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.

All Meshed Up

Whitewater, CO

#7744 May 7, 2013
andie wrote:
hi. i just found this forum. i had atrium c-qur mesh for hernia repair in Nov. 2011. I just had it removed 04/26/2103 due to infection. I lost my umbilicus due to necrosis.(belly button)
i am very upset. it sounds funny not to have a belly button but it is not! i am going to seek an attorney, has anyone had any luck. i was in pain for a very long time with my surgeon telling me to "tough it out". i went to a second surgeon who did surgery as soon as he saw my cat scan with masses and infection. i was in the hospital for a week and have a large open incision which requires a nurse to come in and clean and repack every day. it is very painful. asi stated, i just found this forum and am looking forward to reading other peoples stories to compare.
thanks
andie
Hello "Andie". Check out this link when you can. It is a letter from the FDA to the Manufacturers of the Atrium mesh concerning their packaging, cleanliness and other violations. This is unusual for the FDA to "Publicly" admonish a Manufacturer but to actually publish the letter. http://www.fda.gov/ICECI/EnforcementActions/W... You "should" be able to get a Lawyer. You "could" get a Personal Injury suit against the Manufacturer if you can find the right Lawyer. Please make a full and comprehensive report to the FDA's MAUDE data base. IF your mesh is being stored in a freezer somewhere please send a sample to the FDA and the manufacturer. You will need to get your OP report from the Hospital as it contains all the Lot#'s and Model #'s of the mesh that was implanted and you will need it for the MAUDE report. Please let us know how you are doing. Best Wishes.......

Since: Jan 13

Lake Villa, IL

#7745 May 7, 2013
Good Luck andie, reading back posts takes time, but you will learn a lot/probably get pissed off!? There is nothing "funny" about your situation, or anybody's situation on here, you have every right to be upset, do not take no for an answer...... All Meshed Up is right on with everything he says/posts, may want to read everything posted by AMU? Mesh sucks, the system sucks, simple as that, it's a shame
Ozkayak

West Jordan, UT

#7746 May 7, 2013
I had a repair done 13 years ago with a material that is Gore Tex white on one side and like a tan fuzz on the other. I have had pain for years, now I find out that the material has shrunk and fat and nerves have popped out in one area. I'm told the only fix is to remove the old material, it's 11 x 14 cm. not looking forward to this so can anyone tell me if this is the only option? I don't know what to do.
Chuck

Eastaboga, AL

#7747 May 8, 2013
G.Morning everyone,:} Just found this in e-mail. FDA MED WATCH Covidien Surgical Stapler Reloads Stolen before being STERILIZED!!! Endo GIA Articulating 60-3.5 Reference Code 030458 Lot#N3B0165LX. they are packaged saying they are sterilized. Then turned tv on and heard onCBS where Some doctors nursing homes milking Medicare, Medicaid. Didn't hear whole report. Which isn't nothing new!!! In which on this topic, Did you know that the state of Plorida is the biggest state to fruad the system, anyway anyone fixing to have hernia surgery watch out for what your surgeon putting in you or on you?? ;+{
All Meshed Up

Whitewater, CO

#7748 May 8, 2013
Ozkayak wrote:
I had a repair done 13 years ago with a material that is Gore Tex white on one side and like a tan fuzz on the other. I have had pain for years, now I find out that the material has shrunk and fat and nerves have popped out in one area. I'm told the only fix is to remove the old material, it's 11 x 14 cm. not looking forward to this so can anyone tell me if this is the only option? I don't know what to do.
Howdy "OzKayak"! Welcome to the forum. You will need, as soon as possible, to get your OP Report from the Hospital where the Mesh was installed. This will give you the info on what ever they put in you. Let us know ASAP. Unfortunately what you are describing ( Please realize that we on here are not Dr.'s or medically trained. What we are is a group of people with a lot of mesh implant experience.) sounds to me as if the mesh has possibly torn, given way or possible migration. The older meshs' were very "heavy" compared to what is made today. It was found that a 90 pound weakling has the same internal pressure when lifting weights as does the body builder. The old mesh was usually 110 times stronger, thus thicker, than what was needed. OOPS. Mesh starts breaking down in your body within weeks of implant. Mesh was designed to create scarring and tissue build up around the "foreign" object similar to what happens with a splinter in your finger. This was to "strengthen" your gut and hopefully stop further hernias. So you get inflammation, scarring and your immune system works overtime to get rid of the "foreign" object. You may have had redness, tenderness, shooting pains, pains down the leg, pain in a testicle ( usually on the same side as the scarring )and sometimes bowel problems of varying degrees. Was your surgery for an Inguinal Hernia? What symptoms have you had? Are you over weight? Smoke cigarettes? Are you "active" at all? What are the Dr.'s telling you? The problem with what you are describing is that tissue can get trapped and cause necrosis. Necrosis is tissue dying. That will cause a miriad of major problems and fairly quickly. So, yes the mesh will probably have to be removed. It is not going to be good. You will have lots of scarring to deal with and then the mesh will be difficult to get out because of the amount of time the mesh has had to incorporate itself into your body. Please be prepared for a long recovery. Please be prepared for a large, possibly open, wound. You will need to research for a competant Dr and one that has mass experience with mesh removal and problems. Get back to us and answer as many questions as you can. Get your OP report immediatly. It may be in "Archive" but the hospital WILL have it. We will not pull any punchs when it comes to mesh and implant and especially a removal. Its not good, my friend. There are a lot of us on here that have and ARE going through the results of implants and removals. Get back to us soon and Best of Luck..........
Gina

Gadsden, TN

#7749 May 8, 2013
I had hernia repair, using proceed mesh in 2011 and have alot of problems with diarrhea, distended abdomen, nausea and have been unable to vomit since surgery. Not that I want to vomit, but I have had a couple viruses and could not vomit. Very concerned!! Has anyone had this problem after having hernia repair?
riverrat

Winona, MN

#7750 May 8, 2013
gina take some
tums
ramshawed2000

Union, NJ

#7751 May 8, 2013
Ozkayak wrote:
I had a repair done 13 years ago with a material that is Gore Tex white on one side and like a tan fuzz on the other. I have had pain for years, now I find out that the material has shrunk and fat and nerves have popped out in one area. I'm told the only fix is to remove the old material, it's 11 x 14 cm. not looking forward to this so can anyone tell me if this is the only option? I don't know what to do.
This is the same mesh that eroded in me and I had at least 4 "lysis of adhesions" procedures done, before It perforated my sm bowel & bladder. When they remove it have the use your own Davis to repair the damage. This means bringing in plastics to do abdominoplasty " tummy tuck". I would also suggest a GI consult & Urology evaluation to make sure no one else needs to be involved in removing the mesh. General surgeons Aren't equipped to Remove this mesh by themselves. A teaching hospital Is the best!! These doctors are more likely to evaluate and treat with more tenacity then the average!! I know from experience!!! Good luck to you. After two teams of 10 physicians & 12 hours of surgery I can Finally move forward. I was left with peripheral nerve damage and Live on pain meds. But I Live now Mesh Free!!! Lawyers, Government and physicians could care less abt mesh victims.. It's All abt $$$ to them..
Remember to get full evaluations prior to the surgery. U have but 1 chance to get it right!!!
ramshawed2000

Union, NJ

#7753 May 8, 2013
Lin wrote:
Morning 4/26 Friday. AMU & Bruce, just note haven't heard back from surgeon yet as what type mesh he will be using. Other wise taking it day by day.:}
No more mesh;!! I suggest You find a different doctor. Good luck
All Meshed Up

Whitewater, CO

#7754 May 8, 2013
ramshawed2000 wrote:
<quoted text>
No more mesh;!! I suggest You find a different doctor. Good luck
I am with you on this one, Ramshawed! With other underlying medical problems, Lin. I would be very careful with getting another mesh product, especially twice the amount as before, to get installed. I just hope that the removal goes smoothly because they usually have unforeseen complications usually from adhesions and migration. I for one will be thinking of you and hoping all will be well. Best Wishes.....
Lin

Eastaboga, AL

#7755 May 9, 2013
All Meshed Up wrote:
<quoted text>I am with you on this one, Ramshawed! With other underlying medical problems, Lin. I would be very careful with getting another mesh product, especially twice the amount as before, to get installed. I just hope that the removal goes smoothly because they usually have unforeseen complications usually from adhesions and migration. I for one will be thinking of you and hoping all will be well. Best Wishes.....
Hi Everyone, Thanks to all responses for your alls imput. I 've been down sick. It's beena kick in the BUTTT. This was reaiil off the wall, let me explain, back on May first, I got hungry for Tuna fish sandwhiches,( I use StarKist). in lite water, 2 small cans Kraft Mayo, all in date etc.... little onion. So I made (2) sandwhiches. All was fine. Until about 15 minutes later, I started getting hard gas pains under the left side breast. Then across the whole area. Hurt tried drinking little water , it helped . Then all at once my abdominal swelled, bloated really tighten up. OMG cramps, It felt like how one sees how a replaced skin for a drum being tighten up. I just couldn't do nothing, felt sick, but never did, turn paste white light headed, cold chills, then hot fever in which soaked a tee shirt. Then an asthma attack, I thought am I having a Fish allergy attack never have any allergies to before. So I took a fist full of Tums chewed with little water, about 15 min later, I took double amount of Benadryl liquid. I never have ever gone through anything like this before.( I thought I was on door steps of death.) So won't eat any kind fish for a while.
Lin

Eastaboga, AL

#7756 May 9, 2013
Got timed out from above post,#7754. I feel asleep after all of what ever happened. I did call Family doc, Gallbladder acting up, guess now allergy to fish. Which I guess I had been eating tuna in different ways,as of noddle shells and tuns salads, sandwhiches. crackers etc.. So cause been eating more of lately my system developed an allergy to it. Very odd!!!! Yet this has happen to me in other ways, Bees of all kinds, Any more I get stung server allergy, epie pen better be handie 24/7, same with posion ivy, sumac, oak, I guess my Immune system is fighting it's self. So anyway doc says gallbladder stones, from ct scan needs to be taken out. Yet cause of this, hadn't been in touch with surgeon about the other matter, just haven't up to it yet. Hopefully today I can. I feel like my computer does when it gets a virus in it. A mess. Oh the surgeon was suppose to have a written out Post Op report ready for me a week ago. Let you all know later today. Again Thanks AMU, RamShawed2000.
Lin

Eastaboga, AL

#7757 May 9, 2013
Gina wrote:
I had hernia repair, using proceed mesh in 2011 and have alot of problems with diarrhea, distended abdomen, nausea and have been unable to vomit since surgery. Not that I want to vomit, but I have had a couple viruses and could not vomit. Very concerned!! Has anyone had this problem after having hernia repair?
This happens to me when a new hernia comes on. I get this way when a new hernia comes up. I get nausea, heartburn, acid in belly burn back in throat. But with myself i have other med issues, Like you I had the proceed installed 4x6" Lap surgery in 2010.
Lin

Eastaboga, AL

#7758 May 9, 2013
PS I was told by a friend, that thatBeing I had lap surgery back in 2010, that I may have been damage to Gallbladder from the Rebot during Lap surgery! He heard from afriend of his that the robot lap machine has had its problems of such things happened to people. Guess I have togoogle it.
meshed up daughter

San Leandro, CA

#7759 May 9, 2013
MY mom is literally on her death bed. SHE has stage 4 cancer...ovarian. A rare sliw moving form. She had surgery August 2, 2010 for a hernia and ethicon proceed mesh was used. APRIL 2012 she underwent extensive surgery in an attempt to remove the mesh and repair the damage. March 2013 she underwent another surgery to remove an abscess caused by irritation of the remaining mesh whjch has melted into her small ingestine causing blockage.this week she was given days to live. Who is responsible? Where do I begin? [email protected]
All Meshed Up

Whitewater, CO

#7760 May 9, 2013
meshed up daughter wrote:
MY mom is literally on her death bed. SHE has stage 4 cancer...ovarian. A rare sliw moving form. She had surgery August 2, 2010 for a hernia and ethicon proceed mesh was used. APRIL 2012 she underwent extensive surgery in an attempt to remove the mesh and repair the damage. March 2013 she underwent another surgery to remove an abscess caused by irritation of the remaining mesh whjch has melted into her small ingestine causing blockage.this week she was given days to live. Who is responsible? Where do I begin? [email protected]
I have sent you an e-mail but it was returned as undeliverable. Your address is probably wrong. Please let me know and we will try to help as much as possible.
All Meshed Up

Whitewater, CO

#7761 May 9, 2013
There is a case in the Eastern District Court in Texas against Ethicon and specifically Proceed mesh for damages done by the mesh to the complaintant. In the filing it is alledged that the Mesh was defective but also that Ethicon FRAUDULENTLY advertised and promoted Proceed mesh to the public while knowing the Mesh was not effective and was defective. This will be an interesting case to watch mainly due to the emphasis on fraudulent advertising.. You can find the filing by Googling> Complaints/Ethicon Proceed Mesh.
George

Paramount, CA

#7762 May 9, 2013
We have a Facebook page for people with complications to the mesh if you have a Facebook please join, theirs a few (male and female) who have gotten mesh removed with positive outcomes !!!! The Facebook groups name is ....fighters and survivors of hernia and all vaginal pelvic surgical mesh

If you can't find it email me [email protected]
Celine

Brooklyn, NY

#7763 May 10, 2013
The vaginal mesh has been patterned from this hernia patch and as you may know several complications arise from these vaginal mesh devices such as infection, urinary incontinence, pain during sex, and perforation of the bladder or bowel among others. Try to check out http://avaultavaginalmeshlawsuit.com for comprehensive articles about the complications encountered in a vaginal mesh operation.
Terlin

Wayne, MI

#7764 May 10, 2013
I have whole body nerve pain we think from the
Mesh severe groin pain through to buttocks no urge. To defacate or urinate nerve pain through out legs and feet bad heart burn and
Now swallowing difficulty feels like my whole abdomin is collapsed intestines just hanging. Any body have complete abdominal wall colapse? Hissing in ears head presure

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