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

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I like most here have read through the vast range of posts on this board looking for answers for a loved one. My wife had a standard umbilical hernia repair back in 2004. After ten days or so she felt as though she had a re occurrence. It took almost a year for a different doctor to feel that she did indeed still have a hernia. We found a doctor locally (SW Chicago suburbs) that used what we were told was the Kugel patch. All seemed fine at first but not long after she had a lot of tenderness and pain in the same area. Of course we were told it wasn’t anything regarding the patch, so we looked at a variety of other things. A year later we returned to looking at the patch as a possible source of problems, but were reassured the one used was the smallest Kugel and wasn’t among the defective ones recalled. She was told she had an enlarged uterus, and was scheduled to have a partial hysterectomy. While in there we decided to have the same hernia Dr. re-do the patch. I know we know wish we had gone a different route but at the time it didn’t seem like “the” issue. Well a year later she continued to have increased pain and other weird symptoms evolve. We have been through an apparent misdiagnosis of porphyria and spent most of 2007 chasing that without the labs to support it. One of the things that fit with the porphyria were symptoms that seemed to indicate a wide array of autoimmune diseases. That is where we are at today, no known cause, and much abdominal and pelvic pain. We have had all the work ups for OB/GYM, G.I., you name it. Even went to Mayo last summer and was told there was nothing they found, so they suggested something called visceral abdominal pain which basically means they can find no source. As I said before she has shown indicators for a variety of auto immune diseases including sjogrens, crohns, rheumatoid arthritis, lupus, and hypothyroid (which she takes medicine for now). She often says she just feels ill along with the pain in her groin/abdominal area. Can anyone like Bruce tell me if these are similar symptoms that go along with cases where people experience mesh rejection. If so there are more symptoms to add and would like to see about any recommended doctors in the Midwest experienced with mesh complications and removal, maybe the Dr in St. Louis? FYI, she has been seeing a pain management specialist for as long as this has been going on. We have also requested her surgical reports. Like so many others, at the end of our ropes and looking for answers. Any constructive help would be appreciated.
Thank you.

DG, This is long, sorry!!(:
There are a few theories regarding (seemingly) multiple autoimune responses. Sympathetic symptoms such as night sweats, fevers, weakness, wasting (severe weight loss),
arthritic conditions,(misdiagnosis of lupis, etc.) Many symptoms are likely related to underlying infection trapped in folded mesh, or the pores of the mesh. Hidden small fistulas are hard to detect. Typical blood test may not identify the infection. Sometimes found at exploratory or finally when it breaks out as puss or sores. Try information for Phone number Dr. Robert Galloway in Georgia specializes in this.
Physical pain, though typical of nerve entrapment or the "meshoma" issue of a hardened lump of mesh and scar tissue putting pressure on adjoining structures is a problem because many patients, especially women had mistaken erroneous hysterectomies done, and bladder injuries from tapes for urinary incontinence (See Lana's excellent info on previous posts and her site.)
An excellent theory from Mary Ann Towne, PHD Physical Therapy (Ft. Lauderdale, Fl) is that of Myofascial Pain Syndromes: When the mesh and scar tissue contracts (inherent to mesh complication due to continuous foreign body reaction, which does not happen as severely in traditional non-mesh repair)..The various myofascial plains, from your head to your toes are distorted. This pulling effect can create pain far away from the source of contracture. Picture a t-shirt with graphed lines on it: now twist the groin area with your fingers. Note how the lines distort all the way up to the neck: Conclusion: A contracting mesh in the groin or mid-abdomen can create rib/chest pain, shoulder pain, leg pain. Posture can change, ambulation issues arise.
Your wife is not crazy or alone. You need the right doctor to recognize the cause and severity of her surgical injuries, possible adhesions, infection and mesh contracture. Try Dr. Galloway, or contact me at meshoma1@yahoo.com I'll try and find one for you. Prepare to travel.
Feel Better,
Bruce
National Meshoma Foundation

Had a hurnia repair done in 2001 still having problems with nerve damage.Hurnia in my groin how can I find out what mesh I have and how to find a doctor that will help me I hit a brick wall searching for help. simpsonsadie@aol.com

Chip wrote:

I had surgery for Crohns disease in 1992, took out part of my bowel. The incision became infected and I had to do wet to dry dressings letting it heal from the inside out. This happened while I was in the service. In 2005 I ended up with 2 hernias along the midline scar. I went in for surgery and a Bard Composix mesh patch was put in. I had quite a bit of discomfort, my DR worked with me and we got the pain under control. 6 months later I developed another hernia at the area where the patch would have ended. My DR put another patch in to cover that one. Now remember I suffer from Crohn's disease and stomach pain, fever, and most of the other symptoms most of you all have experienced. While reading the local paper I seen an ad for an attorney about hernia mesh being recalled. After getting copies of my surgical reports, I had the patch that was recalled. My Surgeon did not hesitate, about fixing it. After several discussions we decided to remove the memory ring that was the failure in the recall.
Surgery went well, I was told that the ring had not broke and he was able to remove it. I was also told that part of the mesh had rolled up and he had to disect it from the muscle. The pain in my side is now gone and I am doing well. My doctor also told me that since I have had so many surgerys that I would probably develop another hernia. I really trust my DR. He never tried to sugar coat anything and was upfront about every surgery he has done on me in the past 3 years. I hope you all can find a DR like mine. I know it is hard to find one that is not worried about being sued and worries about his/her patient. I have filed the paper work to go after bard and their defective patches. The law firm tells me that my case is strong. This is my hernia experience and I hope it might help someone to read something kinda positive.

Chip, I am so glad you found a good doctor. I just wanted to mention that in many of these bard davol mesh cases, they have discovered that the mesh shrunk after installation and pulled away from the ring - that's what I believe has happened to me.

My dad had hernia surgery two years ago and has had terrible abdominal pains, fever, passing out, due to blood clots and just had a device put in surgically, a filter to trap the blood clots hopefully as he could have died. He has felt bad since the mesh was placed and has had nothing but trouble, having to continue to go back and forth to the doctor.

Hello Michelle, if you have had the Marlex mesh installed that is a good place to start. Marlex mesh is now being blamed for infections 3-5 years or more after the implant. I have a friend who's Mother is now dealing with infections 8 yrs after surgery. Best Wishes.......rmh

Michelle wrote:

Hi, I have several hernia patches in my abdomen, I had a servere infection for over a year. I went in to have a hystorectomy but the doctor found more problems. My doctors told my family that there was to much damage & I wouldn't make it through the night but I did. I had infection built up in my stomach not to mention blood. Dr. Rupert Thomas went in prepared for complications so He took a surgeon with him just in case. I had a blood vessel in my stomach that was torn. He still doesn't know why I keep geting these infections but NO WILL TOUCH THE MESH IN MY STOMACH. So I have no clue what to do. The mesh I have is Marlex Mesh. I am just trying to find out if there is a recall on it.....
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Contact the hospital where you had the surgery and request your operative report. This will outline all the procedures and products used. Best of Lucl.......rmh

Karen wrote:

Had a hurnia repair done in 2001 still having problems with nerve damage.Hurnia in my groin how can I find out what mesh I have and how to find a doctor that will help me I hit a brick wall searching for help. simpsonsadie@aol.com

hi i had the xl kugel mesh patch that has been recalled and i had it done is march of 06 i have had trouble pinching pulling stingning burning terrible bowel problems. belly button drainage they did a incisianal repair... im scared to death i know it needs removed. but im scared to have it all cut away from the insides it has grown to ...and i refuse to go to just any surgeaon.. i want a professeoinal highly trained surgeion... im scared of pain... any ideas.

to all
In order to get anything done you must file an adverse event thru the FDA. It is kind of funny, now that I have been talking to the new point of contact of this so called invesigation the FDA has supposedly embarked on, they have reiteratted the fact to me that it is vey important to fill out the adverse event form. Now it is on their home page www.fda.gov when it never was before, then they tell you how to fill it out and what you should have in ways of documentation. If that is what they really want the lets make sure that is what they get, go to the website and get them filled out. The new point of contact seems to be a real B#&ch, hopefully I can get her removed from that post and get the old one back, he really did seem to care about what we are going thru.

I had hernia surgery 5 wks ago. I have experienced 2 seperate occurances w/abcesses and pain, nausea, no energy, insomnia, sweats and chills, swelling of my hands and face along with my entire body turning fire engine red. Not to mention the various blisters on my stomach and hip on the same side the hernia was on that start to heal then refill. Every time my husband and I ask about rejection the doctors change the subject. Do these symtoms sound familiar to anyone. I have searched the internet to see if there are any postings for similiar and haven't found any. Please help.

ive had 5 left inguinal surgeries with mesh i have so much pain i cannot work & often up all night in hellish pain. iwas told if they tried to take the mesh out , idprobably die. my last surgery was in 1998 anyone know if the mesh they used was defective? thks ken

KenG riffiths wrote:

ive had 5 left inguinal surgeries with mesh i have so much pain i cannot work & often up all night in hellish pain. iwas told if they tried to take the mesh out , idprobably die. my last surgery was in 1998 anyone know if the mesh they used was defective? thks ken

You need to post what type of mesh you have

amy wrote:

hi i had the xl kugel mesh patch that has been recalled and i had it done is march of 06 i have had trouble pinching pulling stingning burning terrible bowel problems. belly button drainage they did a incisianal repair... im scared to death i know it needs removed. but im scared to have it all cut away from the insides it has grown to ...and i refuse to go to just any surgeaon.. i want a professeoinal highly trained surgeion... im scared of pain... any ideas.

Amy,
Please contact me ASAP, I will refer you to a surgeon in Mo. familiar with mesh removal. The problems with your patch are well documented. Your fears of greater injury are understandable, but you need further treatment right away. You describe symptoms of infection.
Let us know also if you have completed any scan, antibiotics given yet, and what does your surgeon have to say? Contact me at meshoma1@yahoo.com or brosenberg1@bellsouth.net I'll help you out.

Feel better,
Bruce
National Meshoma Foundation

my husband has been in and out of the hospital so much its our second home he has had injections hes has small bowel perforation and cronic enteric fistulas he get small bowel upstructions been in and out of the hospital so much
he was spend 45 days at a time in the hospital for the last five years the mesh is falling apart some of it is still there some the doctors have taken out what they can get too we live in fear the the fisulas will be back anyday the doctor told us this will happen my husband stomach looks like a road map help ua thank you mr solomon mullins i'm fixing to get me a lawyer

I just received a letter from the FDA August 11, 2008. It states that in reviewing existing events, FDA has determined that many of the adverse events are NOT due to an inherent problem with the implanted material but with where and how the mesh is implanted. If the mesh is not properly placed or properly secured, it can detach and migrate, resulting in painful sequelae. The goal of our labeling review and patient information is to make physicians and consumers more aware of potential adverse events and steps to be taken to avoid such problems. It is important to keep in mind that FDA does not regulate the practice of medicine, which is overseen by the state, nor does the Agency specify what type of training a surgeon must have to make use of these meshes in their practice.

The letter was delivered to Senator Casey. I sent him letters in March. I just typed the last two paragraphs. The typed name at the bottom is from Stephen R. Mason. But the person who signed it, I can't make out their signature. My complaint is against the Bard Perfix Hernia Plug of Murray Hill, New Jersey.

I am sending Senator Casey additional material that will put the FDA on the right track. I will also tell thme that I even talked with Dr. Bruce Ramshaw and what he told me.
In any event, when filling out those adverse events, be specific and write down that these meshes are causing you the problem. There is a bit of confusion when the FDA is reading them. Try to mention over and over again that the mesh shrinks and the nerves got entangled in the mesh causing you such debilitating pain.

Did anyone have hernia repair done laparoscopically and have a lump near the naval? I was told by the surgeon that it is scar tissue from where the camera went in. I would like to know if this normal or common. Thanks!

Mike from Philly wrote:

Did anyone have hernia repair done laparoscopically and have a lump near the naval? I was told by the surgeon that it is scar tissue from where the camera went in. I would like to know if this normal or common. Thanks!

I started out with a lump and it's developed into a huge bulge over half my belly - from my symptoms i'm guessing that the mess has balled up and moved my colon to a new location. going to dr. next week. are you having any pain or abnormalities associated with it?

Jan wrote:

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I started out with a lump and it's developed into a huge bulge over half my belly - from my symptoms i'm guessing that the mess has balled up and moved my colon to a new location. going to dr. next week. are you having any pain or abnormalities associated with it?

Hi Jan,
I can not touch it. It is really sore. I see the surgeon for a follow up again in 2 weeks. I showed it to him but wasn't reallly concerned. However, I am going through enough pain as it is and I don't need it. Thanks Jan.