Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8247 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.

Becca

Arlington, TX

#3932 Jan 8, 2011
Thank you for writing. I really appreciate the input. I was seen by an infection specialist in the hospital. He is the one who sent me home on Doxycycline. I don't think I could take 5 weeks of IV treatment in that hospital. None of the nurses washed or used hand sanitizers on their hands either when entering or leaving my hospital room. The floors or bathroom were not cleaned in four days when I was there. This is the only hospital my doctor works in...great!
Thank you for the information on the white cell scan. I never knew that was possible. However, I did mention to my surgeon I thought a blood culture should be done to make certain I was taking the right antibiotic....he didn't think it needed. Since coming home and doing some research, I think he should have done just that. Again, I'm not a doctor. I also found out the initial IV antibiotic, Tygacil, can be life threatening if given to people with allergies to Pennicillin...I am. It was no wonder I was getting sicker by the day. I also read it was important to check liver function while on this antibiotic. That didn't happen to the best of my knowledge.
When I sleep on my right side (that is where the mesh is located), the lump seems to get larger in the morning. After I'm up for a while it isn't as hard and gets smaller. Is this normal?
Yesterday, for the first time since my surgery, I went shopping for a sale. I was on my feet for several hours but never lifted anything heavy. Later that evening, I put my feet up in bed to rest and I got horrid cramps beginning in my left thigh area and moved down to the calf. This is the opposite side of surgery. Some pain also radiated to the left side thigh. The pain got so bad I could hardly walk.
I thought maybe it was potassium imbalance and quickly drank some electrolyte solution and the pain began to subside. I don't understand how I could have a potassim shortage because I had that test within the last two weeks and it was normal. Does that mean something might be going on inside so that I am not absorbing the potassium? I won't be able to see my GP until Monday but as soon as I can get there, I will ask him to do a white blood cell scan. The site is no longer red but has a huge bump at the site. Is that normal. It has only been five weeks since the surgery but I know something is not right...I just don't know what.
tiredofit all mentioned about staples being left in the body. Is that normal proceedure? Years ago, I had gall bladder surgery and they did leave staples inside the body...I thought it was normal. I wish now I had never had this surgery.
The pain that goes down the legs starts when I put my feet up or am lying down...I lay on my right side...the site of the incission. It started again today when I went to take a short nap. I think it could well be never endings which are effected.
Again, thank you for the assistance. You have been most helpful. I guess the burning never goes away...at least it has not for you. However, I am glad you got some pain relief from the other pain. Isn't gabapentin the generic for Neurotin?
Becca

Arlington, TX

#3933 Jan 8, 2011
MotoDiva, I had the Bard mesh put in and have had problems ever since. Bard is the parent company for some of the other brand names of mesh patches. I have pain at the incission site after an infection and am now getting pains down the legs when I am up for very long...as well as an odd pump at the top of the incission. If I lay on my right side the lump gets hard (the inguinal hernia surgery was on the right side). I'm starting to get a little nervous about the lump. My doctor told me the sweeling would be gone in 5-6 weeks...it's been 51/2 weeks...close to six. But it is the change in position which I find more startling. It seems the sweeling is moving upwards. I have no idea if this is normal.
I wish you luck and will let you know what I find out.
justme

Pocatello, ID

#3934 Jan 9, 2011
Hello Becca,

originally the first antibotic I started with was sufla, seven months after the first hernia surgery, and seven months of pain and despair and trips to the er room. I started the sulfa but I had a reaction on the eleventh day, that is when the surgon sent me to a infection dr.
She put me on doxicyline. She said the patches were infected that was obvious, but she also said they cant be removed, at least not in the state that I resided in.
Her plan was for me to take doxiclyne. She said i could be on some type of antibotic forever. so i took the antobitic and it did help. After three months I could at least wake up every day but as soon as I started moving the hernia patches started contracting, throbing and tearing, and a fever would always acompany the pain.
What no body knew is one of the patches were broke and cut through my inststins. I knew... I went to the emergency three days after my first hernia surgery, my concerns were dismised my sympons were dismised.
in addition, I continued to have another surgery six weeks later, where they implnated three more patches in my plevis. Ironcially this surgery was cancleded and rescheduled two weeks later because i had a fever of 103. My concerns about the first patch and my new symptons were dismissed.
After both of these hernia surgerys i developed new problems of course there was tenderness around the hernia sites and now i had severe pain in my groin walking was imposible. The swelling in my abdomin was most concerning and when my finger started turning blue i knew i was in trouble.
I took my concerns to the infection dr and the surgon who didnt even seem concerned with my blue fingers and for swelling in my abdomin the surgon said it was more hernias and scheduled me for a third hernia surgery.
I informed the infection dr about the up comming surgery plan. She was not straight forward but i could read between the lines. She said I could not have a surgery without being cleared of infection. I was scheduled for a day surgery my infection and my blue fingers were not even a concern. Based on previous conversation with her and her beleif that the dr did not have the experience or the facilities to preform such a operation, I beleived i was entering into to a life treating experience. she didnt beleive i had more hernia and either did I. I beleived the dr had no idea what was going on as he stated he was going to implant more synthitc mesh.
know i knew the patch was broke even though the cat scan showed nothing and the dr denied it.I got scared after talking to the infection dr. the surgon was not sure what was going on and intended to implant more synthtic mesh. I took the advice from my infection dr and found a surgon at a university hospital in californis which was not hard i just knocked on a friends door in california and got the name of the dr who saved him just a year before he had a broken patch as well.
justme

Pocatello, ID

#3935 Jan 9, 2011
Becca, it is not just the pain that we who have mesh suffer from, it is everything else the dr who dont reconize the complications the er room that just inject harmful drugs and send you home with life threating conditions.
From my experience if you are complaining about the mesh or the pain at the hernia sites you are quickley ushered out of the hospital.
Then when you go to the surgon or even the infection dr there is a degree of decepiton form the dr. had I not read between the lines of my infection dr I would have died. doctors dont want to point fingers at other doctors or even akowledge complications that could implicate the hospital.
I know I am not the only person conflicted about who is at falut or who to blame the easy target is the Dr or the hospital but in reallity it is the medical product. Our dr's are being compromised and put in terrible postions. Yes i had to go to another state to get help but I harbor no anger towards my local dr.
However, i am concerned about the deception and the deniels related to mesh products it is because the hospital and the dr could potentially be held responsable for something they themself have no control over rather the defective medical products are the root of the problem.
justme

Pocatello, ID

#3936 Jan 9, 2011
Becca, I have had a total of three hernia surgerys. of course the first two were when the synthetic mesh were implanted and the thrid was the explant of one of the synthtic mesh. The one explanted mesh was replaced with colla mend fm this is a bio mesh. I spent eight days in the hospital and five weeks on home health care doing antibotic Iv treatment. The iv treatment was stopped to soon because the infection quickley came back. I had a cat scan to verfy it was gone and blood test before they stoped the treatment but these test proved to be ineffective.
The infection appeared to be gone but i could tell it wasnt my ordeal started over, trips to the emergency room and more harmful drugs. Four months after the iv was stopped the infection dr started me on antibotics, and then did a white blood cell tagging scan
This test would tell her if i needed iv treatment, or send me for pain management. She did not want to be fooled by my infection again. Blood test cant show if there is an infection rather they look for inflamation markers that sugest the presents of an infection, cat scans dont show little infections that could grow.
The white blood cell tagging scan is the only test that can clear you of infection. Finally after two years of infection my infection is gone and cleared by the white blood cell tagging scan. The pain associated with the infection is gone.
The remaining pain is from the patches themself or even the multipal surgerys. The medicine the pain dr put me on is working my hope is it continues to work if not then i am looking at another trip to California and more surgery to remove the intrapped nerves or worse the patches and the mussles in my pelvis. If someone would have told me this burning itching and stabbing pain would go away without surgery i would not have belived them but it has.
Becca, pay attention to the new symptons that arise through this ordeal they do mean something alot of time dr will dismiss these little symptoms but in the end they are relevant. My blue finger was because of the broken patch and the damage caused in my abdomin when it broke. When they did the explant I had a heart specilist, infection specilist and of cousre the surgon that did the explant I did not do a day surgey rather i was prepared by the emergency room under the direction of the surgon and not before the heart specilist cleared me for surgery and in addition i was given antibotic before the surgery for twenty four hours. My situation warranted the skills of many different dr and a hospital that could handel this type of surgery. I was montiored by the heart dr the entire time I was at the hospital and I was scaned every day I was in the hospital. one interesting thing I learned form the heart dr is the synthtic mesh was causing me to have a allergic reaction all the mussles around my heart were swollen mimicing a haert problem..
This was no suprise to me I have the same type of reaction to cats the mussles swell around my heart a slow reaction if i continue to be exposed to cats...what was a suprise is products that people could be allergic too are implanted everyday and continued to be ingored as a potential complication or even explaind to people like you and me and any other person out their.
Becca, most important get a copy of your implant report from medical records at the hospital where you had your surgery. File a adverse event with the FDA. You might be suprised what you find out. I had a new redesigned kugle mesh implanted into me this came out after the the fda recall and market withdraw there was not another approval process for this product. I am apart of the Mdl In Rhoad Island...amazing I should have never got this product it was already recalled and market withdrawn..a year before i received it. lawyers in this litigation will accept claims with duel mesh desgin regardless of the lot number there are at least 30 different kinds of duel mesh made by brad or davol.
justme

Pocatello, ID

#3937 Jan 9, 2011
Becca, I dont want to scare you but the little bump that i noticed on the thrid day that took me to the emergency room was relavant it just got bigger and harder. I felt it snap three days after surgery in the end it was the ring that is inside the duel mesh it criss crossed and presented it self as a bump but is was cutting in to my intestins and because it went on for over a year the broken ring and the patch mangled my vital organs. also causing a infection. the infection is the least of the problem the longer that broken patch in in there the more damage it is causing. as in the words of my explant surgon if the patch was working you should not have any hard mass or buldging at the hernia site otherwise it is broke despit the fact the broken patch never showed up on the seven cat scans i had prior to my explant surgery.
ALS

Azusa, CA

#3939 Jan 9, 2011
Warning to anyone who has chronic pain issues with the UHS dual layer mesh system. I think one of the reasons this mesh fails it that it is hard to taylor the mesh. I could be wrong but I am aware of several failures lately. In some cases it is total mesh retraction. Basically, when that happens, it produces another hernia. Sometimes these hernias are occult (and you cannot see them) and may be hard to palpate (feel the buldge when you cough). Another thing, if what I say is true, I think some surgeons who make a mistake in tayoring the meshe, may just leave it in, because it could be hard to take out!! The meshes are also expensive and maybe the surgeon is more willing to take a chance.

I would stay away from the dual layer meshes of any kind (lightweight or not)

[email protected]
ALS
Anonymous

Casa Grande, AZ

#3940 Jan 9, 2011
justme wrote:
Becca, I dont want to scare you but the little bump that i noticed on the thrid day that took me to the emergency room was relavant it just got bigger and harder. I felt it snap three days after surgery in the end it was the ring that is inside the duel mesh it criss crossed and presented it self as a bump but is was cutting in to my intestins and because it went on for over a year the broken ring and the patch mangled my vital organs. also causing a infection. the infection is the least of the problem the longer that broken patch in in there the more damage it is causing. as in the words of my explant surgon if the patch was working you should not have any hard mass or buldging at the hernia site otherwise it is broke despit the fact the broken patch never showed up on the seven cat scans i had prior to my explant surgery.
I have a very hard mass and every doctor I see says it is just scar tissue. Who is your explant surgeon? Thanks for your help.
Hullenback Cowl

Azusa, CA

#3941 Jan 9, 2011
LARC wrote:
Im trying to contact Dr. Shirin Towfigh
and have been unable to find a number or email for her! Does anyone have her contact info?? thank you for any info you can provied!!
She is in Los Angeles at Cedar Los Angeles. Additional she is in the SAGES directory with additional contact information. You should have no contact locating her at all.
justme

Pocatello, ID

#3943 Jan 9, 2011
ALS wrote:
Warning to anyone who has chronic pain issues with the UHS dual layer mesh system. I think one of the reasons this mesh fails it that it is hard to taylor the mesh. I could be wrong but I am aware of several failures lately. In some cases it is total mesh retraction. Basically, when that happens, it produces another hernia. Sometimes these hernias are occult (and you cannot see them) and may be hard to palpate (feel the buldge when you cough). Another thing, if what I say is true, I think some surgeons who make a mistake in tayoring the meshe, may just leave it in, because it could be hard to take out!! The meshes are also expensive and maybe the surgeon is more willing to take a chance.
I would stay away from the dual layer meshes of any kind (lightweight or not)
[email protected]
ALS
Amen to that ALS, I to would stay away from any kind of duel mesh.
Richard in Montrose Co

Boulder, CO

#3944 Jan 10, 2011
tiredofitall12 wrote:
<quoted text>
Thank you. I'm scheduled for a procedure next Wednesday for them to look in my intestines. I don't think they'll find anything wrong there. I wish I could get a doctor to look at the mesh. I'll keep working on it and I hope you feel better. Did they take the staples out?
No. The staples are in for good. I have asked a couple of different Dr.'s about this but they say that the staples are in a position around the femoral vein that going into remove them would most likely end with me bleeding out. And apparently it is normal that the staples don't come out after a mesh removal because of the way the mesh is "stapled" into place and what happens afterword.( I am refering to an inguinal surgery and mesh placement.) Namely the mesh has crumpled and twisted and therefore finding the little boogers along with any arrent mesh is damn near impossible.My 5th surgery was to go back in and remove my right testicle(also normal with a mesh removal! Read the fine print!) and they found more mesh that they didn't get the 4th surgery and a bunch of scar tissue to boot.I hope that you will have success with your procedure. Please keep us updated. Best Wishes..........rmh
steve

Houston, MN

#3945 Jan 10, 2011
the court should set the percentage a lawyer can get ,mine gets 40& and the court gets 12% thats 62%
$50,000
-62%
________
$19,000.00 for victims
contact the court asap
they ordered 25% on other cases
Cant-take-no-mor e

Sumter, SC

#3946 Jan 10, 2011
MotoDiva wrote:
Is there anyone who has experienced complications with Bard 3D and Bard Ventralex mesh hernia patches? I had a bilateral inguinal and unilateral abdominal mesh reapair almost a year ago, and I have been in constant pain since. I had a seroma the size of a football over one of the surgery sites, I have pain running from my groin to my leg, and when I attempt ANY sort of activity, I will run a high fever. The right side of my abdomen is swollen to about twice the size of the left. I have had two second opinions and even contacted the Mayo Clinic, but no one will recommend anything but pain management. I'm just curious if anyone else has had problems with 3D or Ventralex patches or if they were part of a recall. I have not been able to work since the surgery and this has impacted my life greatly. The ironic thing is that I had an open hernia repair previously, and that surgery went well and caused me no complications whatsoever. I'm very interested in corresponding with anyone who has had a similar experience.
That is almost exactly what I have been going through since Feb. 2010 except I did not have a seroma, but the swelling, the constant pain that gets much worse w/ any activity,& the pain that shoots down through my thigh all the same problems. I also have not been able to work since. I have these issues on both sides every since the two surgeries. All they want to tell me is that it may be nerve damage & pain management along w/ different pain prescriptions is all anyone wants to do about it. My Doctors have told me to file for disability. I'm only 34 yrs old & was in excellent shape before all of this. Now that I've started looking on the web I see this must be more common than I thought. I really wish I knew of something that could be done. I also wonder if there was something that the surgeon did wrong (it was the same surgeon w/ both hernias). I've seen where the companies that made my patches have lawsuits against them, but I'm not sure if the patches used on me are the ones that fall in those categories'. I wish you the best of luck & if I ever figure something out I will pass what ever I find out on to you.
MotoDiva

Shreveport, LA

#3947 Jan 10, 2011
Cant-take-no-more and others who have responded- thanks for the information. I am really shocked to find how common complications from hernia patches can be. If I would have known the true extent of what can go wrong, I would have gone for a second opionion before my surgery, but I had a strangulated bowel and didn't think that I could wait any longer. I do have one other question concerning mesh patch complications-are the effects (chronic pain,infection,bowel problems, etc) something that can be lived with long-term? I've lived with this for a year so far, but due to my finacial situation I don't know when or if I will be able to be evalutated by a hernia specialist. Again, thanks for the response!
DAG

Belle Fourche, SD

#3948 Jan 10, 2011
MRI is helpful to determine irritation to the pubic bone and other inflammation. If hernias were placed open, then best option may be neurectomy with mesh removal. Leads to small area of numbness that doesn't seem to bother most people. Majority of surgeons will not do this procedure and refer you to pain management. Call around, and should be able to find a surgeon in your area.
Cant-take-no-more wrote:
<quoted text> That is almost exactly what I have been going through since Feb. 2010 except I did not have a seroma, but the swelling, the constant pain that gets much worse w/ any activity,& the pain that shoots down through my thigh all the same problems. I also have not been able to work since. I have these issues on both sides every since the two surgeries. All they want to tell me is that it may be nerve damage & pain management along w/ different pain prescriptions is all anyone wants to do about it. My Doctors have told me to file for disability. I'm only 34 yrs old & was in excellent shape before all of this. Now that I've started looking on the web I see this must be more common than I thought. I really wish I knew of something that could be done. I also wonder if there was something that the surgeon did wrong (it was the same surgeon w/ both hernias). I've seen where the companies that made my patches have lawsuits against them, but I'm not sure if the patches used on me are the ones that fall in those categories'. I wish you the best of luck & if I ever figure something out I will pass what ever I find out on to you.
DAG

Belle Fourche, SD

#3949 Jan 10, 2011
MotoDiva wrote:
Cant-take-no-more and others who have responded- thanks for the information. I am really shocked to find how common complications from hernia patches can be. If I would have known the true extent of what can go wrong, I would have gone for a second opionion before my surgery, but I had a strangulated bowel and didn't think that I could wait any longer. I do have one other question concerning mesh patch complications-are the effects (chronic pain,infection,bowel problems, etc) something that can be lived with long-term? I've lived with this for a year so far, but due to my finacial situation I don't know when or if I will be able to be evalutated by a hernia specialist. Again, thanks for the response!
If your hernia was strangulated you were lucky that you did not require more extensive surgery (ie bowel resection). It would be unusual that your surgeon would have placed mesh for a strangulated hernia, but possible (I wouldn't take the chance). If your pain has been constant and you are one year out, then you should seek another surgeon for consultation regarding possible recurrent hernia vs neuroma, etc.
Richard in Montrose Co

Boulder, CO

#3950 Jan 11, 2011
I will have to disagree with DAG as far as a nuerectomy and mesh removal goes. I have had both. The mesh had to be removed. No doubt about that. Although I am still in pain 24/7 I am not sick as I was and am able to go about most of my business. I still have many problems associated with the mesh. I believe there is still small pieces of mesh floating around in me. And because of the amount of abdominal muscle that had to be taken out the hole was filled with a Kugel Patch. That in itself has caused pain and the feeling that I have a pie plate in my gut.Now.....the neurectomy.....I went to a "top notch" sports medicine specialist for a neurectomy to the right inguinal nerve. He cut the wrong nerve.Which happens all the time. The Dr. will say that you had a genetic alteration to your nerve and that was the reason for the wrong nerve being cut. The surgery DID NOT work and it created more problems than it solved. I have a friend who just spent a huge amount of money in travel and surgical expense to try and eleviate the pain he was experiencing and that surgery DID NOT WORK either. The surgeon he saw was supposed to be one of the best on the eastern seaboard.Please be very careful when thinking of a neurectomy.Best Wishes........rmh
Sue

Gilbert, AZ

#3951 Jan 11, 2011
Shannon, were you able to find a Doctor in AZ who will help you? I had my abdominal mesh in 2005 and I've been in pain ever since, I returned to the surgeon 5 times and he keeps saying nothing is wrong and the CT's don't show anything. I just found out about the recall only because I have a bladder mesh and am having to have that removed because of the mesh complications. The bladder mesh has FDA warning not recalled yet, I have a feeling it's not recalled because mostly women are affected by this urinary incontinence surgery. I live in AZ too but none of the Drs in AZ will remove my bladder sling mesh so i am having to travel to CA. Here is my email if you want to respond [email protected]
Shannon wrote:
<quoted text>
I also live in Arizona and need to find a GP who can help. I have been in constant pain for over a year. At times I don't want to be by myself because I think I'm dying. I can't sit for periods of time unless I have my right leg extended to the side. I have a hard lump in my abdomen. I have hip pain, heel pain, but mostly pain along the right lower abdominal area. I've been to 5 doctors and they tell me the lump is scar tissue and my abdominal pain is from my back. I've been to pain management for injections in my back. He gave me the injections but said my bulging disc is on the opposite side from where my pain is. It is frustrating. I've just begun counseling because there are times I don't want to live like this. If you can give me a name of a doctor in AZ who knows about this problem, please help. Thank you.
Victor

Phelan, CA

#3952 Jan 11, 2011
I had the hernia surgery done in 2003 had problems from the start, now im having major probs can't eat much of anything without prblems and constapatation ,stomach and hernia area hurt major infections went to hospital cause heart was miss beating dr in emergency said it was nothing,You think dr.s would find something after colonoscopy
DAG

Belle Fourche, SD

#3953 Jan 11, 2011
Richard in Montrose Co wrote:
I will have to disagree with DAG as far as a nuerectomy and mesh removal goes. I have had both. The mesh had to be removed. No doubt about that. Although I am still in pain 24/7 I am not sick as I was and am able to go about most of my business. I still have many problems associated with the mesh. I believe there is still small pieces of mesh floating around in me. And because of the amount of abdominal muscle that had to be taken out the hole was filled with a Kugel Patch. That in itself has caused pain and the feeling that I have a pie plate in my gut.Now.....the neurectomy.....I went to a "top notch" sports medicine specialist for a neurectomy to the right inguinal nerve. He cut the wrong nerve.Which happens all the time. The Dr. will say that you had a genetic alteration to your nerve and that was the reason for the wrong nerve being cut. The surgery DID NOT work and it created more problems than it solved. I have a friend who just spent a huge amount of money in travel and surgical expense to try and eleviate the pain he was experiencing and that surgery DID NOT WORK either. The surgeon he saw was supposed to be one of the best on the eastern seaboard.Please be very careful when thinking of a neurectomy.Best Wishes........rmh
Counterpoint...
There are only a few nerves in this region, and I don't believe that you can cut the wrong nerve. The inguinal nerve branches, and what the physician may have been telling you is that there are possible branches of this nerve that are still intact and problematic. Second, I don't know of any sports medicine specialists that would be performing a neurectomy. Only two physicians are potentially trained for this procedure...a neurosurgeon, and a general surgeon. Last if this was for a Kugel patch, then this approach would not have been offered since this patch is placed in the preperitoneal location (ie deep to the muscle and abdominal wall). In this circumstances, I advocate a laparoscopic approach since you are able to evaluate the abdominal cavity. It is true that the patch is difficult to remove in its entirety since the mesh tends to become embedded adjacent to the femoral artery and vein. The last patient I operated on with the Kugel patch had a recurrent hernia that was difficult to feel on examination. I was able to remove the majority of the patch and repair the hernia with a biological mesh. Pain did not drop to 0, but by around 80% in their words. In my experience with mesh placed with a Lichtenstein or similar approach that 60 to 70 percent of these people will note dramatic improvement, while others are relatively unchanged.

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