Good intentions
Forum Replies Created
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Last post, just an example. From a 2020 surgery with a da Vinci robot implanting 3D Max. Very familiar story, as far as the mesh implant results. Many of the people talk about “having a life” before. Not simple discomfort reports. Life-altering.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=12303831&pc=FTL
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Another search tip – if you use the word “I” you will get the personal stories. The attorneys all talk in the third person.
“I mesh” brings up a lot, to the 500 limit. To see more you have to limit the search with more search words. Could be very tedious.
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I looked through a few Bard mesh reports and they all look about the same. “Attorney says patient was harned by mesh”. Manufacturer says “No manufacturing lot number is present therefore no conclusion can be drawn”.
The manufacturer is saying that it must be a problem in the manufacturing process. Pretending that it is not a fundamental aspect of the product design. Makes no effort to find out what happened.
The FDA does nothing.
It is pretty depressing reading so be ready if you decide to browse a few. But it’s easy to see where the lawsuits are coming from.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=12479336&pc=FTL
“Manufacturer Narrative
No conclusions can be made. The patient’s attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient. The patient’s attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard mesh (bard flat mesh) (device #1). An additional emdr was submitted to represent the bard/davol marlex mesh (bard flat mesh) (device #2). Should additional information be provided, a supplemental emdr will be submitted. Not returned.Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh) and bard/davol marlex (bard flat mesh) on (b)(6) 2013. As reported, the patient is making a claim for an adverse patient outcome against both devices. Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device. It is also alleged that the patient experienced emotional distress, sustained personal injury and the device was defective.” -
I have found a new way to get to a different Search menu. Click “Search” on the main MAUDE page. A new, different, page will open up. Click “Adverse Events” from the choices at the top. This will open up a new Search page with a single search box and the option to search All Years or a specific year. Put your search word in the box and many results will come up.
Here is the page that comes up. Not clear why it wouldn’t be on the first page.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
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Here is an example of a report where you can see many useful words in the actual report body that would help to categorize reports. But the search fields are not available on the web site.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=16389972&pc=FTL
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Insurance plans can change dramatically from state to state. That might explain the differing opinions on how insurance works. And, each state typically has different levels of risk that a person can choose to pay for. There really are no broad statements that can be made about insurance by country, when the United States are part of the conversation. We are a collection of individual states, each with their own rules and guidelines.
This web site shows just some small differences but the range is worth noting.
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Here is an interesting article showing how the passion and practice of medicine becomes industrialized. Like an actual industrial process, producing a product which can then be billed to the patient and/or their insurer.
https://revcycleintelligence.com/features/exploring-the-fundamentals-of-medical-billing-and-coding
You can see that from almost the very beginning the human patient gets converted in to a number to follow until the end, when collection happens. Pretty fascinating. The surgeons have to fit their work in to this system also.
“Medical billing and coding translate a patient encounter into the languages healthcare facilities use for claims submission and reimbursement.”
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Unfortunately, as I read through a few more articles, I realized that the term is also used for various conspiracy theories. Many of which are especially prevalent today. So it is a difficult concept for discussion.
Anyway, the potential for conflicts of interest are real, and in many cases you can see actual conflicts.
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Here is an article from 1980 –
https://www.nejm.org/doi/full/10.1056/NEJM198010233031703
Dr. Petersen’s story, if I recall correctly, was on his business web page and the site has changed.
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I hope this is my last post here, but I keep finding more. Medtronic’s product portfolio catalog contains all of their mesh products and uses the proper words in the descriptions. Apparently, for whatever reason, the Progrip polypropylene mesh is not specified for laparoscopic procedures. Maybe it’s not flexible enough for the canula.??? Why would it be okay for open but not for laparoscopic? Either of the Progrips, polyester or polypropylene, is specified for open repair.
Anyway, it’s interesting reading. Strange also, that they call out “open inguinal mesh” but not “laparoscopic inguinal mesh”.
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I almost hate to pile on but I think that it is important to understand how these points of confusion happen. Medtronic has, apparently, reviewed what they got when they purchased Covidien and decided to leverage the “Progrip” name and concept. You can see that they even contradict some of the previous selling points of polyester, that were made in the Covidien video, that promoted polyester over polypropylene. Whatever makes the product look good.
Here is the broader view from Medtronic.
“Whether you prefer polyester or polypropylene, ProGrip™ mesh is now available in the material you require for your patients.”
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Here is one of the original Covidien videos where they describe a similar name, ProGrip™ Laparoscopic Self Fixating Mesh, as a polyester mesh substrate. It’s at 2:15 in the video.
You can see that the Progrip name is being used on different substrates. So, unless a person checks the documentation they might not know what they are working with because the supplier has changed the product but kept the name. Not all Progrip is the same.
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SN’s post actually left the polyester or polypropylene question open-ended. For whatever reason Medtronic puts the word polyester in to the name of at least one of their Progrip products on their web site but leaves the other undefined.
The Medtronic Youtube page is more specific. They are using the self-fixation material, aka Progrip, on both polypropylene and polyester mesh substrates. Unless somebody made a mistake in their video production.
My background contains some materials science so these types of questions interest me. For the record, there are many variations within the classifications of polypropylene and polyester. The word “polyester” is especially undefined. Even the polylactic acid polymer is, literally, a “polyester”. A polymer of ester bonds. The manufacturing process used to make the fibers also has a significant impact on properties.
The medical device makers know all of this. But the tradenames allow them to market the product more effectively.
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Recent research on open versus laparoscopic umbilical hernia repair with mesh. Might help you in your search for a solution.
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Here is an interesting article about the financial aspects of the use of robotics. It raises the influence of other large institutions, besides the technology companies – the medical institutions that the surgeons work with, and the insurance companies (related to other recent posts). It’s a hot topic.
https://www.sciencedirect.com/science/article/pii/S1878788611000300
Financial aspects, or how to use a robot assistance without losing money. Perspectives from private practice
Aspects financiers ou comment utiliser le robot et maintenir un équilibre financier ? Point de vue libéral
P. Monod -
And it is linked directly to the International Hernia Symposium, but not directly on the main page. Very similar to “dark money” in politics. Click, click, click… how did I end up on a mesh supplier’s web page?
The surface changes but underneath things are the same.
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Thanks for the reply Dr. Towfigh. My comment about returning to the pre-mesh state by removing mesh was not about the benefits of mesh removal. It was about the irreversible damage of mesh implantation. Most of my posts are about why things are the way they are now, corporate influence, etc., and about preventing or avoiding the problems rather than believing that more surgeries or “pain management” is a reasonable response to problems.
This might feel offensive but I think that you are so deep in to the use of mesh for hernia repair, and modern surgical technology, that your natural inclination in your replies is to defend the status quo. Most of your replies seem to do that.
My original post was just restating, almost verbatim, what the presenter shows in his video, and adding a comment about what he did not state but which seems clear. Longer procedure time (under anesthesia), and higher equipment costs. The actual value of robotics technology is a hot topic today, there are many publications about it.
I did not mention Intuitive Surgical in my post, or you specifically, except as a co-author of the work presented in the video.
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It looks like the word “Progrip” is being used to describe any mesh that has the polylactic acid (PLA) absorbable component. That is approximately 40% of the weight of the material. Apparently, Progrip is applied to both polyester and polypropylene meshes.
The word “Parietex” appears to be a trademark that was originally used for polyester meshes. But now appears to be used for other materials also.
There used to be more information readily available through the internet but Medtronic seems to have removed much of it and now asks people to contact them for information. It wouldn’t be a surprise if this is due to the lawsuits. If you search Progrip and/or Parietex on the internet a bunch of law firm results show up along with Medtronic web sites. There is some poor information on those sites about the difference between polyester and polypropylene.
Sorry, that probably doesn’t help much. The basic materials are essentially the same, of those three. The form is different, and I think that one or two of them might be polypropylene.
I don’t think that you will be able to find any studies that will clearly tell you which of these materials has less risk for chronic pain. Good luck.
https://www.medtronic.com/covidien/en-us/products/hernia-repair/mesh-products.html
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Here is a symposium, a virtual meeting, supposedly supported by “societies” (bottom of the main page). But if you click the Surgical Education link under Courses you might get a different impression. They are hidden but still present. How can they be directly linked to the symposium through the main web page?
“Mastering the art of Hernia Surgery”
https://www.herniau.com/events/virtual-ihs-2023/
https://www.bd.com/en-us/resource-and-education/surgical-education
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If you’ve ever seen the initial bills, the first set, for a procedure from a provider to an insurer you’ll realize that the whole process is very complex and bureaucratic. Mine were sent to me for some reason that I didn’t understand and I watched them go from 10’s (multiple 10’s, shockingly high) of thousands of dollars down to the thousands after the process completed. The first bills come through and then they are negotiated in to a form that fits the process.
As far as the medical-industrial-insurance complex don’t forget that the insurers have codes for each procedure that they will readily reimburse. Procedures that do not have a code have to be explained. The surgeon that implanted my mesh had to go before a board, of surgeon-peers if I recall correctly, to explain what he was proposing when I had mesh problems. I had forgotten about that. Actually I can’t remember clearly who exactly had to go before the board it might have been the one that removed the mesh, Dr. Billing. Often I feel like I have PSTD from that time in my life. I could probably find it in my notes but it’s probably not relevant. The approval boards do exist.
My basic point is that the high volume nature of the industry leads to it becoming very bureaucratized. Once bureaucracy takes hold then results matter much less. The process becomes the goal, not the results.