Good intentions
Forum Replies Created
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I just noticed also the word “catastrophic”. It seems like all of these programs that seem in the right direction, are qualified downward to less impactful, ill-defined efforts. The solution is so simple, but everyone is avoiding it. Afraid of what it will show, I assume.
Really, why is a catastrophe necessary?
“The AHSQC plans to develop a questionnaire that is valid for addressing long-term catastrophic mesh related complications.”
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I just came across this old Topic. It’s very relevant to some very recent discussions on the forum. Several surgeons contributed but they have not been back since, as far as I can tell. The date range is right in the middle of when things were the worst for me in my Bard Soft Mesh ordeal.
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You seem to be making the same, and very significant, error of conflating ALL mesh procedures as the same procedure. Even surgeons who work in the field know that this is a big problem. The best that you can do to reassure people about the use of mesh is to provide very explicit details of your procedure so that people can improve their odds of getting a good mesh repair. Without those details you’re just another person saying “I had ‘mesh’ and nothing bad happened. Don’t worry you’ll be fine”.
The details are what make the difference. Al the way down the surgeon who did your repair.
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Could you describe the material and method? Lichtenstein, Onstep, Kugel, plug, and Prolene Hernia System are all open with mesh. They are very different in form and principle of function though.
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The material was probably ProGrip. You can search the site for ProGrip stories.
Non-mesh procedures are not taught anymore in the schools or residencies. The hernia repair field is controlled by mesh. Only a few surgeons have taken the initiative to learn and apply non-mesh techniques.
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Interesting application of a material with a long history at Penn State. Academics tend to build an area of expertise and work it as hard as they can. Not a bad thing but something to be aware of. They are coming from citrate-based polymer world, not hernia repair world.
https://www.bme.psu.edu/department/directory-detail-g.aspx?q=JXY30
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“Patient reported outcome (PRO)
The AHSQC plans to develop a questionnaire that is valid for addressing long-term catastrophic mesh related complications. ”Maybe the questionnaire is done? @drtowfigh
I don’t see it on the web page.
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Here is more from one of the references. The patient, I assume, is still in the dark. It’s not an open database, as far as I can tell.
http://mdepinet.org/crn-community-practice/
http://mdepinet.org/core-abdominal-health-crn/
“Patient reported outcome (PRO)
The AHSQC plans to develop a questionnaire that is valid for addressing long-term catastrophic mesh related complications. The plan is to decouple the assessment of highly impactful patient events (that patients are very likely to recall) from a clinical visit with a provider to enhance the efficiency of surveillance.In this effort, the CRN prioritizes the evaluation of outcomes such as readmission, reoperation, surgical site infection, and mesh-related complications, developing PROs sensitive to long-term, low rate, serious complications after hernia repair, and developing a common set of core variables in concert with international partners.”
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I don’t know enough to guess on the details. But I think that, basically, mesh removal involves cutting through scar tissue, wherever it is, to get the mesh out. Because the theory of mesh incorporation is that it gets covered in scar tissue. So all mesh removals involve scar tissue.
I would guess that with a laparoscopic removal the surgeon would get a good look at what happened, from inside. Then they could decide whether to go forward or not based on the odds of success. I notified Drs. Brown and Towfigh, hopefully they will reply. Yours is an interesting case, I think.
Good luck.
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That is a very nice Facebook page @cshelter (I notice that your old name is necessary for notification. Not good, people will forget). As I was looking through it I thought about our current social environment and how easy it would be to get blocked by Facebook, due to a complaint from one of the big corporations. Something to consider. I have thought of creating a personal web page, to do what you’re doing, collecting resources for others to use. So far though, Dr. Towfigh’s site works well.
Also, I clicked on “More” to read about your reasons for starting the page and Facebook required a Log-in to go further. It’s the one thing I hate about Facebook and many other sites. They do everything they can to get you to log in so that they can collect your history, for marketing. Anyway, the site is still very useful. I did not realize that Dr. Kang’s hospital had upgraded their web site so much. It is very informative itself.
Good luck with the page.
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@baris thank you for following up with your results. You are one of the few people who has both types of hernia repair at the same time.
For removing the mesh that you have, behind the rectus muscle, that is the normal placement for a laparoscopic implantation, and for certain “anterior” approach open methods. It’s normal to have it there. The mesh is either in between the peritoneum and the muscle wall, or it is in the abdominal cavity behind the peritoneum. I think that the short term for that is IPOM. Intraperitoneal mesh placement. The fluoroplolymers are considered to have less adhesion, in general, (like Teflon) so they have developed a product that, supposedly, is okay to come in to contact with the intestines. But yours could be either of those. Your surgery notes from the mesh implantation will tell.
https://en.dyna-mesh.com/ipom-gb/
https://en.dyna-mesh.com/groin-gb/
You can have the mesh removed by either open or laparoscopic methods. Since you’ve had an open procedure there for the Shouldice repair, a laparoscopic repair might be best, as I understand things. Probably even robotic since it will be complicated by the Shouldice repair.
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That’s good to hear. You might try stairs. It’s similar exertion but a different type of motion. Less leaning forward. I had good results with stairs when I was trying to make my mesh work.
I am still not clear on what you have. I thought that you had a failed Desarda procedure, and now have a mesh implant. Mesh, and the scar tissue, will shrink and tends to bind things up as it does.
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And here is the white paper reporting the results of the seven surgeon panel discussion.
https://www.telabio.com/assets/download/White-Paper-Mesh-Performance.pdf
Excerpt below, their Consensus Statement. It is all familiar, but they are still disingenuous about inguinal hernia repair problems. Deflecting to lawsuits from transvaginal mesh. :
“SURGEONS’ CONSENSUS ON THE STATE OF HERNIA REPAIR AND REINFORCEMENT MATERIALS IN 2017
Developments in the Hernia Repair Market:
• “Mesh fatigue”: Over the past several years, a myriad of mesh products have been introduced, yet, for most, there is little that distinguishes them from
each other. Performance remains suboptimal, and surgeons cannot keep track of differences and evidence for changes in mesh designs
• Streamlined regulatory pathways allow companies to enter the market quickly without having to generate extensive preclinical or clinical data to
establish their clinical and/or safety benefit, leading to many “me-too” products
• Value analysis committees (VACs) play an increasingly powerful role in product selection, substantially increasing the time necessary before the
product can be trialed in the operating room, and even longer to get on the hospital shelf. Existing manufacturer contracts also serve as a barrier to
new product entry
• Increase in patient litigation, in part as a fallout of the vaginal and pelvic floor mesh lawsuits
• Better-educated patients who ask surgeons more questions and increasingly request specific repair materials (eg, biologics) -
It’s very odd that the paper does not reference Dr. Ferzoco’s June 2018 paper in which he reports early results of Ovitex usage on 31 humans. Even though Dr. Ferzoco is a co-author of this paper. How could that not be relevant? That is one and half more years of time in humans that could be reported on. Three to four years total. Maybe those patients had problems, and these materials are attempted improvements over those.
Dr. Ferzoco reported using Ovitex RBS on his patients. But now I see that RBS is just an acronym for Reinforced BioScaffold. It’s not clear at all what material he used, when you look at the variety on TELA Bio’s web site. The scaffolding for this new product seems shaky,
https://www.sciencedirect.com/science/article/pii/S2405857218300196
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Actually their market literature discusses a 31 human patient study already done. These two products might be variations on that material. Looks like they have added layers. “1S” has six, the other, tried inthe 31 humans, has three, I think.
Here is the Hernia Journal article.
https://link.springer.com/article/10.1007/s10029-019-02119-z
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Here is more recent news about TELA Bio’s products. Interesting that they need to point out the problems with synthetic mesh in order to show the proposed superiority of their products. Focused science.
The HERNIA Journal article should be out there somewhere. Might have to pay to read it though.
https://finance.yahoo.com/news/tela-bio-announces-publication-results-211510441.html
Excerpt –
“The data generated from this animal study were a critical tool for us to evaluate and confirm our design concepts prior to human implantation,” said Maarten Persenaire, M.D., co-founder, Chief Medical Officer of TELA Bio. “In the clinic, chronic inflammation associated with synthetic mesh can lead to serious complications including mesh erosion, contraction, chronic pain and infection. While biologic implants avoid the issue of chronic inflammation, they are prone to stretching over time….” -
It looks like posts can still get blocked if too many links are included. I’ll try to break mine up.
I have posted about TELA Bio products before. It’s still very early days for their product line. One year of data for inguinal hernias and only 31 patients. Their literature re inguinal hernias says that nobody reported chronic pain but it’s not clear that anybody even asked. Publications are mentioned but the reference data needed to find them is not provided. I think that you can “Google” Tela Bio and find some. Seems heavy on sales, but light on supporting data. Where’s the data? I want to believe but need more.
I think that I found the paper used to support Ovitex for inguinal hernias. No detail at all about how they determined chronic pain. It’s not a very informative paper.
https://www.sciencedirect.com/science/article/pii/S2405857218300196
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I missed the one month for $9.99 part. Even better if you’re a fast reader.
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Have you had a second opinion? Dr. Towfigh just posted a comment about being able to “sew” laparoscopically using robotics. That seems like what you would need and I don’t think that robotic lap would require cutting away your obliques. I can’t imagine obliterating the obliques for anything but a life-saving effort. Seems like too much. @drtowfigh
If you read through the posts you’ll see the huge variation among surgeons and their methods. Despite the usage of words like standards, gold standards, and standard of care, the variation is incredible. Get some second and third opinions. Technology is advancing rapidly, in both good and bad ways.