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.

Know Better

Garden City, MI

#1106 Jun 20, 2008
When you say "A Biologic Material" you need to KNOW the differences... as many have the same problems as the synthetic's or plactics that have given so many problems here.
1. Make sure the material is non-crosslinked ie: a true Biologic. Because when crosslinked biologic materials are used, it's like putting in a piece of leather, and will always be there. Period. It kind of scars in and encapsulates, and has it's problems. Examples.. Alloderm (human cadaver skin), or Permacol (pig skin). Plus any skin derived biologic graft will stretch over time because of the high Elastin content.
2. Make sure the biologic comes from the small intestinal submucosa layer (SIS), as that is were all the collagen is! Collagen fibers are the strength.. Plus, if the graft comes from the SIS material, it has the growth factors (proteins) that signals your own tissue to regrow.
Again, check out a product called Surgisis.
John

New York, NY

#1107 Jun 20, 2008
Daniel wrote:
<quoted text>
my name is daniel and i live in perris ca.I also have the PHS mesh patch and plug.ive been having constipation,Bad lower abdominal pains to the point of passing out cant handle it any more ive been going to the doctors since 2004, they still tell me they cant find anything wrong with me,so i still suffer
I had hernia surgery in Feb of 2006 and I've had nearly constant lower abdominal ever since. Exact issue, in that doctors don't really see anything wrong so I'm expected to just live with it. So I do, but some days are really bad. I don't know if my mesh was of the recalled stock. Does anyone know if a surgical report would mention the brand?
GDSM

Indianapolis, IN

#1108 Jun 20, 2008
John wrote:
<quoted text>
I had hernia surgery in Feb of 2006 and I've had nearly constant lower abdominal ever since. Exact issue, in that doctors don't really see anything wrong so I'm expected to just live with it. So I do, but some days are really bad. I don't know if my mesh was of the recalled stock. Does anyone know if a surgical report would mention the brand?
you can go to the FDA website www.fda.gov and type in mesh recalls. It will tell you types of mesh that were recalled and lot numbers that are affected, while you are there you should also fill out the adverse event form, you really need to have documentation with what is happening to you, I do believe in my heart of hearts that one day all these meshes will be recalled and I am fighting to do just that, during te teleconference with the FDA Dr. Daniel Schultz offered his opinion. His opinion is that there were not enough people that have filed reports with the FDA and it is only a small percentage of people who have. Right now there are over 3500 reports filed to date. I don't know what kind of numbers he wants but the proof of how terrible these meshes are, are right here and on other forums. All I am doing is trying to get the word out so that everyone can file the reports and shove them down his damn throat.
JLS

Tonkawa, OK

#1109 Jun 20, 2008
Mary wrote:
This site has been helpful and scarey at the same time. i had a ventral hernia repaired with Bard Composix (not Kugel) mesh (Oct 07) 3 weeks after I has a laporotomy for an ovary removal(9/07). The pain has never gotten better. Surgeon did a lap to remove protacts from lower left quadrant where most of the pain is in Feb 08. Still no better. Tearing when I roll over, feel reaaly bruised inside, pulling, tugging...My surgeon says the mesh shoould come out. Has anyone been through this procedure? IT sounds awful. I am scared to death. Fortunately I live near Boston...any recommendations for docs? This removal surgery will be my 10th pelvic/abdominal surgery in 10 years. I am mess inside and everyone thinks its in my head and about the pain meds. Pretty lonely place. Thanks for listening.
Hey Mary,

I have the exact same problem, If you want to talk
Email me a [email protected] t, I look forward to visiting with you.

Sincerely,

JLS
Jan

Minneapolis, MN

#1110 Jun 20, 2008
John wrote:
<quoted text>
I had hernia surgery in Feb of 2006 and I've had nearly constant lower abdominal ever since. Exact issue, in that doctors don't really see anything wrong so I'm expected to just live with it. So I do, but some days are really bad. I don't know if my mesh was of the recalled stock. Does anyone know if a surgical report would mention the brand?
The cheapest way to get the information is to request all the documentation from your surgeon - they usually don't charge - if it's not on any of those pages, the next way is to get the surgery report from the hospital - it has to have stamped on it the product used and its serial number. If you explain to the medical records clerk exactly what you want, you can get just that document and not have to pay for all the pages.
Kelly

AOL

#1112 Jun 20, 2008
Hi I had hernia surgery in 2003 and am not sure what kind of mesh was used. I do not know what I should do. I guess I would contact the surgeon who did my surgery.

I have had pain in and around my belly button, so I figured I ripped my hernia again. Kelly
Kelly

AOL

#1113 Jun 20, 2008
Hi I had surgery in 2004 and I am not sure what kind of mesh was used. Do I ask the doctor or do they have it written down somewhere about what was used. Do I have to have it removed?

I have had extreme fatigue for over a year, and still have pain in the belly button area, so I thought that I had ripped my hernia again.

Kelly
Will

Pittston, PA

#1114 Jun 21, 2008
I have a few questions and I am looking for answers. I have a recurrent umbilical hernia that is about 3" by 3", the first repair was done without mesh in april 2007. I went to a surgeon for advise and he told me that due to the size it would have to be fixed with mesh. He said that if it really wasn't bother me to leave it alone. He didn't seem like he really liked the mesh repair but said if I wanted it repair he would do it. The hernia does cause me some discomfort and I am worried about it increasing in size. I work in a very physical job. After reading all these problems with the mesh repair I do not know what to do at this point. I have been doing alot of research on hernias and that is how I found this forum. It seems like once you get a hernia it is a life changing experience and there really is not any good repair. I have read alot of posts here and am really sorry to hear about all these people suffering like they are. It is really a terrible thing and you are in my prayers. I am 47yrs old am do not know what to do at this point, do I have to live with this hernia for the rest of my life or is there an alternative repair, any help would be appreciated.
LEE

Chicago, IL

#1117 Jun 23, 2008
I HAD SURGERY FOR LEFT SIDE INGUINAL HERNIA.NOTHING WENT LIKE I WAS TOLD BY SURGEON.I WAS IN RECOVERY FOR 7 HRS.I HAD MARLEX mesh extra large plug,has been 2months have burning pain in testical down leg and aroound hip.I went to different surgeon for help ,he suspects some type nerve damage,says pain clinic can target which nerve or nerves to correct problem.does any one know can nerve damage resolved easily?ALSO is there a surgeon in Michigan who will remove mesh / plug ?
Sheri

Shepherd, MI

#1118 Jun 23, 2008
LEE wrote:
I HAD SURGERY FOR LEFT SIDE INGUINAL HERNIA.NOTHING WENT LIKE I WAS TOLD BY SURGEON.I WAS IN RECOVERY FOR 7 HRS.I HAD MARLEX mesh extra large plug,has been 2months have burning pain in testical down leg and aroound hip.I went to different surgeon for help ,he suspects some type nerve damage,says pain clinic can target which nerve or nerves to correct problem.does any one know can nerve damage resolved easily?ALSO is there a surgeon in Michigan who will remove mesh / plug ?
Hi Lee, I am also from Saginaw and going thru the same thing. Email me I would like to know who did your surgery. Also I have info that might be of help. [email protected]

Since: Apr 07

stockton ca

#1119 Jun 23, 2008
Lee I also had a inguinal hernia repair & no nothing went like it was supposed to. Mine was on the right.. I went thru the pain shots & they tried to put me on all kinds of meds for it but, I refused to become a pill pusher because of them. It took me 2 yrs but, with alot of prayer & determination I was able to get it fixed(more or less). I had PHS Mesh orig. I do have another form of mesh but, this one is flat & since my 2nd surgery in feb, 08 I have gotten so much better. I am in Calif & that doesnt help you much but, there are alot of people on here that can possible reccommend someone in your area..Like GDSM or Lana Or Bruce. Don't give up there is hope out there for everyone...All my best to you & everyone else out there...
Linda ([email protected])
LEE wrote:
I HAD SURGERY FOR LEFT SIDE INGUINAL HERNIA.NOTHING WENT LIKE I WAS TOLD BY SURGEON.I WAS IN RECOVERY FOR 7 HRS.I HAD MARLEX mesh extra large plug,has been 2months have burning pain in testical down leg and aroound hip.I went to different surgeon for help ,he suspects some type nerve damage,says pain clinic can target which nerve or nerves to correct problem.does any one know can nerve damage resolved easily?ALSO is there a surgeon in Michigan who will remove mesh / plug ?
Shamrock444

Windham, ME

#1120 Jun 24, 2008
4 years ago I had a hernia repair where they put the mesh on.. not sure exactly which type it was. But soon after a lump wouldn't go away where the cut was made.. then a few months later he had to go back in and remover the "hematoma" the same pinch/pulling/stinging pain that was there after the 1st surgery was still there after the 2nd.. a few months later after the 2nd surgery they went back in to remove the mesh and repair the hernia the "old fashion way" some time went by, the same pain never went away. I recently had the nerves in the area removed and this was supposed to be the "final" surgery.. although now that im healing and the swelling has gone down.. the SAME pain that's been there since the 1st surgery is still there.. and I really just dont know what to do
GDSM

Indianapolis, IN

#1121 Jun 24, 2008
Shamrock444 wrote:
4 years ago I had a hernia repair where they put the mesh on.. not sure exactly which type it was. But soon after a lump wouldn't go away where the cut was made.. then a few months later he had to go back in and remover the "hematoma" the same pinch/pulling/stinging pain that was there after the 1st surgery was still there after the 2nd.. a few months later after the 2nd surgery they went back in to remove the mesh and repair the hernia the "old fashion way" some time went by, the same pain never went away. I recently had the nerves in the area removed and this was supposed to be the "final" surgery.. although now that im healing and the swelling has gone down.. the SAME pain that's been there since the 1st surgery is still there.. and I really just dont know what to do
You should go see a neurologist, he may be able to help you. I am no doctor, but what you have explained is exactly what happened to me. I would get your medical records to see what kind of mesh was implanted. reading your post was like I wrote it myself. I have now been diagnosed with RSD which is a chronic nerve condition caused from severe trauma to the nerves. I have also had 3 operations the last one was had to be done as the mesh balled up and hardened and incorperated all the nerves and surrounding tissue. I was dissected for 2 1/2 hours to get the plug and patch out. I now wear a TENS unit 12 to 16 hours a day, it doesn't get rid of the pain but it helps minimize it. I was told that I will always have pain as this condition can get worse. So, for right now, I am trying to find a way to live with it. It sure is not easy, but I am rying.
Evie Okc Oklahoma

United States

#1122 Jun 25, 2008
I am a 41 year old police officer who had an incisional hernia repair on 04-10-08 using a 3D prolene mesh patch. I have had 6 surgeries prior to this one and never one as difficult. For 2.5 months I have missed work, sleep, fun with my children and relations with my husband. I have sharp, hot pain in my lower left ab. I just found this website today, what an eye opener. I am scheduled for my patch removal next week. My Dr is Dr. Sevin Holsater in OKC OK. He preformed the hernia repair and when I called his office to report the symptoms I have he told me to come in ASAP. I saw him Monday and surgery is next week. I guess I need to be thankful. I am not looking forward to the recovery and did I mention I am resistant to sedation and most narcotics. I blame that on my red hair. I'm wondering if anyone out there has had problems with the 3D prolene mesh. Im looking forward to walking faster and holding my 3 yr old again. Please feel free to respond, and I'll keep you all posted.
God bless, Evie.
Bruce

New Orleans, LA

#1123 Jun 25, 2008
Evie Okc Oklahoma wrote:
I am a 41 year old police officer who had an incisional hernia repair on 04-10-08 using a 3D prolene mesh patch. I have had 6 surgeries prior to this one and never one as difficult. For 2.5 months I have missed work, sleep, fun with my children and relations with my husband. I have sharp, hot pain in my lower left ab. I just found this website today, what an eye opener. I am scheduled for my patch removal next week. My Dr is Dr. Sevin Holsater in OKC OK. He preformed the hernia repair and when I called his office to report the symptoms I have he told me to come in ASAP. I saw him Monday and surgery is next week. I guess I need to be thankful. I am not looking forward to the recovery and did I mention I am resistant to sedation and most narcotics. I blame that on my red hair. I'm wondering if anyone out there has had problems with the 3D prolene mesh. Im looking forward to walking faster and holding my 3 yr old again. Please feel free to respond, and I'll keep you all posted.
God bless, Evie.
Evie,
Glad to hear your surgeon has acknowledged that the surgery is related to your pain. That is the first stumbling block usually keeping patients from getting help: Surgeons who fail to acknowledge potential errors or product problems. Sometimes the surgery just doesn't work out. Most important, find out what his plan is to fix you, as the defect will now be larger with injury created by removal of the product. Ask if it will be possible to do a mesh free surgery. Ask about softer bio products such as Surgisis. Do your research on whatever product he will use. After the surgery be very careful not to overdo it right away (even bending and lifting that 3 year old too soon.) to avoid pulling sutures or causing a not completely adhered product to migrate/crumple. Good luck, and please let us know your outcome.
Feel Better,
Bruce
National Meshoma Foundation
martina

Mandeville, LA

#1124 Jun 25, 2008
my brother had a lichtenstein prolene mesh screen placed in groin are in "99". he has since been in horrible pain constantly getting worse. constant burning at site and pain while urinating. when having bowel movement he describes the pain as having a baby with spikes. numbness in groin and legs. surgeon doesn't want to touch him. i think the screen needs to come out. but will he survive surgery????
Bruce

Hollywood, FL

#1125 Jun 26, 2008
Martina,
Your brother's description of his pain "having a baby with spikes" is very accurate to the pain felt by many on this site...and to the thousands of others who's surgeons have not told them their pain is related to the mesh complications. Please contact me ASAP at [email protected] or [email protected] More info is needed, he will need to get a copy of his scans and the reports. I will try and refer him to a surgeon who has experience in mesh complications which, although there are no gaurantees increases his chances of a better outcome. His chances of surviving the surgery are dependent on his health, the skill of the surgeon and other complications including infection and bowel injury... He likely has nerve entrapment by mesh, suture, tack or staple. The qualified surgeon will evaluate for intermediate steps before removal, such as steroid injections (temporary fix to determine if nerves are involved) nerve transection/neurectomy or partial modification.
Hope to hear from you soon,
Bruce
National Meshoma Foundation
Mike Davis

Chicago, IL

#1126 Jun 26, 2008
I'm scheduled for an Inguinal Hernia repair in 3 weeks with Dr. Keith Millikan in Chicago and he has a "modified" method of the mesh-plug. There is a published long-term study that is posted on the net and can be searched by "Millikan Modified Patch" and according to the stats his recurrence rate is .1% and something like 95% of people return to normal activities within 3 days, operating room time of less than 30 minutes, and less long-term pain because the plug is sutured in place - can a published trial be inaccurate or falsified? Or has this surgeon found a method to make the plug pain-free? He uses a Bard-Davol patch, that's really all I know. He seems highly qualified, with thousands of procedures under his belt as well as other surgeons who come to view his method. I just dicovered this site and am worried. What are my options? Thanks, Mike
Sweetpea

Silver Spring, MD

#1127 Jun 26, 2008
I knew I should have bought a Michelin!
GDSM

Indianapolis, IN

#1128 Jun 27, 2008
Mike Davis wrote:
I'm scheduled for an Inguinal Hernia repair in 3 weeks with Dr. Keith Millikan in Chicago and he has a "modified" method of the mesh-plug. There is a published long-term study that is posted on the net and can be searched by "Millikan Modified Patch" and according to the stats his recurrence rate is .1% and something like 95% of people return to normal activities within 3 days, operating room time of less than 30 minutes, and less long-term pain because the plug is sutured in place - can a published trial be inaccurate or falsified? Or has this surgeon found a method to make the plug pain-free? He uses a Bard-Davol patch, that's really all I know. He seems highly qualified, with thousands of procedures under his belt as well as other surgeons who come to view his method. I just dicovered this site and am worried. What are my options? Thanks, Mike
Speaking as one who has been there. In would stay away from ant plug and patch, especially Bard, it is made of heavyweight polypropylene and can really do damage once it shrinks and hardens. To answer your other question, I would be wary of any published report by the doctor, the reports could be biased and aimed at just filtering paitients to his type of repair. I am no doctor, but I would research heavily and I would stay away fom a plug and patch for reasons indicated on this site, this many people can't be wrong!

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