Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8245 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.

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.
dorothy

AOL

#6924 Dec 3, 2012
sometimes even when I am sitting still I get pain just sitting. I'm trying to make sure someone understands that this is no joke.The injuried area is very tender sometimes. sitting with my knees bent causes pain too sometimes. one night just standing at my sink a pain so bad hit me I screamed out. It was three consecutive pains back to back. that should not be happening. and how are we suppose to hold down a job especially like mine. I am a caregiver and that calls for a lot of pushing and pulling and straining. I'm scared to go back to work knowing it will hurt me. however I am on medication and am hoping that will get me through to retirement. but in the mean time the pain is still there. on any given day at any given time it can happen out of the blue.
All Meshed Up

Grand Junction, CO

#6925 Dec 3, 2012
dorothy wrote:
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.
We have been discussing ( cussing) Atrium products and specifically ProLite. If you go back a page you will see a link and a post giving you that answer. Please read back a few pages and you will find you are not alone on this. Unfortunately I do not have the quick and fast answers. But read back a few pages of this forum and there are several posts concerning Prolite and also links to find help. Best of Luck. Just remember you are just beginning this journey with mesh and its affects. I won't B.S. you to say it will be easy but as I stated before, read through the posts, go on the net and go to the FDA's MAUDE data base and make a report. Please do this as it is very important that the FDA gets as many reports as possible. You will be contacted by the manufacturer as part of the MAUDE report and the FDA's guidelines. I would also suggest you gather ALL of your medical records especially your OP reports from your surgeries. Let us know what you find out or if we can help you more. Take care......
mesh good

Detroit, MI

#6926 Dec 4, 2012
Had inguinal hernia repaired in 2001 with mesh
at Hernia Institute in Miami, Fl and have had
no problems at all. Just had second repair of
other side (no mesh Dr's idea) and not happy
with results at all. The fault of these mesh
repairs I would bet is the Doctors/Surgeons
lack of experience doing the repairs and using
mesh. If you need a Hernia repair check out the
Hernia Instute in Miami that's all they do. Perhaps
contacting them if you are having problems with
a previous repair might be a good idea also.
All Meshed Up

Grand Junction, CO

#6927 Dec 4, 2012
mesh good wrote:
Had inguinal hernia repaired in 2001 with mesh
at Hernia Institute in Miami, Fl and have had
no problems at all. Just had second repair of
other side (no mesh Dr's idea) and not happy
with results at all. The fault of these mesh
repairs I would bet is the Doctors/Surgeons
lack of experience doing the repairs and using
mesh. If you need a Hernia repair check out the
Hernia Instute in Miami that's all they do. Perhaps
contacting them if you are having problems with
a previous repair might be a good idea also.
While I am happy that your experience with mesh was a good one, by your reckoning there are a shit load of inexperienced Dr.'s out there that are installing mesh products! As a matter of fact some of the best hernia Dr.'s in the U.S., Dr. Ramshaw for one, admits that he has had mesh fail after he installed it. My Dr. is a Lt. Col. in the Army reserves and has mass experience with surgeries involving all manner of artificial implants, mesh being one of them. He lost his surgical position at the Hospital because of "Implant Failures" and "Excessive Infections". So please, don't spout the manufacturers excuse for mesh failures as if its GOSPEL! The manufacturers may use that one with some success especially with the FDA but not here on this forum. This congregation is a bit biased about mesh. You had a good experience? Please tell us with what Mesh Product you were implanted with. Thanks much.....

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