Good intentions
Forum Replies Created
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Hello Katherine. Here is a video that you might get some value from watching. I’ve included the link to a Topic I just created. I wish that it was more positive but the reality is that it seems to show that you are at even more risk than a man, in choosing to have a hernia repaired. But, conversely, maybe you can contact the presenter and get some good advice. Good luck.
https://herniatalk.com/forums/topic/gender-specific-hernia-repair/
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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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Hello William. My point was that the problems have been clearly identified but no action is being taken to remove them. The bad products are still for sale all over the world. Dr. Pauli explains how the bad products got in to the market, through the 510(k) program, then describes how it will be harder to introduce new products. In sum, the bad products will remain and product development will be hindered. The horse is out of the barn, they closed the door, and they’re happy to let the bad horses run free, making everybody money, from implantation to pain clinics to explantation.
But no attempt to prevent the problems by removing the bad products or procedures. Lots of talk, the same things repeated over and over, very supposedly conscientious, but no actions taken. Nobody is brave enough to criticize an actual mesh product and push for its removal from the market. The most direct that I’ve seen is “plugs are evil” from a Dr. Novitsky tweet in response to a Dr. Towfigh tweet about a plug removal and all of the damage that the plug caused. Plugs are still being promoted, markets being developed, in foreign countries.
The large organizations like SAGES are more focused on fostering tech entrepreneurs. It’s all very commercial and corporate. Like it’s all a popular cable TV show. Better faster technology to implant the bad mesh products faster and more profitably.
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Their conclusion statement illustrates the dilemma that the surgeons have. If they inform the patients fully of the risks, more patients will refuse the surgery.
The mesh repair industry is in the big bind that they are in now because they have not been informing patients (or surgeons) of the potential for long-term problems from the available mesh products. They have to make the sale, and sales are made with positive words. It’s one of the major downsides of the free market. Hiding flaws sells more product.
This statement, below, is one of those that really doesn’t make sense when you try to break it down. It implies that shifting responsibility for the decision to take on the risk of long-term pain is a better “outcome”. Make it the patient’s problem, not the doctor’s. The pain and recurrence rates will be the same.
From the Conclusion –
“may help moderate post-operative expectations to optimize the outcome of common inguinal hernia repairs.”
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Here is a video discussion that Dr. Towfigh had with Dr. Muschaweck. Her focus is on the groin, both sportsman hernias (athletic pubalgia) and inguinal hernias. But her specialty is athletes. If she does not have a solution she probably knows somebody in Europe who does.
If you’ve already seen the top surgeon in Romania and you have problems then you will need to broaden your search and try to learn on your own. One problem in having a well-known surgeon is that they have a reputation to worry about, and, often, like many smart people, they might have problems accepting that what they did did not give good results. This forum and internet sites around the world have stories of top surgeons avoiding their former patients when they have problems. It’s just the way things are. My surgeon was chair of surgery at a large clinic and was even recommended on this forum. He did his best to get me to move along to someone else, or to just to accept my fate of a degraded life. Luckily I found a surgeon who was able to help me, after a long and tedious search.
Good luck and don’t give up hope. The big names might not be the ones who can help you.
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I think that recovery probably depends on the type of hernia, the type of mesh used, the type of repair, the length of time since the mesh implantation, and the activities that the patient engages in.
One of the huge problems in understanding the current situation is that even the professionals, who have been dealing with the problem for decades, tend to oversimplify things down to “mesh” (used to describe all types of mesh). “open” (used to describe Lichtenstein, Kugel, PHS, etc.), and “laparoscopic” (used to describe TEP, TAPP, and all variations of those two broad acronyms). And today they have a new word, “robotic”. Which is really just another form of TAPP laparoscopic.
Anyway, here is a Topic I started a short while ago. I am at almost 5 years since removal.
https://herniatalk.com/forums/topic/healing-from-mesh-removal-surgery/
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No offense intended Jack2021, but the article reminds me a lot of the Omega-3 fish oil coated hernia mesh that is the subject of one or more lawsuits. Material that passes through the stomach acid and enzymes of the digestive tract is not the same when it reaches the blood stream.
Anyway, if somebody does some trials and shows a true effect that would be interesting. But at this time, really, it’s just another supplement. The supplement market is huge and a big money maker. Like the hernia repair mesh market.
It is interesting to compare it to the biologic “meshes” like Ovitex. Ovitex is essentially collagen in sheet form.
Here is a link to the Guardian article. It works in UK or US I think.
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Here are a couple more links from the site.
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Tightness and loss of flexibility is common around mesh implantations. And, apparently, incisional hernias are difficult to repair. The recurrence rate is higher than for inguinal hernias.
If you can get your medical records, and if necessary, translate them to English, it migth be worthwhile to contact Dr. Meyers at the Vincera Institute. He is well-known for working on runners, among other athletes. He offers a free consultation, but is expensive, as I understand things. But he might have some ideas.
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Dr. van Veenendaal presented at the EHS Manchester meeting on “Recommendations of hernia surge update on CPIP”. The publication in Hernia looks like the official document. “Herniasurge” seems to be some sort of phantom organization now. Professionals are referring to “Herniasurge” but there is no way to find out who or what, exactly, the thing is today. It seems to exist only as a memory of the group that created the “Guidelines”.
The only mention of “Herniasurge” in the paper referred to in the first post is a single reference back to the 2018 Guidelines publication. Edit – actually I see that Dr. Veenendaal split the word in to two in the paper. Even the author does not know what it is.
https://herniatalk.com/forums/topic/european-hernia-society-manchester-2022/
Even the use of “hernia surge” as two separate words is odd. Where is it? What is it? How does a person contact them? Who is leading them?
“CHRONIC PAIN IN INGUINAL HERNIA SURGERY: MDT Main Auditorium
Moderator: Maciej Pawlak, UK, Diego Cuccurollo, Italy
MDT approach to diagnosing and treatment CPIP
Maciej Pawlak, UK
MDT treatment of CPIP in the US
David Chen, USA
Persistent Pain cycle; why we need to focus on patient’s ideas and concerns
Matthew Lund, UK
Non-surgical treatment of CPIP
Eske Kvanner Aasvang, Denmark
Recommendations of hernia surge update on CPIP
Nadine Van Veenendaal, Netherlands
When all else fails is it ACNES?
Rudi Roumen, Netherlands” -
Here is some of Dr. van Veenendaal’s previous work. He did not report a conflict in the latest paper above, even though he is still referring to and supporting the Guidelines that he reported a conflict for below. Ethically, they still seem very well tied together.
https://link.springer.com/article/10.1007/s10029-018-1729-9
“Summary for patients: International guidelines for groin hernia management
N. van Veenendaal, M. P. Simons & H. J. Bonjer
Hernia volume 22, pages167–168 (2018)”“Ethics declarations
Conflict of interest
N van Veenendaal and M.P. Simons report grants for meeting expenses related to the submitted work from Johnson & Johnson and Bard, during the conduct of the study. H.J. Bonjer declares conflict of interest not directly related to the submitted work by receiving grants from Johnson & Johnson, Medtronic, Olympus, Applied Medical and Stryker; and by receiving personal fees from Medtronic, Olympus and Cook and reports grants for meeting expenses related to the submitted work from Johnson & Johnson and Bard, during the conduct of the study.” -
Chuck had a bilateral repair. I had a bilateral repair. The trend today is for all laparoscopic repairs to be bilateral.
But unilateral versus bilateral is a minor issue. You’ve been on the forum for quite a while. You must be reading the posts.
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It would have been interesting to see how Dr. Pawlak’s views were received at the conference. Herniasurge on one side, promoting mesh, others expressing solid counterpoints.
Here is their final paragraph –
“Guidelines – friend or foe? Guidelines that conform to current development standards should be our friend. There seems to be a fear among many herniologists that guidelines set a standard of care. And deviation from them will thus become ammunition for patients and their lawyers to trip us up. This is a view that is very wrong, both for what guidelines are for and what they mean. We end this editorial with the words of John Kinsella, recently retired Chair of the Scottish Intercollegiate Guidelines Network (SIGN). “In the era of realistic medicine, SIGN guidelines should be the starting point for decision-making at the clinician-patient interface, and should inform the joint decision, not dictate a particular course of action.”[21]”
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I don’t remember anything specific to Mark T’s comment but I did post something in the past about Dr. Pawlak and his views on Guidelines. He was on the presentation list at the Manchester conference.
The Manchester conference seems primed to drive change but Dr. Pawlak’s editorial shows why what the Herniasurge group manufactured is so powerful. They have defined an artificial “standard of care” that perpetuates the use of mesh for hernia repair. I think that that is why they get so much support from companies like Medtronic. If I was an executive at Medtronic I would be all-in on helping the Herniasurge group get heir message out. Full funding, whatever they need.
Here is my old Topic. I will pull out the Editorial in the post after this.
https://herniatalk.com/forums/topic/dr-m-pawlak-a-new-surgeon-worth-following-and-hoping-for/
And the Topic about the Manchester conference.
https://herniatalk.com/forums/topic/european-hernia-society-manchester-2022/
Dr. M. Pawlak – a new surgeon worth following (and hoping for)
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The study is incomplete but Ethicon has no problem pulling out anything that helps sell the product. The study started in 2007, it’s 2022, and they use one year as the evidence for their statements. The statement itself is vague, what is “baseline”? Just marketing stuff.
https://www.jnjmedtech.com/en-US/product/ultrapro-mesh-ethicon
“ULTRAPRO® Macroporous Partially Absorbable Mesh offers strength with reduced foreign body mass1,5 and may reduce the risk of patient complications compared with mircroporous mesh.2,6 In a study of patients from the International Mesh Hernia Registry (IHMR), patients demonstrated low rates of intra- and postoperative complications, such as seromas, and recurrence (<1%) after 1 year.2-4,7-12 In the same study, patients reported improvement in pain and movement limitations from baseline at 1 year postsurgery.2,3,7,8 ULTRAPRO Mesh withstands more than 2x the maximum abdominal pressure in healthy adults.13,14”