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

There are 20 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.

Erika

Moscow, ID

#4224 Jun 29, 2011
I had a large Gore-tex dualmesh placed in 2002 and have had sever problems since..... can anyone tell me if this is one that has been recalled.
Jayhawk

Monument, CO

#4225 Jun 29, 2011
All Meshed Up wrote:
<quoted text>Very cool JayHawk!!! We so very rarely read about the good stuff here! The fact that what you read here at the Meshoma blog caused you to take another route for your surgery is gratifying beyond words. I am a bit choked up about it, really. I wish you the best and hope that you will continue to improve. Write again to let us know your progress. Best Wishes from another Colorado resident........
Hey, thanks for the words and I appreciate all of you voicing your concerns about mesh. Believe me, it was a hard road to take as most of my family and friends thought I was NUTS to fly out to CA on my own and have the mesh free surgery done. Most everyone was like "get the mesh! we did, we're fine!". I sleep much better knowing that I don't have that implanted in my body and I'll take my chances with this Desarda method. I''ll report back in from time to time and let you know how things are going.

Best wishes all...Hang in there.
Lisa

Denham Springs, LA

#4226 Jun 29, 2011
wow, I too have had hernia repair and abdominal wall reconstruction , In 2003 the surgeon removed a mass(endometrioma) and had to reconstruct my abdominal wall using marlex , since such time I have been in constant pain that goes from mild to severe depending on how much i move around in the day,night sweats where I awake and am soaking wet, low grade unexplained fever.. Then in 2009, I had developed a hernia and so they went back in by laproscopy and repaired it as well as two more spots that were worn thin , now I am up for another surgery because of another hernia and growth of unknown origin. I just learned about the recall and need to know how to find out what lot number they used in my surgeries to know if this could be the reason for all my symptoms and problems. If anyone knows how please let me know so I may find out before my next surgery, I guess this recall would be why the surgeon spoke of removing and replacing the mesh??? I don't know but I would like to have answers Thanks,:-)
justme

Pocatello, ID

#4227 Jun 30, 2011
Hello Everybody,

Sorry been away for a while having surgery. Last years I had emergency surgry to remove the new redesigned kuglel mesh implanted the year before,Teh kugel mesh was one of four mesh implanted...

So Last year they removed the mangled kugle mesh that had attached itself to various organs and caused multipal infections and replaced it with a bio mesh called Collamend FM ( one of the three bio mesh Davol makes and the only one not recalled to date)

Anyways a year later the collamend fm was removed as well it rolled up into a ball My blood vessel and mussles were suspose to grow through this mesh that did not happen leaving me with a gapping hole in my midline.

Still recovering at this point, I am feeling like the poster child for defective mesh.
All Meshed Up

Boulder, CO

#4228 Jun 30, 2011
Erika wrote:
I had a large Gore-tex dualmesh placed in 2002 and have had sever problems since..... can anyone tell me if this is one that has been recalled.
As with any inquiry about recalls the first question to be answered is...WHAT IS THE MANUFACTURERS NAME and WHAT PRODUCT. Get the OP report from the hospital records and go from there. What you call gore-tex is the possible material. You need more info. Good Luck and let us know.
Erika

Moscow, ID

#4229 Jun 30, 2011
All Meshed Up wrote:
<quoted text>As with any inquiry about recalls the first question to be answered is...WHAT IS THE MANUFACTURERS NAME and WHAT PRODUCT. Get the OP report from the hospital records and go from there. What you call gore-tex is the possible material. You need more info. Good Luck and let us know.
GORTEX is the company name I have the product sticker as well- on their web site however there is not a listing for this product at all. There is a new one listed as of 2009 the GORE-Tex Dualmesh Plus. That is not the one I had placed in 2002. I have been unable to get help from the surgeon or hospital- I contacted the company itself and was sent a form letter telling me i needed to look into matters as they do not list recalls for such a period? I am getting stonewalled everywhere and all I want to know is if this biomaterial is the reason for the burning, the lumps, the illness for the last 9 yrs! and if so how can i get it out of me?
Lisa

Denham Springs, LA

#4230 Jun 30, 2011
Lisa wrote:
wow, I too have had hernia repair and abdominal wall reconstruction , In 2003 the surgeon removed a mass(endometrioma) and had to reconstruct my abdominal wall using marlex , since such time I have been in constant pain that goes from mild to severe depending on how much i move around in the day,night sweats where I awake and am soaking wet, low grade unexplained fever.. Then in 2009, I had developed a hernia and so they went back in by laproscopy and repaired it as well as two more spots that were worn thin , now I am up for another surgery because of another hernia and growth of unknown origin. I just learned about the recall and need to know how to find out what lot number they used in my surgeries to know if this could be the reason for all my symptoms and problems. If anyone knows how please let me know so I may find out before my next surgery, I guess this recall would be why the surgeon spoke of removing and replacing the mesh??? I don't know but I would like to have answers Thanks,:-)
OH and if this is not a doosey, I went to the hospital where they did my surgery in 03 and got my surgical report, looked it over and there was not a lot number one in the file so I ask where the lot number was and was told "don't know, all we can say is it was Duval and we don't carry that size mesh anymore". aren't they suppose to keep that info with the file???
Steve Ambrose

Jena, LA

#4231 Jul 1, 2011
SETTLEMENTS RESULT IN $184M

This article indicates that Bard is prepared to settle! http://www.aboutlawsuits.com/kugel-hernia-mes...

C.R. Bard is prepared to pay $184 million to settle hernia repair lawsuits filed by individuals who suffered severe internal injuries that were allegedly caused by design problems with their Composix Kugel mesh products.
The company announced the charge amount expected to cover any Kugel mesh settlements in its second-quarter report, indicating that the manufacturer has reached agreements in principle with a number of law firms representing a large portion of plaintiffs who have brought a claim.

The settlement comes after only two Kugel hernia mesh trials have been presented to a jury, out of an estimated 3,000 lawsuits that have been filed in courts throughout the United States.

The first Kugel bellwether trial held in federal court, which involved a case brought by John Whittfield, ended in a defense verdict last April. While the jury in that case found that the manufacturers were negligent in the design of the Composix Kugel patch, they indicated that the plaintiff did not provide that his hernia repair problems were directly caused by or contributed by the negligent design.

However, in August 2010, a different plaintiff was awarded $1.5 million in damages for problems caused by the Kugel hernia patch. The lawsuit alleged that Christopher Thorpe suffered severe internal injuries and a sepsis infection when the hernia patch broke inside of him.

The Composix Kugel mesh settlement is expected to resolve the majority of the lawsuits filed against the company. There are about 1,300 cases in federal court that have been consolidated and centralized as part of a multidistrict litigation in the U.S. District Court for the District of Rhode Island. There are also about another 1,700 Composix Kugel patch lawsuits pending in Rhode Island Superior Court, where they have been centralized before Presiding Justice Alice B. Gibney.

The Kugel Patch contains a memory recoil ring around the perimeter of the mesh which allows the doctor to fold it during the hernia repair. It is designed to spring open once in place to lay flat. However, design defects may cause the plastic ring to break, resulting in serious internal injury.

Bard has issued three separate Kugel Patch recalls involving different sizes of their hernia mesh. The recalls were issued in December 2005, March 2006 and January 2007
Lin

AOL

#4232 Jul 1, 2011
Has anyone heaed from Bruce B.? Lately
Lin

AOL

#4233 Jul 1, 2011
has anyone heard from Bruce B LATELY?
Erika

Moscow, ID

#4234 Jul 1, 2011
Lisa wrote:
<quoted text> OH and if this is not a doosey, I went to the hospital where they did my surgery in 03 and got my surgical report, looked it over and there was not a lot number one in the file so I ask where the lot number was and was told "don't know, all we can say is it was Duval and we don't carry that size mesh anymore". aren't they suppose to keep that info with the file???
Yes they are suppose to. Ask them for a copy of the sticker. I had to order mine separate from the hospital and OR reports. Took forever!
Mr T

Los Angeles, CA

#4235 Jul 1, 2011
Looks like the kugel mesh cases may have been settled -

http://www.aboutlawsuits.com/kugel-hernia-mes...

After lawyers take their chunk looks like $30,000 for each of the 3000 plaintiffs?
Maria

Paradise, CA

#4236 Jul 1, 2011
Mr T wrote:
Looks like the kugel mesh cases may have been settled -
http://www.aboutlawsuits.com/kugel-hernia-mes...
After lawyers take their chunk looks like $30,000 for each of the 3000 plaintiffs?
No. The amounts will be settled dependent on the damages each individual has endured. Many of the claimants haven't actually had any problems but are suing simply because they have the mesh implanted; while others have almost died because of the mesh being implanted.
steven435

Aurora, MO

#4237 Jul 1, 2011
has anyone herd from ther lawyer about this settlement offer.
Debbie

Columbus, OH

#4238 Jul 2, 2011
I heard from my attorney and yes they did settle, but with my understanding they only settled with 1300 and the other 1700 is still pending but not real sure on that. My attorney said she will call me back within the month and let me know how much my settlement will be.
Maria

Chico, CA

#4239 Jul 5, 2011
Debbie wrote:
I heard from my attorney and yes they did settle, but with my understanding they only settled with 1300 and the other 1700 is still pending but not real sure on that. My attorney said she will call me back within the month and let me know how much my settlement will be.
Heard from my attorneys last week and was told they're settling 1100 cases and I should know how much within 30 days.
steven435

Aurora, MO

#4240 Jul 5, 2011
Debbie wrote:
I heard from my attorney and yes they did settle, but with my understanding they only settled with 1300 and the other 1700 is still pending but not real sure on that. My attorney said she will call me back within the month and let me know how much my settlement will be.
i spoke with my lawyer and they said this is just another delaying tacktic.next trial is still on.
All Meshed Up

Boulder, CO

#4241 Jul 5, 2011
Lin wrote:
has anyone heard from Bruce B LATELY?
I talked to him last week. Fine, other than a virus. Sorry Bruce...Hope you are better.....
Blair

Charlottetown, Canada

#4242 Jul 5, 2011
John Horn

Washington, DC

#4243 Jul 6, 2011
The problem with mesh is it can contract and ball up. That is why the Kugel patch is still a big seller because the memory ring keeps this from happening. I think the new patch is great.

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