Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8246 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.

Sheryl Ginter

Arlington Heights, IL

#108 Jul 27, 2007
I had a quite large incisional hernia located in the unmbilical area. I had an 18 X 18 CM Prolene Mesh patch used. Since my surgery, 8/31/04, I have had pain in the left side of my belly. I bend over and it hardens as if something is flipping over and then I have to wait 5 minutes or so for it to undue what it did. It then makes the area sore. The doctor told me it was maybe the bowel flipping over the edge of the patch and unflipping. Either way, it causes pain. If I file in a lower drawer at work or if I pick up dirty clothes off the floor, it happens. I also have sensitive skin over the area. Almost a burning sensation when my stomach area is touched lightly. Anybody ever experience this? Let me know. Thanks.
lynn

AOL

#109 Jul 27, 2007
My husband had a dualex mesh implanted during hernia surgery.

Later the doctor removed it.

I'm curious, how was everyone else's patches removed?

Was there anesthesia?, hospital visits? In patient? Out patient? surgery?
linda oppelt

Fort Myers, FL

#110 Jul 27, 2007
QUOTE who="sparky"LINDA, I got all my information from the hospital I have prolene mesh patch (PM II) SIZE 3 INCHES BY 6 INCHES and used on two hernias Nov. of 2005 . I have been sick every
since the surgery and alot of pain. My daughter age 41 also had the pml prolene mesh by ethicon and has been very sick since Dec. 2004 with renal kidney problems. We are in the process of getting the information for the hernia doctors and fda, Hope you have good luck.
I am in the process of rounding up all my dads records to find out the serial numbers for everything they put inside him. I have digital pics of my dads last surgery and it is so plain to see that it was the mesh that was all twisted up around his bowel. I have got to get to the bottom of this for him. I have never seen anyone in that much pain in my life. And as far as I know, they are still using the same patch because I don't think it's been recalled yet..........will keep you updated linda
lana

Sevierville, TN

#111 Jul 28, 2007
margaret wrote:
I ALSO HAD THE PROLENE MESH PATCHREPAIR SURGERY IN 1993 AND HAVE HAD BURNING, STINGING SENSATIONS ALONG WITH CHRONIC DIARRHEA SINCE THE SURGERY. I WOULD LIKE TO KNOW IF THE PROLENE MESH IS RELATED TO THE KUGAL PATCH AND OR IF THE SAME COMPANY MAKES IT. <quoted text>
Cheryl,

The Prolene mesh does not have to be recalled to be the problem. The mesh causes a foreign body response.
Your husband's native tissue will grow into the mesh over time. The edges of Prolene mesh can be very abrasive and cause tissue necrosis and continuing pain as the process repeats itself as it continues to abrade and kill tissue and then heal itself and then the process starts over again.

The sooner you deal with it the better. As the tissue grows into the mesh, it becomes more difficult to remove without damaging healthy tissue.

That violent a reaction means your husband's system was probably trying to get rid of the mesh. Do not think that is normal. It is not. Don't listen to anyone who tells you different.

I had a Gynecare TVT tape, a bladder suspension tape, implanted in me in 2001..it is made of Prolene mesh which is a patented product of Ethicon, Inc, a Johnson & Johnson Company.

I got necrotizing fasciitis (flesh eating bacteria) and almost died from the Gynecare TVT tape which is also a Prolene mesh.

hope your husband is doing better...please feel free to contact me at any time...Lana

[email protected]
Bruce

Fort Lauderdale, FL

#112 Jul 29, 2007
Sheila - Florida wrote:
My husband had hernis surgery in March of 1999. He has had abdominal pain EVER since. He went back to the surgeon once and was told he would have pain for awhile. He has dealt with this pain ever since. Last year it started getting much worse and affected his being able to work, and he had to stay home from work sometimes. He has been to doctors & specialists MANY times and had MANY tests run; including CAT scan,Upper GI w/scope & biopsy, Lower GI, lower intestines live x-rays, colonoscopy, numerous x-rays, blood work to test for other things. ALL the tests came back clean! He has been out of work for two months now. He has an appointment with the surgeon that did the surgery on Thursday. His symptons include pain and burnig in the area and radiating out from the spot of the hernias, nausia, bloated/swollen stomach & ab area, inability to wear anything snug against area, severe pain, fatigue. We feel it is caused by the screen used. We are in the process of getting the information needed to verify what screen was used. if any of you are having issues contact your doctor IMMEDIATELY! If you have trouble remembering who the doctor was, call the hospital you had the surgery in. That is how we got my husbands records. I wish you all luck. Sincerely, Sheila
Sheila,
Please E-mail me as soon as possible. I may have answers for you as I have been researching Mesh complications. I have been suffering for three years after mesh surgery. E-mail me your phone # at [email protected]

Thanks and good luck.
Bruce

Fort Lauderdale, FL

#113 Jul 29, 2007
Daniel wrote:
<quoted text>
my name is daniel and i live in perris ca.I also have the PHS mesh patch and plug.ive been having constipation,Bad lower abdominal pains to the point of passing out cant handle it any more ive been going to the doctors since 2004, they still tell me they cant find anything wrong with me,so i still suffer
**Daniel,
You are not alone, and not crazy.
I have suffered three years now, four operations.
I have much research for you and can recommend a surgeon who can help you. My mesh caused kink in my sigmoid colon with same symptoms. Everything got better when mesh removed and "Shuoldice repair" done. Please e-mail me directly at Brosenber[email protected] for referral info. Don't give up.

Bruce
James

Tyler, TX

#114 Jul 30, 2007
Wil the surgeon even tell me if the patch used on me is a recalled one?
James

Tyler, TX

#115 Jul 30, 2007
Will my surgeon even tell me if the patch used on me is recalled or even know
James

Tyler, TX

#116 Jul 30, 2007
If mesh patch is remved what is used in its place? [email protected]om
Bruce

Fort Lauderdale, FL

#117 Jul 31, 2007
Linda Kaiser wrote:
I had inguinal hernia surgery in jan of 06 & i still have pain. No 2 days are the same. According to the oper report it was a PHS mesh that was used.. Does anyone have any info on this? It is making my life miserable living with this
Linda -please contact me ASAP as I have info for you re: PHS mesh; Some answers and contact #'s of potential experienced treatment providers. E-mail me your phone # at [email protected]

Bruce
Bruce

Fort Lauderdale, FL

#118 Jul 31, 2007
linda oppelt wrote:
Has anyone had any experience with a patch called "prolene mesh patch?" Recently my dad went to the local emergency room keeled over in pain from his abdoman. He sat in a room for 4 days until they decided what to do. They ended up doing surgery and finding the "prolene mesh patch" that he had put in to repair his hernia in 2000 broken apart and wound around his lower bowel strangulating it. The surgeon that did the surgery took digital pics to show me how bad that mesh had become entangle in his bowel. Well needless to say, I watched a healthy man of 70 proceed to die in agony in the course of 6 weeks in the ICU. They cut out the mesh and his bowel went back to normal. But during the course of the surgery, he got sepsis. Then he was down so long he got pnemonia. I recently read where in the early 2000's there was a prolene counterfiet that was being sold to hospitals with the hospitals unaware that the product was not the real thing.The company has admitted this. I guess I need to find out somehow if my dad had that fake mesh. Somehow someway sombody needs to be held accountable for this mix up. I never thought a man who never missed a day of work in 50 years would lay in front of me and suffer in agony with me standing by helpless. If anyone knows or has had experience with this please write and let me know. I have retained council.It's time we held these companys accountable for their actions......Linda
Linda please contact me ASAP as I need to speak with you about your experience. I have been researching this over three years, have been suffering the entire time. I have alot of info for you. Send me your phone # at [email protected]

Bruce
carole-ok city

Bethany, OK

#119 Jul 31, 2007
UPDATE!!! I received my hospital final diagnosis today. Not sure why yet, but the hospital said no cultures were done, just a gross. Believe you me, I am going to find out, because I specifically made my surgeon promise to do cultures on everything including the mesh. What the report does tell me, however, is what I suspected all along & my surgeon kept acting like I was crazy! The report states "INFLAMMATORY REACTION TO PROLENE MESH. THERE WAS A NODULE PALPATED THROUGH THE EXTERNAL OBLIQUE, LIKELY RELATED TO THE MESH. THE PERITONEUM WAS VERY ADHERENT TO THE PREPERITONEAL PATCH, THE PERITONEUM WAS EXCISED WITH THE PATCH. IT COULD NOT BE DISSECTED AWAY FROM THE PROLENE HERHIA SYSTEM. THIS ALLOWED COMPLETE EXCISION. A BASSINI REPAIR WAS PERFORMED. THERE WAS ABSOLUTELY NO INGUINAL FLOOR, SO THIS REPAIR HAD TO BE PERFORMED." I hope this helps many of you out there who are suffering like I was. I am still sore from my surgery, but many of my symptoms have disappeared. I am so glad to have that patch out of me!!! I would appreciate it if someone would email me if you know of any list I can get on regarding problems with this mesh. My email is [email protected] Thanks! Carole
Bruce

Fort Lauderdale, FL

#120 Jul 31, 2007
Anyone who has been suffering since having an Ethicon PHS (Prolene Hernia System) or Ethicon Proceed Patch installed Please contact me at [email protected] immediately. Please leave your phone # on my E-mail.. I will call within 24 hours. I have been researching this problem after suffering for three years. You are not alone, not crazy. I will provide Research info and contact #'s for potential experienced treatment providers.
carole-ok city

Bethany, OK

#121 Jul 31, 2007
James wrote:
If mesh patch is remved what is used in its place? [email protected]
James, no patch is put back in. My surgeon did the Bassini repair, which is the original good old-fashioned way. Good luck!!
Bruce

Fort Lauderdale, FL

#122 Jul 31, 2007
carole-ok city wrote:
update- My surgeon removed my prolene patch this past wednesday. I have not gotten a real update yet. Am going to see him in a few days. He said there was a large irritation & he cleaned out the area & put antibiotics in there. Well, the same thing has happened again and I have redness,pain, and swelling in the abdomenal area! I went to the ER on thursday night & they said it looked liked cellulitis & they gave me atibiotics & meds for vomiting. I am so fed up with all the problems this mesh patch has caused me. Will keep you posted when I see my doctor next week. Of course, he was out of town this weekend & no other doctors want to get involved.
I am interested in speaking to you ASAP. I too had PHS mesh. Severe pain in feet was told plantar fasciitis. Had walking/gait problems. When mesh removed all pain disappeared. Had another mesh put in, disabling pain in both feet and legs since. I have much research on these problems. Please e-mail me your phone # at [email protected]
Bruce
Bruce

Fort Lauderdale, FL

#123 Jul 31, 2007
Sheryl Ginter wrote:
I had a quite large incisional hernia located in the unmbilical area. I had an 18 X 18 CM Prolene Mesh patch used. Since my surgery, 8/31/04, I have had pain in the left side of my belly. I bend over and it hardens as if something is flipping over and then I have to wait 5 minutes or so for it to undue what it did. It then makes the area sore. The doctor told me it was maybe the bowel flipping over the edge of the patch and unflipping. Either way, it causes pain. If I file in a lower drawer at work or if I pick up dirty clothes off the floor, it happens. I also have sensitive skin over the area. Almost a burning sensation when my stomach area is touched lightly. Anybody ever experience this? Let me know. Thanks.
Sheryl,
You are not crazy. I too experienced this with Prolene mesh. The burning sesation was severely aggravating, I couldn't tolerate even the feeling of a/c blowing out of the car a/c vent. I'll search my medical records for the diagnosis I was given. Went away immediately after the mesh was removed. Please contact me at [email protected], provide your phone #, I will call you to discuss your problems and provide research info.
Bruce
ericka j

AOL

#124 Aug 1, 2007
I have had 2 inguinal hernia surgeries (left and right side) and 3 c-sectionsand a Right Leg vein removal.The first hernia repair was in 2003 and was repaired w/ mesh.The doctor and the hospital (i went to the records dept more then once) say that the make and model of the mesh used isnt in my report.They say they have searched and find nothing.I got a copy for myself and there is nothing in theer with a name make model.Only thing in the procedure report is Mesh used to repair indirect inguinal hernia. I cant come up with a thing on this.The dr and hospital are not being to easy about this.What steps can i take to find out what is inside my body?.I want to know!.My second repair on the opposite side was jan 12,2007.the perfix plug mesh was used.This repair hurts worse then the actual hernia.I wish I wouldnt of had it placed in to me.The pain and burning radiates from the plug mesh down my groin and into my leg.It gets to the point I am scared that there is something wrong in there!.I have noticed the past week a small buldge developing again.Could this mean that it has come loose?. I have made an apointment for the first of september. I have had so many surgeries that im scared to do it again. I can barely hold my children on my lap as it is.Is there any type of disability for having to many stomache surgrys? I have not went back to work since my surgry.I was diagnosed march of 2007 with degenerative disk disease/arthritus and spina bifida occulate and possible nerve damage. I mean how much more can i be dished.Im a single mom of 3 supporting my kds and myself on child support and extra help from there father.I cant imagine going back to my job like this.I just dont know what to do??
Rodney

Atlanta, GA

#125 Aug 3, 2007
My father received the Ethicon Prolene Hernia System patch on 9/20/06 and died 5/28/07 as a result of a part of the patch breaking off and sticking to his itestines.
Rodney

Atlanta, GA

#126 Aug 3, 2007
My father received the Ethicon Prolene Hernia System patch on 9/20/06 and died 5/28/07 as a result of a part of the patch breaking off and sticking to his intestines.
[email protected]
Sam Pringle

Macclenny, FL

#127 Aug 4, 2007
I also had the Kugel Mesh implanted as a graft after hernia surgery....6 months later i was in the emergency room with a fever of 105* and excruciating pain....I woke up after surgery to find a hole as big as my fist. They placed a WOUND VAC on my stomach for 6 weeks. I still have pain...constipation and a surgeon that basically told me that he didn't know of the recall and even if he did ...he is too busy to call patients....This is a sad way to treat patients...I wouyld sincerely like to operate on him...to fill in the hole in his head and the hole in his soul and then stitch his hole closed( both ends!)

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