paper that seems to describe what that material would be. A residual pouch of peritoneum material. It has also has some other interesting comments, re the shutter action and other things.
Here’s an excerpt –
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An indirect hernia is generally believed to have a congenital component which requires a potential hernia sac, i.e. the processus vaginalis. After the descent of the foetal testis into the scrotum from the retroperitoneum, the processus vaginalis should obliterate [3]. If the processus vaginalis is not obliterated, fat or bowel may get into it.
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Here is something that might be the telling about how this whole hernia mesh mess has persisted – that 2002 paper has been cited 587 times.
https://scholar.google.com/scholar?cites=14122643666338993732&as_sdt=5,48&sciodt=0,48&hl=en
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It’s been cited in the Guidelines development articles –https://link.springer.com/article/10.1007/s10029-009-0529-7
And, even worse, the people citing the paper in the 2009 EHS Guidelines article have exaggerated the Conclusion, or used the word “significantly” in a disingenuous way. The deeper you look the more you wonder. Kind of depressing when the experts seem to be trying to deceive people.
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This is from the paper linked above, the 2009 Guidelines paper. Ref 72 is the 2002 paper –“… Most studies comparing mesh with non-mesh repair report less chronic pain with mesh repair [2, 72, 242]. The EU Hernia Trialists Collaboration review concluded that significantly less pain followed mesh repairs in randomised studies of open flat mesh versus non-mesh, TAPP versus non-mesh and TEP versus non-mesh [72].
…”I assume that they extrapolated “significant” from the fact that statistical methods were used.
What the paper really said, below. “Appears” has been transformed to “significant”, seven years later.
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Conclusions
The use of synthetic mesh substantially reduces the risk of hernia recurrence irrespective of placement method. Mesh repair appears to reduce the chance of persisting pain rather than increase it.
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Click on the + sign for Table 1 to zoom in and study the listings. You might decide that the main benefit of this effort was to show how poor the existing data was. These meta-analyses take a whole pile of data, ranging from very poor to excellent, refereed, unrefereed, personal notes, etc., and try to combine the findings in to something rational. When they make their final conclusion, notice that there is no error range, just a simple statement of “findings”. When you actually look at the data that was used to draw the conclusion it’s kind of shocking. They make a firm statement from what looks like a pile of scraps.
Look at the categories. “Flat mesh vs other non-mesh”. “Laparoscopic vs open non-mesh”. Duration of follow-up: 6 days, 3 weeks, 1-13 weeks, 1 year. 31 of the 58 “trials” show “Not available” for pain data. Yet, they included a statement, of only two, about pain in the Conclusion.
Seriously, these mate-analyses are meant to try to find a direction from very unclear and sparse sets of data. Part of the Cochrane process requires from the authors; “Identification of relevant studies from a number of different sources (including unpublished sources); … The worse the quality of the data chosen the worse the conclusion will be.
That’s one reason that the registry studies are so much better. Even though they have flaws also, especially if the registry is not collecting the right types of data.
Here is a link to the 2002 paper.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1422456/
And Table 1.
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This reply was modified 1 year, 4 months ago by Good intentions.
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This reply was modified 1 year, 4 months ago by
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spinotza has been on the forum for over two years. The easy test is to click the name and look at their posting history.
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Good luck.
Was it a Lichtenstein repair? Do you know the type of mesh used?
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For any future reader of this long thread, David M. has created a similar thread that is worth reading.
Is this Swedish groin pain study from 2012 to 2015 the best pain study to date?