Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8247 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.

Since: Jul 13

Location hidden

#7938 Jul 8, 2013
Hello All-

Please excuse the questions for I am new to here.

Does anyone know of any lawsuits filed on inguinal hernia surgery complications due to mesh?

Do you have a link to the FDA product recalls?
All Meshed Up

Whitewater, CO

#7939 Jul 9, 2013
tkmd wrote:
Hello All-
Please excuse the questions for I am new to here.
Does anyone know of any lawsuits filed on inguinal hernia surgery complications due to mesh?
Do you have a link to the FDA product recalls?
There is never a reason to apologize for questions on this Forum, especially from a "Newbie". There are currently no active lawsuits concerning HERNIA mesh. That train pulled out of the station a couple of years ago and it was known as a Multi District Litigation (MDL). It was concerning the Bard/Kugel mesh patch ( Large Ovals with Ring ) and was a very limited lawsuit put together by Motley Rice law group in Rhode Island. It was a joke, a scam and no victim really "made out" with their pittance that Motley Rice ( The Motley Crew ) called a "Settlement". You may be able to find a Lawyer (s) that a "Trolling" for victims to try and get a suit going again but most firms now are focusing on the new "gold mine", Trans Vaginal Mesh victims. If you Google, FDA Surgical Mesh recalls you will be sent to their website. The problem being is that the only recall for mesh is the Kugel patch! There are "Warnings" out the wazoo about the TVT/Vaginal/Gyno meshs but a 40%+ failure rate is not quite good enough for the FDA to consider a recall. And there lies the major problem that all Mesh Victims are facing now. The FDA is so far involved with the Manufacturers that they are protecting them. If the FDA recalls Mesh, it CANNOT differentiate between one product and the next because ALL mesh products are made from the same Petroleum based chemicals. And every Mesh product does the same thing in the human body once it is implanted. Mesh contracts, twists, adheres, migrates and breaks apart over time. Some Implantee's do not have the same experiences as others do and these victims are called success stories by the FDA and the Manufacturers while they ignore the rest of us. The Kugel Mesh recall that everyone points at and says that there IS a recall had NOTHING to do with the mesh itself. The recall was for the Plastic Retaining Ring which can break and start puncturing and slicing anything around it. It drives me crazy that victims keep asking about a recall that DOES NOT EXIST when it comes to mesh.I am not blameing you or any other victim because there are advertisments claiming that there is/was a recall of "Mesh". Thats what I call "Trolling for Victims". What product do you have? Please gather all your Medical Records and file a report to the FDA MAUDE data base useing your OP report. Please make a detailed and complete report to the FDA. You will be contacted by the Manufacturer at some point as that is the law. You will have to decide how much info you want to give the manufacturer but please give the FDA all you can. I would also suggest that you go back through the pages of this Forum to answer some of your questions and familiarize yourself with many of the complaints and obstacles you will face as a Mesh Victim. There are many links also in the Posts that are very helpful and informative to a "Newbie" like you. Get back to us and let us know how you are doing and what mesh you have. Best Wishes.......
All Meshed Up

Whitewater, CO

#7940 Jul 9, 2013
Transvaginal Mesh Trial Date Announced August 19, 2013
Judge Charles Goodwin, overseeing the 5 vaginal mesh MDLS in Charleston West Virginia, announced yesterday that jury trials for women seeking damages from CR Bard will be tried in order this summer. Derek Potts, Co Lead of the Bard MDL, along with well-known criminal attorney Allison Van Laningham from North Carolina, will begin a jury trial representing a Wisconsin woman implanted with a CR Bard pelvic organ prolapse mesh in Charleston, West Virginia on August 19, 2013. Ms. Van Laninigham is most recently known for her successful defense at the criminal trial of John Edwards, former candidate for President of the United States.
******** I don't know whether to laugh or cry. Let us see whether this case will actually go after the Mesh product itself instead of the Doctor that doesn't tell the patient there may be side effects with a Mesh implant. Blame the messenger and not the bullet seems to be the norm......
Chuck

Weaver, AL

#7941 Jul 10, 2013
Morning all,?. Is their been a recall on Proceed mesh, within the last 3 years.
All Meshed Up

Whitewater, CO

#7942 Jul 10, 2013
The Proceed Surgical Mesh was hit with an FDA recall on December 21st, 2005 after a troublesome pattern surfaced with regards to a the soft mesh layer of the patch delaminating from the polypropylene layer, leaving it exposed. It was determined that this exposure to the polypropylene could lead to an increased risk of adhesions and bowl fistulization. Symptoms associated with these injuries may include chronic abdominal pain, prolonged fever, or tenderness at the implant site.

The FDA suggested that hospitals immediately suspend use of all affected Proceed Surgical Meshes. In cooperation with the FDA recall, Ethicon, Inc. contacted its patients on January 4, 2006 warning them of the possible defect and alerting them to the hernia patch recall. Patients implanted with an affected hernia device were advised to seek medical attention immediately to determine the best course of action.

The Proceed Surgical Mesh is a medical product that was designed and manufactured by Ethicon, Inc., a division of Johnson & Johnson Gateway, LLC. It is constructed from a layer of soft polypropylene and an oxidized regenerated cellulose and its placement aids in the prevention of new hernias at various potential sites.

The construction of the Proceed mesh was specifically designed to minimize tissue attachment and provide flexible scar tissue. The Proceed Surgical Mesh serves as a reparative device for existing hernias while also serving as a preventative device, minimizing the potential for new hernia formation.

Well, its not in the last 3 years and I am now corrected in my understanding that there was no recalls for the mesh itself! Hope this helps Chuck. Best Wishes.......

Since: Jul 13

Location hidden

#7943 Jul 10, 2013
All Meshed Up wrote:
<quoted text> There is never a reason to apologize for questions on this Forum, especially from a "Newbie". There are currently no active lawsuits concerning HERNIA mesh. That train pulled out of the station a couple of years ago and it was known as a Multi District Litigation (MDL). It was concerning the Bard/Kugel mesh patch ( Large Ovals with Ring ) and was a very limited lawsuit put together by Motley Rice law group in Rhode Island. It was a joke, a scam and no victim really "made out" with their pittance that Motley Rice ( The Motley Crew ) called a "Settlement". You may be able to find a Lawyer (s) that a "Trolling" for victims to try and get a suit going again but most firms now are focusing on the new "gold mine", Trans Vaginal Mesh victims. If you Google, FDA Surgical Mesh recalls you will be sent to their website. The problem being is that the only recall for mesh is the Kugel patch! There are "Warnings" out the wazoo about the TVT/Vaginal/Gyno meshs but a 40%+ failure rate is not quite good enough for the FDA to consider a recall. And there lies the major problem that all Mesh Victims are facing now. The FDA is so far involved with the Manufacturers that they are protecting them. If the FDA recalls Mesh, it CANNOT differentiate between one product and the next because ALL mesh products are made from the same Petroleum based chemicals. And every Mesh product does the same thing in the human body once it is implanted. Mesh contracts, twists, adheres, migrates and breaks apart over time. Some Implantee's do not have the same experiences as others do and these victims are called success stories by the FDA and the Manufacturers while they ignore the rest of us. The Kugel Mesh recall that everyone points at and says that there IS a recall had NOTHING to do with the mesh itself. The recall was for the Plastic Retaining Ring which can break and start puncturing and slicing anything around it. It drives me crazy that victims keep asking about a recall that DOES NOT EXIST when it comes to mesh.I am not blameing you or any other victim because there are advertisments claiming that there is/was a recall of "Mesh". Thats what I call "Trolling for Victims". What product do you have? Please gather all your Medical Records and file a report to the FDA MAUDE data base useing your OP report. Please make a detailed and complete report to the FDA. You will be contacted by the Manufacturer at some point as that is the law. You will have to decide how much info you want to give the manufacturer but please give the FDA all you can. I would also suggest that you go back through the pages of this Forum to answer some of your questions and familiarize yourself with many of the complaints and obstacles you will face as a Mesh Victim. There are many links also in the Posts that are very helpful and informative to a "Newbie" like you. Get back to us and let us know how you are doing and what mesh you have. Best Wishes.......
Thanks for the reply and appreciate your help. What about towards any surgeons like this one below on the post op lack of treatment?

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

SECOND APPELLATE DISTRICT

DIVISION SIX

JAMES JONES,

Plaintiff and Appellant,

v.

MICHAEL R. DRUCKER,

Defendant and Respondent.
2d Civil No. B238437
(Super. Ct. No. 56-2008-00328693)
(Ventura County)
All Meshed Up

Whitewater, CO

#7944 Jul 10, 2013
Regarding a Malpractice Lawsuit against any Doctor will have to involve the money for the Attorney. If you have a "Very" good case you may be able to have a lawyer take 30-40% of the proceeds IF you win. And if you do not win you may be liable for the cost of the Attorney, his Intern/investigator time and any "Expert" witnesses necessary for the trial.( Major Buck-a-roonies!) A Doctor such as Ramshaw will have a Top Notch Lawyer representing him. And finally,( yeah, I know, call me Mr Happy!)getting a Malpractice suit is very difficult to put together and has to be such a situation as to be BLATANT. Just because he does not want to treat you does not dictate a Malpractice suit. If you have verifiable, documented and on going medical problems that can be "Directly" associated with Ramshaw, then you may have a suit and I say, go for it. If there is anything else we can help you with, please do not hesitate to ask......Best Wishes
Terlin

Ann Arbor, MI

#7945 Jul 11, 2013
All Meshed Up wrote:
As a side note, Terlin. There have been at least 4 posts now with people trying to help you with the problems you keep writing about. An acknowledgement, response or at least a Thank You would be approriate at some point. I hope you are feeling better......
Thank you I'm about incapacitated nothing helps me presure in head bloating backed up colon hospital won't help with screw up not much longer to live but thanks
Tabitha

United States

#7946 Jul 12, 2013
All Meshed Up wrote:
Regarding a Malpractice Lawsuit against any Doctor will have to involve the money for the Attorney. If you have a "Very" good case you may be able to have a lawyer take 30-40% of the proceeds IF you win. And if you do not win you may be liable for the cost of the Attorney, his Intern/investigator time and any "Expert" witnesses necessary for the trial.( Major Buck-a-roonies!) A Doctor such as Ramshaw will have a Top Notch Lawyer representing him. And finally,( yeah, I know, call me Mr Happy!)getting a Malpractice suit is very difficult to put together and has to be such a situation as to be BLATANT. Just because he does not want to treat you does not dictate a Malpractice suit. If you have verifiable, documented and on going medical problems that can be "Directly" associated with Ramshaw, then you may have a suit and I say, go for it. If there is anything else we can help you with, please do not hesitate to ask......Best Wishes
Hi AMU,wanted to know if there is a way to find out if your attorney actually added your name to the MDL or just collected a large sum from the manufacturer and divided it as they saw fit? I am asking because after refusing the offer,my attorney informed me that they would send this to the courts and have them dismiss my case,but they are hesitating to send this to the courts. They are constantly lying to me about this issue which makes me wonder what they are doing.. Can u please let me know if u or any one may have info. Thank you.
Chuck

Birmingham, AL

#7947 Jul 14, 2013
All Meshed Up wrote:
Regarding a Malpractice Lawsuit against any Doctor will have to involve the money for the Attorney. If you have a "Very" good case you may be able to have a lawyer take 30-40% of the proceeds IF you win. And if you do not win you may be liable for the cost of the Attorney, his Intern/investigator time and any "Expert" witnesses necessary for the trial.( Major Buck-a-roonies!) A Doctor such as Ramshaw will have a Top Notch Lawyer representing him. And finally,( yeah, I know, call me Mr Happy!)getting a Malpractice suit is very difficult to put together and has to be such a situation as to be BLATANT. Just because he does not want to treat you does not dictate a Malpractice suit. If you have verifiable, documented and on going medical problems that can be "Directly" associated with Ramshaw, then you may have a suit and I say, go for it. If there is anything else we can help you with, please do not hesitate to ask......Best Wishes
Money talks " BullSHIT walks"
Lin

Birmingham, AL

#7948 Jul 14, 2013
Morning ALL :) or ;{ Got question about not getting backing of SCREWED UP Hernia Surgery rather with or without mesh, or the type of surgery used. Lets deal with MESH SURGERY with all types of surgery. Rather open Lap what ever else . Ok Obama BuLLSHIT about Federal cutbacks, ok once a person has any type of hernia surgery they become a job risk to begin with. Not to be choosing one hernia type over others at this point, but abdominal hernias are the higher risk that employers turn down, with a very high% of not getting hired. With the more surgeries one has the more the risk. Ok getting back to my rave on Obama Federal Gov cut backs, Ok cutbacks are getting hit hard for one to get on Disability. Always you get turned away on first try, unless one is smart enough to hire attorney to begin with. Then they win case for you, they get their high% of whats due to you. If you are lucky don't die, or living on the streets Homeless, while waiting. Been their. Yet Obama wants those that get SSDisability to take bigger cuts to their payments. Yet he is brain trust have blinders on when coming to the point as to asking questions investagating as to why are their so many repeated hernia surgeries? Example myself I now have battle scar road map of the abdominal from 3 surgeries. I also know their are many more out their with more. My point is when it comes down to lawsuits, why is the fed Gov or its other medical branches like FDA, CDC, SSD, Medicare, Medicaid taking a stand for us?? For repeated surgeries do take their toal on us. causing multi other health issues.
Barb

Odessa, TX

#7949 Jul 14, 2013
Tabitha wrote:
<quoted text> Hi AMU,wanted to know if there is a way to find out if your attorney actually added your name to the MDL or just collected a large sum from the manufacturer and divided it as they saw fit? I am asking because after refusing the offer,my attorney informed me that they would send this to the courts and have them dismiss my case,but they are hesitating to send this to the courts. They are constantly lying to me about this issue which makes me wonder what they are doing.. Can u please let me know if u or any one may have info. Thank you.
Tabitha, if you want to privately email me your full name I will run a check to see if I can get you the status on your case! I am an independent public consultant therefore I do have access to check status but whatever information I give you please don't mistake it for legal advice! I am a consumer advocate as well and when law firms purposly avoid consumers just rubs me the wrong way!!

Sincerely,

Barb Martin
martinconsumeradvocate@gmail.c om
Lin

Birmingham, AL

#7950 Jul 14, 2013
need make a correction. Statement miss worded, last statement. It should read My point is when it comes down to lawsuites,why is the Fed Gov or it's medical branches of the FDA, CDC, SSDisabilities Medicare, Medicaid agentes not standing with us? For aren't each one of these agency taken oath of the welfare, welcare for each one of us? But in this case aren't each branch costing us and Fed Gov for not doing more for us. With not reporting strong enough that their been lifes being lost or major injury from deffected meds or devices. Leading to fraud, payoffs, etc.. which in end we pay for with our lifes!
Nance

Sayville, NY

#7951 Jul 14, 2013
I am having terrible pain for years due to sepramesh . Help
E mail
Clarkepn@optonline.net
All Meshed Up

Whitewater, CO

#7953 Jul 15, 2013
Lin wrote:
need make a correction. Statement miss worded, last statement. It should read My point is when it comes down to lawsuites,why is the Fed Gov or it's medical branches of the FDA, CDC, SSDisabilities Medicare, Medicaid agentes not standing with us? For aren't each one of these agency taken oath of the welfare, welcare for each one of us? But in this case aren't each branch costing us and Fed Gov for not doing more for us. With not reporting strong enough that their been lifes being lost or major injury from deffected meds or devices. Leading to fraud, payoffs, etc.. which in end we pay for with our lifes!
Hello Lin! Always good to hear from you. We as Mesh Victims are in a very bad spot. Not only do we have to live with what Mesh has and is doing to us but we have to deal with the Medical and Governmental bureacracy's that are inept, non-sympathetic and slow to respond. What you believe to be "Common Sense" does not apply to the Government. If the FDA ( and I have posted this many times!) admits to our Mesh problems as inherent to ALL MESH PRODUCTS then there will be so many law suits and recalls that it would bankrupt Medical Manufacturers, Insurance Companies and there would have to be ( you could only hope!) intense scrutiny of the FDA's involvement with the Manufacturers. The FDA and the Government in general cannot and will not allow that to happen. The Governments ONLY involvment will be to try and recoup monies paid out for surgeries that have failed via Medicare/Medicaid with our law suits. That they are MORE than willing to do. They will come at us with both hands open demanding payment from whatever settlement you may get if you are on Medicare/Medicaid. Not only that but the Insurance Industry will be right along with them to get their money back, also. The Multi-State investigation into J&J/Ethicons fraudulent advertiseing and marketing of their Gyno/Hernia meshs is totally meant to get money from the Manufacturer for the STATE. There is no thought for the victims of the fraudulently marketed medical product. If there is a "BIG BREAK THROUGH" concerning mesh, we as Mesh Victims will be paraded out as the poor victim but we will not be allowed to get compensated for our suffering. I have been trying to get a Lawyer to represent me for YEARS! When I see a new Lawyer advertiseing for Victims I will contact them just to hear them spew another excuse as to why MY case is not worthy of their attention. I believe that our Government will take over any chance of compensation and THEY will decide who is worthy and who is S.O.L.. The FDA will get off scott free, the Manufacturers will pay out a pittance to the victims and the Government will get 100's of Millions for the FINES they get from the Manufacturers. And the largest most complex Medical Fraud conspiracy will be deemed "Over". Except that we as Mesh Victims will again be left behind to fend and die by ourselves. I do not see our Government helping us at all. In fact I believe that they have been and continue to protect the Manufacturers and are more concerned about what this all means to them than what all this means to US. And if OBAMA Care is allowed to go into effect, we as Mesh Victims will be just another case file waiting for the Death Boards decision. What do you think the outcome will be? Just call me Mr. Happy!
All Meshed Up

Whitewater, CO

#7954 Jul 15, 2013
Nance wrote:
I am having terrible pain for years due to sepramesh . Help
E mail
Clarkepn@optonline.net
What help are you looking for? When were you implanted and what does your Dr. say? Let us know and we will try to put you in the right direction. Best Wishes....
All Meshed Up

Whitewater, CO

#7955 Jul 15, 2013
Barb wrote:
<quoted text>
Tabitha, if you want to privately email me your full name I will run a check to see if I can get you the status on your case! I am an independent public consultant therefore I do have access to check status but whatever information I give you please don't mistake it for legal advice! I am a consumer advocate as well and when law firms purposly avoid consumers just rubs me the wrong way!!
Sincerely,
Barb Martin
martinconsumeradvocate@gmail.c om
If you are doing this to help Mesh Victim and NOT trolling for business I will be the first to Thank You! Please help Tabitha with her questions about her Lawyer as there are several other Victims that were on that same MDL and are also concerned about their outcome. I would also be interested on the Legality of them contacting Medicare/Medicaid to let them know about a case status and settlement arrangements without the clients knowledge or consent. Again, I hope you are trying to "Help" and if you are, Thank You.......
All Meshed Up

Whitewater, CO

#7956 Jul 16, 2013
Here are the "Guidelines" for Deaths or Injuries caused by a Medical Device reporting to the FDA and/or the Manufacturer. The hospital where I had my surgeries had "Never Heard" from any Dr. about "Any" mesh products that were defective after implant and had to be removed. I know of at least 6 Hernia Mesh products that WERE removed because they twisted, crumpled and caused mass damage to the patient. Yet Doctors are not reporting these instances of mesh failures to the Hospital which never contacts the Manufacturer. So when we make a report to the FDA or the Manufacturer our report has no back up documentation from the Hospital as to the reason of Explant nor is the product sent to the manufacturer for evaluation. We stand alone especially if the Doctor does not respond to the FDA's request for information.( or if the FDA does NOT contact the Doctor/Hospital as in my case )So here are the "Guidelines" from the FDA's website. If they were followed by these entities as they should, we might be in a different situation right now.*********MDR Mandatory Reporting Requirements:
Manufactureers: Manufacturers are required to report to FDA when they learn one of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to FDA when they become aware that one of their devices has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction happened again.

Importers: Importers are required to report to FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer when they become aware that one of their devices has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to happen again.

User Facilities: User Facilities (e.g., hospitals, nursing homes) are required to report a suspected medical device-related death to both the FDA and the manufacturer. User facilities should report a medical device-related serious injury only to the manufacturer. If the medical device manufacturer is unknown, the user facility should report the serious injury to FDA. A user facility is not required by the MDR regulation to report a malfunction, but can use the voluntary MedWatch program to advise FDA of problems with medical devices. Health-care professionals within a user-facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See "Medical Device Reporting for User Facilities1", a guidance document issued by FDA.

Best Wishes..........
Lin

Birmingham, AL

#7957 Jul 17, 2013
what is Bard elliptical 8x10 ? this is what is shown on my latest surgery. Was mailed to me. haven't been to record department to get my surgery report yet. In which need to. For getting e-mails for deffective hernia surgery useage of Lap robot. thanks for any information
Patty

Eugene, OR

#7958 Jul 18, 2013
Meshoma Foundation wrote:
<quoted text>
Hi Terlin, sorry to hear of your pain. I am not a doctor but have experienced mesh complications and several surgeries with continued pain. I find that Tramadol (not the extended release) although takes about 45 minutes to work does help with the burning feet and some of the groin pain, lasts about three hours, very little side effect at all for me. I have had several hundred calls from other patients who reported that Tramadol worked better for them without side effects as compared to the high doses of neurontin/gabapentin that so many patients are trying with some success but side effects. Talk to your doctor about it (also known as Ultram) if you haven't tried it already.
Avoid, smoking, caffeine (includes chocolate-sorry), high sugar foods anything that excites the nervous system and that increases inflammation and that will further entrap nerves. Try eating more anti-inflammatory foods cherries, blueberries, etc
Feel better,
Bruce Rosenberg
National Meshoma Foundation.
Tramidol can cause serious seizures. It can be highly addictive. I have personally seen it happen to a family member. It does work for pain, but some people build a resistance and need more over time. Just please use it as you would any other pain reliever and don't over use it.

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