Degradation, infection and heat effects on polypropylene mesh

Dr. Ostergard on Degradation, infection and heat effects on polypropylene mesh
Nov 2nd, 2011 | By Jane Akre | Category: Medical News


Degraded single polypropylene fiber 1000x

Donald R. Ostergard, MD, has had a long distinguished career in urogynecology and reconstructive pelvic surgery. Retired from the field, earlier this year he published an article:

Degradation, infection and heat effects on polypropylene mesh for pelvic implantation: what was known and when it was known

Dr. Ostergard is the sort of doctor that others claim they trained with as part of the bragging rights. Here is his contact information at the University of Louisville School of Medicine. Dr. Ostergard is also the past president of the American Urogynecologic Society.

Surgical Mesh Properties Were Known When it Was Approved

Dr. Ostergard writes that many of the properties of surgical mesh were not taken into account before the marketing of mesh kits. This information was available to the Food and Drug Administration and the mesh kit manufacturers. He writes that the first polypropylene mesh kit cleared by the FDA was used in the transvaginal tape or TVT procedure to treat stress urinary incontinence.

The kit clearance was granted in 1998. Two years earlier in 1996, a woven polyester mesh kit obtained FDA approval.

Dr. Ostergard provides citations for what was known about kits implanted in women until 2003 at which time many new kits were cleared.

The information had been accumulating since the 1950s he says, and provides the documentation that was available for years and includes some of the following and more:
◾An implanted device should not incite an inflammatory or foreign body response
◾An implanted device should be chemically inert
◾An implanted device should not encourage an allergic reaction
◾An implanted device should stand up to mechanical stress
◾An implanted device should not be modified by tissue fluids
◾An implanted multifilament suture attracts bacteria 5-8 times greater rate than a monofilament suture
◾Pore size is important for tissues to incorporate with the mesh
◾As soon as mesh is implanted bacteria and host defense cells race to the mesh surface
◾Bacteria migrate alongside the synthetic fibers
◾Polypropylene mesh shrinks 30-50% after four weeks
◾Bacterial colonization was found in 33% of mesh that had been removed
◾The abdominal wall stiffens after mesh is implanted
◾Mesh surface predicts bacterial adherence – multifilament mesh has a 205% increase in surface area which may explain infections up to years after it’s implanted
◾Degradation occurs in all meshes.

http://meshmedicaldevicenewsdesk.com/removing-mesh-and-getting-healthy/dr-ostergard-on-degradation-infection-and-heat-effects-on-polypropylene-mesh/

 

OMG.

 

Yeah, he's the epitome of credibility, right?

 

Ostergard is full of shit. He's only doing this for the money and his peers all know it. The only thing this could do is scare the public, which seeing as he used to be a mesh advocate, seems hypocritical.

Polypropylene mesh is used in more than just slings and vaginal mesh. Look at hernia mesh and other specialties that used it, including CV suture for valve repairs. 40+ years of research aren't going to be impacted by the nonsensical crap he's putting out.

 

Where's the 40+ years of research showing mesh is safe? Ostergard is not the only doctor saying these things. There's over 50,000 lawsuits now all claiming the mesh eroded/cut through vaginal walls, tissues, organs, etc.

What about doctors like Dr. Raz at UCLA and Dr. Veronikis in VT who have women lining up and waiting months for complete mesh removal because most doctors only know how to put it in?

What about the FDA warnings stating complications are “not rare”, how serious and often permanent complications can be, and that there is no evidence that pelvic repairs using mesh provides any clinical benefit compared to traditional surgery?
This is part of what that FDA warning stated:
“The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.”
http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm


As for how safe mesh is for hernia and other surgeries? That's also a debate:
http://www.ktvu.com/news/news/hernia-mesh/nNN99/
http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10897890

?

 

Tick, tick, tick, tick, tick, tick, tick,....I can almost see Camille on 60 minutes, sitting between our attorneys, unable to answer the questions what did you know and when did you know it...

 

I would LOVE to see this on 60 minutes. Too bad main stream media is more worried about pissing off their sponsors than about real news or helping people.

 

I'm sure Camille would have to tone down those "flashy" shirts of his if he went on 60 minutes answering legal questions!

 

Nah. He looks fine, nothing wrong or odd about 3 collars on one shirt. Im sure Anderson Cooper would love to interview camille and talk about vagina, vaginal mesh, and crystal and rubber balls.

 

What about the 1,000's of docs who have implanted vaginal mesh and not had any SIGNIFICANT complications? Maybe a few small erosions, maybe an extrusion or 4 or 5. But when done properly, by the right doc, this procedure works, and works great. I know because I have a number of them in my territory. What about all the docs who despite the 3 years of bullshit since this all blew up, have continued to implant mesh AND NOT BEEN SUED, because their outcomes are so great?

 

Really? That's your response? That because they are still using it, it must be ok? I guess your idea of SIGNIFICANT complications and mine might differ. To me, a piece of plastic that has hardened into a wire screen like consistency, and is CONSTANTLY jabbing and cutting into nerves, tissue, organs - that's pretty significant. Not being able to have sex, or walk, or go to the bathroom normally - THAT is SIGNIFICANT. Living a life that hardly resembles your old life because you can't hardly move due to pain - is F'n SIGNIFICANT. But, who is making the call on what is significant?? How many are reporting complications, significant or not significant? Who's keeping track??

Do you know how many women go back to their implanting doctor and report a problem, and are told "it's not the mesh", and are just referred to other doctors? I don't know the number either, but I know my implanting doctor practically ran out of the room when I went back to him saying I had groin/leg pain. Doctors do not want to believe that mesh is the problem anymore than YOU do. They want to believe the BS YOU guys are selling them - so they do. They probably are afraid of being sued even though all the lawsuits I know of are against the MANUFACTURERS, NOT the doctors.

Unless the mesh is VISIBLY coming through the vaginal wall or colon, women are told it's not the mesh, and the implanting doctor does not do anything but tell them to go to a different type of doctor. Why would they report something, if they can't even acknowledge it? NOT every mesh complication involves mesh protruding through your vaginal wall (mine didn't). Sometimes, it takes YEARS before visible vaginal erosion happens, IF it happens.

And, if/when the mesh IS visibly coming out out a woman's vagina or colon?... and there's no denying it? ("yup - that's a piece of mesh hanging out of your vagina alright!") even then, they still try to act like that is not that big of a deal. Listen to yourself - a "small erosion". ?? Please. You try having something cutting it's way through YOUR private parts from the inside out - see how "small" that erosion feels! Then, they only offer a "partial removal", a little "trim" and they they try to cover the remaining mesh back up with your tissue... maybe put even MORE mesh back in. ? As IF that is going to fix anything?? It just cuts/erodes through again and again, into more areas (nerves, muscle tissues, urethras, bladders, colons) causing more and more damage, more surgeries, and HURTS like hell!!

Even if/when it IS finally acknowledged that the mesh is the problem, women are told that it's NOT possible to remove it. The implanting doctors refer them to other doctors depending on the damage done. Ultimately, many are referred to pain management clinics to live a life of narcotics and pain. There ARE some doctors who CAN remove this crap... but usually women have to figure that out on their own. You guys have every GYN, URO, UROGYN, etc., putting these torture devices IN but, there's like 5 doctors nationwide that I know of that have experience and good success rates for taking it out. Doctors that not every woman can afford to go to.

How often does the implanting doctor ever get involved again after they refer their patient elsewhere? How often do they report ANYTHING?? I think they are in denial. Just like you. So the fact that your doctors are still using it and think its fine, only makes me sad/mad. It doesn't prove anything is safe.

Look, there are 50,000+ lawsuits, and there's NO WAY only a small percentage of them are telling the truth. Even if that WERE true - what percent is "acceptable"? Especially when we are talking about fixing a NON life threatening issue? Issues that have been and CAN be fixed without mesh?? If anything, I bet there are probably a ton of women suffering still who have NO idea it's the mesh and haven't reported anything. They believe their doctors telling them it's not the mesh, and unfortunately it seems most of the doctors still believe the HYPE you are selling. And, if/when the day comes that those women actually see the mesh visibly coming thru their vaginal wall, they will probably also be told, "you're the ONLY one".

I am NOT the only one who feels this way or who's life was turned upside down due to mesh. Not by a LONG shot!!
http://tvtno.org/reality-faces-of-mesh-survivors

Regardless if you believe me or not, there is a record number of reported complications to the FDA, and the FDA warnings reported complications are “NOT Rare” (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm) as well as the enormous number of pending lawsuits (50,000+!?). THESE are the things doctors AND patients should be made aware of BEFORE hand. Not, this "oh it's perfectly safe, quick and easy!" bullshit!!

 

REALLY??? My implanting Dr told me for years, its not the mesh, its not the mesh, but kept giving me shots in my vagina, and then had to surgery for erosion, 10+ years later and several partials removals later and I still can't sit, stand, walk, do things with my family. Drs will not take me but they put it in. how can over 60,000 people in ONE COURT be having the SAME problems. I did not even know this was the cause of my problems until late 2011. Immune problems, infections, yeast inside and out, stroke, seizures, lost all my teeth, loosing my hair, no sex, pain so bad I want to kill myself but I have children, one of them was so young when I had this put in that he does not even know his real mom. Women are killing themselves, husbands are leaving, they are loosing their kids, their homes, there jobs, their ability to take care of themselves and live alone, their lives and this is all you have to say. I tell you what, you go have this stuff put in and come back and talk after you start having problems.

Also did you know that a lot of people don't know they have it. A lot don't talk about it due to the personal nature. Drs don't tell us that all of these could go wrong or that the mesh is the problem. It goes unreported in many cases. You probably know at least one person who has it. I mean look at the population of the US along, you think the amount of lawsuits is all the people I don't think so. Some have problems right away, some not until 3 or 4 years later. You stand up for a company who does not care, who knew they were doing wrong, I don't know how you sleep at night.

 

If your a sales person for any of these medical devices, kits, etc, you really don't want the truth now, do you?
Do you have children? Or for the men, do you have wives? Knowing how disabling this mesh (All Mesh) can be would certainly give me pause.
I would love to believe that you all really do care....but to be honest, I doubt any really do. Not unless it hits home.

I do believe in order to obtain the jobs you have, you must have a basic idea of biology, and how things work? If not, you shouldn't be in this field. As corrupt as it already is, you're not doing anyone a favor.
Now, back to your wife, or God forbid a daughter, niece, Mom. Would you want a surgeon with little skill, (she attended the weekend cadaver course) to implant a product that is made of the same material as a hoola-hoop? There is oil in them there mesh kits. Do you know what polypropylene does to your system? Well, it's not inert as the makers would want you to believe, no, it shrinks, it scars , it wraps itself around really important organs, like your bowel, or bladder. I had mine cutting through my urethra. The surgeon had to scrape it off my bladder, for eight hours, he tried to get that crap out. We still have no clue about the long term damage, the foreign body response, and now all the mysterious diseases we are all getting....
Because very well meaning surgeons that can implant this crap were never given the lesson on how to explant it. Not until recently have only a handful of qualified surgeons been able to remove this crap.
Now, once again, I ask you this question, look at your beautiful wife, and daughter, or whichever female has ever meant anything to you. Would you seriously want this crap in any of them, knowing they have a 40% chance of erosion, foreign body reaction, pain that is equivalent to giving birth, and having cancer. Wanting to die, but knowing that would just hurt your babies more.
Think about what your doing to women. Please try to find that place, where when you began in this business, and wanted to make a difference.
They called Dr. Ostergard a dinosaur. They tried to make him irrelevant. He's not, I wish I had access to his papers, back ten years ago, when I was brutally assaulted by a well meaning surgeon. Ostergard, knew the ramimifications of using mesh, he tried to warn everyone, he was laughed at. Not too much anymore. More enlightened surgeons get "it". But he couldn't stop that money making machine from rolling all over the U.S., and now the world.
My surgeon, She was just trying to help. She had a miracle cure for me, hey, it was the "gold standard" never mentioning what it was made of, I had the surgery. Because I trusted her. Then I trusted her while she tried unsuccessfully three more times to cut here, snip there..never removing it.
I finally found a real surgeon competent enough to remove this stuff. He likened it to removing gum from hair, or rebar from concrete. That eight hour surgery has done little for my pain, but it's out. My operative report reads like someone who has been brutally assaulted. I no longer attend soccer games, or honor assemblies. Once extremely active, I lay in bed most of the time. Occasionally going out with my trusty walker. This is the face of mesh. It's not too pretty. My kids will never have what I worked so very hard for them to have, just a normal childhood, that's all.
Now, one more time....Could you do this to someone you love? Well, sure you can, you're doing it everyday you sell this crap to a surgeon.

 

That's a subpoena for you. A subpoena for you oh and a subpoena for you as well.

 

Love when ambulance chasing lawyers troll cafepharma to inflame and incite. scumbags

 

blah, blah, blah.

Why repeat what we already know...not all surgeons are created equal. The real question is: if territory sales managers can only vouch for the surgical expertise of a small subset of clinicians (3-5), why was the product diffusion so widely distributed?

In addition to the enterprises' responsibility to compensate the end users of these products, perhaps analyses should be completed to identify the product representatives who provided oversight and support during the procedures in question. There are some significant ethical concerns associated with these individuals. Was the sale worth it? Would you have allowed your mother, sister, wife, etc undergo the procedure performed by the surgeon who you don't vouch for? Just sayin...

 

one word ....
POLYPROPYLENE
= TOXIC TO SOME, just like latex... But mesh is permanent and destroys your cells