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.

All Meshed Up

Whitewater, CO

#7663 Apr 15, 2013
If I write something of "content" I am shut out. So I will say that I am OK, still here and recuperating. Best Wishes......
patty

Eugene, OR

#7664 Apr 15, 2013
All Meshed Up wrote:
If I write something of "content" I am shut out. So I will say that I am OK, still here and recuperating. Best Wishes......
Hope you are well:)
Sonia_59

Sydney, Australia

#7665 Apr 15, 2013
Blair wrote:
<quoted text>
Sonia, i am thinking he is taking a break, when you have been let down by the system put in place to fight for you and everyone passing the buck as in your case and mine as well it certianly plays with your mind. Your fight with the surgeons sounds like my story but when i got clear of them and found a plastic surgeon that cared and i had this new team of surgeons in a different province, it was like a heavy load taken off my chest. The surgeon who implanted and explanted the composix mesh, had told the true detials of what happened because of the mesh, instead of a major cover up with his colleagues and making me look like the bad guy. I never gave up and even had to prove he lied on my paper work and yes i did win, but it took a decade off my life. Sometimes in life we just got to walk away and i think All Meshed Up is moving on and putting one hundred precent of his time into his new relationship. I hope you find a way out of this nightmare, i spend a lot of money researching for the truth and i fought hard to get my abdominal wall repaired and medicare had to pay up for the tissue repair and put me back on my feet. Never give up!.
Hi Blair and other Victims of mesh. I have good news and as All Meshed Up kept telling you even though you feel like giving up, make as many complaints to MAUDE as possible, the more we stick together the more we cannot be ignored. I today received a lengthy email from Ethicon the manufacturer of Vycril one of the mesh implanted in me and authorisations to obtain information. The report I filed with MAUDE was not complete but what it did state was all the symptoms I was experiencing. They are now requesting more details i.e. which surgeon which hospital etc. As I have a solicitor acting on my behalf in the class action suite I have forwarded it to them. But what also surprised me not only the Manufacturer actually asking for all this (I beleive to some degree admission of guilt)or (trying to cover their butts), but I also live in Australia, so I would have thought they would ignore it, but as it appears MAUDE sent the adverse event to the Manufacturer, so please everyone no matter what mesh start putting in those adverse events to MAUDE. You never know until you try. ONE PERSON CAN BE IGNORED MANY VOICES CANNOT Kindest regards Sonia down under
All Meshed Up

Whitewater, CO

#7666 Apr 16, 2013
Terlin was inquiring about neurectomy's. Having the nerve cut to "stop" the pain did not work for me nor for Bruce. I went to a top Sport Surgeon in Denver. The surgery did more damage than good. Bruce went to a supposed top surgeon in Maryland and that surgery also did more harm than good. I would think twice before jumping at that surgery to stop your pain. "Any Suggestions" mentioned that his OP report said that Prolene had been implanted? If I got that right, Prolene is an Ethicon/J&J product. If that is indeeed what you had implanted you got the old model which was 110 times stronger than needed. This was admitted in a sales video that Ethicon put out to Doctors to promote their "New, Improved, Thinner, Lighter Prolene". It was admitted on video by an Ethicon Dr. that "those implants with the old Prolene will cause patients problems and that is something that will have to be addressed." The video was given to the FDA and their Office of Criminal Investigation. Their comment was that the video was "an eye opener" and it was "appalling". But that was the end of it. The FDA never went further with the investigation. Just another example of the FDA's bias when it comes to mesh problems and conclusive evidence of the Manufacturers knowing about what mesh does.
Brad

Melbourne, Australia

#7667 Apr 16, 2013
Tony wrote:
Do these mesh recalls affect Australia?
And why can't they use human tissue or sheep skin?
No, i dont think Australians have been informed, it seems?? We had exactly the same patches used on us!! Any other people know of Australians affected?

What stories are there from Australian patients?
All Meshed Up

Whitewater, CO

#7668 Apr 16, 2013
I have not posted on here for a while for a couple of reasons. One is my health. I have been having infections, mainly glandular, occurring more frequently now. I was put on a Steroid and Anti-Biotic regime for 10 days which took a toll. I suffer, as we all do, from many of the same complaints I read about everyday on this forum. I have been now for 6 years. It has been increasingly difficult for me to read then write about all of this and try to be objective. Blair was correct when he said that I was probably tired of the site. I would actually describe it as burnt out. After so many years of trying to explain to victims what needs to be done, how, why etc., I have become convinced that there has to be a light at the end of the tunnel. I am no longer of that opinion. The recent Court ruling in favor of the retired nurse had nothing to do with the mesh she was implanted with. Again, the Courts threw out all of the evidence and testimony about the mesh as they did with the Kugel Mesh cases. The Kugel Court case centered on the Plastic Retention ring that holds that mesh in place. The ring would break and thereby wounding the unfortunate person who had received it, sometimes very badly. The recent case with the nurse had it decision based on WHAT THE DOCTOR DID NOT TELL HER! This decision had nothing to do with the actual mesh product. This was not beneficial to our cause at all. The Manufacturers dodged another bullet and they can do so very easily. Do you know why? The FDA MAUDE data base. The Manufacturers, with the FDA's backing, can point at the MAUDE data base and say, somewhat truthfully, that there is no conclusive evidence to prove that mesh is a bad product. Fully, 4-7% of all mesh victims have filed a report. Of those there is a large percentage that are incomplete and therefore are worthless. Until every victim makes a reliable, verifiable report all the other reports a meaningless. You can read in the reports also that the Manufacturer will state that they did not have a sample of the "Material" to examine and therefore make a conclusive report as to what happened. There has been no, nor is there today, any procedure in place that requires the Hospital to send a piece of any mesh removed to the FDA or the Manufacturer. How convenient is that? So the Manufacturer states that they have gone back to their QC records and By Golly we don't see any problems! Case over. So my Dear Friends, I am going in a different direction by going to my State, as well as every other State Governor, Attorney General, Medical Board and try to convince them to look into J&J/Ethicon's Fraudulent Advertising practices as well as the reliability of their products. The States have spent Millions of dollars via Welfare and Workmens Comp cases fixing Gyno and Hernias as well as replacing Hips with J&J/Ethicon products. I am going to use the power of money to persuade the States to try and recoup from J&J/Ethicon the Millions they have spent on their crap products. I am hoping in this way that I can bring light to ALL of our mesh complications and hopefully then we will ALL have our day in court. I want to Thank Blair, Patty, Sonia, River Rat, Lin, Alien Baby and so many others for their kind words and wishes. I want to Thank you ALL for your indulgence in my many rants over the years. You all have helped me through my problems more than you will ever know. I will pop in now and again but not as frequently as I have done in the past.( Did I hear cheering and applause??!!) I send my Best Wishes to All......
All Meshed Up

Whitewater, CO

#7669 Apr 16, 2013
Brad wrote:
<quoted text>
No, i dont think Australians have been informed, it seems?? We had exactly the same patches used on us!! Any other people know of Australians affected?
What stories are there from Australian patients?
If you do a search Brad you will find that there are many people especially women in Australia that are suffering from mesh complications. There are some lawsuits also.
riverrat

Winona, MN

#7670 Apr 16, 2013
cheers to mesh

ya drop in u can type faster then i can lol
Blair

Montague, Canada

#7671 Apr 16, 2013
riverrat wrote:
cheers to mesh
ya drop in u can type faster then i can lol
I second that,great to hear from you. Riverrat, you must be sharpening your shovel a lot this winter,lots of snow in MN.
Lin

Birmingham, AL

#7672 Apr 16, 2013
All Meshed Up wrote:
It seems that I am no longer able to post on here for some reason. I have tried twice today with no success. I find this rather disturbing.
AMU check your computer setting. Sometimes a virus can do odd things with setting. I have had the same thing happen. It's that we post the truth, that hits on raw nerves!
All Meshed Up

Whitewater, CO

#7673 Apr 16, 2013
Lin wrote:
<quoted text>AMU check your computer setting. Sometimes a virus can do odd things with setting. I have had the same thing happen. It's that we post the truth, that hits on raw nerves!
Thanx Lin. I have a fairly updated Firewall, Virus Protection and such. I have had 3 Cyber hits in the past 2 years so it could be a possibility What I found was that when I tried to submit the post I wound up at another Topix site. OK! Where did the post go and after 2 times I was a bit paranoid. Probably operator error. Getting Old ain't for wussies! What were we talking about.... Best Wishes
patty

Eugene, OR

#7674 Apr 16, 2013
All Meshed Up wrote:
I have not posted on here for a while for a couple of reasons. One is my health. I have been having infections, mainly glandular, occurring more frequently now. I was put on a Steroid and Anti-Biotic regime for 10 days which took a toll. I suffer, as we all do, from many of the same complaints I read about everyday on this forum. I have been now for 6 years. It has been increasingly difficult for me to read then write about all of this and try to be objective. Blair was correct when he said that I was probably tired of the site. I would actually describe it as burnt out. After so many years of trying to explain to victims what needs to be done, how, why etc., I have become convinced that there has to be a light at the end of the tunnel. I am no longer of that opinion. The recent Court ruling in favor of the retired nurse had nothing to do with the mesh she was implanted with. Again, the Courts threw out all of the evidence and testimony about the mesh as they did with the Kugel Mesh cases. The Kugel Court case centered on the Plastic Retention ring that holds that mesh in place. The ring would break and thereby wounding the unfortunate person who had received it, sometimes very badly. The recent case with the nurse had it decision based on WHAT THE DOCTOR DID NOT TELL HER! This decision had nothing to do with the actual mesh product. This was not beneficial to our cause at all. The Manufacturers dodged another bullet and they can do so very easily. Do you know why? The FDA MAUDE data base. The Manufacturers, with the FDA's backing, can point at the MAUDE data base and say, somewhat truthfully, that there is no conclusive evidence to prove that mesh is a bad product. Fully, 4-7% of all mesh victims have filed a report. Of those there is a large percentage that are incomplete and therefore are worthless. Until every victim makes a reliable, verifiable report all the other reports a meaningless. You can read in the reports also that the Manufacturer will state that they did not have a sample of the "Material" to examine and therefore make a conclusive report as to what happened. There has been no, nor is there today, any procedure in place that requires the Hospital to send a piece of any mesh removed to the FDA or the Manufacturer. How convenient is that? So the Manufacturer states that they have gone back to their QC records and By Golly we don't see any problems! Case over. So my Dear Friends, I am going in a different direction by going to my State, as well as every other State Governor, Attorney General, Medical Board and try to convince them to look into J&J/Ethicon's Fraudulent Advertising practices as well as the reliability of their products. The States have spent Millions of dollars via Welfare and Workmens Comp cases fixing Gyno and Hernias as well as replacing Hips with J&J/Ethicon products. I am going to use the power of money to persuade the States to try and recoup from J&J/Ethicon the Millions they have spent on their crap products. I am hoping in this way that I can bring light to ALL of our mesh complications and hopefully then we will ALL have our day in court. I want to Thank Blair, Patty, Sonia, River Rat, Lin, Alien Baby and so many others for their kind words and wishes. I want to Thank you ALL for your indulgence in my many rants over the years. You all have helped me through my problems more than you will ever know. I will pop in now and again but not as frequently as I have done in the past.( Did I hear cheering and applause??!!) I send my Best Wishes to All......
hey meshed.I was just telling Don that I will never get an implant. Id rather go to Mexico, cut my legs off and roll myself around on a little cart begging for pesos than get any type of implant. Hope you have at least been watching the NFL news in your downtime:} The draft is coming up real soon!
Lin

Eastaboga, AL

#7675 Apr 17, 2013
All Meshed Up wrote:
<quoted text> Thanx Lin. I have a fairly updated Firewall, Virus Protection and such. I have had 3 Cyber hits in the past 2 years so it could be a possibility What I found was that when I tried to submit the post I wound up at another Topix site. OK! Where did the post go and after 2 times I was a bit paranoid. Probably operator error. Getting Old ain't for wussies! What were we talking about.... Best Wishes
AMU Glad see you back:),U were missed.;{ I found a new surgeon local, he took a practice over for another surgeon. I will see next Tuesday. My feelings are that the surgeon in BirminghamLied about the 3rd hernia, fears off having to cut mesh to repair another hernia.Question? Do surgeons have to post all types of mesh they use in a person? I know that a 4x6" mesh Proceed used over abdominal area. that outlne shows with the tacks. Ok but what she said was that she doesn't see the wide mouth fat contained ventral hernia. But feels a small navel hernia, in which she was suppose to of fixed back in 2010. Again this is all newer information taken from Ct Scan done back in Feb.2013. yet what puzzles me is the (dark oval patch looking area). Under the left side rib. In which is bloated at times, pains. can't sit up very long. yet the whols abdominal area gets tender around the tacks. So hopefully this new surgeon can figure it out! Someone needs to because it cost SSD, Medicare efery time I have to go see new doctor. To me as to what's happening to us and being lied to is FRAUD,to the Medicare system! I was told that when CtScan were read. By the highly trained tec's they report to the surgeon what they see,? Ok are the surgeons also trained in the field of reading CT Scans..
Lin

Eastaboga, AL

#7677 Apr 17, 2013
Lin wrote:
<quoted text>AMU check your computer setting. Sometimes a virus can do odd things with setting. I have had the same thing happen. It's that we post the truth, that hits on raw nerves!
AMU check in your setting of power setting, their is a setting that times you out, like if on one page to long, sets to long with out any movement can't think the word want to use. anyway the page times out sends to another topix page, I've have had same thing happen to me, which sucks! when posting something to help others.
All Meshed Up

Whitewater, CO

#7678 Apr 17, 2013
Lin wrote:
<quoted text>AMU Glad see you back:),U were missed.;{ I found a new surgeon local, he took a practice over for another surgeon. I will see next Tuesday. My feelings are that the surgeon in BirminghamLied about the 3rd hernia, fears off having to cut mesh to repair another hernia.Question? Do surgeons have to post all types of mesh they use in a person? I know that a 4x6" mesh Proceed used over abdominal area. that outlne shows with the tacks. Ok but what she said was that she doesn't see the wide mouth fat contained ventral hernia. But feels a small navel hernia, in which she was suppose to of fixed back in 2010. Again this is all newer information taken from Ct Scan done back in Feb.2013. yet what puzzles me is the (dark oval patch looking area). Under the left side rib. In which is bloated at times, pains. can't sit up very long. yet the whols abdominal area gets tender around the tacks. So hopefully this new surgeon can figure it out! Someone needs to because it cost SSD, Medicare efery time I have to go see new doctor. To me as to what's happening to us and being lied to is FRAUD,to the Medicare system! I was told that when CtScan were read. By the highly trained tec's they report to the surgeon what they see,? Ok are the surgeons also trained in the field of reading CT Scans..
The OP report should contain ALL items used during the surgery. This includes saline solutions, antibiotics, sutures and especially any surgical implants. When you had posted previously that there was an "Oval" shape showing up, my first thought was that it could be a Bard/Kugel Oval with ring mesh product. But if it is not in the OP report and if the surgeon denies the use of such product, much less any other mesh, then I think you have a mystery. And the needs to be addressed Immediately. If the "Medical Professionals" cannot answer or will not answer I would start climbing the "Medical" ladder as it were and start complaining. LOUDLY! Doctors do analyze CT/MRI scans but they really rely on the CT/MRI Imaging techs to make the determination. But just as there are bad Umpires in a game, a MRI determination is only as good as the tech and the image itself. Thanks for the kind words. I send my Best Wishes to you and your Pop..........
All Meshed Up

Whitewater, CO

#7679 Apr 17, 2013
As an update, Sonia was admitted into the Hospital yesterday. She is still having a lot of problems with bowel obstruction and unexplained infections along with another hernia that they are going to repair with mesh. I hope everyone will say a little prayer today for her and her swift and complete recovery.......
Lin

Phenix City, AL

#7680 Apr 17, 2013
All Meshed Up wrote:
<quoted text> The OP report should contain ALL items used during the surgery. This includes saline solutions, antibiotics, sutures and especially any surgical implants. When you had posted previously that there was an "Oval" shape showing up, my first thought was that it could be a Bard/Kugel Oval with ring mesh product. But if it is not in the OP report and if the surgeon denies the use of such product, much less any other mesh, then I think you have a mystery. And the needs to be addressed Immediately. If the "Medical Professionals" cannot answer or will not answer I would start climbing the "Medical" ladder as it were and start complaining. LOUDLY! Doctors do analyze CT/MRI scans but they really rely on the CT/MRI Imaging techs to make the determination. But just as there are bad Umpires in a game, a MRI determination is only as good as the tech and the image itself. Thanks for the kind words. I send my Best Wishes to you and your Pop..........
AMU thanks for the imformation. Yes this is why going to the new surgeon. Even an xray from 2011 shows this oval shape in which I think to be mesh, yet in all op reports don't say anything of it. Again thanks 4 your input.:)
Cyn

Tucson, AZ

#7681 Apr 19, 2013
XBOXKIDS wrote:
MY HUSBAND HAD HERNIA SURGERY IN APRIL 98.
FOR THE LAST 2/3 MONTHS HE HAS HAD A LOT OF PAIN AND BURNING IN THE LOWER PART OF HIS ABDOMINAL I WAS WONDERING IF THIS COULD BE SOME OF THE SYMPTONS?
For burning senstation you can ask dr if Cymbalta ( or some other anti depression meds) or lyria would help.. It helps with the nerves pains and burning sensation.. I still take Cymbalta when as needed for burning senstation on my feet ( got RA and B 12 defency neuropathy)..I took it for my abdominal pain even tho dr did not tell me to but it helps..
hjoladybug

United States

#7682 Apr 19, 2013
I had a laproscopic ventral hernia repair on 1/29/13 with the ethicon physiomesh.Developed phnemonia the next day so was in hospital foe 1 week.Two days after surgery I started itching at the incision sites but figured it was just the healing process. When I got home the itching became full blown & the surgeon ignored it even though I was actually digging myself open. After 2 months he finally ran a CT & determined the mesh was infected & said I was also possibly allergic to it & scheduled me for surgery again. Second surgery was on 3/26/13 but they had to open me wide up requiring approx. 40 staples & placing 4 tubes in me. Well from day 1 my belly button was filling with fluid he said. After being released home & gettin the tubes taked out about a week later they finally took the staples out. Doctor said we had to clean belly botton every day with betadine & return in 1 week. Daughter was cleaning it found that there was a piece of skin thats just hanging there & there's an open hole with all kinds of yellow pus that she keeps cleaning out of it. Been seeing surgeon weekly since discharged & now scheduled for a debridement surgeryon 4/22/13. This is crazy. Has anyone else had problems with this mesh or has it been recalled? [email protected]

Since: Jan 13

Lake Villa, IL

#7683 Apr 20, 2013
patty wrote:
<quoted text>hey meshed.I was just telling Don that I will never get an implant. Id rather go to Mexico, cut my legs off and roll myself around on a little cart begging for pesos than get any type of implant. Hope you have at least been watching the NFL news in your downtime:} The draft is coming up real soon!
Thank You AMU! I went back and read most of your posts, My Lord what is going on here, Please Help Us All. Good for you, take care of yourself, and please let us know how you are doing. This was getting me so mad(still am) but no more lies, we all just want to feel better, move on, and get the info/help we deserve.... should be very simple....I still do not know exactly what mesh(manufacturer/lot#) is in me, or, if it is causing my problems, but Thanks to You, and Others, I know I have been lied to about very simple, basic, information....no more of this...Good Luck, Feel Better, Etc., I am praying for you, all of us, Take Care.

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