Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8238 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

#7700 Apr 26, 2013
Lin wrote:
Morning 4/26 Friday. AMU & Bruce, just note haven't heard back from surgeon yet as what type mesh he will be using. Other wise taking it day by day.:}
Goodmorning Lin. It was nice to talk to you also. To reiterate what we had talked about....you are thinking about taking one piece of mesh and replacing it with 2. You will have scar tissue removed only to be replaced by more scar tissue. Along with the removal of the mesh there is the possiblity of nerve damage, adhesion damage ( and possible long term side effects ) and since we still do not know what mesh is to be implanted there could be a possible rejection of said material. Now combine that with the other medical issue that we discussed, I would be VERY wary of jumping into this mesh replacment. If the Umbilical Hernia is not a problem then please approach this with much caution. I would also like to have the surgeons name, Please. Anytime I hear of a surgeon saying that they are "well versed" in this type of surgery, especially when they are confident of its outcome, I would want to have them on the short list. Best Wishes.......
All Meshed Up

Whitewater, CO

#7701 Apr 26, 2013
http://www.uropartners.com/our_physicians/phy... http://www.maleinfertility.org/goldstein.html Hey there all you guys out ther that have had hernia surgery with mesh and have all of the typical damage. I am refering of course to damage done to our Sexual performance, pain, shrinkage, loss of testicle and all the other wonderful, wonderful issues we get along with Mesh! The above links are 2 of the best in the country when it comes to their knowledge of what mesh does to men. The first is Dr. Levine and the other is Dr. Goldstein. Dr. Goldstein is near retirment but is a very competant Dr. when it comes to erosian of mesh into the spermatic cord injury and vascular damage by mesh. Dr Levine has the same credentials but in addition is said to be a Micro Surgical expert for repairing Spermatic cord damage. Hope that maybe this info will provide another avenue for those that still can get help. Best Wishes.......
Blair

Montague, Canada

#7702 Apr 27, 2013
All Meshed Up wrote:
<quoted text> Goodmorning Lin. It was nice to talk to you also. To reiterate what we had talked about....you are thinking about taking one piece of mesh and replacing it with 2. You will have scar tissue removed only to be replaced by more scar tissue. Along with the removal of the mesh there is the possiblity of nerve damage, adhesion damage ( and possible long term side effects ) and since we still do not know what mesh is to be implanted there could be a possible rejection of said material. Now combine that with the other medical issue that we discussed, I would be VERY wary of jumping into this mesh replacment. If the Umbilical Hernia is not a problem then please approach this with much caution. I would also like to have the surgeons name, Please. Anytime I hear of a surgeon saying that they are "well versed" in this type of surgery, especially when they are confident of its outcome, I would want to have them on the short list. Best Wishes.......
Lin, your case sounds a lot like mine, this is not a plastic surgeon, it does not sound like component separation, why would they put mesh in again after all your problems the first time, mine was all repaired using my own fascia and no mesh, my one Umbilical Hernia turned out to be five, they never showed up in the scans. Just ask the surgeon why it can not be repaired without mesh. There must be a plastic surgeon in the USA doing tissue flap repair using your own fascia. I would ask questions! No way would i let them but mesh back in me.
John

Los Angeles, CA

#7703 Apr 27, 2013
Do you guys recommend me getting mesh out? Has any one gone to Dr. Petersen in Las Vegas? Did removal of surgery help ?
patty

Cottage Grove, OR

#7706 Apr 27, 2013
Lin wrote:
Morning All :}:0
I going address to both AMU & Bruce B. hey guys need your imput, or anyone else that has had surgery of this type. Ok yesterday Tuesday23, I found a new surgeon went to him yesterday. Ok after he looked at pass surgery reports etc... We talked, he did abdominal exam. His findings, small umbilical hernia. Big problems with the abdominal diastasis rectus. The whole length from under breastbone to umbilical is a mess. I have a separation of the rectus muscle of the medline,which is causing dysfunction of whole abdominal wall. So now this will be open surgery, removing the 4x6" mesh, major surgery. His plan is go in remove gallbladder, fix hernia and the dia rectus, he plans on using 2 sheets of mesh, one under and pull the muscles together kind of layer over lap stitch, then another mesh on top. I didn't ask what type mesh he going to use. Just slipped mind. I kind of stunned cause of I thought from the 2010 surgery fixed all problems. So here I go again. I will be in hospital possible 3-4 days, off feet up to month and half. I sure hope it works. I'm bit concerned about the removing of the mesh, tacks of 2010 surgery. Just worry about nerve tissue damage. So any imput please post. Thanks
My husbands last surgery was a retro rectus, that was in Sept 2012. He is still in pain from the first one in 2011, then the second one in Nov 2011. You will NEVER EVER be the same as you were. Funny, the first on with the Atrium CQUR was supposed to ahve "FIXED" the tiny tiny problem, but it did not. Dont plan on ever working with anything but your mind afterwards. And, ask the surgeon to please please put a binder on before you wake up. If he/she does not, well, you will see. Good luck.
Lin

Sylacauga, AL

#7707 Apr 28, 2013
:} Morning to all,BruceB, got your message having problems with cell phone (Can't hear you company)? Blair, AMU, Patty, Just me. Yhanks You all with your post emails. Come tomorrow morning,Monday29, I plan on calling his office to see if can't get a written out Pre-Op report. In which need that for another purpose. I do know the Gallbladder issue, is causing some of the pain,sour stomach problems, yet their is the Dia REC also, for at bed time I have sleep with 3 pillows proped up. get alot of acid burn back up in throat in which wakes me up middle of night.( don't eat after 5pm. no fried foods, no beef, spices, etc..). for anyway with what ever is going on does cause asthma problems. Anyway when get report will post more about his details. Hopefully will have by this Friday. Yet I don't know why the surgeon back in 2010, that did the rebuild of abdominal didn't take and fix the dia rectus back then, in which her report says that after removual of heavy scar tissue ahesions, that a large Dia Rectus. Again thanks alot. Its crazy!
Papa Joe

Alice, TX

#7708 Apr 28, 2013
wolf99 wrote:
Happy New Years Everyone. 12/29/11. Question on Proceed Mesh? I just received an e-mail from a friend. Stating that their is a recall as of Dec. 15,2011 on the Ethicon J&J Company (PROCEED-Code PCDG1 Lot # BMG618). Potential for delamination resulting in EXPOSURE of underlying POLYPROPYLENE MESH which could potentially result in adhesions and fistulas.
Do you know any lawyers that are taking the proceed mesh cases?
Thanx Papa Joe:)
mike g

Williston, ND

#7709 Apr 28, 2013
Deon De Santis wrote:
Also, anybody can email me about that GENZYME SEPRAMESH post I just sent through to:
[email protected] please...
Sorry for that omission....
Thank you,
Deon De Santis
Lake Isabella, CA.
never used a board like this before so bear with me. my wife had 2 of these sepramesh repairs in 2009 and has had major health issues since, skin rashes, constipation, and pain when eatinglike she can only eat a small amount of food , she says it feels like it is getting stuck.
Chuck

Birmingham, AL

#7710 Apr 28, 2013
Is this hope for our future hernia repairs? Ok, this was on the early Sunday 28, news on CBS. Titled: 3D Printing The Next Dimension very interesting. Bio Printing of your own cells, in making your own tissue. Tissue Engineering. I reseached this it sounds possible. google 3DPrinting The Next Dimension, CBS Sunday Early News
Sonia_59

Sydney, Australia

#7711 Apr 28, 2013
All Meshed Up wrote:
<quoted text> Goodmorning Lin. It was nice to talk to you also. To reiterate what we had talked about....you are thinking about taking one piece of mesh and replacing it with 2. You will have scar tissue removed only to be replaced by more scar tissue. Along with the removal of the mesh there is the possiblity of nerve damage, adhesion damage ( and possible long term side effects ) and since we still do not know what mesh is to be implanted there could be a possible rejection of said material. Now combine that with the other medical issue that we discussed, I would be VERY wary of jumping into this mesh replacment. If the Umbilical Hernia is not a problem then please approach this with much caution. I would also like to have the surgeons name, Please. Anytime I hear of a surgeon saying that they are "well versed" in this type of surgery, especially when they are confident of its outcome, I would want to have them on the short list. Best Wishes.......
Hi nice to see you back. I sent you an email, but in the above blog, you mentioned that hospitals cannot send you away, well that is exactly what happened., it was not the hospital but the surgeon on call was no other than White, and he was very happy to send me away, except the emergency head doctor thought it wise to admit me. Whilst I am pissed off that again palmed off and nothing done, the arrogant son of a bitch played straighted into my solicitors hands, this will cost the prick plenty. Again nice to see you back, hope you are feeling O.K. Love Sonia
All Meshed Up

Whitewater, CO

#7712 Apr 29, 2013
mike g wrote:
<quoted text>
never used a board like this before so bear with me. my wife had 2 of these sepramesh repairs in 2009 and has had major health issues since, skin rashes, constipation, and pain when eatinglike she can only eat a small amount of food , she says it feels like it is getting stuck.
GENZYME SEPRA MESH SURGICAL MESH Back to Search Results

Event Date 01/01/2005
Event Type No Answer Provided
Event Description
Consumer states that, she had a hernia repair in 2005 & 1 month later, she was back in the hospital for re-operation, because of her vomiting bilious contents. An mri done at the time showed that the device was defective and "lifted up" one side. At the time of re-operation, the pt was told that the device was "frozen" to the intestines and that her whole bowel system needed to be reconstructed. Seven months following the 2nd surgery, the hernia reappeared. She states that, she hasn't had any problems since 2006,(after re-operation by a professor of surgery). She's heard about the bard-kugel recall from jan 2007 and wanted to document the adverse effects of the (1) sepra and (2) gore mesh products. She has been in prayer about her situation and has sought legal counsel, but is not looking for a lawsuit. Her attorneys found out that her records indicated the use of 2 defective products, neither of which appears to be that of the recalled product from this year. She feels that the mesh products almost cost her life & wants fda aware.


Search Alerts/Recalls20



New Search | Submit an Adverse Event Report21

Brand Name SEPRA MESH
Type of Device SURGICAL MESH
Manufacturer (Section F) GENZYME
*


Manufacturer (Section D) GENZYME
*


Device Event Key 824464
MDR Report Key 837161
Event Key 800057
Report Number MW1042540
Device Sequence Number 1
Product Code MRN22
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/04/2007
2 DeviceS WERE Involved in the Event: 1 2
1 Patient Was Involved in the Event
Date FDA Received 04/04/2007
Is This An Adverse Event Report? No
Device Operator Invalid Data
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Home
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided



- Hello Mike, this is a report from the FDA MAUDE data base about Sepra mesh. You will notice that the symptoms/complaints are quite similar to those that your wife is experiencing. Please also notice that the lady making this report did not include a lot of info needed for a complete and comprehensive description of the events. Because of incomplete reports like this one, the FDA and the manufacturers cannot and will not acknowledge any problems with any reported mesh. You need to get your OP report from the hospital. It will have the model # and lot# of the mesh. If you haven't alredy done it, call your Dr. ASAP! Do not let him B.S. you about mesh not being the problem with your wife. It could be that mesh MAY NOT be what is causing your wife's problems but I kind of doubt it. Especially with the symptoms you are describing. I hope this helps a bit. Once you have all your info, PLEASE make your own report to the FDA and the Manufacturer. If the mesh has to be removed, please have a sample sent to the FDA and the manufacturer so they will have NO excuse to disbelieve you. Let us know what you find out and get back to us. Best Wishes.......
All Meshed Up

Whitewater, CO

#7713 Apr 29, 2013
I would ask everyone to take a read through the list of questions about this particular report I posted for Mike. "Is this an Adverse Event Report" "NO". "Date reported to the FDA" " 04/04/2007". " Reported to the FDA?" "NO" " Is the device an implant?" "NO".( are you joking?) " Was the device reported to the manufacturer?" "NO". Now ask yourself, what about this does not make sense? What is it about this report, even if it is a "non event", that just gives credence to many of our suspicions about the FDA? There is no follow up, inaccurate information, "Is the Device an Implant" "NO"., no reporting to the manufacturer and even though there was subsequent surgery, the Dr. was not contacted nor medical records checked. Done. Nothing to see here. Another "solved" case. Contact your Attorney General as well your Governor. Tell them what has happened to you. Because sure as Hell...the FDA ain't doin' s*%t.
Terlin

Ann Arbor, MI

#7714 Apr 29, 2013
Mesh removed last oct . More pelvic pain constipation numb rectum and urine retention, stool backed up to assending colon when I do have a bowel movement pass a trap full I still don't get any relief . Can't sit and feels like my abdominal muscle contract just to sit upright . Gastro says I have a non relaxing sphincter causing this. Thinks a colostomy won't help with my abdominal pain. I can live with the groin pain. It feels like my Colon is spilling over my pelvic bone. Any advice
George

Los Angeles, CA

#7715 Apr 29, 2013
Terlin, who did your mesh removal? What pains where you having prior to removal of mesh? Was the symptoms your having now due to removal of mesh or where they their when you had mesh? What's your email so I can ask you more questions , I am planing on getting mesh removed. Email me @ [email protected]
Terlin wrote:
Mesh removed last oct . More pelvic pain constipation numb rectum and urine retention, stool backed up to assending colon when I do have a bowel movement pass a trap full I still don't get any relief . Can't sit and feels like my abdominal muscle contract just to sit upright . Gastro says I have a non relaxing sphincter causing this. Thinks a colostomy won't help with my abdominal pain. I can live with the groin pain. It feels like my Colon is spilling over my pelvic bone. Any advice
All Meshed Up

Whitewater, CO

#7716 Apr 30, 2013
The Medicines and Healthcare products Regulatory Agency (MHRA) received 107 incident reports since 2005 involving vaginal mesh tapes used for stress urinary incontinence (SUI) as follows:

Adverse Incident Reports
2005 8
2006 25
2007 3
2008 18
2009 19
2010 15
2011 19

In addition the MHRA has also had six reports in 2010, and 19 in 2011, where the device was unknown but likely to relate to vaginal tapes for SUI.

Read Hansard record: http://www.publications.parliament.uk/pa/cm20...

The above figures show a significant discrepancy between the number of surgeries recorded by the Hospital Episode Statistics (HES) and the number of “adverse events” recorded by the MHRA to remove TVT or TOT mesh. To be exact, HES records for removals of TVT and TOT between 2006-2011 total 2,659 which contrasts markedly to the adverse incidents recorded by the MHRA for that same period: 124.

It raises questions about how well the MHRA system of adverse incident reporting is working, and whether the current system of voluntary reporting for medical devices is providing any useful information to the regulators about problems with mesh surgery. In Earl Howe’s recent review of the action of the MHRA and department of Health over PiP breast implants, it was acknowledged that “reporting will never reflect 100% of the experience with a device and this means other information must be generated and used”.

It was also emphasised in this review that the MHRA “must be able to obtain evidence from a wider and more detailed set of sources, including robust outcomes data from clinicians”. The report recommended that the MHRA be “at the forefront of using more sophisticated and rich sources of data to determine if there are problems with a device.”

Clearly, relevant and useful information (in the form of the statistics shown above) is available and at the disposal of the MHRA; at present, they do not appear to be making use of the information.********* This is a report out of England concerning the equivelant to our FDA. It points out the discrepencies between what is being reported as a low occurence of mesh product failures and what the Hospitals are showing in their records. The Hospitals are showing that a large number of Mesh removal surgeries ARE NOT being reported/recorded by the"MHRA" (FDA). Sound familiar? Another example of why we ALL need to make reports to the FDA/Manufacturers and to our State Governments. The more the merrier I say! Keep all copies of your correspondences with the FDA/Manufacturers and your State. They may come in handy soon.......Best Wishes

Since: Jan 13

Lake Villa, IL

#7718 May 1, 2013
Good Morning Everyone. I have posted my story numerous times on here, I do not mean to bring this up AGAIN, but I need an answer to this very simple question. I have asked before, and I'm sure it was answered. I would/will look back for the answer, but my head hurts from reading too much info :) How long are hospitals required to keep medical records for mesh implants? I'm in WI. I did get my records, but do not include the manufacturer, or lot # I went into the hospital again yesterday, and after a half hour waiting, I had to leave as I was getting more pissed off by the minute. Again, I feel they were blowing me off,(caught them in a few lies) are just plain incompetent. I am wasting MY time for info that should have been given to me months ago. I am almost sure I know the answer to this, but would love to hear it again, AMU? This is ridiculous, so very simple. Good Luck to all of you, any info on this would be greatly appreciated, AGAIN. Headache from this....I am making more calls today to put an end to this, but was hoping to get lucky and have one of you answer this quickly, Thanks again
Terlin

Ann Arbor, MI

#7719 May 1, 2013
George wrote:
Terlin, who did your mesh removal? What pains where you having prior to removal of mesh? Was the symptoms your having now due to removal of mesh or where they their when you had mesh? What's your email so I can ask you more questions , I am planing on getting mesh removed. Email me @ [email protected]
<quoted text>
dr ramshaw in Daytona more groin pain I just had abdominal pain and problems dfacating before he had to cut nerves to remove mesh I'm now bed ridden with severe groin and bowel issues and now difficulty swallowing and tightnes of chest
All Meshed Up

Whitewater, CO

#7720 May 1, 2013
Any Suggestion, It does not matter if it is a Mesh surgery or any other type of surgery, your records should be available to you. After a period of time, and that is determined by the Hospital ( 7-10 yrs.), your records are archived to a data base. BUT! You should have access to them and any information within those records. Now, I have heard of some OP reports not containing the Lot#'s and model#'s of the mesh but they should be on the accompaning sheets that contain the list of sutures used, saline, anathesia etc. If you are having smoke blown where you do not want it I would suggest telling them that your next option is to 1. Get a Lawyer. 2. Talk to the Administration of the Hospital and tell them what their minions have been putting you through and 3. Call the Wisconsin Medical Board and tell them what is going on. God Forbid that does not work but if not the next step is the State Attorney Generals Office. There IS no excuse for you not having access to your records and especially what was used on you and put IN you. The fact that you have been patient with them and you are getting the run around and possibly thwarted at your attempts is not only wrong but I believe it is Illegal. Best of Luck and let us know how it goes........
All Meshed Up

Whitewater, CO

#7721 May 1, 2013
Terlin wrote:
<quoted text> dr ramshaw in Daytona more groin pain I just had abdominal pain and problems dfacating before he had to cut nerves to remove mesh I'm now bed ridden with severe groin and bowel issues and now difficulty swallowing and tightnes of chest
Terlin, DID you have any symptoms of bowel problems before the mesh was taken out? Have you talked to Dr. Ramshaw? What did he say if you did? If you have NOT talked to Dr. Ramshaw, why not? Also Dr. Ramshaw can put Mesh in and he can take Mesh out. The problem being is that he is a General Surgeon and nothing more. He has made his reputation with the help of the Mesh Manufacturers and he is still "Their Boy" today. While he talks about the problems of mesh and is willing to take them out, the subsequent problems that mesh creates ( i.e. erosian, migration etc.) is not his area of expertise. He is still on the Manufacturers payroll and reports problems with mesh to the manufacturer and NOT the FDA. In my opinion Dr Ramshaw should not be the "Bench Mark" surgeon for mesh removal. He has his own agenda and IT is not being the mesh victims friend. Just like the "Top Mesh Lawyers" they are in it for the money and the "accolades" the manufacturers heap on them when they tow the "Company" line. Please refer to my earlier posting with the links to the 2 Dr.'s that are THE specialists in the field of identifying and doing what they can to repair Mesh damage. That is my Best suggestion. Best Wishes.........

Since: Jan 13

Lake Villa, IL

#7722 May 1, 2013
All Meshed Up wrote:
Any Suggestion, It does not matter if it is a Mesh surgery or any other type of surgery, your records should be available to you. After a period of time, and that is determined by the Hospital ( 7-10 yrs.), your records are archived to a data base. BUT! You should have access to them and any information within those records. Now, I have heard of some OP reports not containing the Lot#'s and model#'s of the mesh but they should be on the accompaning sheets that contain the list of sutures used, saline, anathesia etc. If you are having smoke blown where you do not want it I would suggest telling them that your next option is to 1. Get a Lawyer. 2. Talk to the Administration of the Hospital and tell them what their minions have been putting you through and 3. Call the Wisconsin Medical Board and tell them what is going on. God Forbid that does not work but if not the next step is the State Attorney Generals Office. There IS no excuse for you not having access to your records and especially what was used on you and put IN you. The fact that you have been patient with them and you are getting the run around and possibly thwarted at your attempts is not only wrong but I believe it is Illegal. Best of Luck and let us know how it goes........
Thanks AMU! I am extremely tired of this, The hospital just called, "No Mesh On Record"(OK, BS Again, you told me 6 months ago you had NOTHING AT ALL?) I was told they need to save that info for 25 years, Talked to a few lawyers, hard to find one that will deal with this. It's just a huge headache that nobody should have to go through, Thank You so much for getting back to me so quick, I will let you know how this goes, Thank You for the info! I am going to print off what you just said, and go from there. What a waste of time, energy, LIFE!

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