Good intentions
Forum Replies Created
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Here is the latest article from the new Special Issue. It is about “autoimmunity”, a word that describes when the body develops an autoimmune problem. The conclusion is that mesh does not appear to cause an autoimmune condition. The chronic pain and discomfort results solely from the body’s foreign body reaction to the mesh. It is a physical problem tied to the mesh. Which fits with the result that the problems disappear when the mesh is removed.
It is an interesting article that clarifies the problem, but, again, does not offer a solution or a way to prevent it. So far, the releases for the Special Issue only seem to confirm the problem.
https://link.springer.com/article/10.1007/s10029-023-02749-4
Review
Open Access
Published: 04 February 2023
Autoimmunity and hernia mesh: fact or fiction?
B. Jisova, J. Wolesky, Z. Strizova, A. de Beaux & B. East
Hernia (2023)The authors confirm the ~15% chronic pain rate –
“The use of synthetic mesh in hernia repair is well-established [1, 2]. Indeed, hernia guidelines recommend mesh in most hernias to minimise hernia recurrence. Local complications are well described clinically yet they are not quite so well understood from the histological perspective [10]. For example, it is known that approximately 10–20% of patients after inguinal hernia repair suffer from chronic pain to some degree [5, 35]. However, causes of this pain are variable and most likely linked to nerve injury rather than to mesh-related autoimmunity. To add to this confusion, many authors incorrectly mix autoimmunity and chronic foreign body reaction.
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Conclusion
Currently, there is little evidence that the use of polypropylene mesh can lead to autoimmunity. A large number of potential triggers of autoimmunity along with the genetic predisposition to autoimmune disease and the commonality of hernia, make a cause and effect difficult to unravel at present. Biomaterials cause foreign body reactions, but a chronic foreign body reaction does not indicate autoimmunity, a common misunderstanding in the literature.” -
Here is a link showing T-Line mesh. It’s funny how the product is designed to fix the problem of tension in a “tension-free” repair material. Mesh. The attempts just go on and on. 510(k).
Sorry ajm22, I’m not trying to divert away from your subject. Just filling out my comment about suture pullout and tissue strength. Good luck.
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I don’t think that being back to 100% tissue strength is necessary to get back to normal living. I am not arguing for or against anything just showing some different perspectives.
You can find quite a bit in the mesh repair literature about “burst strength”, where the surgeon/scientist is considering the mesh as prosthetic tissue. A patch over the hernia defect. In theory, the defect area is “tension-free”. But the edges of the mesh do feel tension. Otherwise there would be no need to worry about burst strength. You can also find literature about “small bites” for closing wounds, to avoid suture pullout. That was a hot topic a couple of years ago. There is even a new type of suture material called T-Line that is being promoted for its width, apparently for the benefit of avoiding suture pullout. There is discussion about using a running suture (a single filament passed through the edges of the wound to close it), as opposed to a series of separate sutures. But, like many of the many things to consider in hernia repair the final decision is left up to whatever the surgeon feels comfortable doing.
As far as healing after a suture repair, here is a good review of the healing process. It covers a wide area of healing responses, but it is well-written and understandable. It has an interesting comment about the size of the gap between the two surfaces that are expected to knit together. It made me wonder about how the two surfaces of the layers in a Shouldice procedure knit together. What is the impetus for the body to realize that the pristine surfaces are damaged? Only the edges have been cut. What parts actually form new collagen?
Anyway, it’s easy to get lost in the fine elements of what actually happens during healing of a pure tissue repair. But those fine elements might help explain why surgeons using what seems to be the same technique get different results.
The article doesn’t use the word years, but it does use months.
https://www.ncbi.nlm.nih.gov/books/NBK3938/
“Chapter 1
Overview of Wound Healing in Different Tissue Types
John D. Stroncek and W. Monty Reichert.””’
“1.4.1. Non-CNS Tissue
The first stage of tissue repair is stabilization of the discontinuity created by the injury. Traditionally, there are two broad classifications of healing. Tissue that has little to no gap separating the wound boundaries will undergo “primary healing” from the apposed edges of the tissue. Tissue that is unstable with a large gap or discontinuity injury will undergo “secondary healing,” where excess ECM is produced to secure and fill the lesion. The ECM of secondary healing, which subsequently becomes vascularized, is referred to as granulation tissue—a term arising from its appearance. In general, the amount of granulation tissue formed is proportional to the eventual level of scarring.” -
You might consider the strength of the new tissue/collagen that is holding the layers together. It takes months or years for the collagen to fully convert to the strongest form. Permanent sutures could be considered as a backup or insurance against accidental extreme exertions or increases in abdominal pressure.
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I created a new Topic about the Special Issue itself. As new papers become available I will post the links there. I included a link back to this Topic to keep the chain of information intact.
https://herniatalk.com/forums/topic/hernia-journal-special-issue-on-chronic-pain/#post-33726
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Here is a link to Hernia’s web site. They list the latest articles on the page. They also show the latest Journal that has been released. January 2023 has not been released yet.
https://www.springer.com/journal/10029
Here is a link to a Topic about the Hernia Editor’s original introduction to the project.
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The purpose of the study seemed reasonable but it’s not clear why they went to social media to gather results. As Dr. Towfigh implied, people who don’t have problems rarely talk about their surgeries on social media. Their “aim” really should have said “perspectives of patients around their hernia repair problems”.
“The aim of this study was to explore the perspectives of patients around their hernia and its management, to aid future planning of hernia services to maximise patient experience, and good outcomes for the patient.”
I’ve often thought that a good study for helping to define the hernia repair chronic pain problem would be to compare hernia surgery to other similar surgeries. Classify the surgery by type. For example, survey patients who have had laparoscopic surgery for gall bladder removal or appendectomy or prostate removal in addition to hernia repair. If all of the groups have similar chronic pain problems that might shed some light on something besides mesh. If the other groups have a very low level of problems but only lap mesh patients have the 10 – 15% chronic pain problem, that’s pretty good evidence that mesh might be involved.
It is good to see other groups exploring the problem though. Thanks for posting that article.
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It looks like the issue of Hernia dedicated to chronic pain is about to be released or has been already. Dr. Campanelli has written an introductory Editorial. It kind of fits with the times, he comes very close to using the popular word “woke”. He implies that the chronic pain problem is amplified by patients being too aware and too demanding. He even uses the word “completely” as if 20 years ago is an incomprehensible amount of time. People were “different” back then. Tougher or more ignorant maybe. A little bit disappointing in that it is a form of giving up.
So, just like many of today’s huge issues this one will continue as part of the fabric of today’s modern society.
https://link.springer.com/article/10.1007/s10029-023-02750-x
“EDITOR’S CORNER
Published: 02 February 2023
Primary inguinal hernia, postoperative chronic pain and quality of life
G. Campanelli
Hernia (2023)”“It is also true that the perception of postoperative symptoms has changed completely compared with the past: today’s “self-awareness”, prioritisation of quality of life, and “demand” for perfect results have led to a situation in which postoperative symptoms tend to be overestimated compared with before.
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Nevertheless, the possibility of postoperative pain should not be underestimated, and we should indeed strive to generate more correct data, both on surgical indications and “surgical” prevention of this pain, and on the adoption of an integrated approach to these situations.”
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They don’t say. I think that most surgeons are very short-sighted about the results of their work. It’s the nature of the profession. So much can happen to a patient after they leave and there will be so many over the course of a career, that unless they are truly interested in the long-term results of a procedure they just don’t follow up. It’s too much work and they have other patients waiting.
This is where the larger regulatory and public health institutions have a role.
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Dr. Towfigh, the paper does not say that lap is better than open. It actually ends suggesting that open is the best. But, it’s about economics.
I was actually thinking of this recently. Where are the lawsuits for Lichtenstein repairs? There don’t seem to be any.
One person who might have an objective opinion about open mesh versus laparoscopic mesh would be David Chen of the UCLA Lichtenstein Amid Hernia Clinic.
Here is a recent presentation of his that is very educational in many different ways. He sounds very confident, as we were all taught to be when giving presentations. But if you look at the numbers there is still much work to do. And he does not offer a path to reach the goals he describes. He does offer things to avoid though, like plugs. You can also derive from his presentation that if you decide to get an open repair with mesh you should probably find a well-trained Lichtenstein method surgeon. Not a 10 minutes and done plug surgeon.
Overall, he is suggesting that open mesh, lap, and robotic are all about the same. He does not promote that lap mesh as better than open. The presentation is worth watching, just for general knowledge.
It is from 2017 but not much has changed, except for more robotics.
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That is an interesting comment. It kind of implies that when the mesh is removed the tissues and hernia are all returned to the pre-implantation state.
Unfortunately that is far far from the reality. There is real tissue damage done during the implantation process and as soon as the foreign body response to the mesh begins. Despite how clean the blunt dissection of the pre-peritoneal space looks through the camera lens for TEP, or the neat peeling back of the peritoneum flap for a TAPP repair.
My lower abdomen, all of the area that was in contact with the nesh, is still stiff and distorted. It continues to get better over time, but the area is nothing like it was before the mesh implantation. Patients who have their mesh removed within months probably are closer to their original state than patients like myself who waited years. But the shrinking and stiffening occurs within weeks of implantation, as the body tries to destroy or encapsulate the mesh material.
There is no “undoing” of any of the repair methods. Many do minimal damage, like Dr. Kang seems to imply for his method. Others do intentional damage, cutting flaps and dissecting cremaster tissue, in order to effect a repair. But all of the repair surgeries do some sort of damage.
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Dr. Towfigh makes a very firm statement that “If you have mesh removal after a hernia repair with mesh, you will have a hernia recurrence. Scar tissue alone is not strong enough to keep the hernia from recurring (except in some cases related to mesh removal due to infection).”
But, as far as I’ve seen, there is no evidence supporting that statement. Just like there is no registry for mesh repairs, there is no registry or followup for mesh removal. If the statement is true then there should be as many “repair after removal” stories as there are removal stories. There might be anecdotes among friendly surgeons, but there are no studies focused on the probability of hernia recurrence after mesh removal.
Sorry Dr. Towfigh. If you have evidence please present it. It should even be presented professionally, at a SAGES or AHS conference. If what you say is true then every surgeon who removes mesh should be firmly stating to their patients that they “will have a recurrence”, so that they can plan for the future repair. Dr. Belyansky has not done this in ajm22’s case.
Besides that, what would the repair be? More mesh? If that is the only possibility then the patient has to relive the possible horror of chronic mesh pain. If the recommended repair after mesh removal is a pure tissue repair then that begs the question of why not pure tissue in the first place.
Whenever a person takes a deep dive in to what’s going on in the hernia repair field the question of “why are we using so much mesh?” keeps forming. Mesh removal is mainstream now and the lawsuits keep growing. It must feel like you’re living in an insane world.
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Don’t let one person ruin your experience on an internet forum. Whether it’s me, or Herniated, or Pinto. The internet is a strange place where it is very difficult at times to “not look”.
On other forums that I am member of there is an “Ignore” function that can be chosen that will hide all posts from certain members so that you don’t have to read them. This forum, at the moment, does not seem to have that function.
In the meantime, if we don’t like what somebody is writing we just have to put the effort in to do it ourselves and not look. There is no obligation to respond to every post.
As far as alephy’s comments, I thought that they were reasonable. There is just a difference of opinion, I think, on the inflammatory nature of the word “Nuremberg” and its association with Hitler and the Nazi’s. It might not mean as much there as it does here in the USA. A cultural difference.
Pinto made his point early on and now is just defending his opinion. But there is really no constructive path forward. The points have been made. People’s positions have been established. There’s not much value in writing more words.
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It looks like there was a settlement in the Ethicon Physiomesh case. Ethicon and Johnson & Johnson are essentially the same company.
The writer of this article brings up the fact that the cases will probably keep coming. The mesh makers have created a lifetime of employment for the law firms. They knew better but they did it anyway. Where is/was the FDA?
https://www.millerandzois.com/products-liability/hernia-mesh-case-value/kugel-hernia/
This from almost 9 months ago:
“May 2, 2022 Update: There is a global settlement in the Ethicon Physiomesh hernia repair lawsuits. There are no settlement numbers that have been released so will know know what your individual settlement amount is.
The big question is will there be more Ethicon hernia mesh lawsuits in the future? There will still be more henria mesh lawsuits involving Physiomesh because many victims have not yet had complications. There are still many people out there with a recalled mesh inside of them.”
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I think that the problem is a matter of degree. The atrocities that happened before and during WW2 that were associated with the development of the Nuremberg Code have very little to do with what Dr. Kang is doing.
There is a saying that you might have heard that mentioning Hitler in a conversation is a sure way to end the conversation.
Hitler = WW2 = Nuremberg
Herniated could have included a reference to the Hippocratic Oath. Or he could have just talked about ethics in general. He could have eased his way in to the Nuremberg Code without using it in the title. There was no good reason to use the word Nuremberg in big bold letters to begin the Topic. Anybody who says that they expected a different response is being disingenuous. Especially somebody who knows so much about the Nuremberg Code.
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This is interesting. When J&J created Ethicon it looked like a similar attempt to separate itself from hernia mesh liability. This decision will probably influence mesh litigation cases.
https://finance.yahoo.com/news/j-j-t-bankruptcy-end-165835182.html
“(Bloomberg) — Johnson & Johnson can’t use bankruptcy to resolve more than 40,000 cancer lawsuits over its baby powder, a federal appeals court ruled.
The three-judge panel in Philadelphia sided with cancer victims, who argued that J&J wrongly put its specially created unit, LTL Management, under court protection to block juries around the country from hearing the lawsuits.” -
You chose a sensational term to get attention and got what you wanted. Now you’re off on a tangent. The effort now is not really about Dr. Kang at all. You’re defending yourself instead.
The best thing to do if you really want to discuss hernia related topics is to acknowledge that and move on. Sometimes even intelligent well-meaning people make mistakes. You made a mistake.
If you want to keep the topic going apply your accusation to other areas of hernia repair. How about the use of the 510(k) approval process for the multitude of prosthetics on the market? You can spend a lot of time on it and do some actual good. Your implication that Dr. Kang is experimenting on his patients does nobody any good.
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Here’s a new summary of the mesh litigation situation. It shows how they’ve simplified things down to where the issues can be presented to the general public. Simple explanations, some probably not quite right.
It’s hard to predict how this will all play out. Comparing the mesh MDL’s to a suit like the 3M earplug suit, you can imagine that 3M will fix the flaw in their ear plugs, pay the settlements, and everyone will move on. The damage has been remedied for the plaintiffs and the bad product is removed from the market.
These mesh suits seem more complex though. People who have learned about and followed the mesh problems probably know that there is no simple “fix” that will allow the repair industry to keep using mesh without injuring more people. The 10-15% injury rate seems well-supported over many studies. One possibility is that the defendants agree to pay for more research to understand the source of the damage to the patients. Since they probably already know some of the reasons (there has to be experts that have told them) it seems possible that new products could be developed, but they will have to go through actual product testing trials instead of the inexpensive 510(k) process. What will they do in the meantime though? Maybe surgeons will do more pure tissue repairs? Create a registry to identify the truly bad products and procedures so that they can save some of the overall business from litigation? Who knows. It will probably take years though.
https://www.lawsuit-information-center.com/hernia-mesh-litigation-update.html
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It’s an interesting topic. But I think that Herniated is really stretching things to imply that Dr. Kang’s work is similar in any way to the Nazi experiments of WW2.
It would be more proper to say that it might be unethical to hold back his knowledge if he has evidence that it is better than prevailing practice. If he has a better way he should share it so that society as a whole can benefit. But, of course, in today’s world there are many that might corrupt his method, like many have done with the Bassini and Shouldice procedures. “Modified” for speed or ease or some other reason, leading to poor results from something that is not what he intended.
If you really want to see how a large professional organization can twist in the wind of ethics, read the SAGES statement about new technologies and techniques.
They end the statement with a wishy-washy acknowledgment that market forces might be competing against individual patient welfare.
“Balancing Responsibilities to Patients and Society
Finally, the cost and value of new technologies, to each of the many constituents in healthcare, must be addressed. Forces impacting health care and its delivery are increasingly important, particularly now as the US transitions to a national health care system. (30,31) At times however, a physician’s responsibility to advocate for individual patients on the one hand, and honor the responsibility to society for stewardship of finite resources on the other hand, may be competing considerations. Physicians do have responsibilities to both, as pointed out by the ACS in its “Code of Professional Conduct” and by the American Board of Internal Medicine (ABIM) in its Physician Charter on “Medical Professionalism in the New Millennium”. (32,33) To guide physicians struggling with conflicting responsibilities, the ABIM establishes the following principle: “Principle of primacy of patient welfare…Market forces, societal pressures, and administrative exigencies must not compromise this principle”.
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Was the “other issue” in the groin known before surgery or discovered during surgery? I don’t want to dig in to the details of your ordeal but it kind of confuses the overall assessment of the Shouldice experience. Did they make the situation better or worse? Could there have been better planning if they had known?
I don’t know how much you’ve disclosed to other people about who you are but, really, we’re all anonymous here. Except for the people who use their real names. Even then, not many people will find the name on a hernia discussion forum.
Your comment about the duration of living with the indirect hernia shows that you realize that your situation is not “run-of-the-mill”. The thought occurred to me that watchful waiting can have the downside of letting the body change to adapt to the hernia, especially for those with direct hernias. Newly stretched tissue. Then when it is finally repaired the body has to re-adapt or go back to its previous state. A much better selling point for hernia repair than “you could die due to a strangulated hernia”. In your case, of course, you had already been waiting since birth so no significant time-based decision to make there. But for other people maybe it matters.