Good intentions
Forum Replies Created
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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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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.
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These two references are very descriptive. I am far from an expert. I became more aware of this possibility after my own personal experience with imaging.
About 2 minutes in in the video.
https://www.youtube.com/watch?v=OZP2CYFNfeY
And a summarized publication, with an excerpt of the conclusion.
https://pubmed.ncbi.nlm.nih.gov/30368312/
“Conclusions: Most radiologic reports issued for CT and MRI studies were incorrect for evaluation of occult inguinal hernia. Over-read radiologist reports were more than twice as accurate when evaluating the same images. The physician who is relying on radiologic reports to determine plan of care for a patient with groin or pelvic pain should inquire further into any negative study, especially if there is strong clinical suspicion for inguinal hernia.”
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Doctors trained to read/interpret images are generalists. They will only recognize the common signs of a hernia. They interpret images for a whole range of problems, and basically just look for abnormalities.
Hernia specialists who have learned to interpret images will have the advantage of correlating what they see on the image with what they saw during the physical exam plus the discussion with the patient. They will have all of it in their head at the same time.
That’s just my view. I had imaging done for my mesh problems, Bard SoftMesh implanted via TEP, and the report just listed things that might cause pain but said that they did not see anything significantly wrong. My surgeon did not want to hear about problems because problems are supposed to be the fault of the surgeon, for mesh implantations, so he used the image interpretation as a reason to pass me on to someone else. He did the same thing with other issues, passing me off to a urologist who said that they knew nothing about mesh, except that it got in the way when they did prostate surgery.
That’s also an example of how my surgone was a “mesh implantation expert” but not a hernia expert. He could get the mesh in but was lost when there were problems.
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pinto, you are right, it shouldn’t take such extreme measures. I thought of Dr. Kang first because I remembered the post about the imaging work that they do before surgery, plus the fact that he has examined thousands (I think) of patients.
A better answer is that anyone who thinks that they might have a hernia should find a surgeon who does pure tissue repairs as the first choice,and mesh repairs only for the circumstance where a pure tissue repair would give poorer long-term results. Any surgeon that recommends mesh as a first choice would not be a hernia repair expert. They would be a mesh implantation expert. Find a hernia repair expert.
My views have shifted more and more toward the thought that any surgeon who recommends a mesh repair as the first, or only, choice, is captured by the mesh repair industry. The evidence just seems overwhelming that a pure tissue repair for a typical hernia is the best choice for the long-term welfare of the patient. The deviations that we all see, with all of the variations on mesh devices, and the focus on laparoscopic methods for mesh implantation, just aren’t supported in terms of patient welfare. The patient is paying the price, with their long-term health, for all of these new devices and new technology.
Somehow the hernia repair field has been warped in to a business that has to be maintained by using mesh where it is not best for the patient.
Dr. Brown, Dr. Muschaweck and colleagues, and others that do pure tissue repairs would be where NickMaybe should focus his efforts. Because they have already chosen the best method for the patient’s health and welfare. The others have not, they have chosen the mesh implantation business model, which is constantly working to avoid addressing the problems of mesh.
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Quite a bit has been written on the forum about how difficult it is to identify a hernia by imaging methods. Dr. Towfigh has presented and published about it.
Have you considered Dr. Kang’s Gibbeum Hospital? Apparently they do imaging the day of surgery to confirm the details of the problem. Here is a post from the forum from a patient who had a hernia repaired there. They probably have an extensive record of the various side effects of hernias and might recognize your symptoms. At the least they might be able to tell you that you definitely do not have a hernia, if that is the case.
https://herniatalk.com/members/patientfriedman/forums/replies/
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Here is the conclusion, pasted below. PIH = primary inguinal hernias. NNT = number needed to treat, wiki link in the post above.
From wiki – “A higher NNT indicates that treatment is less effective.”
“Conclusion
The idea that mesh techniques reduce the recurrence rate in all PIHs is not supported by high level of evidence. The NNT for pure lateral hernias was very high and should be interpreted taking into account chronic pain rates and costs.” -
Second one (the site does weird things with Twitter):
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Bruce Ramshaw has created a new Twitter account, leaving MD off of the end of his name. Part of the shift.
First one:
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I don’t want to “pile on” with criticizing Dr. Ramshaw. His disclosure about his surgery mistake showed that he was close to burnout. And I’m not a psychiatrist. But it seems like spreading the word about what he’s seen with his research on “mesh” (he says he’s a scientist on his web page) would be therapeutic for him, in dealing with the damage he caused his patient through his oversight. Make up for the mistakes with truly helpful work, that can actually be seen and measured.
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It looks like Dr. Ramshaw is a consultant now, and has given up being a physician.
His goals seem to be so lofty that the hernia mesh problem is small to him. He has a “mission”. Like a man walking past a car accident with victims that need help because he has to get to work to design safer cars. He has important work to do and can’t be bothered with the small stuff. That sounds insulting but that’s what comes across to me, considering his history and his new career path. He showed that he knows how to identify a problem, but not how to go about solving it.
My apologies to anyone who knows him and is offended. It’s just disappointing to see somebody with the knowledge and abilities and background to help with a problem, and the problem sitting right in front of them, well-defined, asking to be worked on, just ignore it to do something that’s more enjoyable and/or more profitable. He has profited from the use of mesh over his career so far, and is now leaving the problems behind for others to deal with.
“Dr. Ramshaw’s mission is to shift the mindset in healthcare by reimagining patient care through applied Systems Science.”
His upcoming book:
“Finding the W(H)ole in Healthcare”“Healthcare data consulting for the real world.”
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Glad to hear that you’re finally getting in, the pandemic has really made a mess of things.
I still have a lump on my side/flank lower back from when I pulled a muscle in the gym lifting a heavy weight. I felt it tear and it was painful for a few days. I think that the muscle fibers ball up at the point where they tear, creating the lump. In my case the lump has never gone away, but it’s not painful anymore. It might be that the lump you feel is torn muscle fiber. I assume that that would show on imaging, with the density of muscle fiber.
Good luck with Dr. Martindale. Hopefully he’s been studying hard while his case load has been down and he will have some new ideas.
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In 2011 the method was probably very similar to what was done to me in 2014. A single procedure bilateral repair was probably laparoscopic TEP or TAPP. A large cavity is created between the peritoneum and the fascia and two large pieces of mesh are slipped in between. The top of the cavity would be below the navel but pretty close to it. So after implantation there is a line from side-to-side below which is the inflexible, boardy, mesh/tissue composite after “mesh incorporation”, and above which is normal flexible tissue, although it is scarred from the blunt dissection process, the peeling apart of the two layers.
So, it might be that your efforts are tearing/damaging that area, as the flexible tissue stretches and the inflexible mesh composite does not. In engineering terms it might be called a “stress riser”. One side effect of the repeated damage is that more scar tissue will be created as the body heals the new damage.
I still have a stiff thick bowl shaped area where the mesh used to be in my abdomen. It’s getting softer and more flexible over time since mesh removal, and my after-effort pain levels are significantly lower now, at 3 1/2 years after removal, than they were at one and two years. I only had the mesh for three years but I was very active and I think the constant damage created a very thick layer of repair tissue from the constant damage.
None of this really helps your immediate problem but it might help you understand what’s going on in there. I think that your best option might be to let the area settle down and heal completely.
Don’t try to “work” it back into shape like you would a normal muscle injury. It’s not normal muscle or tissue. The foreign body reaction is constant and any newly exposed mesh increases the reaction rate, I think. I spent a lot of time and effort trying to exercise the mesh area in to something healthy, get it to “adapt” to the mesh, but the reality was that it was just damaged tissue that could never fully heal.
The typical surgeon will only see the mechanics of your problem. Is the mesh where it was placed, is there a recurrence, is the mesh impinging on any specific structure that could cause pain? That’s it. If you keep coming back they’ll send you to pain management.
Good luck. Read through as many posts on the site as you have time to. There is a lot already here.
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Forever seems to be the answer. The research in to the absorbable/resorbable biologic materials is done in the hope that the FBR will destroy/replace the foreign biologic material and replace it with human tissue that is strong enough to function properly.
https://link.springer.com/article/10.1007/s00423-011-0780-0
“Abstract
Mesh biocompatibility is basically determined by the foreign body reaction (FBR). In contrast to physiological wound healing and scar formation, the FBR at the host-tissue/biomaterial interface is present for the lifetime of the medical device. The cellular interactions at the mesh/tissue interface proceed over time ending up in a chronic inflammatory process. ” -
I think that mesh is over-used. I think that for the common inguinal hernia a pure tissue repair should be used first. There is no way to undo the results of a mesh implantation, and problems with mesh are not uncommon.
The selling points used today by the surgeons that use mesh are that the results are “about” the same for mesh and pure tissue repairs. But when there are problems with mesh it’s usually a disaster for the patient. Lives ruined.
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That’s a shame Jay. Hope you get through it indecent shape.
Can you share the details of the procedure that was attempted? A surgeon might have some ideas of what to expect.
@drbrown has done many open pure tissue repairs. There are a variety of open mesh repairs, involving different types and shapes of mesh, and different methods of placement. Some of them are placed pretty deeply in to the abdomen even though the procedure is “open”.
It sounds like they cut off the blood supply to your testicle, whatever method they tried. Even a pure tissue repair can have problems like yours.
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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.