Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8252 comments on the PRWeb story from Feb 4, 2007, titled Hernia Mesh Patch Recall - FDA Warns of Death and Serious Healt.... In it, PRWeb reports that:

Patients should review the latest recall information to see if they have been implanted with the recalled device and seek medical attention if symptoms such as unexplained or persistent abdominal pain, fever, ...

Join the discussion below, or Read more at PRWeb.

All Meshed Up

Boulder, CO

#6232 Jul 17, 2012
Patty Williams wrote:
<quoted text>One thing I did was go direct to a "certain manufacturer" website. I found a ton of information. For instance, I found the FDA 501K approvals. I wanted to find out what "predicate" meshes the approval was based on, but hit a brick wall when I asked the FDA what those were based on. They gave me some Freedom of Information act mumbo jumbo, and Im going to follow up with that. Im sure that I will find that the "predicate" meshes have problems as well. I found that I could cross reference other adverse events on certain meshes just by looking at the different adverse event reports which had lot numbers, not many but some did have those. I found that the manufacturer had dozens of pages of claims of the wonderful things their products would do, and a very small section on the user instructions on possible adverse events. That tells me that consumers, unless they know where to look have no way of knowing the harm that happens when these meshes are implanted. Lots of positive written materials but very hard to find anything about adverse events. Its not until people like the ones in this forum are irreparably damaged do they begin to look for information on what they we led to believe was a great product.
Unfortunately you are correct about the FDA and about what consumers don't know before it is too late. Dr.'s are not in the habit of handing over adverse reports about a product that they are suggesting to use on you. And as far as the names of meshes, Prolene mesh is known as "percentage or %" within the FDA system and J&J. You cannot tell me that this is not a way to hide or to confuse those of us that are trying to research a particular mesh product. I go back to my previous posting where I write about the absolute subterfuge that is used by the FDA when dealing with the public trying to get in depth info about certain products. It is and continues to be the FDA modus operandi. This borders on, if not crosses the line in to the criminal.
Chuck

AOL

#6233 Jul 17, 2012
I just was on this site, looking for information on Inguinal hernia for a friend. Wikipedia Innguinal Hernia Surgery en.wikipadia.org/wiki/Inguinal_hernia_surgery
n3129yy

Kankakee, IL

#6236 Jul 17, 2012
how would i get info on kugel hernia mesh my lawyer is bs me hes had my case for 6 yrs are judges every going to end this i have been so sick it is so painful having this mesh my dr said he would not remove it it would be much worse
DDD

Moscow, TN

#6237 Jul 17, 2012
I was told that lawyers are starting to close cases that have not settled because they are not offering any more money and the court is tired of this case. Was told that there are no other options. Money will go back to court and remain there until you decide to settle.
patty

Eugene, OR

#6238 Jul 17, 2012
has anyone had their mesh removed then ahd it preserved in some type of container with some type of fluid or something? Ive read the adverse event reports by the manufacturers. They said mesh was returned but not preserved. My husband is having surgery soon to remove a 15X15 piece of Ethicon Prolene. Im sure it is all hard and crumpled because when he eats its like a lap band for weight loss. he feels full after just a few bites of food. Im sure it is putting pressure on his stomach and esophagus.or whatever it is that the food gets to the stomach. Do we send it to the manufacturer or have the hospital do it? Can we take possession of it? What do we do with it? Give it to the attorney? If anyone has experience with this, please let me know.
nomeshno

Gilbert, AZ

#6240 Jul 18, 2012
All Meshed Up wrote:
<quoted text> As I stated in a previous post, Gynocological mesh in its MANY forms is an easier target and has less victims. PLEASE DEAR LADIES don't get me wrong here! What I am saying is that what is happening is the slight of hand and ignore the 300 pound gorilla. The courts can go after these cases and not the Hernia mesh because the government/manufacturers do not want the Hernia victims and there are probably 10's of thousands of us, many times more than the Gynocological mesh to be brought out. BUT! What I think may happen(don't quote me on this) is that the cases against the Gynocological mesh will then highlight ALL of the other meshes, their uses AND the victims that have been damaged by it. So just maybe, maybe with these women FINALLY getting their day in court...the rest of us may als
o. Now wouldn't that be a kick in the ass?
You may be right. Since the gyn meshes were initially made from cut pieces of the hernia meshes, then the potential to make money was huge with the babyboomer populations, so the big pharma began to make "kits" so just about any doctor can implant them. Then when complications occurred they denied and ignored the women because they were not trained to remove it or any other treatment methods. Women were advised to seek mental help, told it was in their heads. It's bad enough to endure horrendous pain but to discredit the complications, seems even worse. The meshes have ruined lives, broke up marriages, friends and family. The 510k system is the huge problem. The hernia mesh was cleared for market after it was compared to sutures(even though the sutures are removed after healing period), then the female bladder slings were cleared by comparing to the hernia meshes. Basically, no clinical trials were done and no follow ups. We were all unpaid, uninformed guinea pigs. The whole process is messed up!
Mamie

Sarasota, FL

#6241 Jul 18, 2012
patty wrote:
has anyone had their mesh removed then ahd it preserved in some type of container with some type of fluid or something? Ive read the adverse event reports by the manufacturers. They said mesh was returned but not preserved. My husband is having surgery soon to remove a 15X15 piece of Ethicon Prolene. Im sure it is all hard and crumpled because when he eats its like a lap band for weight loss. he feels full after just a few bites of food. Im sure it is putting pressure on his stomach and esophagus.or whatever it is that the food gets to the stomach. Do we send it to the manufacturer or have the hospital do it? Can we take possession of it? What do we do with it? Give it to the attorney? If anyone has experience with this, please let me know.
My attorney sent a letter to the surgeon requesting the excised mesh be preserved. The attorney instructed me to seal it in a box and keep it in the event it would be needed as evidence.
mesh removed

Gilbert, AZ

#6242 Jul 18, 2012
patty wrote:
has anyone had their mesh removed then ahd it preserved in some type of container with some type of fluid or something? Ive read the adverse event reports by the manufacturers. They said mesh was returned but not preserved. My husband is having surgery soon to remove a 15X15 piece of Ethicon Prolene. Im sure it is all hard and crumpled because when he eats its like a lap band for weight loss. he feels full after just a few bites of food. Im sure it is putting pressure on his stomach and esophagus.or whatever it is that the food gets to the stomach. Do we send it to the manufacturer or have the hospital do it? Can we take possession of it? What do we do with it? Give it to the attorney? If anyone has experience with this, please let me know.
I was told by my Attorney not to request it, after pathology dept looks at it, just have the hospital keep it in their medical records. Also make sure the explant surgeon takes pictures during the surgery and picture of the mesh. If the patient has posession of the mesh, the manufacturer may claim it could have been altered or contaminated by the patient. Most important thing to ask is to have the surgeon take pictures then ask for set of the pictures of your records. The Defendants may argue with the wording if the op report and try to say mesh was not causing the problem but when you have pictures it is harder for them argue. Most explant surgeon will dictate the process of the removal, not necessarily dictate any cause or blame the mesh. Pictures, pictures...
Will he just get a stitch repair after the mesh removal? Best wishes...
Chuck

AOL

#6243 Jul 18, 2012
This might be of help, search term Go to Patenstorm hernia mesh and methods of use
Unlucky Guy

Lissone, Italy

#6244 Jul 18, 2012
I was left disable during one of them operations, I do not reccomend it. I have nothing to add.
bob

Pompano Beach, FL

#6245 Jul 18, 2012
Any one heard of Bruce Ramshaw? If so how is he for 1st time laparoscopic inguinal hernia repair (TEP). He said that he will use lightweight mesh with only 2-3 absorbable tacks. Any suggestions?

Thanks
All Meshed Up

Boulder, CO

#6246 Jul 18, 2012
patty wrote:
has anyone had their mesh removed then ahd it preserved in some type of container with some type of fluid or something? Ive read the adverse event reports by the manufacturers. They said mesh was returned but not preserved. My husband is having surgery soon to remove a 15X15 piece of Ethicon Prolene. Im sure it is all hard and crumpled because when he eats its like a lap band for weight loss. he feels full after just a few bites of food. Im sure it is putting pressure on his stomach and esophagus.or whatever it is that the food gets to the stomach. Do we send it to the manufacturer or have the hospital do it? Can we take possession of it? What do we do with it? Give it to the attorney? If anyone has experience with this, please let me know.
My Prolene was frozen and kept at the Pathology Lab so as not to contaminate the evidence by having it in my freezer. Make sure the package is clearly marked Do Not Destroy and have your name, phone # etc. Pictures Pictures pictures with a measuring tape. Any observations by the surgeon and of course the Pathologists report. Best of Luck!
patty

Eugene, OR

#6247 Jul 18, 2012
Here is a very interesting article, all should read. it states that a Supreme court decision rules that Doctors, not drug companies are responsible for warning the patient of possible side effects of drugs, devices and so on.
anyone who is considering litigation or any new treatment should have this information.

http://www.ama-assn.org/amednews/2012/07/16/g...
patty

Eugene, OR

#6248 Jul 18, 2012
mesh removed wrote:
<quoted text>I was told by my Attorney not to request it, after pathology dept looks at it, just have the hospital keep it in their medical records. Also make sure the explant surgeon takes pictures during the surgery and picture of the mesh. If the patient has posession of the mesh, the manufacturer may claim it could have been altered or contaminated by the patient. Most important thing to ask is to have the surgeon take pictures then ask for set of the pictures of your records. The Defendants may argue with the wording if the op report and try to say mesh was not causing the problem but when you have pictures it is harder for them argue. Most explant surgeon will dictate the process of the removal, not necessarily dictate any cause or blame the mesh. Pictures, pictures...
Will he just get a stitch repair after the mesh removal? Best wishes...
Im not sure what the plan is right now. The surgeon was talking about a bio mesh. I had been looking at every single company that makes meshes for use in the FDa database, then cross referenced those with FDAZILLA adverse event reports. I could not find ONE mesh or manufacturer without adverse event reports. If only people who are planning a hernia repair knew about this, maybe they could choose the one with the least reports.
patty

Eugene, OR

#6249 Jul 18, 2012
All Meshed Up wrote:
<quoted text> My Prolene was frozen and kept at the Pathology Lab so as not to contaminate the evidence by having it in my freezer. Make sure the package is clearly marked Do Not Destroy and have your name, phone # etc. Pictures Pictures pictures with a measuring tape. Any observations by the surgeon and of course the Pathologists report. Best of Luck!
the surgery will be done at a university hospital, so Im sure there will be photos. Im requesting video of the surgery. Im going to be there, if I can be in the O.R I will! They have observation booths for students, Ill be there if I can. Ill have my mini video camera rolling and Ill use every single tool I can to get the proof we need. This will be the third surgery in 11 months, so Ill be ready this time!
patty

Eugene, OR

#6250 Jul 18, 2012
sharon wrote:
Is anyone else having problems with the parietex composite mesh? I was just on the fda website and there are alot of reports of adverse reactions. If you go to fda.gov , click on medical devices, then in the search box, type in "paritex mesh recall", then you'll see what I'm talking about. I encourage anyone who has that type of mesh, start calling your surgeon's office and get it out as soon as possible! I see my surgeon on friday, and I told her nurse today who made my surgeon aware of the recall, so hopefully I'll get the mesh out soon.
I didnt find it. What is the parietex? is it for females?
Sharon

Reno, NV

#6251 Jul 18, 2012
Has anyone else had problems with the parietex mesh patch? One of the pieces I had removed was stuck to my small intestine and when the surgeon removed the piece of mesh, it injured a small area of my small intestine. My email is sharonwitzel@ymail.com if anyone knows of surgeons in the sacramento area who removes bad mesh patches and replaces them with mesh that hasn't been recalled.

Since: Apr 12

Location hidden

#6252 Jul 18, 2012
Is there any new meshes that work? So far my husband has had the Alloderm, which lasted 10 years or so, never caused him any problems except he finally herniated after many years, no pain all those years. he could work hard and play hard. Then the "one" made from polypropylene with the 'fish oil" failed miserably, then another poly mesh. We are hoping there are some good ones made from a bio material like the Alloderm was, at least it lasted and didn't hurt like the others have. Even though it was recalled a bio is probably the best bet. But we WILL research this time. I just cannot seem to find any.
annette

Clifton Park, NY

#6253 Jul 19, 2012
I had a wire mesh put in by a proced called a lapoosropy, in 2003-04 I cannot remember my doc name or what type of mesh that it was. It has been 8yrs, ad seems like my problems have started where the surgery was performed,, can the mesh detach themselves after so many years???
mesh removed

Gilbert, AZ

#6254 Jul 19, 2012
annette wrote:
I had a wire mesh put in by a proced called a lapoosropy, in 2003-04 I cannot remember my doc name or what type of mesh that it was. It has been 8yrs, ad seems like my problems have started where the surgery was performed,, can the mesh detach themselves after so many years???
yes. Mesh can kill.

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