Good intentions
Forum Replies Created
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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
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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.”