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Mesh surgeries FDA complaints

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Yesterday, October 3rd, I along with three others had a tele conference with the FDA/CDRH over the complications that people are having with mesh surgeries. If you look back thru all of the posts here on this site, you will see for youself that there are many people who are having complications from these mesh products.

The FDA is aware of the post market complications, but have asked that everyone who is having complications regardless of how small they seem they are they should file an adverse event form with the Government. They have stated, that they feel these complications are well under reported and can not help until they feel a certain percentage is met.

I am sure that some of you here did not know that you could report your complications to the FDA here is the link www.fda.gov/medwatch as you can see these complications strike male and female alike. You have to know your rights.

Not all surgeons are willing to tell you that the mesh they implanted is the source of your problems, they will tell you that what you are experiencing is normal, give it time, they send you to pain management and keep denying that any thing is wrong for legalities. While the whole time you are suffering in pain.

As I said you have to know your rights and it is your right to file with the FDA. If you would like to continue to suffer with your complications then you can ignore this post, if you would like to hold these device manufacturers accountable for what you have been going thru then you must file the report. It is the only way to make the manufacturers and a lot of surgeons understand that what you are going thru is real and you are not crazy, these problems are real and disabling to many people.

BY filing your report, you not only help yourself but you can also help others from going thru the same ordeal as yourself.
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First Helper J_G
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Users who thank GDSM for this post: leewiz 

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replied October 7th, 2008
Experienced User
I agree that we can help others if we report the bad effects of a surgery or procedure. Thanks for the suggestion!
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replied February 4th, 2011
As I am very please with others attempting to get justice for this Hernia stuff. Hear this! This mesh was re-engineered in early 2000 or 2001. The mesh pass through FDA witrhout TESTING!. Although, I strongly suggest everyone report to the FDA Adverse Product Affects. I will relate this:The FDA and Surgeons knew of problems as soon as 2003. Futhermore, they did nothing at that time to notify the public. The head of the FDA (One of Bush's cronies)had a "Don't Test Policy"

In addition, the FDA did not advise Surgeons. Reason being; The FDA is in big trouble over this. They have been "Sand Bagging this" for at least 7 years. So if you think your get justice through them; "Think Again". I suggest you contact your Fed. Representatives, and hold their feet to the fire over this. The FDA will promise, but will not deliver. Only the Congress and Senate has the authority to investigate.

Also, know this; Surgeons have been getting complaints from at least 2004. As a victim I visited the top University Hospitals on the east coast, and found that every surgeon I saw, knew of the problem, and were very defensive. They refused to help me! One even let it slip that he "did not get mesh for his Hernia Surgery because of the problems with the mesh". He is still implanting mesh in people without warning! You will not find; a Doctor, Lawyer, Congressman, Senator, or a person with any social economic status with this mesh in them. Know that if these Surgeons loose this procedure they will lose their practice. They are not going to role over easy. They will fight this as hard as they can. Gather evidence on the surgeons in your area doing this procedure, and keep it to yourself for now. ie: compliants they have recieved, letters saying its not the mesh, etc.

I will only recommend 2 Surgeons in this country, and one in Europe. Take it from me! I was one of the Guinea Pigs getting this out. After a Five year Battle, I won. I am now recovering well, and should be 100% within the next six months. I have also been on TV in Miami warnig people. I almost died on three on separate ocasions. I was on Morphine for 2 years. I could go on. Bottom line someone implanted a TORTURE DEVICE IN ME and knew it. Money for my suffering will not make this go away. I have vowed people will be jailed. Surgeons and FDA personnel.

If you wish to join the real fight for justice Google Truth in Medicine. Ask the lady who runs the site to give you Bob's my e-mail address. If you need help in finding Surgeons who can safely remove this stuff, also contact me. There are some things you really need to know to recover. And it is not easy to recover. I am getting a victim report one per month now in my area. This is not a simple mistake by the system. This fruad is well funded, and is a Human Rights issue. As I have said; "TORTURE for PROFIT". It is very big and very evil.
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replied February 4th, 2011
Experienced User
These doctors that you recommend, are they all hernia specialist? What are their names?
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replied February 6th, 2011
I will not place the names of surgeons on this website.
You must! Google the Truth in Medicine website. Register with that website. We are collecting victim info for the Use Only to present to Congress for investigation. Then e-mail Lana Keaton, the lady who runs the website, and ask for Bob's (the fellow who is helping her)e-mail address.

Now, if you have a problem with this. I only say this! When I was suffering, I would have sold my sole to the Devil to get help. I ask God to die on a daily basis. My wife found these people and I did what they suggested. They we're the only people who had the info I needed!

As to your question, all these Surgeons are well versed in Hernia repair, and have done over 300 mesh removals for one, over and 150 for the other, and the other one actually pioneered the procedure in this country, and trains other surgeons in this. My last procedure was in Europe becuase the pieces of the mesh were located on or close to my femoral arteries. After being denied treatment here in the US. Lana got me in touch with a fellow who went there. He is now fully recovered. I am recovering well. Not many can say that from this. He is actually Vascular trained also. He didn't even sweat over my case. A case that top surgeons in this country said could not be done. Europe's healthcare is light years ahead! Cost for my surgery was, get this, under $5,000 US. Five days private room, 6 hour serious surgery, everything including much better treatment, and a very peaceful hospital. You would have thought, I was this Surgeon's only patient, a real personable fellow, very good,and very careful.

I will let Lana know you might be coming. If not, be advised. Not just any surgeon can do this, and yes I have heared of others, but I only recommend who I know have successfully done this. I will talk with you by phone for all details. I want to help you. I have helped others who are now recovering well. I can give you their e-mails for verification.

The only cost for the info, is you will join the Fight against this hideous procedure.
Good Luck! Bob.
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replied February 6th, 2011
Experienced User
Hmmmm...I went to the website you referenced but saw no names of recommended doctors. Plus, it seems, from the very quick once-over I gave the website, that you have to pay 39.95 to become a member to get help or gain access to said information. I'm already a bit suspicious. As for the doctor in Europe, I went to a doctor in Europe for my hernia repair and it turned into a botched job and dismal post-surgical care because I did not reside in the EU. I sure hope this is NOT the same doctor you are speaking of! Anyway, I'm glad things turned out well for you; but it is a disappointment for you to come here and tell people about these incredible doctors and then, in the same breath, tell people to go google and find these doctors themselves.
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replied February 6th, 2011
Sorry, haven't been on website for a while didn't know cost went up, but you don't to have to join. I understand money can be an issue. However, do wish to help you. I don't know were you went in Europe, but this is why I only recommend the surgeons who worked on me, others, and were successful. Europe, private hospital. You don't have to be member of EU. If you are not comfortable with that, there are two Surgeons in US. However, one is booked for a year. The other might take two, three months. Know, that if the mesh is near femoral area, Europe is your only choice. As I said, I can give you e-mail addresses and phone #s of patients who are doing well, from both US and Europe.

Now, go to Truth in Medicine website. Click on Mission Statement and go to the bottom. Use that e-mail address at bottom to contact Lana. Remember ask for Bob's e-mail address. I gave her a heads up. Info as to were to go cannot be put on website. As said though, still require your contact info for documentation to present to Congressman and Congress.

I know this is hard, believe me I had more disappointments than you can imagine, and being in pain, and meds does not help. First two surgeries got most of mesh, but they were not trained Vascular, and would not go near that area. I traveled to John Hopkins, Thomas Jefferson, and et al. Very disappointing! Note, that my last surgery, the surgeon said everyone had done a great job. No nerve, or muscle damage. This is why, I would need to talk by phone. It is important to know were you been, and what's been said. Try again. Also, I will not give info to those who will not join the fight. I 've done that. This is a fight for yourself and others, not just for you.

One thing you need to recover. Perseverance! Bob
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replied February 8th, 2011
HOW TO REPORT MESH EVENTS TO FDA
It seems many fo you do not want to report to FDA. Well, all I can say is thanks to people like that, many others will suffer. The evil ones ARE counting on you not to report! Very bad Karma.

For those that wish to report to FDA. First, you must get a copy of your original Surgical Report. That is all you need to report FDA Adverse Event. It has all the info you need ie. dates,kind of mesh, Surgeons name, etc.

You can get this report simply by going to the Surgeon's office and asking for it. They must give it to you its the law!

Next go to FDA website.http://www.fda.gov/. Then scrool down, and the left side you will see "Report a Problem" under that you will see " Drugs, Medical Devices...(MedWatch). click on those words. A page will come up with a button on the left side saying "BEGIN". Press it and BEGIN. And yes the FDA doesn't make this very user friendly. They are counting on you giving up! They are in big trouble for this mesh stuff. Thery have beening lying about the victim counts. Don't let them! If you are unable to do this, get someone to help you!

Also, Senator Tom Harken has written a letter to FDA asking what is going on with this stuff! I suggest you contact your Senator and have him support Mr. Harken's request.

As for those that need help. No body says you have to take anyone's advice. But, if you don't investigate every lead on were to go, or who to see. Guess what! you'll remain in pain and goofy on meds. If you wish to spend your life like that, its your choice. I went and found the Surgeons. Yes, I got the info from people, but I also checked everything out myself. I called these people for info. It wasn't just handed to me. I did what I had to do to contact them. Also, I followed every lead. No matter who told what.

Now if you want info from me! Google, Truth in Medicine go to website. YOU DON"T HAVE TO PAY! That cost is only for membership!. All you have to do is: click on Mission Statement on the left, scrool down
and use the E-mail address givin to contact Lana. She will give my e-mail address. Ask for Bob's e-mail.

And know this, you will not get well unless you fighjt with everything you have. I almost died three times. I fought with everything I had for 4 years. I won! I just helped a 69 year man with this. He is more of a fighter than I am. He is right now getting well.
Yes, I have heard from more than one about Peterson in Vegas. I have not meet any of his patients. Therefore, I cannot recommend him. He might good, I don't know. But, if you don't have the cash, he is not a big option. I known Surgeons who take insurance. The Surgeon in Europe is under the World Health Organization, and has written a paper on this, you can read it. He is the only one , I know who can deal with the Femoral Arterial area, if the mesh is located there. And the cost is obtainable about $5,000 US.
Bob
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replied May 8th, 2012
Everyone should report their adverse events to the FDA; it's very important. However, the FDA won't take any action, and that is not a solution to anyone's health issues. People on this message board need to exchange info about doctors and meshes and how to get help.
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