Types of mesh and their manufacturers

[Good intentions]

I think that most people who have hernia repair do not realize the vast number of different types of mesh that are out there. Here is a Topic to try to show the number and variety, and the manufacturers, along with some of the industry consolidation that is happening. two of the big players in the field are now under new management, apparently. Bard Davol has been purchased by Becton Dickinson, and Covidien is now part of Medtronic.

First a simple text list, with some comments. I’ll add links about these companies in following posts.

Medtronic – Recently purchased Covidien

BD – Might stand for Bard Davol or Becton Dickinson. Bard Davol was purchased by Becton Dickinson

Dynamesh Their mesh niche is a polyvinylideneflouride fiber mesh, PVDF. This is a fluoropolymer so should have the poorest tissue adhesion of three main types of thermplastic fiber. It’s main quality is probably being different than the others. Market differentiation.

Gore – Another fluorpolymer mesh. Polytetrafluorethylene. PTFE. An oddball product portfolio. their original products were of the same technology as their GoreTex fabric. They seem to be expanding in to PTFE fibers now.

Ethicon – one of the originals in the field. They seem to be waffling between beong called Johnson & Johnson again or Ethcion. They are a subsidiary of Johnson & Johnson. One of the major drivers of mesh for hernia repair, with extensive influence in the conferences and the Guidelines development.

Atrium – main claim to fame seems to be their Omega 3 oil coated hernia mesh. Apparently they have been purchased or their mesh division has, by Getringe. The Atrium products are not found on Getringe’s main page but can be found using Google.

Getinge – now handles Atrium products

One brand, one source.
Under the name Getinge we are now unifying our offering and combining all our brands.
With brands like Maquet, Lancer, Atrium, Pulsion, Datascope, Getinge, Steritec, Stericool and Trans – just to name a few – the group has grown to become a global market leader in many healthcare and life science segments. We are now unifying our offering and combining all of our talent and resources under one brand.

[Good intentions]

Bard Davol

https://www.bd.com/en-us/company/news-and-media/press-releases/dec-29-2017-bd-completes-bard-acquisition-creating-new-global-health-care-leader

https://www.crbard.com/Davol/en-US/

https://www.crbard.com/Davol/Product-Search?category=Hernia+Repair+%26+Fixation

[Good intentions]

Covidien (Medtronic)

https://www.reuters.com/article/us-covidien-medtronic-inc/medtronic-to-buy-covidien-for-42-9-billion-rebase-in-ireland-idUSKBN0ER03420140616

https://en.wikipedia.org/wiki/Covidien

https://www.medtronic.com/covidien/en-us/products/hernia-repair/mesh-products.html

[Good intentions]

Gore

https://www.goremedical.com/products?f%5B%5D=product_specialty%3AHernia&q=

https://www.gore.com/

[Good intentions]

Dynamesh

https://en.dyna-mesh.com/groin-gb/

https://en.dyna-mesh.com/catalogue-hernias-en/

[Good intentions]

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

[Good intentions]

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.

[Good intentions]

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

[Good intentions]

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

[Good intentions]

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

[Good intentions]

My larger posts are all getting blocked. I’ll try again later.

[DrBrown]

[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

[DrBrown]

[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

[DrBrown]

[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

[DrBrown]

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

[Good intentions]

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

[Jnomesh]

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.

[drtowfigh]

[USER=”2029″]Good intentions[/USER] thanks for all the informative posts. Very nicely done. You make this a better forum because of your participation.

[patient]

[USER=”2029″]Good intentions[/USER] Amazing job!
it also seems doctors who insert you mesh, they receive money or free training for mesh

[Good intentions]

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

https://www.telabio.com/ovitex.html#science

https://www.globenewswire.com/news-release/2019/11/08/1943702/0/en/TELA-Bio-Announces-Pricing-of-Initial-Public-Offering-of-Common-Stock.html

[Good intentions]

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.

https://www.insightra.com/

http://www.angiomedical.com/pdf/freedominguinal.pdf

https://forum.bodybuilding.com/showt…353003&page=44

[Good intentions]

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

• This reply was modified 1 year, 2 months ago by Good intentions.

[Good intentions]

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

[Good intentions]

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.

Homepage

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.”

[Good intentions]

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.

[Alephy]

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….

[Good intentions]

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.

[Stonehood]

I got the GM1510 from gallini medecal devices – managed to download this PDF before it disappeared from the internet 5 years ago.

Gallini medical devices

• This reply was modified 1 year, 2 months ago by Stonehood.

[Good intentions]

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.

https://www.jnjmedicaldevices.com/en-US/company/ethicon/products?jnjmdc_product_category_ref_target_id%5B3051%5D=3051&items_per_page=20

[Good intentions]

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

[newagehernia]

I like this mesh but it´s not available in na. 21gm and 2.3mm pore size, for thin people who want less inflammation.

https://www.cjmedical.com/products/specialties/laparoscopy/ami-laparoscopy/hexapro-mesh

I am not sure if this can be used for hernias but looks interesting
https://www.seri.com/about/seri-at-a-glance.html

[Good intentions]

The Seri material does look interesting. I think that Dr. Brown uses silk sutures for his pure tissue repairs.

The lightweight mesh concept is an idea based on the assumption that if the mass of material is reduced that the inflammatory response will be reduced. But the body cannot “see” mass, it can only respond to surface area. Thinner filaments actually have more surface area per unit of mass. The idea was not proven through long-term studies it was authorized through the 510(k) process and immediately introduced to market as a potentially better product. Overall, it looks like an attempt to show that the pain problem was being addressed, plus an increase in market share for the company that first introduced it. The data is inconclusive as far as the claims being made. I had lightweight mesh implanted, Bard Soft Mesh, and had the typical chronic pain problems described for heavyweight mesh.

https://scholar.google.com/scholar?hl=en&as_sdt=0%2C48&q=lightweight+hernia+mesh&btnG=

[Good intentions]

BD’s advertising doesn’t even really give a reason to use their lightweight mesh. Notice how they refer to actual weight. 60% lighter. Bad rationale.

https://www.bd.com/en-us/offerings/capabilities/hernia-repair-and-fixation/hernia-repair-mesh/synthetic-mesh/bard-soft-mesh

“For surgeons who may prefer to implant less material, it is approximately 60% lighter than traditional polypropylene mesh*,”

“* As compared to other traditional polypropylene mesh, such as Classic Bard™ Mesh”

[newagehernia]

by surface area do you mean pore size? the widest size polypropylene only mesh I’ve seen is a Polish mesh optomesh ultralight which has 6mm pores.

[Good intentions]

No, I mean the area of polymer fiber exposed to the body’s fluids. Macrophages, etc., the things that react to foreign material. More fiber surface means more macrophage reaction. There’s no weight involved, just exposed area. The body can’t detect what’s under the surface it only reacts to surfaces, not interior.

[newagehernia]

Thank you , that makes sense. A little bit like homeopathy, where it is not the quantity of a substance but its mere presence in small quantities that is the issue.

I just wish the scientists would get their act together and develop a non-rejectable, non immunogenic, collagen-self cell or alternative biosubstance that is more biocompatible than petroleum product, and do it faster! The concept of mesh does seem to have advantages, but so does actual tissue.

[Good intentions]

Here is another recent review article covering the wide variety of hernia repair meshes. It is very wide-ranging, the primary author is a graduate student at Stony Brook. Looks like the foundation for a thesis.

Some of the summary points are outdated though, at least for the United States. She says that open Lichtenstein is the predominant repair method but that was probably true 10-15 years ago. Today if you get referred to a surgeon you’re probably going to get a laparoscopic mesh implantation. And, in the collection of biological meshes, the new venture, Tela Bio, is not even mentioned. Things move fast in the new mesh product world though, easy to get left behind. It’s a good thorough review though, of materials, methods, and hernia types.

https://www.sciencedirect.com/science/article/pii/S2666138120300025#!

[newagehernia]

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.

[Good intentions]

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

[Good intentions]

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. “

[Good intentions]

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.

[newagehernia]

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?

[Good intentions]

The link in Reply #20099 above is broken. Here is another. Getinge’s Proloop product.

https://www.getinge.com/siteassets/products-a-z/proloop-mesh/009966-proloop-mesh.pdf?disclaimerAccepted=yes

[Good intentions]

The link in the post after that one about the Omega-3 coated C-QUR mesh is also broken. It turns out that Getinge sold the C-QUR product line to a venture capital firm because the litigation costs were too high, soon after they bought the product line from Atrium. Pretty fascinating…the birth, life, and death of a novel hernia repair mesh all within about 10 years.

https://www.getinge.com/siteassets/products-a-z/c-qur-mesh/009967-c-qur-mesh-flyer.pdf?disclaimerAccepted=yes

[Good intentions]

Here are some links that I tried to add to the Getinge post above. Too many, I guess, didn’t get through.

Getinge Stock Falls as Lawsuits Mount: Getinge Sells Off Atrium’s C-Qur Hernia Mesh Line

https://www.bloomberg.com/profile/company/1666977D:HK

https://patents.justia.com/patent/11083823

[newagehernia]

yes that’s it. so is crosslinking any different than a standard propylene mesh?

[Good intentions]

I just added to the other Reply string above.

[Author]

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