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

Full story: PRWeb 8,113
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, ... Full Story
Putter1

Deltona, FL

#7139 Jan 22, 2013
Amberlei wrote:
I just received my records from my hernia surgery in 2009. I have had pain since I had the surgery and everything is just getting worse and worse to the point I can hardly do anything because of the pain. They've sent me to pain management saying its nerve damage but I know that all of this is due to the hernia repair. All of the problems I'm having are in the same area always. I had the bard modified kugel hernia patch 7.6 cm. I would like to do more research but I'm not sure where to start..... If anyone has any information that could help me get started I would really appreciate it. Thank you for your time
Hi Amberlei, I too have the Kugel mesh patch. In fact I have 2 of them. I have had a terrible tme trying to find someone to help me. The local attorneys don't even want to take anymore cases. The surgeon who did my surgery doen't want to do anything but give me antibotics. The pain is on going and getting worse. Haven't found anyone to help sorry..
george

Winter Haven, FL

#7140 Jan 22, 2013
ihad a hernia surgery in 2011and was used Marlex patch.i get pain in inguinal area and it is getting worse. any one have any suggestions or any similar problems .plese respond.thanks
Blair

Charlottetown, Canada

#7141 Jan 23, 2013
Angry as hell wrote:
<quoted text> 3 for sure maybe, but I believe I am in 1 or 2.
Try this law firm.

http://www.cwcd.com/hernia-danger.php
Blair

Charlottetown, Canada

#7142 Jan 23, 2013
Angry as hell wrote:
<quoted text> 3 for sure maybe, but I believe I am in 1 or 2.
A while back a lady emailed me about her case, turned out she was a category three. I contacted this law firm and she was accepted.The girl was great to deal with and she told me to send along cases i thought should be accepted and they would look into them.
Angry as hell

Chicago, IL

#7143 Jan 23, 2013
Thank you Blair, I just asked them to contact me. The law firm that I had wants me to just sign a piece of paper that Bard is not at fault and that I would never be able to go after them. I am not signing it.
Angry as hell

Chicago, IL

#7144 Jan 23, 2013
Blair the intake people at that law firm just contacted me and they are going to have a lawyer contact me right away. Thank you for your help.
Blair

Charlottetown, Canada

#7145 Jan 23, 2013
Amberlei wrote:
I just received my records from my hernia surgery in 2009. I have had pain since I had the surgery and everything is just getting worse and worse to the point I can hardly do anything because of the pain. They've sent me to pain management saying its nerve damage but I know that all of this is due to the hernia repair. All of the problems I'm having are in the same area always. I had the bard modified kugel hernia patch 7.6 cm. I would like to do more research but I'm not sure where to start..... If anyone has any information that could help me get started I would really appreciate it. Thank you for your time
Contact this law firm, they will be looking fot lot number of mesh used in your sugery.

http://www.cwcd.com/hernia-danger.php
Blair

Charlottetown, Canada

#7146 Jan 23, 2013
Putter1 wrote:
<quoted text> Hi Amberlei, I too have the Kugel mesh patch. In fact I have 2 of them. I have had a terrible tme trying to find someone to help me. The local attorneys don't even want to take anymore cases. The surgeon who did my surgery doen't want to do anything but give me antibotics. The pain is on going and getting worse. Haven't found anyone to help sorry..
You need the lot numbers of the meshs used in your surgerys, then contact this law firm.

http://www.cwcd.com/hernia-danger.php
All Meshed Up

Grand Junction, CO

#7147 Jan 23, 2013
Blair wrote:
<quoted text>
Try this law firm.
http://www.cwcd.com/hernia-danger.php
Hello Blair! As always, Thank Mucho for all of your input. I contacted the Lawyers and am waiting for a consult now. The called me within 5 minutes of logging into their website. I will say that I have been through this so many times that I do not have a lot of faith in lawyers ( as many of my posts have indicated!)but according to their website they are taking all Kugel victims. So I am keeping my fingers ( and toes....OUCH!) crossed and hope I may have my day in court. Thanks again.......
All Meshed Up

Grand Junction, CO

#7148 Jan 23, 2013
Amberlei wrote:
I just received my records from my hernia surgery in 2009. I have had pain since I had the surgery and everything is just getting worse and worse to the point I can hardly do anything because of the pain. They've sent me to pain management saying its nerve damage but I know that all of this is due to the hernia repair. All of the problems I'm having are in the same area always. I had the bard modified kugel hernia patch 7.6 cm. I would like to do more research but I'm not sure where to start..... If anyone has any information that could help me get started I would really appreciate it. Thank you for your time
Was your Kugel patch the type with a ring? Do you have the lot# and such. This will help. Go to the FDA Medical Device Recall site and check there. All the LARGE Kugel patchs WITH Ring have been recalled. Why the FDA did not recall the small patchs with ring also I have no idea since its the same manufacturering technique. Let us know and best of luck.....
All Meshed Up

Grand Junction, CO

#7149 Jan 23, 2013
September 7, 2011 – Cook Medical supports the FDA’s recent review of the issues surrounding the use of surgical mesh for the treatment of pelvic floor disorders and commends the administration’s open scientific discussion regarding these matters. However, Cook believes that the FDA has so far neglected to recognize the important differences between synthetic mesh products and biologic grafts in terms of tissue response, inherent risks, and successful clinical outcomes. The company has submitted a detailed review of the published clinical literature which provides compelling evidence for the safety of the newer so-called ‘non-crosslinked’ biologic grafts, and is encouraging the FDA to use this information when considering possible recommendations about the use of transvaginal mesh products in the future.
According to Cook, the FDA has grouped the different types of surgical mesh materials together and failed to acknowledge the vastly different clinical outcomes obtained with different materials. The company believes the success of any procedure involving mesh depends on at least three factors:
1.assuring that the patient is a suitable candidate
2.performing the procedure correctly
3.choosing the appropriate product
Additionally, the FDA does not discuss what Cook views as the most significant difference between types of grafts, namely, chemically cross-linked vs. non-crosslinked grafts. And though the FDA does differentiate between synthetic and biologic-derived materials, the reviews fail to recognize the difference between chemically cross-linked and non-crosslinked biologic grafts when assessing safety and effectiveness. Finally, the administration’s report only provides one example in which consideration is given to the type of transvaginal mesh material used in a procedure, stating that ‘more than half of the women who experienced erosion from non-absorbable synthetic mesh required surgical excision in the operating room.’
Vaginal mesh products for pelvic organ prolapse repair can be divided into four groups:
1.Synthetic, non-absorbable
2.Absorbable synthetic mesh
3.Chemically cross-linked biologic mesh
4.Non-crosslinked biologic grafts
Cook’s literature review illustrates the following important differences between the safety and effectiveness of these types of biomaterials:
•Non-absorbable synthetic mesh products are permanent implants that provoke a foreign body response. Non-crosslinked biologic grafts remodel into normal host tissue, thereby reducing long-term foreign body response, and do not leave behind foreign material that may have to be removed at a later date.
•Non-crosslinked grafts have a lower erosion rate than their non-absorbable synthetic counterparts (1.2% vs. 10.0%).
•Non-crosslinked biologic grafts have a low prolapse recurrence rate compared to non-absorbable synthetic mesh products (14.5% vs. 8.2%), especially when compared to standard colporrhaphy (30.0%).
•Erosion associated with non-absorbable synthetic mesh products typically requires one or more surgeries to remove the mesh, while non-crosslinked biologic grafts allow natural remodeling and non-surgical management.
•Recurrence of POP associated with non-absorbable synthetic mesh requires removing the mesh or attempting surgical intervention while the mesh is in place, while a non-crosslinked biologic graft is intended to eventually be reabsorbed by the body.
In conclusion, Cook’s review shows the medical literature strongly suggests that important differences exist between transvaginal mesh materials in terms of tissue response, risks, and overall successful clinical outcomes. It also provides convincing evidence of the safety and efficacy of non-crosslinked biologic grafts.
All Meshed Up

Grand Junction, CO

#7150 Jan 23, 2013
My last post is from the Scmidt and Clark Law firms website concerning Gyno/Vaginal mesh. Kind of interesting the way it is stated. Cook acknowledges problems with mesh products but then blames the FDA for not catagorizing them properly. Great. Catagorize, indentify, realize, and ignore. Thank you FDA. Hope this may be a good contact fore you in the US, Sonia. I will continue to look for more info. Thanks for the invite by the by! My girl friend and I would Love to come to Australia. We shall see what we can do! As soon as I own Bard/Kugel! Take Care......
Blair

Charlottetown, Canada

#7152 Jan 23, 2013
All Meshed Up wrote:
<quoted text> Hello Blair! As always, Thank Mucho for all of your input. I contacted the Lawyers and am waiting for a consult now. The called me within 5 minutes of logging into their website. I will say that I have been through this so many times that I do not have a lot of faith in lawyers ( as many of my posts have indicated!)but according to their website they are taking all Kugel victims. So I am keeping my fingers ( and toes....OUCH!) crossed and hope I may have my day in court. Thanks again.......
All Meshed Up,
I tried to get you, me and River Rat hooked up but i had no luck. With a lawyer looking at your case the outcome might be different. No harm in trying, Steven hopefully gets back to us on the outcome of the trial in Jan./2013. Lets hope the lawyer is on the ball! All i got was the girl taking names of victims.
All Meshed Up

Grand Junction, CO

#7153 Jan 23, 2013
Blair wrote:
<quoted text>
All Meshed Up,
I tried to get you, me and River Rat hooked up but i had no luck. With a lawyer looking at your case the outcome might be different. No harm in trying, Steven hopefully gets back to us on the outcome of the trial in Jan./2013. Lets hope the lawyer is on the ball! All i got was the girl taking names of victims.
Thanks again, Blair. Its not a sure thing anytime you get a lawyer working for you. I just would like the chance at being part of one of these suits against Bard/Kugel. I may not get a thing out of it but it sure is better than not doing anything. When I settled my Workmens Comp case the insurance company threatened to come after me for medical expenditures if I ever won a lawsuit against a mesh manufacturer. An accupuncturist (?) that I told in complete confidentiality of her office told the insurance company that I was trying to get a lawsuit going against Ethicon or Bard. It cost me $45,000 for that woman telling them that. And of course I have NOT been able to get a lawsuit going. Anyway, Thanks for the info, Blair and I will keep you apprised of the outcome. Best Wishes.......
Blair

Charlottetown, Canada

#7154 Jan 23, 2013
All Meshed Up wrote:
<quoted text> Thanks again, Blair. Its not a sure thing anytime you get a lawyer working for you. I just would like the chance at being part of one of these suits against Bard/Kugel. I may not get a thing out of it but it sure is better than not doing anything. When I settled my Workmens Comp case the insurance company threatened to come after me for medical expenditures if I ever won a lawsuit against a mesh manufacturer. An accupuncturist (?) that I told in complete confidentiality of her office told the insurance company that I was trying to get a lawsuit going against Ethicon or Bard. It cost me $45,000 for that woman telling them that. And of course I have NOT been able to get a lawsuit going. Anyway, Thanks for the info, Blair and I will keep you apprised of the outcome. Best Wishes.......
All Meshed Up, Remember to be calm, cool and collective, find out why we are on the category list but are not getting a payout. I can not get the real truth as to why some are getting payouts but others are not. If it starts to go south then tell them how you feel. This lawyer who is at the trials in Rhode Island should be able to answer you questions. Like to be in on this conference call. Good Luck
Terlin

Wayne, MI

#7155 Jan 23, 2013
Suzie wrote:
<quoted text>
Terlin-
I am in Michigan also and need help. I have two mesh pieces from three surgeries in me from a hernia that resulted from four C-sections. For 5 years I have been dealing with chronic pain, sometimes debilitating. I have been in and out of Beaumont hospital with the last visit having the surgeon come in for less than a minute, say Ive dont all I can, and refer me to a pain specialist. I have not yet gone to the pain clinic. I just want these patches removed. I am WAY WAY worse off than I was when I noticed the first hernia almost 6 years ago. Are you getting any help from a doctor or hospital in Michigan? I have the same issues with nerve pain and scar tissue. I need someone who can at least do more than put me on narcotics.
I have been going to u of m no help from them they don't admit it's the mesh
Terlin

Wayne, MI

#7156 Jan 23, 2013
I found dr ramshaw in Daytona very compationet and does give you referrals to patience that had meshed removed by him not all good though. He does respond back to e-mails and some times phone calls , he is very busy removing hundred of mesh
Terlin

Wayne, MI

#7157 Jan 23, 2013
Has anyone have severe joint and muscle pain and lower abdominal pain after inguinal hernia surgery. And have anybody else have mesh removed by Dr ramshaw as I recently did, if so how are you doing?
All Meshed Up

Grand Junction, CO

#7160 Jan 24, 2013
Suzie wrote:
Does anyone know if the Parietex polyester mesh by Covidien has been recalled? I have two patches from three separate surgeries to repair a ventral hernia which occurred after my fourth Csection. I cannot find any SOLID documentation as to whether or not this has been recalled. Mesh was put in in July 2007, and a second one in 2008. Having severe difficulties with everything from carrying laundry to having sex. It totally sucks. Advise????
I spent quite a bit of time trying to get the answer for you. My conclusion is that NO the Covidian Parietex Pro Grip is not recalled. What I did find in the 2011 10K financial report by Covidian states that there was a "voluntary" recall of the Parietex mesh but it apparently was then stopped. I can find no further notes or explanation as to why there was a "voluntary" recall but Covidian in their finacial report were quite worried what this would do to their market share. I will continue to "poke" around and see what I can find. As I have stated before...the only mesh that has been recalled at this time IS the Kugel Large Patch with ring. Best Wishes.....
All Meshed Up

Grand Junction, CO

#7161 Jan 24, 2013
Blair wrote:
<quoted text>
All Meshed Up, Remember to be calm, cool and collective, find out why we are on the category list but are not getting a payout. I can not get the real truth as to why some are getting payouts but others are not. If it starts to go south then tell them how you feel. This lawyer who is at the trials in Rhode Island should be able to answer you questions. Like to be in on this conference call. Good Luck
I have no idea if I will be even considered to be on the "list". I will stay calm,( I am cool ) and collected because this is not my first rodeo when dealing with lawyers. I am hoping I will be "screwed up" enough to make the grade with these folks but if not.....same crap....different day!.....

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