Good intentions
Forum Replies Created
-
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.” -
Thank you for the very detailed post. That’s a shame that Dr. Grishkan has failed you so dramatically. The glowing info on the internet makes you wonder if there is any way at all to know for sure if a surgeon is competent. Your story makes one wonder if Dr. Grishkan is losing his facilities. Front office people often bend procedures to keep the practice running smoothly. I think that sometimes the physician is unaware of what’s really going on. But in your case Dr. Grishkan just seemed to drop the ball. His web page reads like somebody focused on high volume.
Good luck. Be careful and try to accept any healing that seems to be happening. Don’t think, or believe if someone tells you, that more surgeries will quickly get you to where you want to be. The one difference that I noticed between Dr. Billing, who removed the mesh inside me, and the surgeon who implanted it, was that Dr. Billing told me to “take it easy” after surgery, especially when I told him how much better I felt after mesh removal. Let things heal. As opposed to the implant surgeon who told me I was free to do whatever I wanted to do after just 21 days.
-
Adding a recent thread from somebody who had a repair from Dr. Brown. The practice is run by Dr. Richard Nguyen now.
https://herniatalk.com/forums/topic/no-mesh-hernia-surgery-with-dr-brown/#post-33038
-
I hope you don’t mind my adding a few things to your Topic G. It would be great to find that Dr. Brown’s methods had been fully transitioned to a new surgeon though.
Here is a separate web page about Dr. Nguyen. He seems to be from the weight loss world, like Dr. Billing (who removed the mesh I had).
https://lifetimesurgical.com/dr-nguyen/
Another page from Dr. Nguyen’s new practice, the sportshernia web site. It looks promising but it’s hard to tell if these are his thoughts or just left over from the old web site, although Dr. Nguyen’s name is there. It’s promising. I think that he should be on anyone’s “no-mesh” list for a consultation.
https://www.sportshernia.com/sports-hernia-approach/sports-hernia-options-operation/
“There are two different surgical procedures used to treat sports hernias. One is the open operation. The other is a laparoscopic procedure with mesh. Both can yield excellent results. Dr. Nguyen prefers the open operation.
During the laparoscopic operation, it is difficult to see all the nerves and tendons. Thus some damage may be missed and not treated. The laparoscopic procedure also involves placing a large piece of plastic mesh to reinforce the lower abdominal wall; the muscles are not repaired only patched; the mesh can potentially cause problems from shear stresses and nerve damage and shrinkage. The mesh is tough to remove if it becomes a problem.”
-
Thanks for the follow-up G. It’s good to know that it is possible to have a good hernia repair. There must still be surgeons out there like Dr. Brown. They just need to be sought out.
I wonder if the surgeon who took over Dr. Brown’s practice uses Dr. Brown’s methods. It doesn’t seem like he would. The web site is very confusing, with new material seeming to contradict old material. Laparoscopic and robotic methods depend on the use of mesh.
“About the Doctor
Dr. Richard Nguyen is a board certified General Surgeon and is fellowship trained in Minimally Invasive and Bariatric Surgery from Vanderbilt University. He has helped to pioneer single incision laparoscopic procedures as well as being da Vinci Robot Certified. He currently trains other surgeons in both of these fields, contributing to the further innovation of surgical techniques. Dr. Nguyen has been practicing in San Jose since 2007 and a surgeon since 2001, working with the most cutting-edge techniques available.”https://www.sportshernia.com/why-not-mesh/
“None of the current meshes are compatible with the body. Because of this, chronic pain is a significant problem. If the benefits of mesh greatly outweighed the difficulties of mesh, then it might make sense to use mesh. But that is not the case! When you compare the results of a sports hernia repair with and without mesh in athletes, the long term results are much better without mesh. None of the Sports Hernia Experts use mesh. Also, when you compare the results of inguinal hernia repairs in young men, the results are better without mesh. In all other groups of patients, non-mesh hernia repairs have less pain than mesh hernia repairs.
Please do not let your surgeon use mesh.”
-
So that looks like one of the modified Shouldice methods that have been discussed in other threads on the forum. I am not familiar with all of the ins and outs of the variations like others are. Vicryl is an absorbable suture material. Prolene is polypropylene.
The runaround that you’re getting is very typical for all types of medical procedures today, unfortunately. Surgeons and specialists are becoming more like workers on a factory assembly line. They do their little part then move the product down the line. Sorry, this does not help your situation but it might give you incentive to search for 2nd, 3rd, and 4th opinions.
Not all doctors are bureaucratic. Some are very independent and passionate about their work. Keep searching. Good luck.
-
It doesn’t sound like you went to the Shouldice Hospital. Can you give details on the “method”? The materials used, how many layers, the type of hernia that was repaired, etc. The more details the better.
No offense, but by the post you are just a person who had a repair that the surgeon called “Shouldice method”. Not really clear where you started or what you had done. There is hope, I’m still getting better almost 5 years after mesh removal. The body can take a long time but it will just keep trying. Healing can be slow.
-
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/
-
Finally, the true owners of the product.
-
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 “
-
The company that sells it, Insightra, has apparently been bought by a medical devices company.
-
It’s already for sale in the USA and India.
https://www.insightra.com/wp-content/uploads/2019/01/PROFLOR_patient_info-1.pdf
-
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.
-
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.”
-
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.
-
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/
-
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.
-
-
Here are a couple more links from the site.