Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8243 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.

Richard in Montrose Co

Boulder, CO

#4081 Feb 28, 2011
Jason wrote:
My hernia repair healed in six weeks and then I proceded to exercise after seven weeks making great progress. I lift weights and ride my bicycicle 15 to 20 mi. 4 to 5 days per week. Then, while repairing a license plate, sitting on a curb for 15 min. or so something changed. When I got up I experienced pain that felt like being cut with needles from the inside out. The pain is in my upper abdomen above my left leg and it feels like it is just under the layer of flesh under the skin. It is intermitant and hurts most when I stand up or walk
You may have had an adherment of some kind and tore it loose. Did you have a mesh implant and if so what kind. Get your OP report from the hospital where you had the surgery and it should have all that info. Try a cold pack every so often and hopefully that will relieve most of the pain Get to your Dr. if it continues or gets worse. If you had a Kugel Mesh implant with a PET ring you may have broken that ring as a worse case scenario. Good Luck..........rmh
Tina

Kingston, OK

#4082 Mar 4, 2011
I had a Hernia surgery in 2009 they used a PHS Mesh and now I have to run everyone out of the bathroom so I can get in there. I have frequent issues with bowel movements that I never had before. Also my stomach hurts alot where the Hernia was feels like I have to stoop over to walk.
Peggyann

Bangor, ME

#4083 Mar 5, 2011
I had hernia surgery 09/99. Thoughtout the years I felt pain upon occasion. I run and lift weights. Then, this past December, I started having cramping and dirrahea in the area of my hernia surgery. I also have lower back pain. Sometmes the pain is so bad I can't move. At first my doctor thought I had a virus. Then I had blood work and stool testing. Nothing showed. Then I had a colonoscopy. Still nothing. The pain continues and some days it does not stop. I can't run anymore. I have had to pull out of a cross country ski race (being held today). My doctor and the gastro specialist suggested we wait and see how everything pans out. I started crying. So, they talked again and yesterday I had a CT Scan, lots of blood work. Tomorrow I am doing a 24 hour urine test. I have mentioned that this might be related to the Marlex mesh in my left side. Both doctors told me no. I am going to get the records anyway. If they still can't figure this out, I will send my doctor a copy of the FDA report on the Marlex Mesh. I truly believe thie problem is the Marlex Mesh. I hope there is a doctor somewhen in New England, Vermont, who does this proceure. I live near Fletcher Allen Medical Center and Dartmouth Medical Center.
unknown

AOL

#4084 Mar 5, 2011
03/04/11. Just received this in e-mail. MED WATCH DAVOL XENMATRIX SURGICAL GRAFT: Class 1 RECALL Manufactured from June 1, 2010 through October 31,2010. RECALL: Due To Elevated ENDOTOXION Levels, can cause serious illness which can be fatal. Used for Hernias & abdominal wall repair. http://www.fda.gov/Safety/MedWatch/SafetyInfo...
Allen

Hillsboro, KS

#4085 Mar 7, 2011
Everything they make is crap!!
Posted: 07 Mar 2011 06:15 AM PST

Federal regulators say that contamination levels in some XenMatrix Surgical Grafts could lead to serious and potentially fatal injuries if used on a patient.
The FDA has classified a XenMatrix Surgical Graft recall issued in January as a Class 1 medical device recall, meaning that the agency believes there is a reasonable probability of death or serious injury for any patient implanted with a contaminated grafts.

The XenMatrix recall was first announced in a letter to customers sent on January 6 by Davol, a subsidiary of C.R. Bard, after samples of the hernia and abdominal surgical graft were found to contain endotoxins that exceed the FDA’s acceptable levels. However, the company indicates that there have been no consumer complaints regarding problems with the XenMatrix.

Davol acquired the XenMatrix in September 2009 from Brennan Medical. It is a collagen matrix patch used to treat hernias in the abdominal wall when the connective tissue has ruptured.

Endotoxins are usually gram-negative bacteria which can cause toxicity in the human body. Examples include bacterial meningitis, and meningococcal disease; which causes sepsis.

The endotoxins have been detected in several lots. The affected XenMatrix Surgical Grafts have lot numbers beginning with the following four letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ. The grafts were distributed between July 1, 2010 and October 31, 2010.

The XenMatrix is not the only surgical product that C.R. Bard and Davol have had problems with in recent years. The companies currently face about 3,000 lawsuits over their Kugel hernia patch products, which allegedly contain design defectives that caused plaintiffs to suffer severe internal injuries. A Kugel hernia mesh recall has been issued for several different models of the patch.

C.R. Bard also faces a growing number of Bard Avaulta lawsuits, involving their vaginal surgical mesh that is used to treat pelvic organ prolapse in women. Complaints allege that the Bard Avaulta system was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement. In October, the federal Bard Avaulta litigation was consolidated for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia as part of a multidistrict litigation (MDL).
Terrie

AOL

#4086 Mar 8, 2011
Allen wrote:
Everything they make is crap!!
Posted: 07 Mar 2011 06:15 AM PST
Federal regulators say that contamination levels in some XenMatrix Surgical Grafts could lead to serious and potentially fatal injuries if used on a patient.
The FDA has classified a XenMatrix Surgical Graft recall issued in January as a Class 1 medical device recall, meaning that the agency believes there is a reasonable probability of death or serious injury for any patient implanted with a contaminated grafts.
The XenMatrix recall was first announced in a letter to customers sent on January 6 by Davol, a subsidiary of C.R. Bard, after samples of the hernia and abdominal surgical graft were found to contain endotoxins that exceed the FDA’s acceptable levels. However, the company indicates that there have been no consumer complaints regarding problems with the XenMatrix.
Davol acquired the XenMatrix in September 2009 from Brennan Medical. It is a collagen matrix patch used to treat hernias in the abdominal wall when the connective tissue has ruptured.
Endotoxins are usually gram-negative bacteria which can cause toxicity in the human body. Examples include bacterial meningitis, and meningococcal disease; which causes sepsis.
The endotoxins have been detected in several lots. The affected XenMatrix Surgical Grafts have lot numbers beginning with the following four letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ. The grafts were distributed between July 1, 2010 and October 31, 2010.
The XenMatrix is not the only surgical product that C.R. Bard and Davol have had problems with in recent years. The companies currently face about 3,000 lawsuits over their Kugel hernia patch products, which allegedly contain design defectives that caused plaintiffs to suffer severe internal injuries. A Kugel hernia mesh recall has been issued for several different models of the patch.
C.R. Bard also faces a growing number of Bard Avaulta lawsuits, involving their vaginal surgical mesh that is used to treat pelvic organ prolapse in women. Complaints allege that the Bard Avaulta system was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement. In October, the federal Bard Avaulta litigation was consolidated for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia as part of a multidistrict litigation (MDL).
It sure is really scary that surgeons don't go into the real behind the scene true stories of the side effects from Women having UI Bladder surgery. Their is so many stories of Women having their lives tore up by having the prolapse surgery. I know that last year I was refered to one of our top UI surgeons for this type surgery. He was very up front with all information. I guess I was very negative about having surgery. I was given booklets on the I think their was 3 different methods of repair. He said take read them then whitin a week come back and talk more. So on next appointment, I told him I didn't want surgery. I said that I heard from other women that their was more danger to this type surgery. I had pulled up from computer about different ladies and all that went wrong after they had surgery. All dealing with the ribbon mesh. So I op out and go the other route of using Vesicare 10mg tablets. Yet even with known past failed surgeries and lifes for ever changed, these surgeons still push this type surgery.
Richard in Montrose Co

Boulder, CO

#4088 Mar 8, 2011
Chin MD wrote:
In malaysia we also use the patch but most patients succumb to liver cancer first as the patients are operated by hep b and C positive patientd legally. The scandal of the killing of thr patient in Columbia Asia hospital shocked the nation . A surgeon injected Tracium which is the same poison as that used by Swango. When asked by the police why, he claimed to have been possesed by a demon and the computer system in Columbia Asia malaysia is faulty. To add salt to the wound , the man is hapilly back operating and possibly doing the same thing in Columbia Asia hospital. The investors and the person who owns the hospital are Americans. Is this a form of racism where the life of the lady is less valuable as this is an Islamic country. why was the surgeons mandlaughter charge hushed up. This is a form of new American colonialism where the lives of those who live in Islamic countries are seen as dispensible. This is the pax Americana we fear and dread.
Although I am terribly sorry about what has happened in your country please read the pages of this blog and you will find that "Mesh-Racisim" is wide spread among christians, jews, muslims, hindu, black, red, yellow, brown and white.And there is probably a smatering of Athiests and agnostics! Please do not use this site as a geopolitical forum against the west. This forum is for the topic of mesh related products and the damage they are doing to alot of people including people in Islamic countries. Again my sincere apologies. But don't blame allof us for the few as we try not to judge a few Radical Islamists for the damage they have done to us. Peace.
Richard in Montrose Co

Boulder, CO

#4089 Mar 8, 2011
Peggyann wrote:
I had hernia surgery 09/99. Thoughtout the years I felt pain upon occasion. I run and lift weights. Then, this past December, I started having cramping and dirrahea in the area of my hernia surgery. I also have lower back pain. Sometmes the pain is so bad I can't move. At first my doctor thought I had a virus. Then I had blood work and stool testing. Nothing showed. Then I had a colonoscopy. Still nothing. The pain continues and some days it does not stop. I can't run anymore. I have had to pull out of a cross country ski race (being held today). My doctor and the gastro specialist suggested we wait and see how everything pans out. I started crying. So, they talked again and yesterday I had a CT Scan, lots of blood work. Tomorrow I am doing a 24 hour urine test. I have mentioned that this might be related to the Marlex mesh in my left side. Both doctors told me no. I am going to get the records anyway. If they still can't figure this out, I will send my doctor a copy of the FDA report on the Marlex Mesh. I truly believe thie problem is the Marlex Mesh. I hope there is a doctor somewhen in New England, Vermont, who does this proceure. I live near Fletcher Allen Medical Center and Dartmouth Medical Center.
Hello PeggyAnn.....Marlex mesh ( and I am by no means an expert but I have read quite a lot about it) "CAN" "Some Times" hold an infection for up to 5 years. You will be fine but then bladder infections and worse after a period of time. Most of the stuff I have read indicates that the Marlex will emit the infection after about 3 years. I have not read any thing to indicate the WHY of it though. And it seems that the Marlex is used most often on women for various reasons. Hope you are better soon. Best Wishes.........rmh
Mark

Peck, KS

#4090 Mar 8, 2011
Posted: 08 Mar 2011 09:20 AM PST

C.R. Bard has filed an appeal of the $1.5 million verdict returned by a Rhode Island jury in a Kugel hernia patch lawsuit, after the trial judge refused to overturn the decision or allow a new trial.
The medical device company claims that the expert witnesses used by Christopher and Laura Thorpe did not provide legally acceptable evidence linking the Composix Kugel patch with Christopher Thorpe’s injuries.

Thorpe and his wife, from North Carolina, filed a lawsuit against C.R. Bard and their Davol subsidiary claiming that a defective design caused their Composix Kugel patch to break inside of him, causing internal injuries and a sepsis infection.

The month-long trial ended in late August, with the jury siding with the Thorpes’ and awarding them $1.5 million in damages. The jury ruled that C.R. Bard and Davol designed a defective device and failed to give proper warning about the risk of Kugel hernia patch problems.

C.R. Bard filed notice of the appeal last week, taking their argument to the U.S. Court of Appeals for the First Circuit.

The case was the second Kugel hernia lawsuit to go to trial in federal court, where more than 1,300 other lawsuits are currently pending as part of an MDL, or multidistrict litigation, in the U.S. District Court for the District of Rhode Island. There are also another 1,700 Composix Kugel patch lawsuits pending in Rhode Island Superior Court, which have been centralized before Presiding Justice Alice B. Gibney.

Thorpe’s case was selected for an early trial in the federal MDL, known as a “bellwether” case, to help the parties get a sense of how juries will respond to evidence that may be similar to what will be presented in other cases. The results of the bellwether trials may lead to the settlement of Kugel hernia patch lawsuits over broken rings in other cases.

The first Kugel bellwether trial, which involved a case brought by John Whittfield, ended in a defense verdict last April. While the jury in that case found that Davol and Bard 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.
C J Brainard

Reykjavík, Iceland

#4091 Mar 11, 2011
Chin MD wrote:
In malaysia we also use the patch but most patients succumb to liver cancer first as the patients are operated by hep b and C positive patientd legally. The scandal of the killing of thr patient in Columbia Asia hospital shocked the nation . A surgeon injected Tracium which is the same poison as that used by Swango. When asked by the police why, he claimed to have been possesed by a demon and the computer system in Columbia Asia malaysia is faulty. To add salt to the wound , the man is hapilly back operating and possibly doing the same thing in Columbia Asia hospital. The investors and the person who owns the hospital are Americans. Is this a form of racism where the life of the lady is less valuable as this is an Islamic country. why was the surgeons mandlaughter charge hushed up. This is a form of new American colonialism where the lives of those who live in Islamic countries are seen as dispensible. This is the pax Americana we fear and dread.
They do the same to their fellow Americans. It's not about racism or religious persecution. It's simply about loving money more than their fellow humans.
Anonymous

Casa Grande, AZ

#4092 Mar 11, 2011
Richard in Montrose Co wrote:
<quoted text>If you google pelvic sranding and select pelvic STRANDING again to filter out pevic STANDING you will find a couple of sites. The basic item I found is that pelvic stranding or pelvic FAT stranding is a indicator of inflammation. The examples I saw were of appendesitis cases where the appendix was inflamed etc. Check it out hopefully it will answer your questions.......rmh
Thank you for checking this out. The doc said my appendix is fine. I'll keep looking.
sue henderson

Holly, MI

#4093 Mar 12, 2011
Janice Bembry wrote:
I had the Gore-Tex Dual Mesh used in a ventral hernia repair in 2004. I've had nothing but problems with it since.I've had numerous places drained after mesh got infected, been hospitalized and also had places drained under local anesthetic in doctor's office several times. I no longer see that doctor since he has relocated to another state. Now I've been to new doctor who has operated twice and I have permanent drainage after he has removed some mesh twice. He says if he operates again I may end up wearing a "bag" because some of my bowel may be caught up in the mesh that's left in me. I have to change the dressing on my abdoman at least twice a day and it has a terrible odor that I can smell all the time. If you know of anything that is being done about this, please let me know.
Sincerely,
Janice S Bembry
[email protected]
janice, i sure hope you are seeing an infectous disease doctor. right after my hernia repair i was having about one half a cup of nasty smelly drainage. the surgeon put me on keflex, it did not help, called his office several times crying. they called in two more refills of the keflex,even though i told them it was not getting better. i demanded a culture on the infection of course the doc should have done this on his own, but didn't for 2 or 3 months. it came back i had e coli and another infection and had to spend 3 days in the hospital on heavy duty antibiotics, one cost 800.00 per tablet, thank god i have insurance. it took another three month to clear it up. i layed on the sofa for 5 months on my back with 4 maxi pads across my belly to catch the drainage. so please i hope you have seen an infectious disease doctor, you have to. good luck god bless, know what you are going thru. hang in there. sue
Fred Amir

Hayward, CA

#4094 Mar 12, 2011
I wrote a few months ago to thank everyone here for sharing their stories and helping each other. I want to thank you all again.

It was your stories about mesh that made me decide against mesh for my inguinal hernia repair and it was these posts that helped me discover the work of Dr. Desarda in India. Fortunately I was able to find a good surgeon in Fresno, CA, Dr. Zafar Parvez, who was willing to do the Desarda repair on me.

I have recently updated my progress and I hope anyone who is looking for a mesh-free repair can benefit from my experience.

http://www.rapidrecovery.net/hernia.html

Thank you again and I wish you all complete recovery from pain and suffering caused by mesh and mesh salesmen masquerading as doctors.
hurt 4 ever by bard mesh

Brooklyn, NY

#4095 Mar 12, 2011
Richard in Montrose Co wrote:
Does anybody know if I might have a case against my local hospital? I have had stored in the freezer of the pathology lab the Prolene Mesh that was removed in Jan. 2008. Labeled with my name and ph.# and I called every 3 months to tell them I was still around and needed the mesh. It was destroyed 6 months ago. I just found this out Thur. morning 24 hrs after calling the lab. I was hoping on hoping it could be used in a case against Ethicon. Now it is gone. No one tried to contact me and apparently they ignored my last call.I am friggin devestated and pissed about this. But I don't know if I can go a legal route. Any suggestions? Thanx Mucho.......rmh
Call Candice McNabb at Kher Kher Williams law firm and ask her do you have a case... do not delay anyone that has had these mesh products inside of you break away and injure you!

http://www.williamskherkher.com/
Lookingforadocto r

New York, NY

#4096 Mar 14, 2011
Well my name tells the story. Im looking for the best hernia doctor for a inguinal hernia procedure.
Does anyone have good recommendations based on hard facts and personal history?
charles puterbaugh

Bullhead City, AZ

#4097 Mar 16, 2011
i had hernia repair lower gi 16 years ago with mesh to hold it as i had repair a couple years before regular hernia .2 differrnt patrs of country.when i moved back to minnesota 1995 they put mesh in .it seems to bother we alot now the pain i can/t stand in that area .i take painkillers for my bad back but when that starts hurting i/mm really hurting .it sucKS.
Richard in Montrose Co

United States

#4098 Mar 16, 2011
charles puterbaugh wrote:
i had hernia repair lower gi 16 years ago with mesh to hold it as i had repair a couple years before regular hernia .2 differrnt patrs of country.when i moved back to minnesota 1995 they put mesh in .it seems to bother we alot now the pain i can/t stand in that area .i take painkillers for my bad back but when that starts hurting i/mm really hurting .it sucKS.
Find out from your op report what mesh brand you had implanted.Is the pain sharp or dull? Does it go down your leg? Post whan you can......rmh

Since: Mar 11

Hoboken, NJ

#4099 Mar 17, 2011
deb wrote:
<quoted text>
Why don't you ask the Dr if you can have anal sex! They don't make penis mesh anyways.
That could be how you got the hernia in the first place. The anatomy is not made to have anything stuck up your butt.
Anonymous

Casa Grande, AZ

#4100 Mar 17, 2011
My primary care physician sent me to yet another surgeon last week. He agreed that I must have entrapped nerves, but said if he does any additional surgery I may be worse off than I am now. The frustration gets to be so much to handle. I am in a little less pain now but I still can't sit in a straight up position--I have to lean back in a slouched position. There are so many things I would love to do but can't. For one thing I have to lie on the bed to type on my laptop or to do research. Haw anyone just recovered with time from these issues?
dog man

Charleston, WV

#4101 Mar 18, 2011
i have had 25 hernias on my right side they put 12 lays of core tex in me the side afects iam having bad is every time i get a cold or have the flu my skin turns blood red the doctor told me every thing goes thur the gore tex and it stays lumpy in side me is there a way to counter react this core tex from doing this no doctor will talke to me about this because i had so many hernias i dont money i want relif i live in wva if someone could anwer me about this thank you.

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