Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8231 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.

Shelia

Pearl River, LA

#6903 Nov 30, 2012
My case is non ring also. I did not settle. Maybe this conference will bring all good news for everyone so we can try and get well. God bless us all.
Blair

Montague, Canada

#6904 Nov 30, 2012
Lee Lee, Shelia, Steven, hopefully your settlement offer increases. Keep us updated. Best of luck from a non ring victim who will never get justice.
All Meshed Up

Grand Junction, CO

#6905 Nov 30, 2012
Blair wrote:
Lee Lee, Shelia, Steven, hopefully your settlement offer increases. Keep us updated. Best of luck from a non ring victim who will never get justice.
I'll join Blair on that wish. After 6 years of pain and surgery I have no hope of ever getting any type of compensation from Kugel or J&J. I'm just not the right kind of client I guess. When you get above 50 you here all sorts of things from the medical community and even a few friends about being "older". I had to have my right testicle removed, Thank you Prolene and J&J, and I must have been told half a dozen times " Oh, but you don't need that anyway". I guess because I'm to old to procreate? WHAT!!??? After the surgery they sent in a shrink to discuss my loss. Do I have thoughts of suicide? Say WHAT?!! It was the smallest casket you ever saw, Doc! Don't know if I can get over the loss! It was very close to me, Doc. It was just like, just like a testicle to me. Anyway Sorry, BAD humor. The callus way that all of us have been handled by the medical and legal community is disgraceful. The loss of mobility, activities we enjoy, body parts, livelyhood, homes, sanity and general well being is disregarded by just about everyone ( unfortunately for some of us )includeing family members because we for the most part do not look like we are in distress. As I sit here typeing this morning my right side is burning and I have a dull pain going up my chest. What are you going through this morning? These are the symptoms that we all share and we can all relate but how do you convince the unbeliever? That is our lot in life now. I hope and pray that with a settlement that those of you that do get it, that it will bring you some peace and satisfaction. Best Wishes......
All Meshed Up

Grand Junction, CO

#6906 Nov 30, 2012
Now on a different subject. CYBER ATTACK. I have been attacked now twice by a "MALICIOUS VIRUS'. Both attacks came just before meetings with a government agency that oversee's medical devices and prescriptions. I WAS NOT PART OF THE MEETINGS. I have provided documentation and investigative papers. I am associated with this forum and I work with the Meshoma Foundation in anyway I can. I have become close friends with certain people and they were the main target of these attacks. The virus is after files but destroys your computer. Luckily I now have a damn good firewall and it stopped this attack. The reason I post this is because although we are fighting for our rights as victims our opposition is fighting the loss of revenue, disclosure and possible prosecution. While our health is at risk these people are making more mesh and marketing it in places that have not been as affected as the U.S. and continueing to harm others. It is not in their nature to care about us as potential "consumers". It has become very evident that money is their main concern. There is now movement within the FDA concerning mesh. While some disclosure will be forthcoming what is really happening is that they are "circling the wagons" and are protecting their collective asses. A cyber attack on me and others is just another way of trying to protect themselves. It shows that they know whats coming but are trying to obvuscate, deny and ignore the facts while the rats jump ship. Its a very quiet war out there folks. These people are serious and they have our government behind them. I am ashamed of the FDA and their investigative branch the OCI. It has become abundantly clear that the know, they don't care and they are being paid off. There can be no other explanation for their refusal to recall mesh products that have abundantly shown to be dangerous. Be Safe......
heatha anderson

Auckland, New Zealand

#6907 Nov 30, 2012
I live in sheer hell because of the pain. I cannot take this rotten product in my body.
I have questions we have 2 lots of product we would like checked if it was ever recalled!
ProLite ref.1000306-00
Lot 22222799

and a friend has the same ProLite product
ProLite 1001212-00
Lot 10426926

can anyone tell us where we go to check out these 2 ProLite Products.
we both live in pain.
[email protected]
All Meshed Up

Grand Junction, CO

#6908 Dec 1, 2012
Polypropylene Mesh Schmitt and Griman in 1967 first described successful use of polypropylene mesh in contaminated wounds Subsequent reports showed good initial healing but were fraught with long term complications Those complications are chronic infection, fistula formation, erosion into bowels or through skin grafts Jones and Jurkoyiun in 1989 reviewed 14 studies, 128 patients, and found 55 overall complication rate - enteric fistulization being the most common.
I thought this might peak everybodies interest. Notice this study was done in 1967 Against polypropylene mesh: It is extremely difficult to lyse adhesions to polypropylene without causing enterotomies* Major complications with polypropylene not evident until years later 9 cases of mesh erosion fistula stainless steel (1) tantalum (1) mersilene (1) dexon (1) ppm (5). The time to the development of these fistulas ranged from 3 months to 14 years *Losanoff JE et al. Entero-colocutaneous fistula: a late consequence of polypropylene mesh abdominal wall repair: case report and review of the literature, Hernia 2002; 6: 144-147 And here we have a study done in 2002 still showing the long term complications of mesh implants. There can be no doubt about what Polypropolene does to the human body, as we all know. Its a shame that the FDA is staffed by professionals that can't read or understand the material that they have and have had for several years. This is just another example.
All Meshed Up

Grand Junction, CO

#6909 Dec 1, 2012
heatha anderson wrote:
I live in sheer hell because of the pain. I cannot take this rotten product in my body.
I have questions we have 2 lots of product we would like checked if it was ever recalled!
ProLite ref.1000306-00
Lot 22222799
and a friend has the same ProLite product
ProLite 1001212-00
Lot 10426926
can anyone tell us where we go to check out these 2 ProLite Products.
we both live in pain.
[email protected]
I searched the Atrium web site for you and came up with nothing. Plenty of advertiseing of their products but nothing when I searched for your product codes. I will try a couple of other sites and see if I can find any reference to your little monsters. I wish you the best of luck. My suggestion is to find a competant Dr. and get that crap out of you,ASAP. Best Wishes.......
All Meshed Up

Grand Junction, CO

#6910 Dec 1, 2012
http://www.fda.gov/MedicalDevices/Productsand... Check out this site. This is as close as you will see of the FDA admitting to the complications of mesh. Very BIG of them......

Since: Apr 12

Location hidden

#6912 Dec 1, 2012
All Meshed Up wrote:
http://www.fda.gov/MedicalDevi ces/ProductsandMedicalProcedur es/ImplantsandProsthetics/Hern iaSurgicalMesh/default.htm Check out this site. This is as close as you will see of the FDA admitting to the complications of mesh. Very BIG of them......
Oh since when does the fda want patients to make informed decisions? That's news to all of the people who were not warned in the past 30 years.

Since: Apr 12

Location hidden

#6913 Dec 1, 2012
All Meshed Up wrote:
<quoted text> I searched the Atrium web site for you and came up with nothing. Plenty of advertiseing of their products but nothing when I searched for your product codes. I will try a couple of other sites and see if I can find any reference to your little monsters. I wish you the best of luck. My suggestion is to find a competant Dr. and get that crap out of you,ASAP. Best Wishes.......
If those are Atrium meshes they should check out the link I posted. The warning letter to Atrium from the FDA dated back in September 2012. I posted the link two days ago. Oh meshed looking like our teams are going head to head. No worries the Raiders don't have a snowballs chance in hell.
All Meshed Up

Grand Junction, CO

#6914 Dec 1, 2012
Patty Williams wrote:
<quoted text>If those are Atrium meshes they should check out the link I posted. The warning letter to Atrium from the FDA dated back in September 2012. I posted the link two days ago. Oh meshed looking like our teams are going head to head. No worries the Raiders don't have a snowballs chance in hell.
I had forgotten about your link, Patty. If Healda reads this I hope she will go back and check that out. Its interesting that only the manufacturers reply and info would come up on the search I did on the FDA web site. And Patty, Patty, Patty don't be so glum about your Raiders..... OK maybe a little... ;>) Best Wishes to you and Don......
All Meshed Up

Grand Junction, CO

#6915 Dec 1, 2012
http://www.fda.gov/ICECI/EnforcementActions/W... Hello Heatha...here is the link concerning Atrium mesh and the FDA's statement. Sorry I mispelled your name in the previous post......
Don williams

Eugene, OR

#6916 Dec 1, 2012
I had the atrium C-QUR implanted in sept 2011 had to have it removed less than 9 weeks later it dissolved and caused all kinds of damage ;(, than I had the prolene mesh put in and just had it removed sept 2012 I am disabled from all these meshes the truth is there is no good mesh they r all bad and I suffer everyday am on high dosage of pain killers and stlll no relief there is no fix guys Just more surgery and pain meds to have any kind of life . I am slowly dying my doctors told me I won't live to c 50 the problem is there is no clear guidelines for these meshes and even if there where there is no one to make sure it is regulated most of theses Maude reports go to the manufactures of the mesh not the FDA we are all alone and have no advocates that's what needs to be addressed first!!!!! And to answer one of u who asked do I deserve to b compensated your Dam right u do we all do u just need to find a lawyer who actually cares them take it to them . Thank you and God Bless each and everyone of us .:))
Bruce

Pompano Beach, FL

#6917 Dec 2, 2012
Hey everyone: Please remember to contact the FDA and make those Adverse Event reports. You can google "FDA Maude Adverse Event Report" then search the FDA database to see other reports made for your specific device.
Documentation is key to proving there is a problem. We need your help to build the database to validate these mesh device complications.
If you have a mesh related complication, or have questions about your device, or how to file the report please contact me at [email protected]
You are not crazy or alone.
Feel better,
Bruce
National Meshoma Foundation

Since: Apr 12

Location hidden

#6918 Dec 2, 2012
Don williams wrote:
I had the atrium C-QUR implanted in sept 2011 had to have it removed less than 9 weeks later it dissolved and caused all kinds of damage ;(, than I had the prolene mesh put in and just had it removed sept 2012 I am disabled from all these meshes the truth is there is no good mesh they r all bad and I suffer everyday am on high dosage of pain killers and stlll no relief there is no fix guys Just more surgery and pain meds to have any kind of life . I am slowly dying my doctors told me I won't live to c 50 the problem is there is no clear guidelines for these meshes and even if there where there is no one to make sure it is regulated most of theses Maude reports go to the manufactures of the mesh not the FDA we are all alone and have no advocates that's what needs to be addressed first!!!!! And to answer one of u who asked do I deserve to b compensated your Dam right u do we all do u just need to find a lawyer who actually cares them take it to them . Thank you and God Bless each and everyone of us .:))
You said it sweetie! Every single victim of failed medical devices deserve compensation. Much of what you and I have lost cannot be replaced. Its time that these manufacturing giants are cut down to size.

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#6919 Dec 2, 2012
I received this invitation from the FDA/CDRH Acting Chief Scientist, Michelle McMurry-Heath on Thursday for an event tomorrow in Washington, D.C. Since there are supposed to be registries for the pelvic organ prolapse meshes, maybe they will come through this MDIC. We will see tomorrow.

Best, Lana

p.s. check out my blog
http://www.theladyisachamp.blogspot.com/ for my response.

----- Original Message -----
From: Williams, Letise
To: [email protected] com
Sent: Thursday, November 29, 2012 1:44 PM
Subject: Announcing:“Medical Device Innovation Consortium”

Greetings,

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration would like to make you aware of an upcoming event. Next Monday the independent non-profit Medical Device Innovation Consortium (MDIC) will be announcing a new public-private partnership between the MDIC, FDA, other government agencies, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues. Additional information on the MDIC can be found at http://www.deviceconsortium.org/

As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.

Please join us if you can,
Michelle McMurry-Heath
Associate Director for Science, Acting Chief Scientist
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
----------

You are invited to attend the Senate MedTech Caucus briefing:
Monday, December 3rd, 10:30 am – 12:00 pm
Room 106, Dirksen Senate Office Building
Announcing:“Medical Device Innovation Consortium”
Featuring: FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).

The MDIC is a Public-Private Partnership (PPP) whose mission is to improve health through the application of shared knowledge in medical device regulatory science. It is the first-ever PPP created to focus exclusively on advancing medical device regulatory science.

The MDIC will create a collaborative environment where nationwide representatives from industry, non-profits, and FDA can work together to keep pace with the needs of patients in the United States.

Speakers will include:

Senator Amy Klobuchar
Senator Al Franken
FDA Commissioner, Margaret Hamburg, M.D.
FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.
Immucor, Inc., CEO, William Hawkins
LifeScience Alley CEO, Dale Wahlstrom
riverrat

Winona, MN

#6920 Dec 3, 2012
hope my senetor al gives them hell
Blair

Montague, Canada

#6921 Dec 3, 2012
Bruce wrote:
Hey everyone: Please remember to contact the FDA and make those Adverse Event reports. You can google "FDA Maude Adverse Event Report" then search the FDA database to see other reports made for your specific device.
Documentation is key to proving there is a problem. We need your help to build the database to validate these mesh device complications.
If you have a mesh related complication, or have questions about your device, or how to file the report please contact me at [email protected]
You are not crazy or alone.
Feel better,
Bruce
National Meshoma Foundation
Thanks Bruce for all of the info i learned from your site over the years. You have helped a lot of victims to understand it is not in their head and their surgeons are hiding the truth after mesh removal.
All Meshed Up

Grand Junction, CO

#6922 Dec 3, 2012
Lana Keeton wrote:
I received this invitation from the FDA/CDRH Acting Chief Scientist, Michelle McMurry-Heath on Thursday for an event tomorrow in Washington, D.C. Since there are supposed to be registries for the pelvic organ prolapse meshes,, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues. Additional information on the MDIC can be found at http://www.deviceconsortium.org/
As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.
Please join us if you can,
Michelle McMurry-Heath
Associate Director for Science, Acting Chief Scientist
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration
----------
You are invited to attend the Senate MedTech Caucus briefing:
Monday, December 3rd, 10:30 am – 12:00 pm
Room 106, Dirksen Senate Office Building
Announcing:“Medical Device Innovation Consortium”
Featuring: FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).
States.
Speakers will include:
Senator Amy Klobuchar
Senator Al Franken
FDA Commissioner, Margaret Hamburg, M.D.
FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.
Immucor, Inc., CEO, William Hawkins
LifeScience Alley CEO, Dale Wahlstrom
I don't want to be negative Lana but I don't trust a damn thing that comes out of Washington. I do not believe that they are doing anything other than covering their asses. The fact that AL FRANKEN is part of this shows how little this is regarded. I am not putting your efforts down, Lana. I am saying that past history with these lying, blind, self centered, non-educated( about mesh ), publicity seeking jackasses does not give me an iota of confidence about a positive outcome to the "consortium". I want to know what they are going to do for all of us that are affected by and are victims of mesh. I want to hear, see and participate in a meaningful dialogue about helping the tens of thousands of us that are suffering everyday while the courts pick and choose who gets compensated. I want a solid, no-bullshit, no backing out, done NOW program of helping all of us who have lost everything. I want manufacturers sweating it out in front of TV cameras as they get to meet us face to face and have to answer the question we want to ask and not some jackass x-comedian who is more interested in his own publicity that the damage done by these medical devices. I am happy you were invited to this conference, Lana. But a conference that was set up, I am sure, weeks ago if not months and they invite you as a last minute thought. How good of them. How inclusive of them. How standard of them. Are you going to participate in the conference or are you an observer of the travicty that has been the past "conferences"? Until we have manufacturers being grilled by experts in the field in front of Senators and the public I won't expect crap out of Washington or the mouth pieces that represent them.
dorothy

AOL

#6923 Dec 3, 2012
I have a Prolite Mesh implant that was used to repair an incisional hernia. I get the worst pain ever sometimes.mostly while being phisically active for more then a few hours at a time. on any given day climbing the stairs hurts too. The pain slows me down at work. I have been off now for three months because the work is too heavy and my job doesn't do light duty. so I had to go off on a medical while my doctors search for the best way to ease my pain. and get me back on the job.The pain is terrible. my mesh patch is made by Atrium medical. no wants to take my case either. what should I do? The doctor says it's too far gone for another surgery and that another surgery would only produce the same results. and it only gets worse with time. Is there a list of lawyers for people like me? where are they? maybe these patches should be recalled too. I'll try sending Atrium an email and see if that helps. and yes this is scary. not knowing what will happen later with the pain.

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