Hernia Mesh Patch Recall - FDA Warns of Death and Serious Healt...

This story was first on AOL. Study Finds; MDs not always HONEST with Patients.

doctors better be scared they put a medical device in thousands and didnt even check if it past all the testings ect

the doc will thump on ur belly and say your good to go

Left a message for Erin Brokovich. What the Hell? You never know, folks!

Read this today :
What's the best way to cut down on medical mistakes? If you're thinking "improve safety and learn from previous mistakes," then you don't have what it takes to be a doctor these days.

No, here's their idea of boosting safety: Change the definition of "mistake" so it doesn't include your own screw-up -- and whatever you do, don't report it... don't investigate it... and don't take steps to make sure it never happens again.

There. Except for the dead patient, it's like it never happened.

Believe it or not, that's not some wild exaggeration -- that's the picture of American hospitals painted by a damning new report from our own government.

The Department of Health and Human Services says six out of seven medical mistakes are never reported, as required under Medicare rules -- in many cases because these mistakes happen so often that doctors and nurses don't even think of them as mistakes!

Injuries, infections, wrong meds, overdoses, bedsores, patient mix-ups -- you name it, it's happening... and it's happening thousands of times a day.

That's why doctors and nurses are REQUIRED to report them... that's why hospitals are REQUIRED to keep a record on them.

But according to the new report, only a fraction of those mistakes are reported -- and only a fraction of those ever lead to changes in policy or practice designed to prevent the mistake from happening again.

That's why 130,000 patients are hurt -- and 15,000 people are KILLED -- by medical screw-ups every single month.

And that's why it's going to keep happening.

Want to know what's really scary here? Those are just the numbers for Medicare patients. Throw in everyone else, and who knows how high the real numbers are -- but it's clear your life is on the line every time you set foot in a hospital.

I have read countless pages on this post and I am left confused and worried. I am eventually most likely going to need a repair, but the amount of horror stories has me more content to deal with moderate daily pain then risk chronic intense pain. All I have seen on this forum are negative outcomes, does anybody have a success story or a Dr. to recommend who did things right the first time? Is mesh strictly a no-go or does it depend?

I see alot of recommendations here and elsewhere for Grischkan (among others such as the guy at Penn), yet his site states it uses gore-tex mesh (which he claims is not associated with chronic pain post-op like nylon meshes, yet this site has several users with opinions to the contrary).

I think there is alot of good information on this forum, but no real solution for first timers looking for guidance. I figured I would see if anybody can help me out, because at this point all I have taken away from these posts is that mesh is a one way ticket to chronic pain, nerve entrapment, tissue compromise, etc. Tension approaches binding fascia together apparently have mixed results as well. Biomesh using pigskin was mentioned a few times as positive results, but I would assume since many people didn't experience issues for several years and this appears to be a new product, that the long-term effects of this also are yet to be seen.

Seeking Guidance,

There is no single result here for everybody. If your hernia is recent then maybe "watchful waiting"
is the right choice for you.
If you have had any bowel problems then you risk strangulation if the hernia is left alone. I am going in Weds for another mesh implant for a recurrent incisional hernia and umbilical hernia. Not real happy but my bulge has grown dramatically in 8 weeks since the recalled mesh I had was removed, after pieces broke off. I live in fear of more adhesions which result in irritable bowel syndrome which require surgery to cut the filmy scar tissue, or I risk strangulated bowels - which is deadly.
So my take home is your need to separate "The Cause" of the FDA and medical device science and "The "Cause" of taking care of your health problems. You need to remain a alive to create change in the less than credible health system, but 1000's do not have adverse affects from mesh - even years later.
Who ever can create a simple mesh reaction test will get a Noble Prize. Insert some in your abdomnen and check various white blood cells - like an allergy test. If the reaction is there try another material,

Anyway - good luck George

Seeking guidance wrote:

I have read countless pages on this post and I am left confused and worried. I am eventually most likely going to need a repair, but the amount of horror stories has me more content to deal with moderate daily pain then risk chronic intense pain. All I have seen on this forum are negative outcomes, does anybody have a success story or a Dr. to recommend who did things right the first time? Is mesh strictly a no-go or does it depend?
I see alot of recommendations here and elsewhere for Grischkan (among others such as the guy at Penn), yet his site states it uses gore-tex mesh (which he claims is not associated with chronic pain post-op like nylon meshes, yet this site has several users with opinions to the contrary).
I think there is alot of good information on this forum, but no real solution for first timers looking for guidance. I figured I would see if anybody can help me out, because at this point all I have taken away from these posts is that mesh is a one way ticket to chronic pain, nerve entrapment, tissue compromise, etc. Tension approaches binding fascia together apparently have mixed results as well. Biomesh using pigskin was mentioned a few times as positive results, but I would assume since many people didn't experience issues for several years and this appears to be a new product, that the long-term effects of this also are yet to be seen.

Check out Dr. Kevin Peterson in Las Vegas. I have just recently contacted him myself and am hoping to send him a recent CT for eval. He is an Anti-mesh Dr.. He also works out payment plans and "no insurance" situations. So far so good.

Just me wrote:

Read this today :
What's the best way to cut down on medical mistakes? If you're thinking "improve safety and learn from previous mistakes," then you don't have what it takes to be a doctor these days.
No, here's their idea of boosting safety: Change the definition of "mistake" so it doesn't include your own screw-up -- and whatever you do, don't report it... don't investigate it... and don't take steps to make sure it never happens again.
There. Except for the dead patient, it's like it never happened.
Believe it or not, that's not some wild exaggeration -- that's the picture of American hospitals painted by a damning new report from our own government.
The Department of Health and Human Services says six out of seven medical mistakes are never reported, as required under Medicare rules -- in many cases because these mistakes happen so often that doctors and nurses don't even think of them as mistakes!
Injuries, infections, wrong meds, overdoses, bedsores, patient mix-ups -- you name it, it's happening... and it's happening thousands of times a day.
That's why doctors and nurses are REQUIRED to report them... that's why hospitals are REQUIRED to keep a record on them.
But according to the new report, only a fraction of those mistakes are reported -- and only a fraction of those ever lead to changes in policy or practice designed to prevent the mistake from happening again.
That's why 130,000 patients are hurt -- and 15,000 people are KILLED -- by medical screw-ups every single month.
And that's why it's going to keep happening.
Want to know what's really scary here? Those are just the numbers for Medicare patients. Throw in everyone else, and who knows how high the real numbers are -- but it's clear your life is on the line every time you set foot in a hospital.

Well stated! Did you know that everyone of us that had a mesh failure are supposed to have been reported to the FDA by the Dr. and/or the hospital? I wonder how many of those reports were sent? Inquiring minds want to know? Its the same old tune.....The FDA doesn't do anything with our Adverse Reaction reports, the Dr.'s don't report it and the Hospitals obviously is not reporting it....SO WHO IN THEIR RIGHT MIND WOULD BELIEVE THAT THESE FOLKS ARE NOT COVERING THEIR OWN ASSES? And if the FDA isn't doing their job then someone is getting very rich by NOT following the law. At least that is the way I see it. I'm not paranoid I KNOW they are out to get me. Till then lets raise a little hell, call your Senators, Congressmen, Call your hospital and see if your mesh failure was reported and if not why! Ask your Dr.! Why the heck not? If these people were supposed to do this....lets find out if they did! And get a copy...... ;>)

All Meshed Up wrote:

Left a message for Erin Brokovich. What the Hell? You never know, folks!

Oh that is wonderful new! Hope something comes of it!!!

djbds wrote:

"It is easier to find men who will volunteer to die, than to find those who are willing to endure pain with patience."
~Julius Caesar
Take a few minutes...check out my petition...help me make some BIG CHANGES around here!! Every revolution starts with a small spark.
http://www.change.org/petitions/fda-and-us-su...

Is your petition complete?? I will gladly sign your petition if it is in its final form and locked. I read your petition and I think it sounds good. Did you have a legal person read it???

I was shocked to see so few signature since this is a pretty big forum. What is wrong with the rest of the people on this forum. At the risk of making people dislike me ...I have to say We are all on here telling our stories and asking for help and info. Well here is an opportunity to not only help someone else but really it is about helping all of you...and every other person who has had medical devices implanted in them or considering it in the future...including the surgical mesh! Let's rally together here....Believe me it is the only way any of us will ever be able to make a difference and to safeguard those who may follow in our footsteps as we try to repair our own mind and bodies.

By the way are any of you on facebook...do you have a facebook page? On twitter? If not I would suggest sign up for both of them. A good way to get a cause supported. Send some tweets with a link to your petition. I have already been putting info out there as to the dangers of the surgical mesh.

Amy S wrote:

I to had hernia surgery in may of 1998. since then I have terrible bowel problems, blood in my stool, quite often and sometimes alot. severe pain in the spot of my hernia and burning.it is a gore-tex dualmesh. I think the fda should look into a recall on this brand.. if anyone knows anything please e-mail me at, aseeley2000@yahoo.com thank-you

what patch is it???

Anyone at all had the Atrium CQVR patch??? Contact me here and I will give you the name if a good attorney who is handeling my husbands case.

Mocha wrote:

I had a triple hernia repair on December 6, 2011. Two weeks after discharge I started having severe pain with nausea and vomiting. I went to the hospital and got my medical (operative report)to get the vendors name and other information. The operative report only gave the name SURGIPRO but no other information.
I went back to the surgeon that performed the surgery and she told me that I was fine. I've made an appointment with another surgeon because I am not ok. I have pain, nausea, vomiting, nerve pain and my stomach swollen. I look like i'm about 5 months pregnant with additional swelling that looks like a big knot.
I've been searching for a recall on the DAD website but could only find recall for a certain lot number. I pray that everyone complaining will also file a complaint with the FDA so that they could do a recall on this product.
I will update you all after I see the second surgeon. Good luck to all of you I will keep you all in my prayers...

Demand a copy of the name, manufacturer and lot number and report it here, see how many other people have had the same trouble with that same thing.

Jim wrote:

Anyone have any insight on Atrium Medical? Apparently they are using an all natural Omega 3 Fatty acid on their mesh. Seems like a good idea...

yes!!! My husband had it, it failed miserably just about killed him our life as we knew it is over. If you know anyone who had it please contact me at raidrz06@yahoo.com

bebe10 wrote:

<quoted text>
Hi there....you need to get your surgery records and it will be noted in the records the type and size of the mesh that was use. Good luck.

when you get your report if it was an Atrium CQVR please email me, raidrz06@yahoo.com

Christine wrote:

Can anyone Please tell me how you no what classification you are in? Just pure disgusted with all this!!! This whole surgery has destroyed my life, had 4 hernia repairs the last 1 in July to fix 2 and remove the mesh, and when I tell you nothing but issues!!! Drain tubes, infections, needles put in stomach to take out fluids from the 2 pockets, losing everything but the shirt off my back, lawyer said special master and defends are reveiwing cases now? So who knows how much longer.........PLEASE any help would GREATLY be appreciated, And I wish all of yous BEST WISHES and hopefully a Happy Heathier Future

what was the name of the one you had put in first?

All Meshed Up wrote:

Left a message for Erin Brokovich. What the Hell? You never know, folks!

I'm all for that. Tell her to call me...I have a story, pics, video.

All Meshed Up wrote:

Left a message for Erin Brokovich. What the Hell? You never know, folks!

I think Erin would be great. We need to get the word out that even if you don't present with signs of infection, you could be filled with it. I have pictures, videos, hospital surgical reports from the mesh removal from which my husband is now recovering. 8 months of pure hell!! We finally found our answer and it only presented itself with pain.

Patty wrote:

<quoted text> yes!!! My husband had it, it failed miserably just about killed him our life as we knew it is over. If you know anyone who had it please contact me at raidrz06@yahoo.com

My husband also had the Atrium mesh.
After countless doctors visits and refusal to remove it from
the surgeon that put it in, we went to UT Southwestern in Dallas with the diagnosis of "Abdominal Nerve Pain Syndrome"...yeah right.
Our next day we were at Scott and White hospital in Temple, Texas.
First doctor we saw diagnosed it as a Mesh problem, who immediatley refered us to their surgical department. Within 10 minutes we were sitting in front of a surgeon that finally read the actual scan from the computer and diagnosed the same: Mesh!!
One week later the mesh was removed and reports sent to the FDA. Thanks to Dr. Justin Regner at Scott and White we are now hopeful to resume our life as we knew it before Mesh! It was replaced with a biomedical mesh which will disolve in two months. Some inflammation pain remains but seems to be handled with Motrin and Tramadol.

abouttoraisehell wrote:

<quoted text>My husband also had the Atrium mesh.
After countless doctors visits and refusal to remove it from
the surgeon that put it in, we went to UT Southwestern in Dallas with the diagnosis of "Abdominal Nerve Pain Syndrome"...yeah right.
Our next day we were at Scott and White hospital in Temple, Texas.
First doctor we saw diagnosed it as a Mesh problem, who immediatley refered us to their surgical department. Within 10 minutes we were sitting in front of a surgeon that finally read the actual scan from the computer and diagnosed the same: Mesh!!
One week later the mesh was removed and reports sent to the FDA. Thanks to Dr. Justin Regner at Scott and White we are now hopeful to resume our life as we knew it before Mesh! It was replaced with a biomedical mesh which will disolve in two months. Some inflammation pain remains but seems to be handled with Motrin and Tramadol.

Who sent the reports to the FDA? And can you get copies of what was sent? Did you report your problem to the FDA through their Adverse Reaction site? If not, please do! If you do have copies and/or replies please let me know @ rm.howden@hotmail.com Greatly appreciate it!