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Warning for anyone who has had a hernia operation in the last few years.

post #1 of 9
Thread Starter 
DH had 2 hernia operations in 2005 and had kevlar patches put in both times. Since then he has been having problems with pain in his lower right hand side and a few unexplained fevers (which could or could not be related). We found out today from a friend that there was actually a recall on some lots of kevlar mesh starting in Dec of 2005 (after DH's surgeries), the last one being Jan 2007.

Here is a link to all the info we got from Google:

http://search.yahoo.com/search;_ylt=...mesh&fr2=sc-sb.

Here is the actual FDA recall notice with lot numbers:

http://www.fda.gov/cdrh/recalls/recall-122205.html

There is apparently a lawsuit pending against the manufacturer because the patients that received the patches are NOT BEING NOTIFIED of the recall! The problem is with the memory ring they use to implant the patch during surgery is breaking, causing minor to major problems from pain to bowel perferation to death.

If anyone has had surgery for a hernia I strongly recommend calling the hospital and getting your surgery records. The lot number of the mesh should be on the surgical records. The manufacturer says they notified the hospitals, but according to one FDA report (I need to find it again, sorry don't have the link) they were very negligent in who they did and didn't notify. Just to be on the safe side, check.
post #2 of 9
I haven't or nor do I know anyone who has had it but I hope everyone that has is okay and there were no major problems to anyone. I hope everything turns out okay with hubby
post #3 of 9
Thread Starter 
He's getting his surgical records tomorrow from the hospital to check. He's kinda freaking out about it, so I am too. DH also has Crohn's disease, so some of the symptoms they describe are things he lives with everyday so he wouldn't know if something is wrong with the patch. What worries him the most is the pain he has, and it's not where the incision is, it's where the ring would be.
post #4 of 9
Thank you - printed this out for DH - he had a 2nd hernia surgery this past year (after we moved).
post #5 of 9
Going to send this off to my mom, thanks for the heads up.
post #6 of 9
So thoughtful of you to post this -- I don't know anyone with the issue, but it's good to be aware. I'm so sorry your husband suffers Crohn's... and I dearly hope his patches are not part of the recall!
post #7 of 9
Thread Starter 
Quote:
Originally Posted by CarolPetunia View Post
So thoughtful of you to post this -- I don't know anyone with the issue, but it's good to be aware. I'm so sorry your husband suffers Crohn's... and I dearly hope his patches are not part of the recall!
Thanks. Unfortunately, after we got his records and checked the lot number, his patch is part of the recall. So, he's calling the doctor on Monday to have him order the tests to find out what he has to do. When he got his records, the nurse even said they had to do a few replacement surgeries because of problems. Just, no one is sure if the surgery will be billed to us, or if it will be taken care of by the manufacturer. I'm guessing will will have to wait years to get reimbursed if we have to pay. Right now, he's only experiencing pain, but as active as he is, he can't afford to have problems 5 years down the road.

This just sucks!
post #8 of 9
It's Kugel Composix mesh, not Kevlar.

I believe it's up to the hospital facility that implanted the mesh to notify patients, as the manufacturer does not have that information due to HIPPA (privacy) regulations. The company sent notifications to all everyone they sell to, as I remember seeing the recall information posted at my hospital.
post #9 of 9
Thread Starter 
Quote:
Originally Posted by Pookie-poo View Post
It's Kugel Composix mesh, not Kevlar.

I believe it's up to the hospital facility that implanted the mesh to notify patients, as the manufacturer does not have that information due to HIPPA (privacy) regulations. The company sent notifications to all everyone they sell to, as I remember seeing the recall information posted at my hospital.
You're right, that is the correct brand. And, according to one website the FDA said the notifications were "sketchy" and didn't explain how dangerous these could be. I don't care who is at fault...the manufacturer for not giving proper notification, or the doctors for not telling their patients. I just would like to know who is going to pay for the surgery to replace it.
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