Good intentions
Forum Replies Created
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I had a good explantation experience, from Dr. Billing in Kirkland, Washington. But it has taken about 3 1/2 years to finally get to the point where I don’t consider how the surgery site will be affected by my planned activities for the day. It’s been a very slow process, with many points along the way where I thought progres was done. Much waiting for things to settle down before trying to expand the envelope of possible activities again.
The great shame of all of this is that the surgeons who try to help fix the problem that the original mesh implantation created end up, in some cases, taking the blame for the original problem – the mesh implantation. The problem is the mesh. All of the data shows it, the more that is collected the clearer the picture becomes. Mesh implantation is damaging a significant number of people. The root cause is the mesh, not the removal.
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The primary author is from a large laparoscopic mesh implantation center.
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The video is worth watching. It is surprising, or not, that this large group of authors, some of them representing several of the big mesh makers, combined all types of mesh materials and forms, in to “mesh”. And they did not define the method of implantation. Apparently they just see it all as essentially the same. All mesh is the same and it doesn’t matter how it is implanted.
Overall, frankly, it seems like a project simplified down to “mesh is okay”. It is very thin on useful information.
And, again, if you add up everything greater than and including “bothersome” you get about 15%. 16% to be exact.
In the end, just another report that everything is fine with mesh implantation, except watch out if you’re a young woman and avoid Surgeon A.
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I just found a video presentation about the study. Posting before I watch it.
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There are powerful financial forces supporting the use of mesh. A good open objective honest debate would probably leave most surgeons wondering why they continue to use mesh. The facts of long-term patient welfare don’t support the breadth of its use across the medical profession. Only financial reasons support it.
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If I was in your situation I would check the professional organization web sites, and the professional publications, looking for presenters/publishers in your area. You could also contact research universities directly.
Here are some starting points. It will probably be tedious. Good luck.
https://www.youtube.com/c/SAGESVideo/search?query=mesh%20removal
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C48&q=mesh+removal&btnG=
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Dr. Towfigh would probably have as much experience as anyone in your type of problem, and expected outcomes. She has published on chronic pain, and mesh removal, and has been researching mesh compatibility for many years.
https://scholar.google.com/scholar?q=%22s.+towfigh%22+mesh+&hl=en&as_sdt=0,48
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Here is a report about Vypro. It looks like the polyglactin degraded but instead of being absorbed by the body, was encapsulated. The mesh was likely not attached to or incorporated by the surrounding tissue and the patient had a recurrence. I am not a physician.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2379741
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There are two different types of Vypro. One of them has an absorbable component, polyglactin. That might be part of the reason you felt effects immediately after implantation. The other part of the mesh is polypropylene fibers.
https://www.medicommers.hu/katalogus/134-145.pdf
Here are some examples of polyglactin hypersensitivity.
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Here is a link to Google Scholar, a source for scientific publications.
I saw one that suggested it was used in undeveloped countries because it is cheaper than mesh. There are efforts to get mesh in to the underdeveloped countries though, so the methods might die away as other suture-based methods have.
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C48&q=Moloney+Darn&btnG=
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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…
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Here is a good collection of the types of mesh materials and a short history of suture material and mesh material developed for hernia repair. There is no substantive conclusion about the drawbacks or benefits but it is a thorough collection of information. I doubt that any surgeon trying to choose a mesh device would feel more comfortable about the decision after reading it. The hernia itself is a simple problem, the choice of material is chaos.
It’s from nine years ago. I don’t think things are simpler now. The search is more difficult.
https://www.sciencedirect.com/science/article/pii/S1743919112000921
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Dr. Towfigh would have the real world experience and history of many examinations and the results from mesh explantation. She would have seen the patients before and after. Most of the doctors you are talking to will not have that experience and will only know what they have been trained – that mesh materials are inert in the body. I think that Dr. Towfigh’s opinion has more value than the common physician’s.
What type of mesh did you get and by what procedure? That will help determine your risk level. If you can get to South Korea then Dr. Kang at the Gibbeum Hospital would be a good choice, I think. He has done thousands of repairs and I think that he does explantations/removals as well. Good luck.
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Somehow I left Ethicon’s page off of the list. It looks like they have come back under the wing of Johnson & Johnson now. The names seem to be used interchangeably.
Their portfolio contains all of the established designs and materials. Flat, plugs, two layer systems, etc.
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Finally, the primary author of the papers used to support the benefits of the device is the inventor of the device.
Conflicts of interest don’t get much more clear than that.
https://core.ac.uk/download/pdf/53302875.pdf
GA = Giuseppe Amato
Conflict of Interest: GA is the inventor of the 3D
dynamic implant. The remaining authors have no
conflicts of interest to report. -
It looks like Insightra has formed something called the “Hernia Alliance”. Designed to promote the Proflor product. Seems very similar to HerniaSurge, designed to promote mesh use overall.
This seems to be the state of the world we live in. Get the product to market and start marketing. No outside objective way to determine which is best. Horribly fascinating.
Hernia Alliance sounds like a group dedicated to hernia repair. Not a medical device company trying to sell devices.
https://hernia-alliance.com/about-us/
“THE HERNIA ALLIANCE
The Hernia Alliance is a new business unit of Insightra Medical, under which Insightra enters into exclusive partnerships with select Ambulatory Surgery Centers globally, to provide patients access to its revolutionary ProFlor Dynamic Hernia Implant.
INSIGHTRA MEDICL INC.
Insightra Medical is an innovative medical device company focused on developing, manufacturing and selling value-add devices to Ambulatory Surgery Centers. Insightra Medical Inc. was founded in March of 2001 and was originally located in Irvine, California. Today headquartered in Clarksville, Tennessee, Insightra has grown into a true global company with a presence in over 30 countries.”
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Here’s a description of a selling point for the product, and the brochure link below it. Get those blood vessels growing through the polypropylene structure.
https://en.wikipedia.org/wiki/Angiogenesis
https://www.insightra.com/wp-content/uploads/2019/01/PROFLOR_patient_info-1.pdf
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I just came across these recent articles about Insightra’s Proflor product.
It just looks like a bigger piece of mesh to me, with a significant third dimension of thickness. It springs open to fill the defect, creating a larger mass of tissue and intertwined polypropylene fibers afterward.
The brochure does have some nice simple illustrations showing the difference between indirect and direct hernias. There are references also to the small studies they did before putting the product on the market.
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It’s described in the thread that you posted in Ric. In the posts above yours. Yes, some people do have this pain after mesh implantation. For some it resolves over time, for others it does not.
Three weeks is still early. I don’t think that you will find a surgeon who would do any type of exploratory surgery to see what is happening. Wait and hope is the path forward. Good luck.
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Dr. Bendavid’s work showed that the shape or thickness of the tissue did not stop the ingrowth of nerves and blood vessels. The discussion in those papers of the benefits of the Proflor design overlook, or ignore, the fact that there is a flat sheet of mesh attached to the 3D structure. They also overlook, or ignore, the fact that fixation is not recommended, and often not used, for today’s flat mesh devices. The discussion does not support those purported benefits of the design. That is a red flag as far as objectivity.
Overall, the fact that there is no objective deliberative body to evaluate the efficacy of any new hernia repair device is illustrated in this story. A guy had an idea and designed a new device, tested it on some animals, implanted it in some humans, saw what he wanted to see, ignored the facts that damaged the effort, and there is now one more unproven device added to the overall hernia repair field.
You can look at several of the US based products listed above and see the same thing. Coating a synthetic polymer fiber based device with a food supplement. Designing a device that can be pushed down to the pelvic bone with a finger. Changing the design of the plug from a folded piece of flat mesh to a tangled bundle of plastic fibers. Changing the fiber polymer from polypropylene to a fluoropolymer.
And they all have gone through similar short time frame evaluations, then put on the market for the final long-term experiment on humans. Slick marketing brochures and marketing groups are created to sell the product, instead of completing the long-term studies that should be used to “sell” the product.
Somehow, in the end, it always gets warped in to a business effort. Once the money starts rolling in who is going to stop it if the results aren’t as expected? If the stock price stays high, it must be good.
It’s hard to not be cynical.