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Dr. Bachman discusses more people inquiring about no mesh repairs
2) She confesses that even though she is a skilled surgeon understanding how to do a textbook tissue repair is very challenging for even the most skilled surgeon of this isn’t their speciality.
she noted when you look at the textbook diagrams they are very different from what the patients insides look like when she actually gets in there3) she also confesses-which is quite logical-that even if she was confident in doing a native tissue repair the fact she just doesn’t do many-99% are lapro mesh repairs-so it’s not her specialty and the quality of the non mesh repair will reflect that.
She said people are good at what they do the most of.
This is again one of the problems for the patient when seeking a non mesh repair-except for a few surgeons just either don’t do them, and if they do they don’t do a lot of them-which automatically reduces the quality of the repair. Not every surgery is textbook. You need to do many to see the unusual cases and no how best to repair it.
She acknowledges one of the reason the Shouldice Hospital is so proficient is Bc that’s all they do-shouldice residents have to do many (I think she said 200) surgeries and supervised surgeries of this type of repair before they can indeledntly operate.
So again a US resident has to travel to Toronto, Florida or CA or Korea to find a hospital and two surgeons who specialize in a pure tissue repair.
A big burden is placed on the patient if they want a non mesh hernia repair that they can feel confident will be successful long term.
below is the link -
28 Replies
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Well, I tried to add a reply here and they flagged me as spam!
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Nice topic by Jnomesh and all main points are there:
1. recurrence rates again and again.
– There are hundreds of studies that demonstrate that recurrence are low whatever the repair. The problem isn’t that. Problem is all complications from hernia repair and those are less acceptable to many people if they can be attributed to mesh.
– Also, whatever the repair, too much sound tissue is cut perhaps because they don’t know for sure what they are doing. Knowing what they are doing and reducing tissue cut to the least necessary is more important than counting recurrences.
– In the past they treated peptic ulcer with surgery and now they do that with medicines. Of course this is (purposefully) an extreme example, but I don’t think a patient would take surgery just because the rate of recurrence is the same. People always want (and deserve) the most physiologic and least aggressive treatment.
2. ease of doing mesh repairs saves doctors lot of time, but doesn’t help patients.
3. patients not wishing to have mesh repairs face lots of problems.
– So far one can only have high quality tissue repairs in Canada, USA, India or Korea (one center or surgeon in each country).
– It’s useless to tell a doctor you want a tissue repair. They’ll tell you go elsewhere or call you nuts (there are people who heard that).
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Well, I defer to Senator Shaheen’s direct response to the 60 minutes program by getting on the FDA to engage in more oversight:
Presumably she has full-time staff working on this issue, and they were convinced enough by 60 Minutes to engage the FDA about it. Far from to me to presume that I might have a better handle on the matter than a whole gaggle of staffers working furiously to weigh the merits of the program. Apparently they and you might differ on this score.
Suffice it for me to say that when surgeons who have repaired the pelvic mesh failures in women report that mesh is problematic, then it seems reasonable to investigate this avenue for possible causation. I am thankful for the help this present thread gave me in sorting out the 60 Minutes program. The finer details that you raise may have merit, but I don’t see them altering the importance of the 60 Minutes expose in informing the public about the potential defects in pelvic mesh.
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quote pinto:Do you disagree with that point?
And are you arguing that all the uses made of polypropylene human implantation are beyond reproach?
Yes, I do, I addressed it in my other post, above. Oversimplifying things down to a sound bite for a TV camera is not what someone knowledgeable and respected in science would do. He has moved on to his second career. Just because he published a lot of papers in one area doesn’t mean he’s an expert in another.
No, I am not. Don’t believe everything you read, or see, or hear, and don’t rely on single sources. Get many different views and see what the true picture is.
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Whatever, but Priddy is a fellow with the American Chemical Society, which I presume like with most learned societies, was a status elected by his peers for his expertise. You may not agree with his opinion but you cannot toss him out of hand for lack of chemical knowledge. Again, he expressed an opinion, an opinion recognized as an expert in chemistry. I will not piddle as to what ultimate extent his opinion counts. However his point that polypropylene is oxidatively unstable is pertinent. Do you disagree with that point? And are you arguing that all the uses made of polypropylene human implantation are beyond reproach?
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Here is a link to Dr. Priddy’s Curriculum Vitae. It’s impressive, but the 60 Minutes topic is not in his wheelhouse. Smart people tend to think that they’re smart about anything and everything.
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Dr. Priddy has no apparent experience with degradation of polymers in the human body. You can look through his Vitae and see that despite his huge number of publications, none of them are about this topic.
Expert witnesses are chosen for their ability to sway a jury, and the impressiveness of their credentials, relevant or not.. Not for their expertise. There are polymer scientists who work in the biomedical field, on these types of subjects, that could probably have offered a more trustworthy opinion. Dr. Priddy was a poor choice, except that he created a quote-worthy definitive statement, true or not. He doesn’t even realize (or maybe he does) that oxidative degradation is not the suggested cause of the mesh problem. Big picture wise, his statement is essentially irrelevant. It might be true that polypropylene is a poor choice of material but not for the reason that he stated.
Rejecting the material for the wrong reasons just allows more wrong material to be chosen, just to fail again. It’s best, in my opinion, to reject all unproven or verifiable statements, even if they support your overall position.
The counterfeit material proposal is one of those things that also distracts from determining the truth. If there’s no evidence that the original polypropylene was better then there’s no way to show that the counterfeit material was the cause.
What the program did show though, which I believe is the most important thing, is that there are dishonest morally corrupt people in high positions at these types of companies. Boston Scientific is probably no different than any of the other companies, except that they got caught.
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The issue of authoritative sources, the crux of the matter, is an important matter. Although media reports deserve our caution, 60 Minutes appears to have chosen that “engineer” wisely and appropriately–he happens to be a fellow with the American Chemical Society and a recognized trial witness for chemical matters. https://www.massdevice.com/60-minutes-report-claims-unapproved-plastic-sources-used-in-boston-scientific-pelvic-meshes/
So he would appear as a reasonable expert to speak about the chemical properties of polypropylene. His central point is that polypropylene is oxidatively unstable, a well-known fact, a point quite confirmable as I found. Chemistry, a basis of medical science, stands behind him. The issue becomes can polypropylene become malleable for implantation. He does not appear to think so. That is his opinion but quite an expert one on the matter.
You can disagree with 60 Minutes of course but I don’t think you have sufficient grounds for suggesting that this particular engineer is unqualified to speak on the matter. As I previously posted, his view about the potential of polypropylene for implantation needs confirmation, but nevertheless his expertise is quite relevant for our discussion.
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Extrapolating from a small set of data, or a very narrowly defined “fact”, to all of what’s happening today is actually a huge part of the problem, I believe. The FDA’s 510(k) process is essentially a continuous “safety” extrapolation, assuming that because something is safe in small does that it must be safe in large does. I’ve tried to think of an analogy and one that keeps coming to mind is bee stings. If you get stung by one bee, it’s usually not a big deal. 3 or 4, you’ll probably be in pain for a while but will recover. Hundreds or thousands of bee stings though and you could die, or suffer organ damage and be debilitated for life.
Polypropylene is a very inert polymer, chemically. One thing that I think often gets blended together in thinking about or discussing mesh reactions is the biochemical reaction and the physical damage reaction. Two different things. The body would normally just encapsulate a small piece of polypropylene and would be done with it. But the mesh devices are placed in physically active regions, with lots of surface area. Maybe it’s like 100 bee stings, 100 times per day. The body never “heals” in the area of the mesh and just continues to try to remove the damage, physical, biochemical, or both.
As far as the 60 minutes program, it was interesting that they chose it as a topic but they also chose interview subjects that would say the right things, for a dramatic TV show. A plastics engineer is generally not trained in polymer science or in medicine. I think that 60 minutes went for a dramatic sound bite in that interview. That type of journalism actually hurts the efforts of people trying to really understand the problem.
Even the engineer’s dramatic statement was poorly formed. Why would a plastics, or polymer, scientist even being determining what’s appropriate to place in the human body? That’s not what polymer scientists do. That should be a collaborative effort between medical doctors and materials scientists, with real data, generated from well-designed experiments, being used to make decisions.
Nothing like the current 510(k) process though, which is being used to shortcut real science for the sake of, apparently, selling new unproven medical devices.
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I wish to clarify a possible misunderstanding earlier in this thread.
Surely, Marlex is polypropylene:
https://onlinelibrary.wiley.com/doi/…nau.1930020208
http://europepmc.org/abstract/MED/3589922
So the Boston Scientific case very much involves polypropylene in one way or another.
PlasticsToday tries to make sense of this:“To make its case against Boston Scientific, 60 Minutes went so far as to make a blanket statement about how polypropylene is inappropriate to use in any type of implantable medical device. Notably, a plastics engineer was quoted to have said, ‘I can’t, in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body.'”
https://www.plasticstoday.com/medica…66860623758811
PlasticsToday clarifies and concludes:
- Polypropylene is safe to use in certain medical implants. There is evidence suggesting it is suitable in the peritoneum (e.g., hernia repair), but unsuitable in the vagina. …
- The charge against Boston Scientific is for its disputed sourcing practices ….
PlasticsToday does us service in pointing out that polypropylene, a common material in hernia mesh, has been deemed safe for that use. Vaginal mesh if found defective does not directly implicate hernia mesh, at least as far as we presently know. I am glad to have this clarification because I didn’t want to condemn hernia mesh for that sole reason. Then again, if the above quoted plastics engineer’s statement is valid, hernia mesh will become a bigger mess than it already is.
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quote drtowfigh:My personal feeling is that today’s mesh is not the same as the original mesh in their manufacturing. I believe that companies have changed the contents of mesh and no longer buy from the same manufacturer. As a result, we are seeing way more mesh-related complications that are not explained by surgical technique alone. I think the inflection point occurred somewhere in the late 90s/early 2000 when mesh companies surged in their products to market.
The 60 minutes exposé on Boston Scientific’s transvaginal mesh basically proves my point. I believe the same actions are being taken by the hernia mesh companies. I wish someone (60 minutes?) would try to prove (or disprove) my theory.
Thank you Dr. Towfigh for acknowledging that there are possibly problems with the material itself. From out here though, the broad view, looking at the forest itself, the picture seems more complex than just a batch of bad or counterfeit materials.
The transvaginal mesh situation seems to actually confirm that the device makers are responsible, in large part, for the pushing of new untested materials out to the market, for the sake of making money. The investigative work done is pretty damning, especially for Johnson & Johnson (Ethicon). I’ve included three links below.
I wish it was so easy as just a one time mistake. When I started looking in to why I had my problems I was ready to find and accept that I was one of the very few, and just move on with my life. But instead the more I look the deeper it gets.
The executives that decided what to do with TVM are the same ones that decided what to do with hernia repair mesh. And it is true that the lawyers are like scavengers, looking wherever they can for a case. But without proper regulation, that is their purpose. They are actually dong the public a service. Instead of complaining about them and fighting them the community of surgeons should be helping them, for everybody’s benefit. Except the executives who caused the problems, they should go to jail.
https://www.thedailybeast.com/the-million-dollar-deal-behind-the-vaginal-mesh-implant-mess
https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html
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There were a lot of issues. But they moved from Marlex, which is a brand of mesh made in Austin, to a cheaper dissimilar product that only had 2 of 9 components shared with Marlex.
Bad analogy alert: I equate it to moving from pure cocaine to highly contaminated crack cocaine.
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Wasn’t the main problem BS’s misuse of the mesh material (polypropylen?), ignoring the specific warning by the material producer against such medical use? A chemist noted that polypropylen is well known incapable to withstand the requirements needed for effective medical mesh. Moreover, a larger problem lie in the apparently loose FDA regulations that “rubber stamp” new devices if they are appreciably similar to devices already in the market? And finally, the FDA is probably under pressure to make speedy medical device approvals. In some cases, mesh saves lives. GoodIntentions cited this article
https://www.nytimes.com/2018/05/20/o…-approval.html
in which the doctor/author (Warraich) remarks how the US could learn from how Euro medical practice reformed its oversight system(s). Maybe that’s the way forward. -
I believe Dr Felix had laparoscopic inguinal hernia repair with mesh.
Also note that he was trained in the 1960s, where he saw the shortcomings of tissue based repairs and how patients did better from mesh repair. That’s a unique perspective that shouldn’t be discounted.
My personal feeling is that today’s mesh is not the same as the original mesh in their manufacturing. I believe that companies have changed the contents of mesh and no longer buy from the same manufacturer. As a result, we are seeing way more mesh-related complications that are not explained by surgical technique alone. I think the inflection point occurred somewhere in the late 90s/early 2000 when mesh companies surged in their products to market.
The 60 minutes exposé on Boston Scientific’s transvaginal mesh basically proves my point. I believe the same actions are being taken by the hernia mesh companies. I wish someone (60 minutes?) would try to prove (or disprove) my theory.
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Here is another of Dr. Felix’s presentations. You can see how people are pushing for laparoscopic mesh placement to be the state-of-the-art, or “gold standard” as they like to say. Apparently Dr. Felix considers himself to be a spokesperson for lap and mesh. He seems to be on a mission to make it the “gold standard”.
MIS is short for Minimally Invasive Surgery, even though much more space is invaded than for an open procedure. It’s a misnomer carried over from procedures where it actually is minimally invasive. But it’s not for hernia repair.
The presentation gives a nice short history of mesh development. 5:20 is telling, in that he describes the placement of large pieces of mesh as the goal of laparoscopic methods training today. Lap placement of large pieces of mesh is the future, and the people promoting it still focus on the level of pain, compared to other methods, but don’t talk about the difficulty of removing the pain if it occurs.
What is fascinating, from a psych perspective, is how he can be so pro-mesh and pro-lap, then a year later give a presentation describing how there is no useful data about chronic pain. He is enthusiastic about forging ahead with new unknown techniques, at the expense of the patient. He doesn’t see the correlation with the lawyers that he keeps talking about.
These two presentations are both within the last two years. You can really see the army forming. He makes a call-to-action at 11:30. Pretty amazing. He is a “believer”, he’s really selling it.
He does mention his own repair though, at the end. Apparently it was a lap repair with mesh. If you watch his first presentation you’ll see that he said that he had “almost no pain”, and that old people don’t complain (he mentions it above as a reason that younger people seem to have more pain). Who knows. One of thousands.
Anyway, this is the future. Good luck to all.
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That explains some of the inconsistency I perceived in the presentation –but doesn’t he state that pain is relatively equivalent or even less than non-mesh repairs? The latter is extraordinary given what you point out about absence of pain reporting in the non-mesh era. How can the claim be made that mesh repair is superior to non-mesh repair? Comparison cannot be made in the absence of hard data.
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quote HoleintheWall:Here is another talk that followed. Apparently there is not only nothing wrong with mesh, there is nothing wrong with anything.
Thanks for posting that. I watched it and, frankly, was embarrassed for him. What he said at 7:00, basically explained what he was doing with his presentation. He said that the data in the meta-analyses can be used to show whatever that surgeon doing the analysis wants. He cherry-picked data from the papers, sometimes showing better or worse comparisons with no number and sometimes showing pain numbers. Whatever was needed to make the point.
His overall message was that there’s nothing to worry about with “mesh”, just work on your skills. I think that any surgeon who was there probably felt like they wasted their time. It was another “mesh” defense. He even mentioned that what he was presenting could be used as “defense against those lawyers”. At about 3:10 he talks about “the lawyers”. At least he was honest about that part.
And, somehow, he didn’t even describe his own hernia repair. It was probably Shouldice. Who knows. Seriously, does anyone know how his hernia was repaired? That might be the most honest answer to his presentation.
If you search his name on the internet you’ll see that he is one of the vocal defenders of mesh, he’s a popular speaker. He really should tell people what repair method he chose.
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If you review the literature from the 1980’s (before mesh), there are no articles about post operative pain following hernia repair. That is strong evidence that when surgeons were trained for pure tissue repairs then pain was not a post operative problem.
Also if you have pain after a mesh hernia repair it can be debilitating. If you have pain after a pure tissue repair it resolves with time and it is not debilitating.
Bill Brown MD
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@ HoleintheWall, thanks for the posting. My take is that the Dr. essentially claims that post-op pain is relatively the same between methods and that mesh has less recurrence than non-mesh. However, his presentation appears flawed because of inconsistency and unclarity about his method of comparison.
Non-mesh is not consistently part of his comparisons of method, so he cannot claim that post-op pain favors no particular approach. And when non-mesh is included, he does not specify how really more or less the data favors mesh. Because the related literature is uneven about determining actual pain as he states, implying that unreliability of some pain reporting, it becomes necessary to know how he chose which research results to include, their categorizing, and ultimate matching between the surgery methods. Without such information, we cannot accept his conclusions.
Some things though we can reasonably take: he reports that less post-op pain will be reported the less pre-op pain felt and the older the patient is. Presumably such was found across the research literature regardless of methodology employed.
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Here is another talk that followed. Apparently there is not only nothing wrong with mesh, there is nothing wrong with anything.
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