news on physio mesh

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Been in on a few recurrences with this product. It has poor tissue ingrowth, the docs were able to peel it out of the hernia sac it conformed to, and lots of adhesions. You can call me a Bard guy fanning the flames all you want, but it's true. It seems your mesh is having problems.

The spear gun you sell is doing ok.
 






Anonymous said:
In response to the chemical reaction. It is not that one side chooses to break down and the other does not. Every doctor knows that. They are both going to break down. Possibly some parts faster than others. That is why it is good you haven't asked the question. It would make you look foolish. The fact comes down to serous peritoneal healing time. I have been given the whole deal about micro fractures and fibroblast infiltration, but this MOA (mechanism of action) is not the concern. It is the end result! There are too many variables within the human body that can't be replicated in labs and animals. Therefore no study for any device or medication is solidified until there is good clinical data. This means several gold standard studies. A non-funded double blinded randomized study of a large sample size that comes from multiple health care centers. The multiple health care center is important, so that you can differentiate technique error that may have played into the mechanical disfunction of any device. This is because a lot of surgeons in the same health care facilities migrate to similar techniques. Without this you are forced to sell. That is why they pay you. No single device is made for every patient. That is why many surgeons prefer to have different device options. Good luck!
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Actually, sometimes the simple question is the right question. Since you are so intelligent and us reps are dummies, explain serous peritoneal healing time and when adhesions form. The simple question that you say would make you foolish is actually a common sense question that many nerdy surgeons do not ask themselves. Adhesions can occur early after a hernia repair. The neoperitoneum forms in a week or so. So if your mesh prevents adhesions on one side, but encourages ingrowth on the other, it would seem to me there is a conflict.

The paradox that is physio-mesh.
 






3-5 days: neoperitoneum forms covering the bottom side of the mesh.

9-12 days: inflammation occurs and fibroplasts proliferate and begin integrating into any porous foreign body

Fact.
 












Not defending the mesh. Just saying good thing you didn't ask the dumb question. Yes, some reps are intelligent, but none have the education to truly understand what occurs with the mesh and what matters. They have some EI and street smarts. That is why they are reps. Those peritoneal healing times listed are not absolute. It depends on the patients comorbidities among other things. These are the things reps don't understand and medical providers do understand due to their education. It is called medicine. This is also why a lot of marketing claims are not taken seriously. The marketing claims are very one dimensional.

You are absolutely correct it is impossible to say that one side is protective and the other side has ingrowth. However, structure of the mesh leads to functional capabilities theoretically. The intuitive answer to that is only the parietal side of the mesh where adequate blood flow is available can ingrowth properly occur. The visceral side may be said to stay intact enough with micro fracture to protect from adhesions (patient dependent). This may be very hard to substantiate with human data as you would need many second looks. The major issue around adhesions and protective barriers with all meshes comes down to blood on the mesh and fixations. These both cause adhesions due to the physiological nature of tissue. Adhesions occur with all meshes irregardless of company claims, so they rarely keep a general surgeon up at night. It is fistulas and possible obstruction (followed by ischemia, necrosis, etc.) that worry surgeons most. This is an acute situation and can cause many other complications. On another note if their is a mesh failure leading to recurrence it is generally two things. First surgeons technique error often in fixation and placement. Second is the body has managed to encapsulate the mesh shrinking it reducing it from its original surface area. This is well published and the reason many surgeons have moved to macroporous mesh. The rest is really doesn't matter. Again no mesh is perfect and if you have a mesh with large enough pores it is hard to differentiate it from another mesh with similar properties. The rest comes down to the individual patient and surgeon technique. Good luck selling I do not have to.
 






Physiomesh seems to have a lot of reported adverse events on the FDA website (Manufacturer and User Facility Device Experience Database).

Not that every event is an "adverse" event, but is 81 reported events on 2011 more than normal??
 






I recently saw a PhysioMesh 2nd look and you could barely see the mesh...in a good way. The surgeon was very pleased when he saw the incorporation and lack of adhesions. I'm not a "homer" or someone who "drinks the kool-aid" Just passing along what I saw.
 












Anonymous said:
I work for Ethicon and have had great results with Physio, but that post is funny. I love these boards.
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I'm glad that you work for Ethicon, your physiomesh is shit....been suffering with the pain of something that didn't stay in my body for 8 days....the pain, the problem with not being able to have any type of sex with my husband for the last 5+ years, the problem of you not being sued because of the pain you have caused me and so many others, because of your product causing infection to me I had a FOOTBALL SIZED HOLE CONSISTING OF EVERYTHING THAT TOUCHED "YOUR" PRODUCT......GLAD YOU PEOPLE THINK THIS IS SOOOO FUNNY......
 






anonymous denise schrader said:
I'm glad that you work for Ethicon, your physiomesh is shit....been suffering with the pain of something that didn't stay in my body for 8 days....the pain, the problem with not being able to have any type of sex with my husband for the last 5+ years, the problem of you not being sued because of the pain you have caused me and so many others, because of your product causing infection to me I had a FOOTBALL SIZED HOLE CONSISTING OF EVERYTHING THAT TOUCHED "YOUR" PRODUCT......GLAD YOU PEOPLE THINK THIS IS SOOOO FUNNY......
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I hate to break it to you, but the product itself cannot cause infection. No matter what product it was, if you had an infected hernia then the only solution would have been a biologic mesh. Don't blame the product, infections happen.
 






anonymous said:
I hate to break it to you, but the product itself cannot cause infection. No matter what product it was, if you had an infected hernia then the only solution would have been a biologic mesh. Don't blame the product, infections happen.
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I want to tell you that, no I was not infected, these holes were from a BI-FEMORAL BYPASS done 8 yrs prior, no pain, swelling, or even knew they were there, JUST STUPID SURGEON WANTING TO DO THINGS QUICK by using mesh.... Is this why they took EVERYTHING THAT TOUCHED THE MESH OUT??? MY ABDOMINAL MUSCLES, BELLY BUTTON, AND ALL???? then they have URGENT RECALL OF THIS MESH, OH, YOU DIDN'T KNOW ABOUT THIS ??? MAY 25 2016????? URGENT VOLUNTARY RECALL...... HUH, MUST HAVE BEEN INFECTED..... BULLSHIT
 






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