Good intentions
Forum Replies Created
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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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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?
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Thanks David M. It is described by Dr. Kang himself, in post #35303 for anyone who wants to go directly to it.
I see that you have stuck with level #4 as the break point but in that thread Watchful had chosen #2. Defining any pain at all as chronic pain. Then followed up in several other posts reporting very high levels of pain for Dr. Kang’s repair method. No offense intended to Watchful but that is the way the words come out.
So, using #4 as the cutoff point, as the authors of the Swedish study did, in a one-to-one comparison, the Kang repair is at 1.7% and there are none at 5 or higher. The Swedish study is as as you show aboe, with any mesh repair being at 14.9% or higher for a level of #4. Kang – 1.7%, mesh – ~15%. Mesh also shows levels of significantly higher pain, level 5 or higher.
I am going to cross-post this thread in to that other thread so that people can see the one-to-one comparison.
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The questionnaire that Dr. Kang used would be important to know also. I remember the posts about it but can’t remember if they used the same study, or if somebody assumed a correlation.
One thing that I see missing that would be important to know is whether or not the patients thought the pain was getting worse, better, or had leveled out. One year seems like a long time but it’s really not considering how long the mesh will be there. The choice of one year is arbitrary. Also, whether or not the patients had recovered their prior activity level or had reduced it to avoid the pain.
The study also has the same basic flaw that many do in not identifying the type of mesh used. All are lumped together as “mesh”. Maybe because the Registry does not record that data.
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That is an interesting perspective. Another of those things that doesn’t seem to be discussed in depth – how does one method affect recurrence repairs? Generally, like many of the complex questions, it seems to be oversimplified. Open or lap. Mesh or non-mesh.
I haven’t studied or thought much about the pure tissue methods. But, these “layered” techniques have to be creating weaknesses in other areas of the abdominal wall. The body does not create “free” spare tissue, ready to be moved to some other part of the body. A person should consider the time factor involved for the area around the layer that has been removed to regain its strength or to fill in.
It would be very interesting to hear an expert in the various repair methods describe what method they would choose for repair and how they would handle the healing process. Would they trust the method to bring them back to full strength in a week or two? Or would they have a plan to take months or even years to work their way back to full strength?
In the early days of ACL repair of the knee, recurrences (re-ruptures) were pretty common because the athletes tried to get back in to action too quickly. Now, it’s not uncommon for an athlete to expect a year of time to recover after an ACL operation. They’ve learned.
It’s a good idea to think past the initial repair. Really, a person should plan out the rest of their life. Include financial realities, time available, responsibilities, etc. before choosing a hernia repair. It’s not really just outpatient surgery. Good luck with the research.
The Cleveland Clinic has an interesting page about the layers involved in pure tissue repairs.
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When you say “reoperation with mesh” do you mean open mesh? Lichtenstein? Plug and patch (still popular)? Or laparoscopy? Placing mesh on the backside would be easy I think. Just cover it all up.
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We are seven months through 2023, over halfway through the year, and still no word from the EHS or the HerniaSurge people about the delay in the new Groin Hernia Guidelines. Maybe they’ve realized that the title should be “Guidelines for mesh repair of groin hernias”. They are on the wrong side of the trend now. Fighting the tide.
“this year!” on the LinkedIn page was last year. 2022.
Also just noticed that if you scroll down the EHS Guidelines page linked in the post above the three “Platinum” sponsors of the EHS pop up at the bottom. Mesh, mesh, and robotic surgery (also mesh by default).
PLATINUM CORPORATE ALLIANCE OF THE EHS
BD, Medtronics, and Intuitive. -
Here is an interesting story about how the big corporations try to avoid liability for faulty products. I’ve posted about it before. If this type of maneuver succeeds then corporations can just rake in the money from bad products until the lawsuits build up, then split the division off and declare bankruptcy. Johnson & Johnson owns Ethicon, one of the big hernia mesh product suppliers.
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Thanks for posting that William. If you look further, links below, you can see how it shows that medicine is a business with the purpose of keeping the majority of the workforce working. The injured people are collateral damage. As individuals we all need to be aware of that, I think. Surgeons need to be aware of that also. They are seen as tools to be used to keep the workforce functioning.
Despite the results of the engagement survey that you posted, completed in 2021, the SHTG still recommended the use of mesh for hernia repair for elective hernia repair. Also interesting, as usual, that all mesh is blobbed together and all surgery methods are blobbed together. A sign, to me, that the people involved in this type of work don’t really understand what they are seeing. They see a surgeon and a piece of mesh, both disappearing in to a clinic, and a patient walking out ready to go back to work.
https://shtg.scot/search-results/?q=hernia
https://shtg.scot/our-advice/surgical-mesh-repair-of-primary-inguinal-hernia-in-men/
Notice the focus on cost. It’s not cost to the patient. It’s cost to the healthcare system. Whose purpose is to keep the workforce working.
“Recommendation for NHSScotland
Surgical mesh should be used for elective repair of primary inguinal hernia in adult males in Scotland. Mesh repair of inguinal hernia provides lower rates of hernia recurrence, lower rates of serious adverse events and similar or reduced risk of chronic pain, compared with non-mesh procedures. Mesh repair of inguinal hernias is a cost-effective treatment option.”
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I miswrote above. An indirect hernia would be evidenced by abdominal contents squeezing through the deep ring inside the spermatic cord casing, the parietal peritoneum (I think). Not beside it, but inside it.
Anyway, I think that you can imagine that with the peritoneum peeled back to the deep ring you would be able to see any extra space around the cord itself, that might provide room for material to squeeze in, Fat or omentum or intestine. I have images captured during the surgery, I might go back and see if I can identify anything. They’re pretty bloody though and I don’t really know what I’m looking at.
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I was trying to make that point in my two posts. He said that he saw an indirect hernia when he had the peritoneum down and was removing the mesh. But afterward there was no indication of a hernia.
From what I’ve read about indirect hernias, defining them is often a matter of degree. How much stuff is squeezing through next to the spermatic cord? Or, how much extra space is there around the spermatic cord? That would be the “hernia”, the extra space that stuff might squeeze through.
My takeaway is that the ring was visibly stretched but nothing substantial was happening there. Once the peritoneum was stitched up and healed he could not see a depression that would indicate a hernia. So, I just take extra care to avoid pressure-causing activities. So far it seems to be working. Nothing extra seems to be moving down in to the canal with either of my cords.
Compare the above to descriptions of direct hernias. Oftentimes they are just called posterior wall weaknesses.
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Above, when I say that he did not see an indirect hernia before opening the peritoneum, I meant when he went back in to do the left side he said that both groins were examined and no hernia was seen on either side. Even though he had said he saw an indirect hernia when he took the right side out. I did have some small bowel attached to the right side port area though.
Just completing the observation. I was so happy to get the mesh out that I wasn’t and still am not too worried about an indirect hernia. The mesh was worse.
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64 years ago? 1959? You must have been very young. Do you remember the details?
Your surgeon said “there’s nowhere to go”? Do you mean to find a Shouldice or Desarda surgeon? How did you learn about Shouldice and Desarda? That’s a bit deep in to the hernia repair methods, for a person new to the field.
Good luck.