Good intentions
Forum Replies Created
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I think that mesh is over-used and I think that the reason is corporate influence. Money over medicine. My posts are very clear on this. My experience working for large corporations probably gives me more insight in to the details of how the business world works, although the news media is full of stories of corporate influence affecting the welfare of the people that they are supposed to be serving. Guns, tobacco, self-driving cars, opioids, asbestos-containing talc, herbicides (Roundup), etc. Hernia repair mesh is part of the club now, there are large class action lawsuits in progress at this moment.
Dr. Towfigh has also suggested that mesh might be over-used in women. I have not kept up with her efforts but I suspect and have suggested that they will have little effect. Once somebody shows that mesh is over-used in one area it will give impetus to reducing its use on other areas. That will be profit lost.
There is a place for mesh in the world of hernia repair. But its over-use is a violation of the Hippocratic oath, because of the harm that is caused in trying to fix the problems that it causes. Although I think that many surgeons are ignorant of what they are doing, or don’t feel responsible, because they have no ready and reasonable alternative. Because they have been trained in the medical institutions that are being supported financially by the corporations that profit from the over-use of mesh, then joining organizations that have established mesh repair standards. They have been captured and are being used.
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Here is an interesting new paper about the effect of smoking on short-term outcomes after inguinal hernia surgery. They use ACHQC data for the study. Almost 20,000 subjects. There must be some correlations with mesh type and/or surgery method.
A focus on smoking is a start. Hopefully somebody will be brave enough some day to call out the bad mesh products. I wonder if the lawyers have thought about discovery as a way to get access to the data. Or maybe the mesh makers also, to show how their product is better than the competition’s. Assuming that mesh information is part of the information acquired. It’s easy to imagine though that all of the meshes are lumped together in to one category – mesh.
https://link.springer.com/article/10.1007/s00464-023-10055-4
Published: 12 April 2023
The effect of smoking status on inguinal hernia repair outcomes: An ACHQC analysis
Celeste G. Yergin, Delaney D. Ding, Sharon Phillips, Thomas E. Read & Mazen R. Al-Mansour
Surgical Endoscopy (2023)“Background
Smoking has been shown to negatively affect surgical outcomes, so smoking cessation prior to elective operations is often recommended. …Results
19,866 inguinal hernia repairs were included (current smokers?=?2239, former smokers?=?4064 and never smokers?=?13,563). …Conclusions
Smoking status is not associated with short-term adverse outcomes following inguinal hernia repair. Mandating smoking cessation does not appear necessary to prevent short-term adverse outcomes.” -
Here are a couple of things from Dr. Towfigh about imaging, linked below. You are in a risky spot, with your assumption that you might have a hernia. The edge of a slippery slope leading to hernia surgery. Inguinal hernia repair is not the same as umbilical repair. Don’t assume that good results for one means that you’ll have good results for the other.
Have you taken a long rest period since you first had the pain or have you continued doing your normal activities? When I had my direct hernia I could rest and recover to a pain-free condition, even to the level where I could go for training runs and do light workouts. I chose surgery in an attempt to get back to my high level of physical activity, playing soccer several times per week. I think that I would have been better off retiring soccer and just living healthily at a lower level of physical activity. Surgery is very risky.
Good luck. Be careful.
https://jamanetwork.com/journals/jamasurgery/fullarticle/1893806
Role of Imaging in the Diagnosis of Occult Hernias
Joseph Miller, MD, MS; Janice Cho, BA; Meina Joseph Michael, BS; Rola Saouaf, MD; Shirin Towfigh, MD
Author Affiliations Article Information
JAMA Surg. 2014;149(10):1077-1080. doi:10.1001/jamasurg.2014.484 -
SAGES has an interesting article about it.
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One more. Corporations really don’t care about anything except shareholder value. Their ethos is that anything that makes a profit is good and that if harm is done they will just pay the lawsuit costs.
https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/
“Facing thousands of lawsuits alleging that its talc caused cancer, J&J insists on the safety and purity of its iconic product. But internal documents examined by Reuters show that the company’s powder was sometimes tainted with carcinogenic asbestos and that J&J kept that information from regulators and the public.”
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Here is an interesting recent article about the topic.
Talc, Asbestos, and Epidemiology: Corporate Influence and Scientific Incognizance
Tran, Triet H.a; Steffen, Joan E.a; Clancy, Kate M.a,b; Bird, Tessa,c; Egilman, David S.a,d
Epidemiology 30(6):p 783-788, November 2019. | DOI: 10.1097/EDE.0000000000001091
Here is the first paragraph –
“In the early 1970s, findings of asbestos in talc, and findings of talc colocated in ovarian tumor tissue, led to public controversy.1–5 For over 40 years, talc mining and manufacturing companies attempted to obfuscate the importance of these findings by keeping exposure information behind a corporate veil and otherwise influencing medical information concerning the health effects and asbestos content of talc used in cosmetics.6–9 Control over information is a recognized method by which industries maintain sales and avoid regulation and tort liability.10–16 There are many examples when companies have concealed the presence of hazardous components in products; failed to publish study results indicating that their products presented health risks; and manipulated studies to publish false results that encouraged product use or hid side effects.10–16 For example, in 1971, Henderson et al. found talc in an ovarian cancer tissue sample and raised concerns about the relation between talc use and ovarian cancer.17 Johnson & Johnson hired Arthur Langer, a mineralogist at Mount Sinai, to reexamine the tissue.9,17 Langer confirmed the presence of talc, and also found asbestos in ovarian cancer tissue. Evidence shows that Johnson & Johnson successfully dissuaded him from publishing these findings.9”
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A recent example of the power of the lawsuit. Johnson & Johnson, owners of Ethicon, have stopped selling a product that was making them money because the lawsuits were so strong that it would be too expensive to keep the product. The story of asbestos in talc is long and complex, but it has been in the news for decades.
They’ve stopped selling the product and they’re trying to minimize their losses with a settlement agreement.
https://finance.yahoo.com/news/j-j-proposes-paying-8-220350173.html
“The lawsuits filed against J&J had alleged its talcum powder caused users to develop ovarian cancer, through use for feminine hygiene, or mesothelioma, a cancer that strikes the lungs and other organs.
The claims contributed to drop in J&J’s sales of baby powder, prompting the company to stop selling its talc-based products in 2020. Last year, J&J announced plans to cease sales of the product worldwide.”
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The notes seem to refer to a preloaded Medtronic fixation device. 30 5mm absorbable tacks are preloaded in the instrument, ready for use. The tacks are absorbable so would not show up on any imaging after a certain period of time. The surgeon could have used anything from one to 30 of them. I pasted a link below that shows many details.
Many surgeons cut and paste their post-surgery notes together, from what I’ve seen. My implantation surgeon reported 5 titanium tacks in his notes. When I talked to him afterward about how the mesh didn’t need fixation so fixation shouldn’t be the cause of my pain he rambled about using some tacks because the hernia was bigger than he thought it would be. No titanium tacks showed up in the MRI that I had done as part of the path to mesh removal.
When the mesh was removed Dr. Billing did not find any tacks.Here is a pdf file from Medtronic about the tacking device and its contents.
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The authors categorized the results. Hernia surgery would most likely be under general surgery or undifferentiated surgery. It’s not clear why you would think that expectations from hernia surgery would be different than expectations from any other surgery. They all start from the same place – patient has medical problem, sees doctor, gets referred to surgeon, expects surgery to heal them and make them whole again. Except, of course, for amputation surgery, which is actually called out in the paper.
A scoping study is basically a broad review of how widespread a certain area of interest is being studied.
This didn’t copy over very well but you can see that they created categories and assigned each individual study to a category.
Table 1. Surgical Focus of Included Literature: Number of Studies
Orthopedic surgery General surgery Obstetric surgery Cardiac surgery Neuro-surgery Urological surgery Mixed or not defined surgery Spine surgery Reconstructive surgery
6 6 3 3 1 1 8 2 1 -
Here is a short video from General Surgery News.
https://www.generalsurgerynews.com/Video/Article/05-22/Hernias-in-Women/66994
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You might find something on her Youtube channel.
https://www.youtube.com/@herniadoc
And here are some of her professional publications. Some of them are the full paper, free to view. “Occult” or “hidden” seem to be the words to use for searching. Many of them are “pay-per-view” unfortunately.
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C48&q=towfigh+occult&btnG=
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Watchful and NFG12, what do you think about the math that resulted in this conclusion? When discussing complex subjects it’s very important that the “facts” are real, and relevant to the discussion. This math seems off unless the person used weight instead of volume for the comparison. Stainless steel sutures compared to polypropylene mesh. 8 gm/cm^3 versus 0.9 gm/cm^3. About a 9 to 1 weight ratio.
Even then, it seems off. “Facts” can be twisted.
“A friend did some math and said with all the suturing—you get as much plastic with shouldice as you do with mesh.”
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The name HerniaSurge has made a new appearance. It’s been modified again, it’s now HerniaSurge Collaboration. Dr. Maarten Simons is the representative. At the end of the article the full HerniaSurge Collaboration list of members is shown. Still odd in how mysterious the group is. Who pays for their efforts?
Apparently the Collaboration has identified a specific sub-category of hernia and determined that it needs specific guidelines. The study follows the same general format as the original guidelines. It’s interesting to see how almost all of the levels of evidence are low and the recommendations are weak (by their definitions). In other words, of little real value except to show that nobody knows what’s best.
The Collaboration seems to be generally defining the world in terms of low resource and high resource. In other words, poor and rich.
The original 2018 Guidelines remain unchanged, despite promises of updates. But it is still the first reference in this paper.
https://linktr.ee/EHSguidelines
https://www.frontierspartnerships.org/articles/10.3389/jaws.2023.11195/full
ORIGINAL RESEARCH
J. Abdom. Wall Surg., 27 March 2023
https://doi.org/10.3389/jaws.2023.11195
Systematic Review and Guidelines for Management of Scrotal Inguinal Hernias
Hanh Minh Tran1*, Ian MacQueen, David Chen, Maarten Simons on behalf of HerniaSurge Collaboration“…In high resource settings, an open anterior repair is the default operation. The Lichtenstein operation is still considered the gold standard for anterior open repair (1). The endoscopic hernia repair methods have been shown to be safe and effective with acceptable low complication rates in specialized centers (5, 15, 17, 20). There is a high conversion rate when starting with an endo-laparoscopic technique, especially TEP. Low resource countries may not be able to afford the mesh and/or consider their operative settings to be sufficient for sterile standards to prevent mesh infection and its sequelae. Therefore, suture repair still remains a standard option in these settings. Teaching and training to master the Shouldice technique remains an important cornerstone for surgical management of inguinal hernias in low resource settings. …
HerniaSurge Collaboration
F. Agresta, F. Berrevoet, I. Burgmans, D. C. Chen (AHS), A. de Beaux, B. East, N. Henriksen, F. Köckerling, M. Lopez-Cano, R. Lorenz, M. Miserez, A. Montgomery, S. Morales-Conde, C. Oppong, M. Pawlak, M. Podda, D. Sanders, A. Sartori, M.P. Simons (former EHS secretary for quality), C. Stabilini (EHS secretary for Science), H. M. Tran (Australasian Hernia Society), N. van Veenendaal, M. Verdauguer, R. Wiessner.” -
Here are a couple of new updates on the Bard mesh multi-district litigation case. Interesting that they are still describing the latest case as proposing that the polypropylene itself is the cause of the problems. Medtronic just introduced a new Progrip mesh made from polypropylene.
18,000 cases in the class action. The thought is that Bard will settle this single case, and set the standard for future payouts. It kind of looks like a giant supertanker heading for the rocks. Maybe it will finally drive the mesh producers to invest in research to actually understnad cause and effect nad produce a better product. The profits are too easy with polypropylene and the 510(k) process.
“March 20, 2023 Update
As predicted, a settlement appears imminent in Stinson v. C.R. Bard, which was slated to serve as the third test case in the C.R. Bard hernia mesh MDL on May 15, 2023. The trial has been delayed without objection from the plaintiff which is a strong sign of settlement. has been delayed.Despite the denial of a summary judgment motion by the defense, allowing the case to move forward, Bard’s defense team requested a postponement, which was granted by the MDL judge two days later. It is unclear when a new trial date will be set. This delay may indicate a possible settlement in the works. We will keep you updated in this space as we learn more.
March 15, 2023 Update
The Stinson trial is locked the loaded for May 15th. Plaintiff’s lawyers fought off a motion to dismiss and C.R. Bard and Davol will face most of the claims in a lawsuit filed by a Maine man who alleged that a flawed hernia mesh product caused him pain and other complications.The suit is scheduled to be the third – we call it the fourth – bellwether trial in the multidistrict litigation, which has over 18,000 cases pending against the two companies.
Plaintiff alleges that the polypropylene used in the mesh isn’t suitable for permanent implantation and leads to complications. The judge not only allowed the plaintiff to take his design defect claim to go forward, but he is also allowing the plaintiff to claim punitive damages. The court also cleared negligence and warranty claims for trial but granted judgment for the companies on other claims.”
https://www.lawsuit-information-center.com/bard-hernia-mesh-lawsuits.html
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Some of them have strange information that seems incorrect. Almost like an AI Chatbot wrote them. This looks like information scavenged from the 80’s.
“Open Surgeries to gain popularity due to lesser complications”
https://www.gminsights.com/industry-analysis/hernia-repair-devices-market
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They see the FDA as supporting the use of mesh. Not really one of the FDA’s original purposes, promoting products.
https://www.reportsanddata.com/report-detail/hernia-mesh-market
“Mesh repair is largely acknowledged as better than basic suture repair in most countries. Tensile strength and porosity are factors that influence mesh’s weight and biocompatibility. Tensile strength is substantially lower than previously assumed, and lightweight meshes are regarded to be preferable due to their enhanced flexibility and less discomfort. According to the U.S. Food and Drug Administration (FDA), utilizing hernia mesh may enhance a patient’s results after the surgery, and recovery time may be shorter than with other therapy options.”
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Two and a half months in to 2023 and no mention at all of the updated inguinal hernia repair guidelines. It really looks like they are going to pretend that no commitments were made. If they believe that the current Guidelines are sufficient then ethics and professionalism suggest that they should just say so. Why are they hiding? Dr. Towfigh believed in them. That must be a disappointment.
This is from their LinkedIn page –
“European Hernia Society
European Hernia SocietyEuropean Hernia Society
2,088 followers2,088 followers
7mo • 7 months agoFollow
HerniaSurge #InguinalHernia updates guidelines team discussing recommendations. Publication this year!”
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What is described on that web page is essentially the Kugel patch procedure (the initial subject of the Bard class action suit). Or, it might be the Prolene Hernia System (PHS) used, which combines preperitoneal and onlay. The hole is created, the space for the mesh is cleared with a finger (typically, from what I’ve read), and the patch is pushed through the hole and allowed to spring open. If you look at the two references on the Boston Hernia page, they are about laparoscopic TAPP and TEP mesh procedures,and the “Guidelines”, not the procedure they describe. There are many Kugel and PHS references out there. Kind of disingenuous to not show any.
Here is a description of the Kugel patch method. You can see the same terminology used.
https://www.bd.com/assets/documents/pdh/initial/Kugel-TG-with-Onflex.pdf
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Actually, here is another. Somebody reported the results of a study to the FDA through the MAUDE system. Apparently the FDA just passes it through to the manufacturer. If the manufacturer says that they don’t see anything to act on, the case is closed.
The FDA is not overseeing or regulating anything. They are actually collecting market results for the manufacturers. It looks like they are doing something but the reality is that they are helping the manufacturers anticipate their legal problems.
It’s actually very strange to see what is happening.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=11617005&pc=FTL