Possible explanation for mesh problems (from a product standpoint)

Hernia Discussion Forums Hernia Discussion Possible explanation for mesh problems (from a product standpoint)

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    • #12027
      UhOh!
      Member

      I work in marketing, constantly evaluating the problem-solving potential of different products and helping position them in the marketplace. So I might be seeing these things from a slightly different angle, but here goes, my hypothesis about why mesh products sound great in theory, but have so many problems in practice:

      Mesh theoretically serves two purposes, it acts as a prosthesis and promotes healing through tissue ingrowth. The problem is, it hasn’t been OPTIMIZED for either purpose. From a product standpoint, that’s a huge issue; combining two conflicting, partial solutions is problematic. The same would ostensibly be true for the procedures used to insert that mesh.

      If mesh is supposed to be a prosthetic, then shouldn’t it mimic the form and function of the tissue it replaces? Rather than something that shrinks and hardens, shouldn’t it be flexible and expandable, serving the purpose of damaged fascia?

      On the other hand, if the purpose is a healing aide, then it should be thought of like a splint or bandage, right? That is, something that isn’t meant to be there forever. Since removal would be more invasive surgery, absorbable would seem to be the answer, but that only works if the procedure for insertion addresses the actual tear (per one of Dr. Kang’s primary operating principles). Otherwise, it would be like bandaging a deep laceration without closing it.

      From this perspective, it’s easier to see the shortcomings of mesh from a product development standpoint. I’d be very interested to hear the opinions of experts in terms of optimizing a product to serve its intended purpose (instead of serving two somewhat conflicting purposes).

    • #20160
      DrBrown
      Participant

      [USER=”1391″]UhOh![/USER]
      Mesh is not as flexible nor as elastic as your normal tissues.
      It always elicites a foreign body reactions.
      It shrinks with time.
      It easily becomes infected.
      What could go wrong?
      Bill Brown MD

    • #20161
      UhOh!
      Member
      quote DrBrown:

      [USER=”1391″]UhOh![/USER]
      Mesh is not as flexible nor as elastic as your normal tissues.
      It always elicites a foreign body reactions.
      It shrinks with time.
      It easily becomes infected.
      What could go wrong?
      Bill Brown MD

      Yes, exactly. It sounds like it was engineered (or chosen, from a pile of “stuff”) because it checked some boxes in terms of serving a dual purpose (prosthetic; healing aid) without anyone ever thinking about optimizing it for either purpose.

      Huge failing from a product development standpoint (true whether it’s a medical product, or meant for any other industry requiring precision).

      What do you think the results of “mesh” repairs would look like if, either:

      1. A fully absorbable mesh were used in conjunction with tissue repair techniques, to promote healing, and then go away (like a splint, cast or bandage)

      or

      2. A true prosthetic, meant to mimic the form and function of the damaged tissue, had been developed (along with the right technique for integration)?

      Do you think that it would have led to better overall results, instead of new problems (chronic pain vs. recurrence)?

    • #20162
      Good intentions
      Participant

      I think that your logic is on target. Of course you know, that business is not really about making the best product, it’s about maximizing shareholder value. It’s the major flaw of free market economics. The business model is not for the benefit of the consumer it’s for the benefit of the business owners, the shareholders. Unfortunately, in this case, maximum shareholder value comes at about a 15% chronic pain rate for the consumer.

      You can see this in Johnson & Johnson. They are actually buying companies that have been shown to harm consumers, and are paying the settlement costs. But the business is still profitable and worth owning, for the shareholders.

      Free market economics are based on the principle that everything has a monetary value. That it’s possible to quantify a ruined life in dollar terms.

    • #20166
      Jnomesh
      Participant

      A pure tissue repair with a absorbable mesh is something I’ve been pondering and asking about on these forums. If “perfected” it seems for a certain population it could be a great solution.
      For inguinal repairs it could start with the premise that a non mesh repair repair will be the first line of defense for small hernias and strong surrounding tissue. If upon surgical exploration it is determined that the hernia is to big or that surrounding tissue is also weak in addition to the hernia defect a natural repair with a onlay of absorbable mesh could be the protocol.
      The absorbable mesh could also be a additional safeguard should the surgeon not bring an expert in non mesh repairs with the absorbable mesh being an extra layer of defense.
      Bridging the two methods tissue repair and absorbable mesh seems to have as a idea promise
      Ofcourse we know very little about absorbable meshes: do they really completely absorb 100% and what are some of the risks inherent to this kind of device. And ofcourse as good intentions mentioned we can’t trust the manufacturer to really have the patients best health interests in mind when developing this product .

    • #21153
      Alephy
      Participant

      Interesting post….what about creating a mesh with “cloned” tissue from the patient in the future? at the very least no inflammation response will be triggered, which would also mean no nerves growing over it (not sure about adhesions though)? depending on the tissue the flexibility long term would also be guaranteed…

      I cannot see the market of plastic meshes continue much longer frankly…I am wondering if this is why nobody is interested in any long term follow up: they know it is the past and that the future will be quite different

    • #21532
      drtowfigh
      Keymaster

      – absorbable Mesh (aka biologic mesh or synthetic absorbables) don’t work. That’s been tried. And they are very very expensive—they cost more than the
      Insurance reimbursement for the operation.
      – I think the hybrid mesh has been the best option so far. I use Ovitex by Tela Bio. It has just enough synthetic to prevent a recurrence but not enough to have the inflammatory reaction that can cause chronic pain.

      If hernias would have higher reimbursements from insurers, then that would allow technology to strive for better options.

    • #21881
      Alan
      Participant

      Re: Ovitex.

      All, has anyone seen data or representations comparing properties, characteristics like post-op shrinkage, erosion, or migration for Ovitex versus conventional synthetic meshes?

    • #21883
      Good intentions
      Participant

      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

    • #21884
      Good intentions
      Participant
    • #21888
      Colt
      Participant

      Has anyone ever listened to the podcast about mesh from Ralph Nader
      Who incidentally had his hernia repair in Canada at shouldice clinic
      It’s very interesting and scary at the same time
      Never thought having a hernia could scramble my head up
      Like this
      Scott

    • #21890
      Good intentions
      Participant

      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….”

    • #21891
      Alephy
      Participant

      This is the first time that I hear of a clinical trial for a mesh before being used on patients….while I should be happy about this the thought of those animals suffering makes me shiver…

    • #21892
      Good intentions
      Participant

      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

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

    • #21898
      Alan
      Participant

      GI, thanks for the Springer study. The findings on the speed and quality of tissue formation for the Ovitex hybrids was encouraging.

    • #21899
      Good intentions
      Participant

      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

    • #21900
      Good intentions
      Participant

      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)

    • #21906
      Stan K
      Participant

      The biggest challenge facing this mesh conundrum is that data and research have become works of fiction dictated by industry lobbyist. False findings are the majority. Surgeon’s use the mesh by the company that pays them to “consult” and because of this there is extreme bias, which I believe is significantly holding the industry back from making real advancements in mesh design. The current paradigm searches for a solution based off false scientific rationale, driven by the messaging of the mesh companies. Capitalism at it’s finest.

    • #21921
      Stan K
      Participant

      I find it a little inappropriate when someone that’s a thought leader in the hernia space, particularly in a forum that I thought was objective, is plugging a product such as Ovitex by Telabio when the surgeon has significant equity in the company and is paid thousands to “consult” for them. This seems like a big conflict of interest.

      If everyone pushes the product they are paid to use, how are we to make real advances in mesh design? It is a truism that for every statistic in the surgical literature, there is an equal and opposite statistic in the same literature.

      -Stan

    • #21991
      Good intentions
      Participant

      The Tela Bio Ovitex product line is about as perfect as things can get for a registry. A new product, relatively low volume, competing against industry products with a worsening reputation for chronic pain. Closely held by just a few people.

      Create a good questionnaire and start tracking results. As they come in use them to show that it’s better than the industry “standard” of chronic pain. documented results, guaranteed to help sales.

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