Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8252 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.

Star

Garden City, MI

#5028 Jan 2, 2012
Also wondering if the doctors are contacting the patients with whom they placed the recalled mesh in??
mesh removed

Van Nuys, CA

#5029 Jan 2, 2012
Star wrote:
Hello,im just start reading this forum yestetday & I have a couple of question...i had a hernia repair surgery in 2007 I was wondering if mesh used during these surgery are bad? I noticed I lot of you have been having pain from day one I recently fell & broke my leg & ever since then I've been having blood after a bowel movement wondering if this could be from mesh? As far as pain I have pain every now & then the heavy feeling all the time but since my fall I've been having this burning feeling wonder is this a symptom?I'm always tired but I thought that was working 3rd shift so I've been told numerous times by my doctor...also wondering has anyone had the mesh removed & been ok since having it removed?..just getting really nervous from all the reading
I had mine removed, i had all the symptoms you described plus bowel obstructions. The surgeon found my intestines balled up and thick scar tissue build up below the mesh. The dr fixed my hernia without any mesh, only sutures. I cant carry anything over 10lbs or I risk hernia reoccurrance.
The mesh is poison in your body it attacks endocrine systems, like pancreas and cause diabetes and other hormonal problems.
Yes, I do feel better but I still suffer from pain and tenderness from the effects from all damage already done from the mesh. Ill never be normal but if i didn't have the mesh out, I'd probably dying or dead already.
Btw, my implant was in 2005.
Star

Garden City, MI

#5030 Jan 2, 2012
Is it only.certain mesh?...&when did u guys realize the mesh.was.causing the problems? Sorry to be asking.so many question but im 31yrs old & very nervous about this..
All Meshed Up

Boulder, CO

#5033 Jan 3, 2012
Star wrote:
Is it only.certain mesh?...&when did u guys realize the mesh.was.causing the problems? Sorry to be asking.so many question but im 31yrs old & very nervous about this..
If you were implanted in 2007 and do not know what product you have, go to the hospital and get a copy of your OP report that will shopw ALL products used on you AND implanted. Make sure that this info contains the manufacturers product and batch codes. Let us know and we can go from there. There is a lot of speculation about leeching of chemicals and such into the body. I will not dispute this but I have not read any reports about leeching. What I do know is the body fights this foreign object 24/7/365 and this will take a toll on your body, mind and spirit. It is an awful place to be. Get back to us as soon as you get your info. Keep the faith
Jaybird

Chesapeake, VA

#5034 Jan 3, 2012
Has anyone out there requested an higher classification and has anyone at all ever received a dime from this ridiculous settlement
LARC

Canyon Country, CA

#5035 Jan 3, 2012
anyone have a law firm that is sueing ethicon for thier prolene patch in men?
roxanne

Rochester, PA

#5036 Jan 3, 2012
have not recieved my dime yet still waiting

Since: Dec 11

Staten Island, NY

#5038 Jan 3, 2012
Alina Thornbuirg wrote:
Just had surgery to remove old mesh the Ethicon Prolene,with a lightweight, more flexible, part dissolveable one made of the same material. I was having pain from day one after my original hernia repair. My surgeon told me it was scarring and I needed to learn to deal and live with the pain. Im not sure how this new mesh will be, but I know my stomach now looks like a road map of scars. I had a historectomy in 2008 which was the start of my hernia problems. I had to go all the way to St Louis Mo from Ft wayne In to get a doctor who would at least try and help with a different mesh. He has said I have Diastasis but feels I should be able to return to work as usual even after telling him that my job requires me to lift 40lbs or more kicking and screaming 3-5yr olds as well as pushing and pulling on heavy objects. Am I thinking wrong that my body can't seem to do my job like it use too? I've commented to my family that Im just not sure if I can proform the duties expected of me any longer. It was becoming very difficult before the new mesh was put in on Dec 20 2011. I've contemplated filing for disability, but not sure I have a leg to stand on, even though I know how my abdomen feels tender, sore and heavy all the time. I also feel tired a lot. On top of this I am a diabetic. I guess I will see once I am released back to work in Feb. This is crap, the way I feel we are being used like guniea pigs. Thanks for listening.
Hi: I just need to comment. I'm sorry you are having so much pain but I do understand. I have mesh, two sheets, across my entire abdomen and have been suffering ever since. I can't have any further surgeries and my muscle wall in center of my ab is split open as well as another previous surgery wound never closed. I wear abdominal binders but now shouldn't due to hiatal hernia and netting split. These nettings are terrible and riddled with problems. If you have a weakness, it could be your muscle wall is not supporting your intestines and bowels. If you lift your ab and hold it, does the weakness go away? That would be very important to know. It's not something to play around with, seriously. I don't see how you can even contemplate working and it might be a good idea to get to another doctor. 40 pound children, pushing and pulling, lifting, not anything, in my opinion, you can physically do. I received pension disability and ss for 10 years now. I take herbal remedies for pain and detoxing. Ice packs. Limited. Never heard of mesh that is supposed to break up. It's not a healthy substance,in my opinion and experience. Here is my email for you or anyone. Please feel free to email any time: dmaria1mp@yahoo.com
mesh removed

Van Nuys, CA

#5039 Jan 3, 2012
Star....
I felt awful from day one from the implant. It was much worse painful surgery then when i had my kidney removed. Even after six months after the recovery time i still felt pain , tenderness, digestive issues since line was an abdominal mesh and exhausted all the time. I also had chronic hives since the implant. I went to the implant surgeon 8 Times to complain about all my complications but he denied the mesh was causing Amy of my ailments. I was hospitalized for severe pain and or bowel obstructions. Saw about 20 drs in 5yr span but none would admit the mesh was the cause. I felt like they knew about the problem but didn't want to tell me.
Well after years of suffering i knew it in my heart my body was not normal and my health was going downhill and if i didn't find an answer i was going to die soon. So about a year ago, I went on the internet and found out the mesh on my body was recalled. I went out of state to have it removed. The surgeon who removed it was shocked how I was even alive since my intestines were on terrible shape. He basically saved my life. To make long story short, I knew something was wrong since the implant but when numerous drs told me I was fine and just to change my diet and take bunch of unnecrssary meds, what could I do but get frustrated. Thank goodness for the internet so I finally could find the truth, fellow sufferers support and the right doctor to help me get the poison out of me.
mesh removed

Van Nuys, CA

#5040 Jan 3, 2012
Star wrote:
Is it only.certain mesh?...&when did u guys realize the mesh.was.causing the problems? Sorry to be asking.so many question but im 31yrs old & very nervous about this..
Most mesh is made out of polyproplene no matter what brand or model#. It is made out of chemicals, chemicals do not belong in human body.

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#5041 Jan 3, 2012
OMG..Will this never end? Every time I come here, it rips my heart out. So many injured people seeking medical treatment from doctors who deny mesh is the problem. So much misinformation. So much denial. So much harm. Sickening. Absolutely sickening.

This site is the reason I started Truth in Medicine. I was so appalled the first time I came here and I am just as appalled today as I was in 2007. After 10 years, and multiple surgeries, I still have about 4" of a bladder suspension mesh in me. So I know the pain and destruction it causes in each of your lives. No one who does not have mesh can ever understand what it does to you.

I respect each and every one of you and know nothing will ever make it right, not surgeries, not money, nothing will give you your life back.

I say this because the next post will be about pending legislation in the Senate. It is too little, too late for all of us. But maybe, just maybe, it will pass and stop others from being harmed in the future.

And maybe, just maybe, some of you will feel vindicated in some small way if the mesh companies are held accountable by stronger laws.

blessings, Lana

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#5045 Jan 3, 2012
http://kohl.senate.gov/newsroom/pressrelease....

For Immediate Release

GRASSLEY, BLUMENTHAL AND KOHL SEEK TO IMPROVE MEDICAL DEVICE SAFETY

WASHINGTON U.S. Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.) and Herb Kohl (D-Wis.) today introduced legislation to help protect patients from unsafe medical devices and improve the management of recalls.

The Medical Device Patient Safety Act would give the Food and Drug Administration (FDA) important tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices.

The bipartisan legislation would allow the FDA to require post-market clinical studies for medical devices that pose potential safety risks, if they were approved through the expedited 510(k) review process. The bill also would implement Government Accountability Office (GAO) recommendations for improving recalls and give the FDA new authority to require conditional clearance pending safety studies for devices reviewed under the fast-track, 510(k) approval process.

"This reform legislation should be part of the reauthorization of the medical device user fee law next year," Grassley said. "The reforms incorporate well-founded recommendations from the Government Accountability Office and reflect the value of having a robust post-market surveillance operation in the FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better."

"Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices causing significant costs to our economy as well as health," said Blumenthal. "This bill will help protect people from dangerous unsafe medical devices by demanding more consumer safeguards, improving recall management, avoiding costly recalls, and preventing irreversible injury to patients. By removing unsafe devices from the market more quickly and efficiently, we're preserving a faster approval track for safe and effective products to reach patients."

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#5046 Jan 3, 2012
Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients," Kohl said. "This legislation will help ensure that FDA can act quickly and decisively when there's a problem, and that the drive toward getting new technologies to market won't come at the risk of patient safety."

Grassley, Blumenthal and Kohl have also sent investigative letters to five companies that recalled faulty medical devices requesting detailed information about how the companies conduct post-market surveillance and how the companies manage recalls when a product is pulled from the market. Letters were sent to Johnson & Johnson, for its DePuy metal-on-metal hip implant, which was the subject of a worldwide recall and an April 13, 2011, hearing of the Senate Special Committee on Aging; Medtronic for its Infuse product; Boston Scientific for Guidant's defibrillators; CR Bard for vaginal and hernia mesh products; and, Zimmer Holdings for its knee replacements.

"As the Special Committee on Aging's recent oversight hearing detailed, effective post-marketing surveillance practices allow companies to recognize problems with medical devices in a timely fashion, preventing expensive recalls later, and can also save lives and prevent unnecessary suffering," the letters state.

Background on 510(k)

FDA can clear new medical devices through the 510(k) process, named after section 510(k) of the Food, Drug, and Cosmetic Act, if the product is found to be substantially equivalent to a product already on the market. A device is considered substantially equivalent if the company shows it is at least as safe and effective as the predicate device.

While the FDA can request clinical study data, the 510(k) process is still considered a "fast-track" approval compared to the more lengthy Premarket Approval, or PMA, process. The 510(k) clearance process is intended for moderate risk devices, while the PMA process is intended for high risk devices.

TRUTH IN MEDICINE IS ACTIVELY INVOLVED IN THIS PROCESS AND WILL CONTINUE TO BE. PLEASE SUPPORT THIS LEGISLATION IN ANY WAY YOU CAN!

TOGETHER WE CAN STOP OTHERS FROM BEING HARMED BY MESH!

Blessings, Lana Keeton
LARC

Canyon Country, CA

#5047 Jan 4, 2012
i have talk to three law firms and all of said they were only taking women with prolene mesh and said because of erosion and all the other horrible things that i dont have to mention.i told them i have a surgical report stating that the mesh has shrank hardend and is falling apart and eroding.i have bilateral inguinal hernias live with constant testicular pain CONSTANTLY not to mention all the other bs i endure but i dont see how the very same mesh used in men or women is any diffrent.
emgee

United States

#5050 Jan 6, 2012
Star wrote:
Also wondering if the doctors are contacting the patients with whom they placed the recalled mesh in??
I had my surgery in April 2005. The mesh that was used was recalled eight months later. Neither the doctor nor the hospital ever notified me. I didn't learn of the recall until several years later when the mesh had to be recalled.
emgee

United States

#5051 Jan 6, 2012
Jaybird wrote:
Has anyone out there requested an higher classification and has anyone at all ever received a dime from this ridiculous settlement
I was reclassified from a 1B to a 1A.
emgee

United States

#5052 Jan 6, 2012
emgee wrote:
<quoted text>I had my surgery in April 2005. The mesh that was used was recalled eight months later. Neither the doctor nor the hospital ever notified me. I didn't learn of the recall until several years later when the mesh had to be recalled.
I meant extracted. Sorry.
mesh removed

Van Nuys, CA

#5053 Jan 7, 2012
emgee wrote:
<quoted text>I had my surgery in April 2005. The mesh that was used was recalled eight months later. Neither the doctor nor the hospital ever notified me. I didn't learn of the recall until several years later when the mesh had to be recalled.
Same here, had the implant in 2005, my mesh model was recalled only after 6 to 9mos after the implant. I was never notified from anyone. In addition, i experienced complications from the beginning i went to my surgeon 7 additional Times to compain of the mesh, but each time i was lied to and was told all my problems were not from the mesh. The truth was all of my ailments from bowel obstructions to severe pain, allergies, autoimmine diseases, endocrine systems failures, infections and more were all from the mesh. After seeing about 20 drs over the years, I found out doctors protect their own kind and was protecting the implant surgeon, even though my situation was life and death. I had to find the truth on the internet only about a year ago. Sadly, I have lost trust in the medical system. These meshes have ruined my life and my family's life as well.
Rejected reseacher

AOL

#5054 Jan 8, 2012
Hi. I just found something that others with more knowledge on the mesh lawsuites might take alook at. AOL News High RISK MEDICAL DEVIES ESCAPED CLOSE REVIEW dated back in 2009. another FDA SCREW UP! Congress ordered the FDA years ago to RESOLVE the issue, the agency approved 228 medical devices without a full scale review from 2003-2007, this stated by GOA GOVERNMENT ACCOUNTABILITY OFFICE IN A REPORT! Some devices approved under the less rigorous process have been recalled because of malfunctions and other problems, according to the Consumer group Public Citizen the story goes on. That was in 2009. Now going forward to today. Update Jan 05,2012. FDA RECLASSIFICATION HIGH RISK MEDICAL DEVICES from a CLASS 2 meaning medium risk, to CLASS 3 HIGH RISK Trans Vaginal Mesh/ PELVIC ORGAN PROLAPSE (POP)-(SUI). Synthetic or biologic material. This may also include HERNIA MESH..
tammy

Pierre, SD

#5055 Jan 8, 2012
Hey, rejected researcher! What web-site did you find this on? Would love to read it. As always looking for any info out there. The smallest article or piece might be THE ONE that helps one or all that post or read posts on here. Let all of us know, please!

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