Good intentions
Forum Replies Created
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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.”
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Unfortunately, as I read through a few more articles, I realized that the term is also used for various conspiracy theories. Many of which are especially prevalent today. So it is a difficult concept for discussion.
Anyway, the potential for conflicts of interest are real, and in many cases you can see actual conflicts.
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Here is an article from 1980 –
https://www.nejm.org/doi/full/10.1056/NEJM198010233031703
Dr. Petersen’s story, if I recall correctly, was on his business web page and the site has changed.
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I hope this is my last post here, but I keep finding more. Medtronic’s product portfolio catalog contains all of their mesh products and uses the proper words in the descriptions. Apparently, for whatever reason, the Progrip polypropylene mesh is not specified for laparoscopic procedures. Maybe it’s not flexible enough for the canula.??? Why would it be okay for open but not for laparoscopic? Either of the Progrips, polyester or polypropylene, is specified for open repair.
Anyway, it’s interesting reading. Strange also, that they call out “open inguinal mesh” but not “laparoscopic inguinal mesh”.
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I almost hate to pile on but I think that it is important to understand how these points of confusion happen. Medtronic has, apparently, reviewed what they got when they purchased Covidien and decided to leverage the “Progrip” name and concept. You can see that they even contradict some of the previous selling points of polyester, that were made in the Covidien video, that promoted polyester over polypropylene. Whatever makes the product look good.
Here is the broader view from Medtronic.
“Whether you prefer polyester or polypropylene, ProGrip™ mesh is now available in the material you require for your patients.”
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Here is one of the original Covidien videos where they describe a similar name, ProGrip™ Laparoscopic Self Fixating Mesh, as a polyester mesh substrate. It’s at 2:15 in the video.
You can see that the Progrip name is being used on different substrates. So, unless a person checks the documentation they might not know what they are working with because the supplier has changed the product but kept the name. Not all Progrip is the same.
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SN’s post actually left the polyester or polypropylene question open-ended. For whatever reason Medtronic puts the word polyester in to the name of at least one of their Progrip products on their web site but leaves the other undefined.
The Medtronic Youtube page is more specific. They are using the self-fixation material, aka Progrip, on both polypropylene and polyester mesh substrates. Unless somebody made a mistake in their video production.
My background contains some materials science so these types of questions interest me. For the record, there are many variations within the classifications of polypropylene and polyester. The word “polyester” is especially undefined. Even the polylactic acid polymer is, literally, a “polyester”. A polymer of ester bonds. The manufacturing process used to make the fibers also has a significant impact on properties.
The medical device makers know all of this. But the tradenames allow them to market the product more effectively.