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.

Ellen

United States

#355 Oct 13, 2007
Linda Bass wrote:
I represent a client who had the Apogee mesh system used for rectocele repair. I would appreciate hearing from others who have had a rectocele repair. Please contact me with complete confidence:
Linda@lindabasslaw.com
Anyone that has this same problem please contact Linda
Jan

Minneapolis, MN

#356 Oct 13, 2007
Lana, thank you for the information. It is most helpful.
RKM

AOL

#357 Oct 13, 2007
My mother has had to have multiple surgery's since her first hernia repair, and just recently had to have another surgery due to obstruction of bowels after a knee replacement... Which has no resulted in another ongoing infection, and surgery today and one next week to remove mesh.... this is getting scary to say the least.. I would like to know how to go about tracking down the orignal mesh used for the first hernia surgery. Thanks

“frank”

Since: Sep 07

everywhere

#358 Oct 14, 2007
Dee wrote:
I WENT INTO SURGEORY IN JANUARY OF 05 FOR A RESECTION OF MY BOWELS. AFTER SEVERAL OPERATIONS THERE AFTER, IT FINALLY CAME TO A HERNIA REPAIR AND A MESH PUT IN.WITHIN LESS THAN 30 DAYS THE MESH HAD TO BE REMOVED, THE DOCTORS SAID MY BODY REJECTED THE MESH????? I'M NOT QUITE SURE WHAT KIND OF MESH IT WAS, BUT I JUST REQUESTED ALL MY RECORDS OF ALL MY OPERATIONS FROM THAT HOSPITAL. I CAN RELATE TO 90% OF THE OTHER TESTAMONIALS.HELP WHAT DO I DO?????
Dee My name is jim I live in browns mill and would seriously love to talk to you you have options my email is coach_jim2001@yahoo.com contact me please. I am now facing a third operation to have this mesh removed. it is not in your head and don't let these doctors tell you otherwise I have an MRI as proof that there is a problem. please contact me you are 10 min. away you need to know your options.Again coach_jim2001@yahoo.com

“frank”

Since: Sep 07

everywhere

#359 Oct 14, 2007
Dee wrote:
I WENT INTO SURGEORY IN JANUARY OF 05 FOR A RESECTION OF MY BOWELS. AFTER SEVERAL OPERATIONS THERE AFTER, IT FINALLY CAME TO A HERNIA REPAIR AND A MESH PUT IN.WITHIN LESS THAN 30 DAYS THE MESH HAD TO BE REMOVED, THE DOCTORS SAID MY BODY REJECTED THE MESH????? I'M NOT QUITE SURE WHAT KIND OF MESH IT WAS, BUT I JUST REQUESTED ALL MY RECORDS OF ALL MY OPERATIONS FROM THAT HOSPITAL. I CAN RELATE TO 90% OF THE OTHER TESTAMONIALS.HELP WHAT DO I DO?????
Dee by the way, I will guarentee that the mesh inside of you is the Bard Perfix Plug system, If you had the operation in Mt. Holly that is what they use first and foremost. please contact me with you number. I will only tell you the truth as much as it might be difficult you need to know the truth. I have been in constant dibilitating pain for 2 years now all because of a hernia operation I didn't need to begin with, but the surgeon performed one anyway. Email me your number so I may have 10 min. of your time. good luck. I only want to help you go in the right direction.

“frank”

Since: Sep 07

everywhere

#360 Oct 14, 2007
RKM wrote:
My mother has had to have multiple surgery's since her first hernia repair, and just recently had to have another surgery due to obstruction of bowels after a knee replacement... Which has no resulted in another ongoing infection, and surgery today and one next week to remove mesh.... this is getting scary to say the least.. I would like to know how to go about tracking down the orignal mesh used for the first hernia surgery. Thanks
RKM you need to go to the hospital, where the hernia operation was performed and request the COMPLETE chart of the day of the operation. Somewhere in that chart will be a label telling you what kind of mesh is inside of her along with the name of the mesh a model number and lot number. Then you need to get all of her patent records from the doctor who performed the operation. It probably, will only state that he uses a polypropyline mesh and wont be specific of brand name, you can ask hm/her what the brand is but he probably won't tell you fearing a lawsuit. they are very secretive. Good luck. As things have gotton so bad for me and I can barely help myself any more, maybe I can help others. also contact Lana from this site she has been so supportive for everyones cause. you will relly like her she is an angel. Jim
edy

AOL

#361 Oct 14, 2007
Every one tells me to give it time to heal. a right inguinal hernia felt tearing sensation after 2 week after that pain in stomach, leg ang groin area,3 prolen mesh was used been in hospital three times due to pain ct xrays nothing comes up. i feel a long hard feels like tube or somehing and it jabs me in the gut and groin area. after walking or standing or sitting leg gets numb and lower right abdomen starts too hurt and it feels really hot in the groin area. last surgeon i talk to told me it sound like neuroma. i asked him if the mesh could of buddle up and he sain that could not happen with this mesh. not sure what to do cant work tried to work but it was imposssible for me to stand for very long. any suggestion let me know getting very depressed and fustrated should i wait or keep looking for some surgeon to help .

Since: Oct 07

Miami, Florida

#362 Oct 14, 2007
edy wrote:
Every one tells me to give it time to heal. a right inguinal hernia felt tearing sensation after 2 week after that pain in stomach, leg ang groin area,3 prolen mesh was used been in hospital three times due to pain ct xrays nothing comes up. i feel a long hard feels like tube or somehing and it jabs me in the gut and groin area. after walking or standing or sitting leg gets numb and lower right abdomen starts too hurt and it feels really hot in the groin area. last surgeon i talk to told me it sound like neuroma. i asked him if the mesh could of buddle up and he sain that could not happen with this mesh. not sure what to do cant work tried to work but it was imposssible for me to stand for very long. any suggestion let me know getting very depressed and fustrated should i wait or keep looking for some surgeon to help .
Do Not Wait...it will not get better.

1) GOOGLE SEARCH:
prosthetic mesh used for inguinal and vental hernia repair: normal appearance and complications in untrasound and CT

2) FIRST LISTING ON GOOGLE:
Prosthetic mesh used for inguinal and ventral hernia repair ...
Pictorial review. Prosthetic mesh used for inguinal and ventral hernia repair:. normal appearance and complications in ultrasound and CT ...
bjr.birjournals.org/cgi/reprint/77/915/261.pd... -

3) CONTENT OF ARTICLE:
Pictorial Review from the British Journal of Radiology, 2004. This pictorial review illustrates the various radiological appearances of prosthetic meshes used for hernia and also demonstrates the post-operative complications associated with their implantation.

4) LINK:
bjr.birjournals.org/cgi/reprint/77/915/261.pd...

Print this article out and take it to a doctor.

That mesh is all balled up inside of you...they can find it. And it does not matter what kind of mesh it is, every brand of mesh has the possibilty of moving within your body by itself no matter which doctor put it in you.

This information is all over the internet and the doctors are irresponsible that they do not educate themselves to know the real complications of mesh and how to manage them.

Believe your self. You are the only one in your body and you know how you feel. Do you really think you have neuroma or do you believe the mesh is the problem?

There is a woman I know who is in intensive care tonight after a surgery last week (for something else). They have been telling her for a year that it is everyting else, including that she might have a neurogenic bladder. She has two meshes in her bladder and the problems only started after she had the operation to implant the Gynecare TVT mesh.

God bless you, Edy!
Find a doctor who will listen. Write me if you want. peace and blessings,Lana

my e-mail address: miamiblog@bellsouth.net
evelyne

Boise, ID

#364 Oct 14, 2007
I am between sacramento and lake Tahoe.If you are looking for a good Doc in cali. than research Stanford hospital on line they are a state of the atr hospital thats where I had my mesh removed good luck

Ellen,
I drove down to UC Davis Sacramento in May and saw a surgeon there.
she sent me to a physical therapist and later said she had seen "nothing obvious" about my hernia. consequently she felt there was no problem with my mesh. In spite of all the symptoms I was describing which pointed to pudendal nerve entrapment. She now is simply refusing to see me again or refer me anywhere, my pains arer out of her "expertise" and the hernia surgeon colleague she talked to supposedly said it could not be related to my mesh. How could he know since he never even saw me? Who did you see? Who removed your mesh? Were you happy
with his help? I need so much to find someone. I flew 2000 miles to see
someone in Philadelphia, an athletic oriented groin repair surgeon. He would not consider my hernia, and had me do an MRI of my hip (which did not hurt) and then recommended I'd go see a hip surgeon in Vale, Colorado!!! I had hernia surgery in september 2006 and have been in
pain since oct. 2006. I know it is not my hip. Can you please email me?
ebrigeois@fiberpipe.net
thanks you very very much in advance.

“frank”

Since: Sep 07

everywhere

#365 Oct 15, 2007
edy wrote:
Every one tells me to give it time to heal. a right inguinal hernia felt tearing sensation after 2 week after that pain in stomach, leg ang groin area,3 prolen mesh was used been in hospital three times due to pain ct xrays nothing comes up. i feel a long hard feels like tube or somehing and it jabs me in the gut and groin area. after walking or standing or sitting leg gets numb and lower right abdomen starts too hurt and it feels really hot in the groin area. last surgeon i talk to told me it sound like neuroma. i asked him if the mesh could of buddle up and he sain that could not happen with this mesh. not sure what to do cant work tried to work but it was imposssible for me to stand for very long. any suggestion let me know getting very depressed and fustrated should i wait or keep looking for some surgeon to help .
edy, this is not in your head and is absolutely not part of the healing process, I had a left inguinal hernia and had the identical problems you are having. they kept telling me it is in my head and is phantom pain, It is absolutely not phantom pain. I had a second sergery that I though he was going to remove the mesh, he did not, he dut and tied the nerve thinking that was the source of my problem. I am now having a third operation in 2 years, finally to remove the mesh. you need to get to a qualified surgeon and make sure you get an MRI done on your groin. It absolutely will show that there is a problem and if the people reading the results are good enough they will see the mesh, but if not they will see there is a problem in your groin. good luck coach_jim2001@yahoo.com
patti

United States

#366 Oct 15, 2007
My husband had hernia surgery 4 years ago with the mesh device being used for both of his hernias..since then he has had abdominal pain and pain in his scrotum area ..One side particually..Could this be caused by the mesh device????
patricia hernandez

Seattle, WA

#367 Oct 15, 2007
I had a hernia repair from a ventral hernia in 2005 i had lots of pain in abdomen after that surgery . i went back to doc. and seem like he didn't believe so i went to a different doc. in in may 18 , 2007 i had a mass tissue removal . with lots complications i had fluid collection draining out of my wound then my wound opened up very big you could even fit your whole fist inside . i also had a wound vac the doc told me the wound to heal from inside out and i was home bound for 3 months i also had mrsa ,infected seroma inflammatory tissue left inside my belly was very red and warm i had very low blood pressure temp of 103 and lots of nassea and pain i still have all that going on and who is there to help ? iask my self i feel like no one understands what im going through IT IS VERY PAINFUL. I ALSO FEEL PALPITATIONS IN ABDOMEN IF ANY ONE OUT THERE COULD YOU PLEASE TELL ME IF THATS DO ALSO TO THE KUGEL MESH THANK YOU.

Since: Oct 07

United States

#368 Oct 15, 2007
I had bilateral inguinal hernia repair in 2005. They used the Perfix Plug. I have been trying to tell doctors that there is something seriously wrong because the pain has increased two and three fold since then. I can't stand or walk for to long nor lye on my left side. Both my testicles hurt 24/7 including my groin, crotch, top of thigh and shin area. I have seen surgeons but they tell me everything seems fine. Yesterday, the pain went past 10. Does anyone have similar symptoms? What can you tell these surgeons to make them believe you? I have a more difficult task. I had a heart attack in 2000. It took me 20 months to find a surgeon who will do the surgery even though my Cardiologist gave me a verbal medical clearance. I need strong proof before a surgeon will cut me again. I believe the FDA is conducting an investigation on the Perfix Plug.
evelyne

Boise, ID

#369 Oct 15, 2007
Does anyone knows whether Dr. Parviz Amid has been or is being sued for malpractice? I have an appt. and would like to be sure I will not see another incompetent doctor...
dr. Meyers of Drexel Univ. Philadelphia was highly recommended by Dr. Sedlack. I understand some people have been happy with dr. Meyers. That was not my experience. and now I am finding out that Dr. Sedlack is
a doctor who is being sued...
Just to spare others my experience, I will share it here on this site. I flew 2000 miles from home to sonsult with Dr. Meyers. Had to wait several hours because so many patients had appts the same day with him. I saw him a total of 10 minutes max. I had filled the requested forms and I was there to discuss the issue of removing my hernia mesh. He did not even
examine it, instead he rotated my left hip asking whether it hurt. It did not.
He then said he would send me to have an MRI with dye of my hip. I am allergic to iodine so I asked his assistant whether I should start taking my allergy medication (which I had brought with me). she said, no need to,
iodine is not used for this test. when I showed up the next day for the injection of the dye, the doctor said he needed to use iodine in order to guide the needle to the right spot in the hip articulation. since I was "unprepared" he would insert the needle blindly and hope for the best.
Up to that point nobody had told me that the dye is gadolinium, a highly toxic product if it is not excreted by the kidneys rapidly. After the injection
I walk to the Jefferson imaging center, a few blocks away. there nobody
had been informed I was to have a hip MRI. after long discussions, they accepted to do it. A pelvic MRI was done at the same time. It took about 40 minutes total. when I got up, I had excruciating perineal pains, could not sit at all and could barely walk. after about 3 hours the pain started to decrease. On that day in the space of about 8 hours I only had had a cup of tea and a small Coke. so there was not much urination and elimination of the dye. Would you believe that NO ONE at the imaging center warns you of the toxicity and advise you to drink as much as you can after the procedure to help the body to get rid of this poison? a few days later I went back to ask for my own copy of the MRI report. I was very alarmed
to read one of the diagnosis "extravasation of intra-articular gadolinium into the obturator muscle compartment". At this time I was seeing a urologist who felt my pudendal nerve and obturator nerve may be entrapped and that the cause was most likely my hernia mesh. I asked what "extravasation..." was. basically the "blind" injection spilled into the obturator area, probably causing more pressure on the entrapped nerves.
I must underline that when I arrived in Philadelphia I had no hip pain whatsoever. After this MRI I had severe pain for a week or so, making it hard to go up and down stairs. But it was only after I returned home and
"googled" gadolinium that I realize what the consequences of this may be.
since 2000 there is a new disease called Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD). I quote from one of the web sites :
QUOTE People who receive kidney dialysis are a known risk but some people might have kidney problems and not be aware of them.
Gadolinium is poisonous. To protect the body from direct contact with
gadolinium used in injections, the gadolinium in the solution is chemically combined with chelates. Every manufacturer has a different ...
(please see next post)
evelyne

Boise, ID

#370 Oct 15, 2007
Follow up post (as each can only be 4000 characters long)
.......Every manufacturer has a different
patented compound with different molecular structures. In a person with normally functioning kidneys, gadolinium is eliminated from the body in less than two hours. However, in people with kidney problems, it might take up to 36 hours to eliminate gadolinium. During this amount of time,
the chelate compound becomes unstable as chelates have a stronger attraction for substances in the body, particularly iron. As time goes on, the chelates break their bond with gadolinium and attach to other substances, leaving the body unprotected from the poisonous gadolinium. UNQUOTE
At this point I do not know yet whether I could develop the disease or not.
One thing is certain, I did not eliminate the poison in less than 2 hours.
To add insult to injury Dr. Meyers felt that my mesh was not the cause
of my ongoing rectal-perineal pains (almost a year now) but s small
labral tear which was detected at the same time by the MRI. He advised
me to consult with a hip surgeon in Vale, colorado!! I returned to see the
urologist who felt very strongly my symptoms have nothing to do with my hip. Intensive search on Internet confirms this as well as the fact that
surgery is usually not recommended for such labral tear.
So I am back home suffering as much as ever, and living now with the fear that I could develop this new NSF diesease for which there is apparently no cure.
So I would like to warn EVERYONE, be very, very careful if you are to consult with this Dr. Meyers. He has little time to examine you or ask relevant questions, is mostly interested in athletic groin injuries and will do his best to make you fit the "mold", and his staff is not knowledgeable about the procedures they send you to have. I hope the above will help others to avoid possible dangers associated with this doctor.
evelyne

Boise, ID

#371 Oct 15, 2007
I would demand the tension surgery. I would also check out the hospital in Mexico and avoid the American doctors who I call trained idiots. The only hospital I trust is www.oasisofhope.com

HI, I fully agree with you. A friend anesthesist told me that over 50% of the doctors in this country are incompetent. would you believe I saw a hernia surgeon in my town and asked about removal of my repair mesh which is causing all kinds of trouble. He had 5 minutes time, pushed on my abdomen twice, saying "cough, cough again" and concluded I was fine, and my problem must be endometriosis. there never was a case in my family, I never had it in my reproductive years and am now past menopause. also my symptoms in no way ressembled that disease.
for his "consultation" he sent me a bill for 333 $ which I will dispute.
If you want to reach me : ebrigeois@fiberpipe.net
evelyne

Boise, ID

#372 Oct 15, 2007
Hi everyone I am in the uk and had surgery for a big hernia on christmas day, after the surgery about two weeks I kept getting hot and cold flushes and throat infections could not move my bowel unless I took laxatives, around about april this year my abdomen started to swell I went to my doctor who gave me antibiotics as my wound would not heal a few weeks after this my abdomen was that swollen people were asking me when my baby was due I saw my consultant who ordered a ct scan and said if there was anything wrong he would get in touch with me, I waited five weeks with a dull ache and thought it can be really seriouse they would have contacted me. I woke one morning and it felt as if someone was stabbing me I went to Accident and emergency in another hospital and the doctor was horrified at the size of my abdomen, to cut a long story short they operated and found the mesh had broken down into tiny pieces and I had and abcess which they drained five pints of puss and muck out of me,I have lost over a stone in weight and I have a big cavity where the abcess was my abdomen is disfigured for life and I still have adrain tube in I am eight days post op and my abdomen is still draining. the mesh was infected please if you get any swelling or pain please get it seen to I would not wish anyone to go through what I have.Until I get my medical records I dont know what mesh was used. I hope this helps

Because you are in the UK I am wondering whether you received one of the new European meshes as I have. I have been suffering for a year now and fighting to find a surgeon to remove the mesh. Mine is made vy Sofradim and is called 3D Parietex mesh. You can answer me at ebrigeois@fiberpipe.net if you like. Please let me know how you are doing in the meantime...
Ellen

United States

#373 Oct 15, 2007
Good luck Evelyne,it was nice talking to you what a story best wishes
Theresa -Buckeye AZ

Scottsdale, AZ

#374 Oct 15, 2007
Hi Everyone - this is an update on my mesh follow up. I filed a report online and received an e-mail from Med-Watch which advised me to contact the FDA. I went on the FDA website and called the number listed for my state. They called me back. I spent 45 minutes on the phone giving them all my information - including Name of mesh, product #, order # and manufacturer. I received this from the hospital where I had the Permacol mesh inserted in me. They were very interested in facts, Doctor's names & phone #, Hospital name and addresses, etc. I have a very full legal envelope with all this information. I went to each hospital and requested my full medical report including bill. I was assigned a case #. A little while later they called me back and informed that my file was being transfered to the Atlanta FDA (they had confirmed that is where the company is located that makes Permacol mesh), my case # was the same, I could still call the same women with any questions and she informed me that my report was immediately transfered to FDA Headquarters and a Medical Device Investigator.
Needlesss to say I was surprised that they called me back. I left a message on their phone line on Friday. I will keep everyone informed on what happens.

Most of all - my prayers and thoughts are with everyone. I feel so fortunate to have this mesh out of me. Recovery from each surgery was long and difficult,,,but worth it. I Thank God everyday that I found a surgeon who listened to me and did not rely on test results. Keep changing DoctorS TILL YOU FIND SOMEONE WHO WILL SIT DOWN AND TALK TO YOU!!! That is so important. Plus walk into their office with your full medical report from any surgery you had when the mesh was inserted. Contact That hospitals Legal Dept - that is what I did to obtain my Mesh information when the Doctors and Surgical Dept. would not respond to my requests.

We all need to keep the faith. Love and prayers, Terry

Since: Oct 07

United States

#375 Oct 16, 2007
Bruce wrote:
<quoted text>
Robert,
I will call you Wednesday. Likely you had a scan done and they won't diagnose mesh complication. Few radiologists recognize the problem, although they should recognize inflammation around the site of the mesh.(Now coined as a "Meshoma", a crumpled ball of mesh with scar tissue, entrapping nerves.) I'll give you the names of some physicians who might help you.. You may have to travel.
Bruce
Can you give me some names. I have had bilateral inguinal hernia repair in 2005. I also have hydroceles which are directly related to the hernias. I can't handle this pain anymore.

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