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Types of mesh and their manufacturers
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Here’s another Getinge product. Basically a copy of the 3D products but with a “light spray” of Omega 3 fatty acid.
“Polypropylene mesh with a light spray coating of Omega 3 fatty acid (O3FA) on the monofilaments,”
Atrium originally polymerized the fatty acid but must have eventually realized that polymerizing the fatty acid converts it to a non-FDA-approved material. Somehow the FDA missed that point when they approved the first product which is the subject of several lawsuits.
So now, instead, they are spraying a polypropylene mesh product, meant to be placed outside of the digestive system, but inside the body, with a food supplement, the actual Omega 3 fatty acid, meant to be digested by acids and enzymes of the digestive system. Very simplistic idea but somehow it’s out there, being implanted in to people.
http://www.atriummed.com/EN/Biosurgery/Documents/009969-CentriFX.pdf
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Here is a scary looking device, from Getinge. A nasty looking plug. Imagine trying to peel all of those fibers back out of the tissue if there is a problem. Plugs are the only mesh device that the Guidelines recommend against. Since the Guidelines are all pro-mesh, that says something. This has to be the worst form of plug that could be imagined.
http://www.atriummed.com/en/biosurgery/Documents/009966-PROLOOP.pdf
This one is also fascinating because they don’t even try very hard to explain its value. A single reference, about “Demonstrated stability”.. From a 2011 paper. Amazing.
* Mandai Y, Naito M, Hayashi T, Asano H, Ino H, Tsukuda K, Miyoshi S. Impact of endoscopic and histological evaluations of two different types of mesh plug for a groin hernia model. Surg Today. 2011 Nov;41(11):1512-8.
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Here is one of the odder new products. Onflex, used in the Onstep procedure. Already replaced by “Modified Onflex”.
Apparently they didn’t realize that the stiff ring around the device could poke people in sensitive areas. They somehow missed it in the extensive human-based product testing that must have been done before the product was released for usage in people..https://bdsurged.bd.com/videos/kugel…ng-onflex-mesh
https://www.crbard.com/Davol/en-US/products/OnFlex-Mesh
https://www.medline.com/product/Modi…D/Z05-PF165043
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crosslinking I assumed was also to prevent degradation, or rather perhaps to delay it? crosslinked meshes presumably do not integrate and just remain there, a biological equivalent of the plastic mesh?
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I just added to the other Reply string above.
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The premise of the extracellular matrix (ECM) meshes is that the body will absorb them, replacing the denatured collagen with the body’s own collagen. The premise of polypropylene mesh is that the body can do absolutely nothing with it, that it is impervious to degradation. Identical starting points as far as implantation and initial hernia defect closure but completely different end points.
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Here is the abstract introduction from the referenced article.
“Extracted forms of collagen are subjected to chemical cross-linking to enhance their stability. However, traditional cross-linking approaches are associated with toxicity and inflammation. This work investigates the stabilization capacity, cytotoxicity and inflammatory response of collagen scaffolds cross-linked with glutaraldehyde (GTA), 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide, 4-arm polyethylene glycol (PEG) succinimidyl glutarate (4SP), genipin (GEN), and oleuropein. “
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Crosslinking agents (chemicals used to connect two collagen molecules) were mentioned, but in addition, the molecular structure of the fragments produced during degradation in the body might not be able to be handled well by the body’s removal mechanisms. A fragment with a crosslink could have a molecular structure that is not degradable (I think that this also applies to the C-Qur mesh that used crosslinked Omega-3 fish oil. Once it is crosslinked it is not Omega-3 oil anymore).
Here is the paragraph that I think you were referring to.
“Cross-linking strengthens the mechanical properties of the ECM and slows down degredation [68,69]. Although the properties of the mesh is improved, slower degradation rate creates a slower release of growth factors (GFs) and other cell proliferation molecules in the biological mesh [70]. Furthermore, cross-linking is associated with increased toxicity and inflammation possibly due to the presence of the crosslinking agents [69]. ”
And the reference – https://www.liebertpub.com/doi/10.1089/ten.tea.2016.0415
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why is crosslinking considered toxic in that article? I would think its not a bad idea. the mesh lasts longer, if not forever and gets encapsulated, providing permanent biological support while absorbables might not.
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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.
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I was also interested in this device, as according to their studies it promotes the growth of healthy tissue (not scar tissue that is), because allegedly the 3d mesh moves freely: I don’t think I read this w.r.t any other mesh device out there, which would be a major selling point…
While it is true that the inventor of the device also conducted the studies in animals for its efficacy, I also read that he had a legal dispute with the manufacturer, which was resolved with the two sides parting ways….
I would be interested to read a long term follow up of the patients that received the device…I think these days it is used mostly in India if I am not mistaken…I have read about the many problems of the past 3d devices, but at the same time the hernia is a 3d problem in many ways, so I am not surprised that a 3d approach is still considered….
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