Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8244 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.

Howie

Centreville, VA

#2547 Aug 26, 2009
Removing mesh:Mentioned Previously by a researcher
in Columbus,Ohio

Best surgeons:
Dr. Bruce Ramshaw - Univeristy of Missouri
Dr. Shirin Towfigh - Cedar Sinai , LA
Dr. Peter S. Billing - Puget Sound Surgical, Edmonds, WA

This was in a college newletter at Columbus. Please mention this if you call any of these surgeons.

Thank You
Howie Green
___Sandra___MS__ ____

Brandon, MS

#2548 Aug 26, 2009
wolf99 aol
Hi wolf99, right on girl. You are right about the things you've been talking about. Whenever there's money involved, people get taken advantage of in the medical field and other fields as well. Sometimes guys just don't get it.
Sometimes I think they're on another planet. Maybe planet Crypton or something. Anyhow, I've had problems getting my entries on this site. I've sent you many entries which didn't get through. I had to start entering my name in a different way. Senatobia was just too long. I'm
still trying to figure out what to do about my situation also. I'm trying to get hold of a specialist, the best, I've heard. I missed his call, my fault. I'll keep trying. Hopefully, I will find out one way or the other which way to go. I don't think I can live with this mesh forever. Keep trying. Don't give up. God's going to bring you through this ordeal. There are still good surgeons out there who really care. We have to believe that. Sandra
Bruce

Hollywood, FL

#2549 Aug 26, 2009
Hey all,
Bruce here, haven't posted in awhile. Have been doing much research into mesh complications. Early research (Klinge, et al) dating back to 1992 and again 1999 indicates the manufacturers knew of materials degradation and contraction. Great book by Maximo Deysine supports mesh infection complications.(available on Amazon, if you have mesh infection buy this book. Dr. Galloway in Georgia works on mesh infection patients. Studies by Shin, Goldstein, Fitzgibbons support infertility-spermatic cord and seminal vesicle injury by mesh erosion/contraction. Even a perfectly implanted mesh can degrade over time and contract, erode through surrounding structures due to chronic foreign body response, excessive inflammation leads to severe pain, need to remove the product. You were not told of this potential failure, which is what it is...product failure. And lies...inhumane treatment abounds for the sake of big company profits.
By their own admission, the industry researchers are finding rates as high as 30% chronic pain with mesh. Shouldice in Toronto claims < 2% complication rate. Had we had known...We would have gone to the great white north. There is no true treatment protocol for mesh removal or pain treatment. True permanent injuries..
So what to do? Make it better for those future patients. The progression of science will make a better mousetrap, a safer mesh.
Your pain is the result of a mechanical foul-up:
Nerve entrapment, cord entrapment, infection/seroma, "Meshoma" (google Parviz Amid) direct pain from balled up contracted mesh.
You must report to the FDA Adverse Event line. You must call the manufacturer customer service line your symptoms and product.
Most of all, you should not give up.
I won't. More research to come, names of helpful physicians, and a plan. E-mail me with your name, symptoms, product and your contact info. I am collecting data for a database.
Meanwhile, Hang in there, and feel better,

Bruce [email protected]
National Meshoma Foundation

Mark

Seattle, WA

#2550 Aug 26, 2009
To the Doctor: I had complications due to a severely protracted (folded up) heavy weight mesh that was removed laparsocpically with a TAPP repair.
I had a couple of adhesion removal surgeries since then and I think they are coming back.(Note the replacement mesh was a light weight Ethicon mesh)
I was thinking about having another surgery to remove the adhesions again but then I was reading about someone who went to see Dr. Towfigh. She did an adhesion removal using an open incision using SeprFilm. I was told she used two layers of Separfilm. They also said Seprafilm is hard to work with Laparoscopically. Can you tell me what you would do to remove adhesions?
Is Dr. Towfigh's idea a good one and if so, how long is the recovery time.
wolf99

AOL

#2551 Aug 27, 2009
Bruce wrote:
Hey all,
Bruce here, haven't posted in awhile. Have been doing much research into mesh complications. Early research (Klinge, et al) dating back to 1992 and again 1999 indicates the manufacturers knew of materials degradation and contraction. Great book by Maximo Deysine supports mesh infection complications.(available on Amazon, if you have mesh infection buy this book. Dr. Galloway in Georgia works on mesh infection patients. Studies by Shin, Goldstein, Fitzgibbons support infertility-spermatic cord and seminal vesicle injury by mesh erosion/contraction. Even a perfectly implanted mesh can degrade over time and contract, erode through surrounding structures due to chronic foreign body response, excessive inflammation leads to severe pain, need to remove the product. You were not told of this potential failure, which is what it is...product failure. And lies...inhumane treatment abounds for the sake of big company profits.
By their own admission, the industry researchers are finding rates as high as 30% chronic pain with mesh. Shouldice in Toronto claims < 2% complication rate. Had we had known...We would have gone to the great white north. There is no true treatment protocol for mesh removal or pain treatment. True permanent injuries..
So what to do? Make it better for those future patients. The progression of science will make a better mousetrap, a safer mesh.
Your pain is the result of a mechanical foul-up:
Nerve entrapment, cord entrapment, infection/seroma, "Meshoma" (google Parviz Amid) direct pain from balled up contracted mesh.
You must report to the FDA Adverse Event line. You must call the manufacturer customer service line your symptoms and product.
Most of all, you should not give up.
I won't. More research to come, names of helpful physicians, and a plan. E-mail me with your name, symptoms, product and your contact info. I am collecting data for a database.
Meanwhile, Hang in there, and feel better,
Bruce [email protected]
National Meshoma Foundation
Hi Bruce, Thank for your posting this. This is even posted when these meshes have been patent penned. Look at patentstorm.com at the history of any one mesh.
Kent

Edmonds, WA

#2552 Aug 27, 2009
IMPORTANT NEWS

On Dr. Goodyears board, someone commented that Dr. Ramshaw is leaving his practice. I find this hard to believe. Does anyone have any first hand knowledge?

He was one listed with Dr. Shirin Towfigh at Cedar Sinai and Dr. Peter S. Billing near Seattle (Edmonds)

Dr. Ramshaw was featured in a college newspaper in Ohio by a student who had severe mesh problems that he resolved.
Dave

Rapid City, SD

#2553 Aug 28, 2009
Mark wrote:
To the Doctor: I had complications due to a severely protracted (folded up) heavy weight mesh that was removed laparsocpically with a TAPP repair.
I had a couple of adhesion removal surgeries since then and I think they are coming back.(Note the replacement mesh was a light weight Ethicon mesh)
I was thinking about having another surgery to remove the adhesions again but then I was reading about someone who went to see Dr. Towfigh. She did an adhesion removal using an open incision using SeprFilm. I was told she used two layers of Separfilm. They also said Seprafilm is hard to work with Laparoscopically. Can you tell me what you would do to remove adhesions?
Is Dr. Towfigh's idea a good one and if so, how long is the recovery time.
I wouldn't recommend it. Why place an open incision with its own inherent risks of hernia, wound infection, etc. I think that a diagnostic laparoscopy is sufficient. Document their presence and perform a simple adhesiolysis. The efficacy of seprafilm is questionable. I still place it in certain situations, but it may not absolutely prevent adhesions.
Dave

Rapid City, SD

#2554 Aug 28, 2009
Bruce,

I hate to say this, but I think your facts are incorrect. The 2% you quote is also what the Shouldice clinic quotes for recurrence of hernia. 30% for chronic pain is way too high. I think if you asked every surgeon what they see in their practice, and you would get the answer "rarely". There are a number of good studies that discuss chronic pain as being the same with any type of hernia repair regardless of mesh. Another interesting subject to research regards patients who have undergone surgery for worker comp related issues and how many of those patients have chronic pain as compared to the general population. This study exists and is an interesting read.
Medical Nightmare

AOL

#2555 Aug 28, 2009
Dave wrote:
Bruce,
I hate to say this, but I think your facts are incorrect. The 2% you quote is also what the Shouldice clinic quotes for recurrence of hernia. 30% for chronic pain is way too high. I think if you asked every surgeon what they see in their practice, and you would get the answer "rarely". There are a number of good studies that discuss chronic pain as being the same with any type of hernia repair regardless of mesh. Another interesting subject to research regards patients who have undergone surgery for worker comp related issues and how many of those patients have chronic pain as compared to the general population. This study exists and is an interesting read.
Dave,

Please accept my apology for cutting in on Bruce's blog. I am not comupter savy and thought perhaps you could answer a quick questin for me. Someone wants to do a ultrasound on my abdomen to see what is happening with my recalled mesh. Is this an effective test? I heard that one has to undergo the knife again. I want to leave everything alone. Thank you for your consideration.
wolf99

AOL

#2556 Aug 28, 2009
Dave wrote:
Bruce,
I hate to say this, but I think your facts are incorrect. The 2% you quote is also what the Shouldice clinic quotes for recurrence of hernia. 30% for chronic pain is way too high. I think if you asked every surgeon what they see in their practice, and you would get the answer "rarely". There are a number of good studies that discuss chronic pain as being the same with any type of hernia repair regardless of mesh. Another interesting subject to research regards patients who have undergone surgery for worker comp related issues and how many of those patients have chronic pain as compared to the general population. This study exists and is an interesting read.
Hi Dave, How are you tieing Workers Comp in with Hernia's? I will say that employer's and their attornys fight to the end over this issue. Mine was job related, but the night mare that went with it. I feel that the case studies to research is of indigent care in emergency case, compare to those that have coverage.
wolf99

AOL

#2557 Aug 28, 2009
wolf99 wrote:
<quoted text>Hi Dave, How are you tieing Workers Comp in with Hernia's? I will say that employer's and their attornys fight to the end over this issue. Mine was job related, but the night mare that went with it. I feel that the case studies to research is of indigent care in emergency case, compare to those that have coverage.
Dave I had to sign out earlier. Phone call coming in. I need some answers. I am having fears over this next repair. With all this mesh causing problems. Why would a surgeon ever use the Mayo Technique when other prior surgery is present. I know he had know that their was a higher risk of recurrence, this just don't make any sense at all. The only thing that does is that I fell under the county emergency indigent medical needy program. This after three weeks after being told I had entrapped herina, and need quit job right then, and became under doctors care. What could of posible changed the surgeons mind, after being under the scalpel, he never said anything about infection after the removal of the entrapment. The only thing I feel is because of the time of surgery, it cut into the county budget, the last 1/4, with the holidays. Looking for the lowest cost to fixing it.
ken griffiths

Lloydminster, Canada

#2558 Aug 29, 2009
hi Duncan, but what about these top notch surgeons. Have they ever removed mesh from a guy like me who has had 5 left hernia operations w/ mesh put in eveytime? Sholdice clinic refused me because they said if i got it removed, I most likely would die on the operating table. Also I have sever nerve damage because in 1994 they dissected my illoinguinal and femoral nerves I cannot sleep most nights because of hellish pain. Do you think they could help me or am I incurable? thanks for your posts. By the way if any Canadian wants to enter the lawsuit for mesh problems contact lawyer ''Ken Kolthammer in Edmonton Alberta
wolf99

AOL

#2559 Aug 29, 2009
To Dave or Bruce, Hi. I don't remember where I read this. "The comment was that their is not that many people that have either repeated mesh or hernia problems after the first repair". Is this a true statement? Is the ratio a small amount, compared to people that don't have problems? If it is or isn't has their ever been some type of report as to why. If people's bodies are not rejecting the mesh, is the problems, lieing that heavy on mesh surgery not properly being done right?? I read where some people have had more then 2 or more surgeries.
Michelle

Kenmore, WA

#2560 Aug 29, 2009
Shouldice will not operate on hard on hard to find occult hernias not recurrences of occult hernias. In other words, don't waste your time going to Toronto. They play a game- an easy game. Do a lot of simple repairs.

In contrast to Dr. Kevin Petersen in Las Vegas, who I "also" talked with, he will take on hard cases and is not afraid.

But on the other hand, I don't know where Dr. Ramshaw is going. I believe he is going into private practice somewhere. My guess is this will give him more freedom to use innovative techniques. Could he be interested in Rebound HRD I don't know.

!. Dr. William Meyers in PA
2. Dr. Peter S. Billing in the state of Washington
3. Dr. Shirin Towfigh, at Cedar Sinai.

I would suppose you can contact these surgeons by phone if you are out of state etc. I don't know.

Please keep in mind inguinal hernias vs. incisional hernias
__Sandra___MS___ _

Brandon, MS

#2561 Aug 29, 2009
Kent wrote:
IMPORTANT NEWS
On Dr. Goodyears board, someone commented that Dr. Ramshaw is leaving his practice. I find this hard to believe. Does anyone have any first hand knowledge?
He was one listed with Dr. Shirin Towfigh at Cedar Sinai and Dr. Peter S. Billing near Seattle (Edmonds)
Dr. Ramshaw was featured in a college newspaper in Ohio by a student who had severe mesh problems that he resolved.
Hi Kent,
I don't know for sure if Dr. Ramshaw is leaving his practice but I heard through the grapevine that he may be moving to another location.
Duncan

Bremerton, WA

#2562 Aug 29, 2009
Dr. Ramshaw, is leaving his University position at the University of Missouri .
No further patients will be accepted.
Dave

Belle Fourche, SD

#2563 Aug 29, 2009
Medical Nightmare wrote:
<quoted text>
Dave,
Please accept my apology for cutting in on Bruce's blog. I am not comupter savy and thought perhaps you could answer a quick questin for me. Someone wants to do a ultrasound on my abdomen to see what is happening with my recalled mesh. Is this an effective test? I heard that one has to undergo the knife again. I want to leave everything alone. Thank you for your consideration.
An ultrasound will not be able to tell much.
Dave

Belle Fourche, SD

#2564 Aug 29, 2009
wolf99 wrote:
<quoted text>Hi Dave, How are you tieing Workers Comp in with Hernia's? I will say that employer's and their attornys fight to the end over this issue. Mine was job related, but the night mare that went with it. I feel that the case studies to research is of indigent care in emergency case, compare to those that have coverage.
A study looked at chronic pain complaints after hernia repairs if the indication for surgery was a workers compensation claim. The rate of chronic post-op pain was substantially higher in this group. One can only speculate to why this occurs.
wolf99

AOL

#2565 Aug 29, 2009
Dave wrote:
<quoted text>
A study looked at chronic pain complaints after hernia repairs if the indication for surgery was a workers compensation claim. The rate of chronic post-op pain was substantially higher in this group. One can only speculate to why this occurs.
Hi Dave, Where can I read up on these case's??? I typed in hernia's and workers Comp. This sent me to Hernia surgery in Sarasota Fl. Plus other items of interest. After reading what I did, I now think a possible rat in my case. My ex-employer, never turn my case into workers comp. They don't have anything on record of it. So he had to of paid out of pocket. Unless his insurance company never reported it. For on a medical Cd,It shows a medical file of clearance to return to work. yet also that report say's surgeon used a "Marlex Mesh"??? Yet the surgeon said he was going to used Gore Tec. Which even after being under the scalpel he changed that, which brings up a new point, who gave him the go ahead to cange this, for I signed waver for the mesh.This is really crazy. I turned this over to law firm back in 07, when the defective mesh recall was starting up. Workers Comp never paid for this,the county emergency indigent care did. This is why the report's must be different?? The county was looking for the cheapest method of repair, without regards to long term out come.Meaning the high rate of recurrence on top of the two older surgeries. does this ever suck. Just another case of where Florida screws the indigent person.
Medical Nightmare

AOL

#2566 Aug 30, 2009
Dave wrote:
<quoted text>
An ultrasound will not be able to tell much.
Thank you Dave, you have been very kind and informative during this time of strife for me. I believe that unless something becomes life threatening I am going to live life the best I can without intervention. Life leads us where it does. We accept it or we do not. I choose to accept it. Thank you for being who you are; giving of yourself and your time. May God stand by you all the days of your life.

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