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Plugs are evil, should be avoided, surgeon invents the “mother of all plugs”
This article just popped up, coincidentally to a recent post I made. I have posted about Dr. Amato in the past. He designed a new plug and patch device, but doesn’t call it a plug and patch. He owns the patent on the design. And, what seems to be a peer-reviewed journal has published what looks like an advertisement for the new product. It’s hard to comprehend.
It’s a plug and patch. With a large springy plug instead of a flower-shaped folded plug. The large springy bundle of polypropylene is sitting next to the spermatic cord. Supposedly the springiness of the plug causes the body to treat it differently. Hard to imagine.
There are pictures. At least one patient got three devices in one procedure.
https://www.nature.com/articles/s41598-022-23128-6
“Fixation free laparoscopic obliteration of inguinal hernia defects with the 3D dynamic responsive scaffold ProFlor
Giuseppe Amato, Antonino Agrusa, Pietro Giorgio Calò, Giuseppe Di Buono, Salvatore Buscemi, Adriana Cordova, Guido Zanghì & Giorgio Romano
Scientific Reports volume 12, Article number: 18971 (2022) ”No details about long-term chronic pain. A single statement that says none was “reported”. No evidence of an actual survey, no data referenced (should have been called out by a referee). Sketchy. They must know how to do a proper pain survey. But they apparently did not do one.
“No sense of foreign body, discomfort, or chronic pain was reported among the operated patients, even long term. In a follow up, from 36 to 6 months, no recurrence occurred in any patients of the cohort. All data of the postoperative outcomes are detailed in Table 3. Postoperative pain, assessed with the VAS scale, showed very low-pain scores starting from the first post-operative day.”
“Ethics declarations
Competing interests
Dr. Giuseppe Amato is the developer and patent owner of the device being discussed in the article, despite in the recent past he had financial/commercial relationships, such connections are not present at the moment. Drs. Antonino Agrusa, Pietro Giorgio Calò, Giuseppe Di Buono, Salvatore Buscemi, Adriana Cordova, Guido Zanghì and Giorgio Romano have no conflict of interest or financial ties to disclose. Overall, except those disclosed by Dr. Giuseppe Amato, there are no other relationships or activities to declare that could have potentially influenced the outcomes of the submitted work.” -
14 Replies
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Completely agree. I have seen this product come and go in the US market for so many years, as each company keeps handing it around like a hot potato. I even posted about it on Twitter in response to a Tweet (since deleted) that asked if anyone would consider using this mesh given all the raving about it by the Company. This was my response: https://twitter.com/Herniadoc/status/1324928701671243777?s=20&t=kjIGzCkd5843jBFuR6KEbg
I got a DM from the Company at the time, admonishing me for being unprofessional in my post. Oh well.
I stand by my statement, btw.
The ProFlor never caught on in the US (and the company went bankrupt). And that’s a good thing. If the plug is too bulky, this is even worse. And any claims that an implant will maintain its springiness after implantation is melarkey. pic.twitter.com/INrwdL5WfL
— Dr. Shirin Towfigh (@Herniadoc) November 7, 2020
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Look at the description of the first three pictures in the paper linked below, and the picture in Dr. Towfigh’s tweet. The ProFlor plug was removed due to recurrence after three years (how did that happen if the repair was “finalized” and the defect obliterated?). The plug looks just like the Perfix plug that Dr. Towfigh removed. All contracted and filled with new tissue.
It’s almost like they are showing that their claims don’t match the reality. The ProFlor ends up just like the other plugs.
Many doctors don’t use the term “scar tissue”. It’s all just tissue in different stages of regeneration.
Anyway, I think that the key issues are return of function and quality of life. That’s the reason that people let any kind of plastic be inserted in to their body. Time will tell on Proflor. Insightra has been bought by a venture capital company and they will promote this product until they sell the company to a larger medical device company or until they package it up for a public offering to the market. That’s what venture capital firms do. It’s all about the money. They have to generate excitement. Tela Bio followed a similar path with their Ovitex products.
https://www.mdpi.com/2079-4983/13/4/253
https://twitter.com/novitskyyuri/status/1021596087600271360
plugs are evil and should not be extrapolated as all things "mesh"
— Yuri Novitsky (@NovitskyYuri) July 24, 2018
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I think that is the crux of the problem ie whether their claim that healthy tissue forms around this mesh is correct, as opposed to scar tissue which is commonly found in virtually all the other meshes?
Ps: maybe we should have two sections in this forum: one for personal stories and experiences (which will be probably very wild) and another one focused on doctor opinions, papers, research as well as useful info when looking for a doctor
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If we know anything at this point it’s that three-dimensional meshes Do not integrate well simply because they do not retain their designed shape. They contract, pull away from the defect, migrate, entangle sensitive structures as they do so, and are highly perceptible to the end user because they become a big lump of scar tissue concentrated in a particular area which push pressure on everything around it.
Agree 100%. I’d challenge any surgeon pushing plugs, new or old, to place it in their loved one if they believe in it so much. Doubt they would. Don’t care how many animals they’re tested in.
I had a plug in me for less than 2 years until it had to be removed due to recurrence. The surgeon who kindly removed the plug described it just as you have. Stiff, contracted, failed. I can only describe the feeling it created in me as hell. Every waking moment.
A life ruining nightmare.
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This reply was modified 2 years ago by helpmehere.
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This reply was modified 2 years ago by
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One thing perhaps worth noticing is that these plugs were tested on animals (I think pigs), which were then explanted and showed healthy tissue built around (they even published the pictures). They maintain that the shape is the critical aspect together with the lack of fixation.
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If we know anything at this point it’s that three-dimensional meshes Do not integrate well simply because they do not retain their designed shape. They contract, pull away from the defect, migrate, entangle sensitive structures as they do so, and are highly perceptible to the end user because they become a big lump of scar tissue concentrated in a particular area which push pressure on everything around it.
It’s a failed concept. I think half the reason why people still use this technique is simply because it’s what they were taught in residency. There’s a lot of people out there that were trained on it.
So it’s the thing that they use and they are trying to improve upon it utilizing the same concept.
But it’s a failed concept at this point.
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Here is another new paper about this. I’m kind of shocked at how much effort is put in to hiding the fact that this device is just a giant plug and patch. All of the words used to describe it seem meant to obfuscate and sensationalize. His latest paper seems to be claiming that the damaged tissue is completely recreated. The product is the ultimate hernia repair devices. It’s incredible. The selling is really accelerating for this one. Venture capital needs rapid returns.
One major flaw in the claims is that polypropylene fibers do not have good fatigue resistance. If what he claims is true, then the product will almost certainly fail from fiber fatigue and failure, from the constant motion that he describes. Lots of sharp pointy fiber ends in the defect. Polypropylene was probably chosen because it will slip through the 510(k) protocol for rapid market introduction. A good inventor would have researched the the fiber qualities needed for the product and went out and found the proper material. If the product does what he says it is almost guaranteed to fail. If it doesn’t, it’s just another plug.
https://www.mdpi.com/2079-4983/13/4/253
“Dynamic Responsive Inguinal Scaffold Activates Myogenic Growth Factors Finalizing the Regeneration of the Herniated Groin
by Giuseppe Amato 1,*,Giorgio Romano 1,Vito Rodolico 2ORCID,Roberto Puleio 3ORCID,Pietro Giorgio Calò 4ORCID,Giuseppe Di Buono 1,Luca Cicero 5,*,Giorgio Romano 6ORCID,Thorsten Oliver Goetze 7 andAntonino Agrusa 1”
“5. Conclusions
All of the above would appear to confirm that, unlike the ordinary 50-year-old treatment concept with conventional flat static meshes, the 3D dynamic responsive structure of the ProFlor device attracts tissue growth factors acting as a true regenerative scaffold. The updated physiological and pathogenetically coherent treatment concept embodied by ProFlor seems to represent a game changer in the intricate realm of inguinal hernia repair. Effectively, ProFlor probably embodies a new category of hernia devices presenting with completely new and updated concepts for the treatment of inguinal protrusions: fixation-free deployment, permanent defect obliteration, dynamic responsive behavior, and regenerative scaffold. These innovative concepts constitute a turning point for the cure of inguinal hernia and may represent the basis for the development of more advanced devices for the future therapy of this frequently occurring disease.” -
I came across this type of mesh few years ago as the surgeon is Italian.
From my understanding the surprising observation was that around this mesh healthy tissue grows, as opposed to the scar tissue in the other meshes?
I guess if confirmed this would mean less inflammation as a whole.
The other thing is that the plug is not attached but free to move within the space, which they claim makes it less “present” to the patient. These are the key points that they were trying to convey back then when I asked about this mesh…
Personally I would love to see a paper where patients are also divided based on their physical activity level pre and post surgery. On the same token I would be curious to see some stats for watchful waiting with also the fitness level of the patient factored in 🤔 -
I really hate this site sometimes…type up a detailed reply, but it times out and requires login again, with the entire post gone.
I give up…the short of my reply, from memory:
The follow-up time convention seems confusing…what does “36-6 months” mean…36 hours to 6 months or counting backwards from 36 months to 6 months? In one spot they talk about follow up 1 week, 4 weeks…six months…and each year post-op. They mention MRI at 3 and 6 months…ultrasound over the long-term…They could do a much better job of clearly summarizing all follow-up protocols in one spot. The table provided does a weak job of that.
They claim ZERO adverse events beyond three seromas…ZERO infection, recurrence, chronic pain, and even ‘discomfort’. Impressive…and hard to believe.
The video (not part of the study) cites a sub-20min. repair time under local, and yet the study notes a mean repair time closer to an hour even for the single hernias…is that because the recurrence repairs are a different procedure?
I’m curious to know what that springy little flower looks (and feels) like over the longer term? What about the flat mesh portion?
Maybe I’m naive, but some of the figures concern me…Figure 6 shows two 40mm plugs with about that same distance between them, surrounded quite a bit of flat mesh. What is that going to look and feel like years down the road?
I hope there will be longer-term data and (importantly) replication studies.
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Finally, the true owners of the product.
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Here is the message from the Inightra.com page –
“Insightra Medical Inc and all its subsidiaries are now owned and operated by Tennessee Medical Innovations Inc (TNMI)
Please visit http://www.tn-mi.com to find out about the company and our products:” -
If you search “Insightra.com you’ll see the message about tn-mi.
tn-mi has been acquired by a company called Mundomedis.
https://tn-mi.com/mundomedis-acquires-us-medical-device-manufacturer-tnmi/
Munomedis is a venture capital company focused on the medical device market. Venture capital only cares about return on investment. Products have to sell.
“ABOUT MUNDOMEDIS
Mundomedis is a global incubator for startup and early-stage medical device companies and serves as a growth accelerator for more advanced medical device companies. Located in Dubai Silicon Oasis, a fully integrated technology park with the aim to foster technology and entrepreneurship, Mundomedis utilizes its global network of strategic partners, distributors, manufacturers and healthcare providers to:– Raise Capital
– Assist and drive M&A strategies
– Develop global sales and marketing strategies
– Build and expand distribution channels
– Source suppliers and assist in outsourcing production
– Support in Regulatory AffairsFor more information about Mundomedis visit: http://www.mundomedis.ae “
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The company that sells it, Insightra, has apparently been bought by a medical devices company.
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It’s already for sale in the USA and India.
https://www.insightra.com/wp-content/uploads/2019/01/PROFLOR_patient_info-1.pdf
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