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Types of mesh and their manufacturers
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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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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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I got the GM1510 from gallini medecal devices – managed to download this PDF before it disappeared from the internet 5 years ago.
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This reply was modified 3 years, 6 months ago by Stonehood.
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This reply was modified 3 years, 6 months ago by
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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.
https://europepmc.org/article/med/33942884
https://onlinelibrary.wiley.com/doi/abs/10.1111/aor.13926
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This reply was modified 3 years, 6 months ago by Good intentions.
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This reply was modified 3 years, 6 months ago by
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Here is another one. You can see that people are still coming up with new ideas and driving them to market. Imagine the chunk of mesh and body tissue that is formed.
http://www.angiomedical.com/pdf/freedominguinal.pdf
https://forum.bodybuilding.com/showt…353003&page=44
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Here’s another one. Ovitex. The company that makes it is about to go public. They have amazing confidence in the product, based a on a 32 patient study, at one year. If there are problems, I can’t imagine trying to peel the polymer fibers out that make up 5% of the structure. The long term results on real patients will be fascinating, I’m sure.
https://www.telabio.com/ovitex.html#ovitex-prs
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[USER=”2029″]Good intentions[/USER] Amazing job!
it also seems doctors who insert you mesh, they receive money or free training for mesh -
[USER=”2029″]Good intentions[/USER] thanks for all the informative posts. Very nicely done. You make this a better forum because of your participation.
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It’s the perfect crime. Mesh can’t be seen (for the most part) once implanted and the medical professions (but a few ) will deny any symptoms are related or caused by the mesh. And no registry to track any complaints or failures.
the perfect crime and cover up. -
Here’s another Getinge product, from their Atrium purchase. Basically a copy of the other makers 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, solidified it on the plastic mesh, 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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I always learn something when I read your comments.
Note the mesh companies are not required to inform the patient nor the doctor if a mesh has been recalled.
If you try to use the FDA website to find out if your mesh has been recalled, the mesh is usually listed by product number and lot number.
What is the chance that anyone remembers the lot number of their mesh? Zero.
Also, the companies are not required to pay for the removal of a recalled mesh.
Please be an informed patient before you allow someone to put mesh in your body.
Regards.
Bill Brown MD -
[USER=”2029″]Good intentions[/USER]
I always learn something when I read your comments.
Note the mesh companies are not required to inform the patient nor the doctor if a mesh has been recalled.
Also, the companies are not required to pay for the removal of a recalled mesh.
If you try to use the FDA website to find out if your mesh has been recalled, the mesh is usually listed by product number and lot number.
What is the chance that anyone remembers the lot number of their mesh? Zero.
Please be an informed patient before you allow someone to put mesh in your body.
Regards.
Bill Brown MD -
[USER=”2029″]Good intentions[/USER]
I always learn something when I read your comments.
Note the mesh companies are not required to inform the patient nor the doctor if a mesh has been recalled.
Also, the companies are not required to pay for the removal of a recalled mesh.
If you try to use the FDA website to find out if your mesh has been recalled, the mesh is usually listed by product number and lot number.
What is the chance that anyone remembers the lot number of their mesh? Zero.
Please be an informed patient before you allow someone to put mesh in your body.
Regards.
Bill Brown MD -
[USER=”2029″]Good intentions[/USER]
I always learn when I read your comments.
It should also be noted that if there is a recall of a mesh, the companies are not required to inform the patient nor inform the doctor.
It is up to the patient to look at the FDA website to find out if his/her mesh is on the recall list. Most of the recalled meshes are listed by product number and lot number. What is the chance that a patient knows the product number and lot number of his or her mesh?
In addition, Mesh companies do not offer to pay for the removal of recalled mesh, the lost time from work, nor the suffering.
Please be an informed patient before you allow mesh to be put into your body.
Regards.
Bill Brown MD -
My larger posts are all getting blocked. I’ll try again later.
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Dr. Earl, of HerniaTalk, is,or was, promoting the Omega 3 coating. Sorry Dr. Earle. The research behind the product seems very sketchy. How do “issues encountered during hernia surgery” relate to long-term results of the mesh implantation. Where is the data? Your statement seems to be hanging, alone, in the middle of the promotional literature. No reference indicated. There are no supporting references for any of the statements in the sales brochure.
http://www.surgilife.gr/atrium/Atriu…esh-family.pdf
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Unapproved, try again
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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