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.

Don Williams

Eugene, OR

#5447 Feb 23, 2012
well the C-QUR patch dissolved and shrank in me within days I got a bad infection from this patch I had to have it removed and additional surgery to repair damage from Atrium C-QUR mesh this mesh is not a good product and needs to needs to be recalled asap I have spoken to many people who have had same results and my doctor and other doctors have pulled it from there supply and are not using it anymore !!! people are suffering all across the United States from this mesh . if you are having same result please respond to my email raidrz07@yahoo.com Ty for this forum and God bless you all .

Since: Feb 12

Brainerd, MN

#5448 Feb 24, 2012
I've been reading posts related to mesh complications for almost a week and Topix website seems to be the most active. I've decided to join in your discussions as I have been having problems since undergoing surgery 28 Nov 2011.

I have been a firefighter since 1983 and have had a fair-share of being knocked off my feet with an injury a time or two as all of us have. After nearly three months post-operation, the pain issues, inclusive of a couple weeks away from being most likely terminated from my job, has me very worried.

Prior to surgery, the urologist discussed a possibility of incorporating mesh if needed, but the hernia was very large and installed both plug and mesh. Pain levels are a constant 2-3, with sharp daily stings at 6-7, and have incurred 10 level five times in the last two months. Pain transpires during no-stress physical activities: In early Jan, I woke up from a deep sleep screaming from two sharp level 10 pain strikes. In discussion with the surgeon, he indicated that my body is rejecting the mesh.

I've maintained a daily log of issues since 15 Dec, the time-frame when I was SUPPOSE to return to duty. I have an appt for a second opinion on Monday, but it's going to be too late as FMLA runs out at the end of this month. I do have councel, and once the medical reports are received I'll post product information on this discussion board, inclusive of submitting a report to the FDA.

Since: Feb 12

Nairobi, Kenya

#5449 Feb 24, 2012
Connectkenya - Travelling to kenya and need some guidance visit www.connectkenya.info for more information find a place to stay
Blair

Montague, Canada

#5451 Feb 24, 2012
These are real story's and you all have read their posts on Topix. So many years have gone by and still no results. To many lives changed for ever!

Jimmy

Bethlehem, PA

#5452 Feb 24, 2012
Mesh is a necessary evil. If a surgeon does not use it, you have a unacceptable high rate of recurrence (repeat surgery to fix the problem). If they do, and should, there are risk of complications. This information should be informed to each patient. There are 600,000 hernias repaired a year. This is one of the most common operations. When statistics is factored in, the incident of complications is still relativley low. Clinicians/Surgeons need to take responsibilities in proper technique, proper prosthetic, proper patient selection based off their experience level.

As far as meshes are concerned, it would be nice to have a voice in mesh selection rather than trusting in a surgeon's lack of understanding the differences. However, the way health care is headed I am sure the least expensive mesh with no clinical data will win.
Brenda

Ypsilanti, MI

#5453 Feb 24, 2012
tammy wrote:
@Brenda, hope good comes from you're doing this. What products (brand) of mesh does Ethicon make? Best of luck to u girl, blessed be!
Hi Tammy,
Thank you and I also hope something good comes from this. I had a Ethicon Prolene Mesh. Ethicon is part of Johnson & Johnson, so I am sure they make more than I know of. Good Health to all.
Brenda

Ypsilanti, MI

#5454 Feb 24, 2012
I just received a e-mail from Suzanne Henry from @ consumer.org , reminding me to visit my local congressman's office and remind him how I feel about what is going on with the FDA and congress voting on how the FDA makes decisions on medical devices. So Please if you can stop in voice your opinion. Some times face to face is better. If we bombard our local congress they can't continue to ignore us. This is America and I am tired of money speaks. Now it's my turn. I guess you could say I have a little pitbull in me. Once I get a hold of something I will not let go.
I don't mean to sound preachy but it is time to stand up and be counted. I am writing and e-mailing everyone I can find, even my local news stations. Sending to their health reporters. I will find someone to report this on the airways. It is taking a long time, but I will keep working. I wish you all Good Health.
steven435

Montreal, MO

#5455 Feb 24, 2012
Brenda wrote:
I just received a e-mail from Suzanne Henry from @ consumer.org , reminding me to visit my local congressman's office and remind him how I feel about what is going on with the FDA and congress voting on how the FDA makes decisions on medical devices. So Please if you can stop in voice your opinion. Some times face to face is better. If we bombard our local congress they can't continue to ignore us. This is America and I am tired of money speaks. Now it's my turn. I guess you could say I have a little pitbull in me. Once I get a hold of something I will not let go.
I don't mean to sound preachy but it is time to stand up and be counted. I am writing and e-mailing everyone I can find, even my local news stations. Sending to their health reporters. I will find someone to report this on the airways. It is taking a long itime, but I will keep working. I wish you all Good Health.
i agree ,i contact brian ross and abc news tow or three times a week.if we all did so maybee they will pay attention?
patricia

Decatur, AL

#5456 Feb 24, 2012
Brenda wrote:
<quoted text>
Hi Tammy,
Thank you and I also hope something good comes from this. I had a Ethicon Prolene Mesh. Ethicon is part of Johnson & Johnson, so I am sure they make more than I know of. Good Health to all.

I to have 2 of the ethicon prolene mesh in me they were put in in 95 have had pain ever since I was told I would be back to work in 2 weeks wound up being off 4 months then was forced to go back or lose my job I had 4 small children to support there father was fighting cancer at the time and could not work so I was the sole bread winner I have never had a day that was pain free . My understanding the prolene part of this is what they use to sew the mesh in you ...now nearly 17 years later I have so many medical issues and can not work at all my husband died in 98 I draw his retirement which is more then social security but not enough to acturaly live on and no insurance so since I can not work I am truggling to survive just want my life back or something simular to a life instead of having to sit with legs propted up and when I stand up I walk hunched over because if I try to stand up straight it pulls so bad with so much pain I also chock when trying to eat or drink a lot lots more thing had my thyroid removed in 2005 have developed diabeties ..fibro, meniners diease just so much pain it is really hard some days to have the will to get out of the bed . the shooting electrical pains that come and go makes me lose body function at times and that is so embarssing sorry just wanted to vent if my dr had of told me what could happen down the line I never would of had this ut in he never told me anyting before my surgery and with all my complaining he told me it was just the mesh rubbing and it would get better just takes time .....nearly 17 years has past since he told me that /
Patty

Eugene, OR

#5457 Feb 24, 2012
I read the so many adverse event reports in MAUDE. There are dozens from patients who report adverse events, telling of pain, infections and so on. Then I read a few from manufacturers, damage control. In each report by the latter, they dispute and post blame on mis use by doctors. Read it yourself, it does not appear that the FDA is listening until people die. Just horrid!
Patty

Eugene, OR

#5458 Feb 24, 2012
twins2raise wrote:
I've been reading posts related to mesh complications for almost a week and Topix website seems to be the most active. I've decided to join in your discussions as I have been having problems since undergoing surgery 28 Nov 2011.
I have been a firefighter since 1983 and have had a fair-share of being knocked off my feet with an injury a time or two as all of us have. After nearly three months post-operation, the pain issues, inclusive of a couple weeks away from being most likely terminated from my job, has me very worried.
Prior to surgery, the urologist discussed a possibility of incorporating mesh if needed, but the hernia was very large and installed both plug and mesh. Pain levels are a constant 2-3, with sharp daily stings at 6-7, and have incurred 10 level five times in the last two months. Pain transpires during no-stress physical activities: In early Jan, I woke up from a deep sleep screaming from two sharp level 10 pain strikes. In discussion with the surgeon, he indicated that my body is rejecting the mesh.
I've maintained a daily log of issues since 15 Dec, the time-frame when I was SUPPOSE to return to duty. I have an appt for a second opinion on Monday, but it's going to be too late as FMLA runs out at the end of this month. I do have councel, and once the medical reports are received I'll post product information on this discussion board, inclusive of submitting a report to the FDA.
real interseted to see what mesh it is. Good luck with your second opinion, praying you can return to your job.
All Meshed Up

Boulder, CO

#5459 Feb 24, 2012
Patty wrote:
<quoted text> good luck.
Thanks Patty. My attorney in Denver is Bachus and Schanker and they have just informed me there are no more cases being brought up in court. Anyone with a Kugel/Bard patch with the ring and the ring hasn't broken we are out of luck....again.Bachus and Schanker have been better than the other attorneys I have dealt with.( Motley Rice, Peterson, etc etc.) I cannot get an attorney to take any cases. My Prolene mesh NADA! Now I have this Kugel time bomb and its already been acknowledged that there is a manufacturing defect but even that doesn't matter! The FDA ia a criminal organization that has been taking money from manufacturers and totally disregarding the very people that are supposed to be protected. The FDA is in colusion with and has directly helped the Medical Community keep this abomination called mesh from being recalled completely. The FDA has proven itself to be criminally negligent it its duties. And NO ONE GIVES A DAMN. Yes there were congressional hearings and people were aghast that the FDA didn't know where all the money went that was supposed to verify the 501(K) statement put out by the manufacturers. Congressman were disappointed and very upset about this situation and will investigate it fully. MY BUTT. You bastards probably went out for martinis after words with the same people that disappointed you and asked about your next contribution. Congress is filled with pitifull, cowardly, money grubbing elitists who care nothing for us and only care about their next election. Prove me wrong! And if the FDA has a problem with me, well TOO BAD. I have written 3 adverse reaction reports. I recieved letters of Thanks from the FDA in which they state that if they get 3 reports about the same product they will issue a warning. If that is indeed the truth then my reports alone should have caused a report. They never did. This whole thing with mesh could have been stopped a LONG TIME AGO. But our government and most particullary the FDA took the money and ran.
Patty

Eugene, OR

#5460 Feb 24, 2012
All Meshed Up wrote:
<quoted text>Thanks Patty. My attorney in Denver is Bachus and Schanker and they have just informed me there are no more cases being brought up in court. Anyone with a Kugel/Bard patch with the ring and the ring hasn't broken we are out of luck....again.Bachus and Schanker have been better than the other attorneys I have dealt with.( Motley Rice, Peterson, etc etc.) I cannot get an attorney to take any cases. My Prolene mesh NADA! Now I have this Kugel time bomb and its already been acknowledged that there is a manufacturing defect but even that doesn't matter! The FDA ia a criminal organization that has been taking money from manufacturers and totally disregarding the very people that are supposed to be protected. The FDA is in colusion with and has directly helped the Medical Community keep this abomination called mesh from being recalled completely. The FDA has proven itself to be criminally negligent it its duties. And NO ONE GIVES A DAMN. Yes there were congressional hearings and people were aghast that the FDA didn't know where all the money went that was supposed to verify the 501(K) statement put out by the manufacturers. Congressman were disappointed and very upset about this situation and will investigate it fully. MY BUTT. You bastards probably went out for martinis after words with the same people that disappointed you and asked about your next contribution. Congress is filled with pitifull, cowardly, money grubbing elitists who care nothing for us and only care about their next election. Prove me wrong! And if the FDA has a problem with me, well TOO BAD. I have written 3 adverse reaction reports. I recieved letters of Thanks from the FDA in which they state that if they get 3 reports about the same product they will issue a warning. If that is indeed the truth then my reports alone should have caused a report. They never did. This whole thing with mesh could have been stopped a LONG TIME AGO. But our government and most particullary the FDA took the money and ran.
what does your doctor say? In support of you? I looked at the MAUDE website, its easy to use, i just looked at adverse event reports and typed in the manufacturer. It gave me report numbers, then I had to go to the fda website, search and put in adverse event # and it brings up the report. You can look and see if it helps. 3 reports is all? Do they have to be from doctors. Or the manufacturer or a patient? Good luck, keep us updated.
David

Clarks Summit, PA

#5461 Feb 24, 2012
Actually, as far as recalling goes, I'm quite surprised that Fosamax has not been recalled yet. http://www.fosamaxfemurfracturelawsuit.com/

“United States”

Since: Feb 12

Llano

#5462 Feb 24, 2012
Patty, from Eugene, you go girl. I've enjoyed your posts'. I've been reading this forum since 2010 and only just posted a couple of weeks ago. I had my first ventral hernia repair in Nov. 2008. Mine is the same story here--buckling mesh, infections, open running wounds that won't heal, good doctors, bad surgeons,SSDI, work comp., class action law suit participant and on and on. At present I am facing my 5th hernia repair with a surgeon at Scott & White out of Round Rock, TX. He has spealized in the last year and works with a plastic surgeon doing meshectomies. I am a nurse who was fully insured when the first hernia reoccured, because it happened at work I could not use my own insurance and had to use a WC carrier and ended up with a hack surgeon. I just basically gave up the last half of 2011. I began occupying my couch last Sept.,a full month before occupy Wall Street took place--the system had just ground me down. Not anymore, and I applaund you going down every trail you can to find info. and pass it on. Thanks
Patty

Eugene, OR

#5463 Feb 24, 2012
mbushey wrote:
Patty, from Eugene, you go girl. I've enjoyed your posts'. I've been reading this forum since 2010 and only just posted a couple of weeks ago. I had my first ventral hernia repair in Nov. 2008. Mine is the same story here--buckling mesh, infections, open running wounds that won't heal, good doctors, bad surgeons,SSDI, work comp., class action law suit participant and on and on. At present I am facing my 5th hernia repair with a surgeon at Scott & White out of Round Rock, TX. He has spealized in the last year and works with a plastic surgeon doing meshectomies. I am a nurse who was fully insured when the first hernia reoccured, because it happened at work I could not use my own insurance and had to use a WC carrier and ended up with a hack surgeon. I just basically gave up the last half of 2011. I began occupying my couch last Sept.,a full month before occupy Wall Street took place--the system had just ground me down. Not anymore, and I applaund you going down every trail you can to find info. and pass it on. Thanks
Scott and white? Wow! A person who had their Atrium CQUR taken out at that same hospital. They live in Texas and they told me that their internal medicine doctor said he does not like that type, it caused a huge mess and he is going to do what he can to get it out of his hospital and off the market. Atrium just called my husband today, concerning the priblems with the same Atrium cqur. I think the FDA will issue a warning if they revieve 3 adverse event reports from doctors? I may be mistaken. Good luck with yours and a speedy recovery. Which one damaged you?

“United States”

Since: Feb 12

Llano

#5464 Feb 24, 2012
Patty,(Eugene OR), I've read "abouttoraisehell"s posts'. Her husband is at Scott & White in Temple, TX. Scott & White is one of the medical giants incorperating TX at the moment. What I've found hopefull in "atrh" posts' is the 50 mile radius of 2 surgeons who realize the problems mesh cause. I came to this forum because I was made to feel I was crazy, a complainer, a slacker, a malingerer, etc. etc..: Not any more, I now know I was right. There was something wrong and I finally have a surgeon who agree's. Now if he can help me, that will be a gift--I figure at least he'll get the mesh out. As this is my 5th surgery I am tamping down the panic mode on a daily basis as the count down to 3-28 approach's.

“United States”

Since: Feb 12

Llano

#5465 Feb 24, 2012
Oh, I have Kugel Composix X-large mesh at present.
Patty

Eugene, OR

#5466 Feb 24, 2012
mbushey wrote:
Patty,(Eugene OR), I've read "abouttoraisehell"s posts'. Her husband is at Scott & White in Temple, TX. Scott & White is one of the medical giants incorperating TX at the moment. What I've found hopefull in "atrh" posts' is the 50 mile radius of 2 surgeons who realize the problems mesh cause. I came to this forum because I was made to feel I was crazy, a complainer, a slacker, a malingerer, etc. etc..: Not any more, I now know I was right. There was something wrong and I finally have a surgeon who agree's. Now if he can help me, that will be a gift--I figure at least he'll get the mesh out. As this is my 5th surgery I am tamping down the panic mode on a daily basis as the count down to 3-28 approach's.
I dont understand why you are being treated as such. I dont believe the doctors are at fault, unless the do a hack jib. They use what they believe is the best, and if it turns out to be a bad product, they have done their best.
Ive read so many posts that say the patient is wrong. We cant see inside, but we know our bodies. The main issue with my husbands mesh was that when he had surgery to remove it , the doctor found that the coating had come off, not absorbed but had created a real mess. The healthy tissue that he had fixated the mesh to was pretty destroyed. The doctor had to do some serious cutting of now unhealthy tissue. The next mesh he implanted has so far held up, as far as we know. His doctor told him he will always be in pain. I dont know if his doctor filed an adverse event report on the Atrium yet, I have not seen it anyway. Wow, class action? Good luck with that. What manufacturer? Best of luck with your surgery. If I understand, I believe that you can request that the surgery be video recorded?
Patty

Eugene, OR

#5467 Feb 24, 2012
mbushey wrote:
Oh, I have Kugel Composix X-large mesh at present.
oh! Was it recalled? If so, how many had to fail before they recalled those?

Tell me when this thread is updated:

Subscribe Now Add to my Tracker

Add your comments below

Characters left: 4000

Please note by submitting this form you acknowledge that you have read the Terms of Service and the comment you are posting is in compliance with such terms. Be polite. Inappropriate posts may be removed by the moderator. Send us your feedback.

Health Discussions

Title Updated Last By Comments
News President George H.W. Bush Is in Intensive Care... 2 hr Dig Gravers 2
News GOP Gov: Brewer Defends Medicaid Expansion: 'We... (Jun '13) 2 hr Appalachian Indian 52
News Pregnancy Symptoms - 12 Very Early Symptoms of ... (Jun '07) 6 hr Lexy19 7,351
pokerVita lagi 14 hr gisel 1
Pokervita 14 hr gisel 1
News Harbor-UCLA Medical Center cited for safety vio... (Oct '11) 18 hr Human 280
News Spokesman: George HW Bush hospitalized with blo... Tue Father and Son 1
watching wife get pregnant by another man (Jan '17) Apr 18 mikeae102754_att_net 76