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

There are 20 comments on the Feb 4, 2007, PRWeb story 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: Apr 07

stockton ca

#901 Mar 7, 2008
Dennis, I had the triple neurectomy on feb 6,08. Dr Amid was a godsend. Almost all the problems I had before are gone. I know how bad the sitting was & the pain across the hip.After my first surgery in jan 06. It was constant along with all the other problems.. Dr Amid gave me my life back. Best of luck to you. Keep the faith that it will be better....
Dennis wrote:
I have had groin pain for about 4 years in the area of an inguinal hernia repair in 1994 with mesh plug and patch (Dr. Rutkow-NJ). Was symptom free until about 2000 when after 3 motnhs of cross country driving, i developed a lancing pain in my groin that lasted about 3 weeks. It went away 90% for several years and then flared back up in 2003 after a serious bout of constipation. Took about 3 months to go away, but have been in almost daily general discomfort in my groin and hip (along the outside of the hipbone down to the top of my femur). The discomfort is aggravated noticibly from sitting > 15 minutes, sexual intercourse, and bowel movements. No more lancing pain, but the fear of that has been tough to deal with. Saw my new doctor and he suggested removing the mesh patch and posssibly the mesh plug but keeping the nerves intact if they seem ok. I have researched Dr. Amid's triple neurectomy and it seems that that might be less invasive (even with the mesh patch removed in conjunction). I just am very concerned about removing the plug. As my doctor described it, it will leave a big hole that will need to be filled with a new (albeit better) mesh plug. So, my question is- do my symptoms seem familiar to anyone here and for anyone who has had the triple neurectomy by Dr. Amid., how has it worked, what was your recovery time, and would you recommend him? There's alot here, but you all know how tough this stuff is.
Thanks!
Dennis

Corvallis, OR

#902 Mar 7, 2008
Zippy59- Thanks so much! I have read considerably about the procedure, but have not answered a couple questions--(1) in general is the mesh patch and/or plug removed, or just resection of the 3 nerves, and (2) what is the recovery time after surgery until you can be mobile reasonably pain-free (from the surgical pain -I remember that it was about 10 or 12 days when I originally had my hernia repair (when I was a much younger 20.), and (3) does he basically open up the old wound to do the procedure (same size incision) or is it smaller/larger?. I'd love to hear anything about your experience that would confirm that this would be a good preocedure for me. It will be several months before I can go see Dr. Amid for an appointment (insurance!).
Thanks for the reply.

Since: Apr 07

stockton ca

#903 Mar 7, 2008
Dennis, Yes he removed the mesh& The triple neurectomy. Mine had done the meshoma thing & was causing me considerable pain. The surgical pain wasn't bad at all. He said I had no limitations & if it hurt don't do it. I took a month off of work only because I clean houses for a living & it is hard work. I worked by myself today & did just fine. My Daughter helps when needed. Once the staples were out the pain wasn't bad at all. He went in thru the original incision & did make it a lil bigger. He had to dig from my hip down to my privats to be able to fix everything. You can eail him & ask him all the questions you want. That is how I originally contacted him. Then I just pushed for my PCP to get things going on this end to get this fixed..I hope this answered some of your questions. Oh I was able to go off the pain pills during the day within 5 days after & at night th follwing sun. Linda
Dennis wrote:
Zippy59- Thanks so much! I have read considerably about the procedure, but have not answered a couple questions--(1) in general is the mesh patch and/or plug removed, or just resection of the 3 nerves, and (2) what is the recovery time after surgery until you can be mobile reasonably pain-free (from the surgical pain -I remember that it was about 10 or 12 days when I originally had my hernia repair (when I was a much younger 20.), and (3) does he basically open up the old wound to do the procedure (same size incision) or is it smaller/larger?. I'd love to hear anything about your experience that would confirm that this would be a good preocedure for me. It will be several months before I can go see Dr. Amid for an appointment (insurance!).
Thanks for the reply.
Nansie

Concord, NH

#904 Mar 7, 2008
Thank you everyone for all your info here! I had a kugel mesh patch used in my hernia operation. The sight was between my rib cage in my upper abdomen. This area of my abdomen has not felt right since. It does hurt there and at times it is lumpy. I have complained to my surgeon many times. But...because my patch was not one of the numbers recalled this falls on deaf ears. All of the numbers before and after mine were recalled. My patch is from the same time and place and style that the others were made so I don't understand. I understand that the RI court handling this has agreed to open up the investigation to all of these patches but still my number is not listed. My patch has bothered me from day one and I have been made to feel like a hypo. Can anyone offer any advise and insight into this for me? I keep researching on the internet but never end up with anything concrete. Thank you everyone for sharing your info here.
Nansie
Dennis

Corvallis, OR

#905 Mar 7, 2008
Linda- Thanks for your reply. Its helpful to hear this even though it's different from person to person, I'm sure. My dilemna is that I live in Portland OR and to have him do the procedure, I am going to have to fly down and then back, or fly down and rent a Van or something in LA and drive it back up to Portland with my wife (she drives and I sleep!). For you- how soon after the operation do you think you could have coped with sitting on a plane for 2.5 hours? Also, was your meshoma diagnosed prior to the surgery, or was it kind of understood that he'd go in and see what he finds? Sorry for all the Qs- its just been a long road and I'm excited to start getting my wheels turning. I emailed several questions to Dr. Amid yesterday and hope to hear back next week. Thanks again!!!

Since: Apr 07

stockton ca

#906 Mar 7, 2008
Dennis. He only operates on wed & sees patients on fridays. So you would have srgery on a wed & see him that friday. That is how it was with me. I went back to see him the following friday but, that was my choice. He took my staples out that friday & I would say that if you could at least recline a bit you should be able to handle a plane ride. We live about 3 hrs drive time away & I was able to handle that on the first friday. This Dr is amazing as far as I can see. Like I said he gave me my life back after 2 yrs of battling it..Yes the meshoma was diagnosed before. Dr Amid told my PCP I needed an MRI & to have it put on CD & that is how they found it. For 2 yrs I thought the Dr that put it in messed me up big time but, the problem was the product. If you want you can email me at zipp1959@hotmail.com... Good Luck & he usually responds to emails pretty quick... Linda
Dennis wrote:
Linda- Thanks for your reply. Its helpful to hear this even though it's different from person to person, I'm sure. My dilemna is that I live in Portland OR and to have him do the procedure, I am going to have to fly down and then back, or fly down and rent a Van or something in LA and drive it back up to Portland with my wife (she drives and I sleep!). For you- how soon after the operation do you think you could have coped with sitting on a plane for 2.5 hours? Also, was your meshoma diagnosed prior to the surgery, or was it kind of understood that he'd go in and see what he finds? Sorry for all the Qs- its just been a long road and I'm excited to start getting my wheels turning. I emailed several questions to Dr. Amid yesterday and hope to hear back next week. Thanks again!!!

Since: Apr 07

stockton ca

#907 Mar 7, 2008
sorry email is zippy1959@hotmail.com.. The first friday visit is when he took the staples out...
Dennis wrote:
Linda- Thanks for your reply. Its helpful to hear this even though it's different from person to person, I'm sure. My dilemna is that I live in Portland OR and to have him do the procedure, I am going to have to fly down and then back, or fly down and rent a Van or something in LA and drive it back up to Portland with my wife (she drives and I sleep!). For you- how soon after the operation do you think you could have coped with sitting on a plane for 2.5 hours? Also, was your meshoma diagnosed prior to the surgery, or was it kind of understood that he'd go in and see what he finds? Sorry for all the Qs- its just been a long road and I'm excited to start getting my wheels turning. I emailed several questions to Dr. Amid yesterday and hope to hear back next week. Thanks again!!!
kat

AOL

#908 Mar 8, 2008
I am a hernia mess-up and now have a large panniculus too. Is there anyone who has had a good experience with a good doctor anywhere in florida tiptop813@aol.com
Melody

AOL

#909 Mar 10, 2008
Sorry wish I did ... hope you feel better ... my husband and I can relate to what you are going through. Take care ...
kat wrote:
I am a hernia mess-up and now have a large panniculus too. Is there anyone who has had a good experience with a good doctor anywhere in florida tiptop813@aol.com
Bruce

Delray Beach, FL

#910 Mar 11, 2008
Please know that the Supreme Court recently ruled that litigation against medical device manufacturers is no longer allowed. You can search this ruling on the Net. It is a blow against the public, as responsibility and liability have been diminished...Do not be surprised if you have already hired an attorney, and they drop your case.
Good luck to everyone, focus on getting better and finding the right surgeon to address your injuries. Contact me for possible referrals.
Feel better,
Bruce brosenberg1@bellsouth.net
National Meshoma Foundation
Melody

AOL

#911 Mar 12, 2008
Terrible newss... where did you hear about this ?
Bruce wrote:
Please know that the Supreme Court recently ruled that litigation against medical device manufacturers is no longer allowed. You can search this ruling on the Net. It is a blow against the public, as responsibility and liability have been diminished...Do not be surprised if you have already hired an attorney, and they drop your case.
Good luck to everyone, focus on getting better and finding the right surgeon to address your injuries. Contact me for possible referrals.
Feel better,
Bruce brosenberg1@bellsouth.net
National Meshoma Foundation
Evelyne

Boise, ID

#912 Mar 12, 2008
Bruce wrote:
Please know that the Supreme Court recently ruled that litigation against medical device manufacturers is no longer allowed. You can search this ruling on the Net. It is a blow against the public, as responsibility and liability have been diminished...Do not be surprised if you have already hired an attorney, and they drop your case.
Good luck to everyone, focus on getting better and finding the right surgeon to address your injuries. Contact me for possible referrals.
Feel better,
Bruce brosenberg1@bellsouth.net
National Meshoma Foundation
Bruce, since people will contact you regarding surgeons referral, I better inform you of my experience with Dr. Schuricht of Philadelphia. Personally I would not recommend him. I am very sorry indeed I let him perform the surgery on me. this is now about 14 weeks after removal of the Parietex mesh I had. I had always insisted that I had excruciating rectal-perineal pains which started about 2 months after my previous hernia surgery. Dr. S. looked at the pelvic MRI and convinced me that the area around the mesh was inflammed, my body was rejecting the mesh and it needed to be taken out. so he did. Found NO inflammation, NO infection but INTACT mesh which had been implanted meticulusly (in his surgery report). He also wrote in the report that I was suffering of intractable inguinal pain. I asked whether we had miscommunicated because I never said I had inguinal pain. His answer: this is what he wrote in order to avoid problems with my insurance. So he knew that perineal pain may not be caused by mesh? fact is, I am now in A LOT more pain than I was before he removed the mesh, and now the pain is going all thru le hip joint and left buttocks as well. I am MUCH WORSE than ever before. Have tried to reach Dr. Schuricht several times, but he never answers, I think he is well aware of having made a wrong diagnose. Maybe other patients had good luck with him, I sure did not.
For whatever it is worth, I am passing on the information. Maybe I can save another patient the increased problems I have now as a result of trusting that surgeon.

Since: Mar 08

Milford, NH

#913 Mar 12, 2008
Hey Bruce,
Can you give us the citation on this? I am wondering if there will be a grandfather clause or if the decision will be in effect on the day it was made. The Rhode Island Court has this and is making decisions on what will be allowed in the suit and also they have approved to expand the research onto more numbers of patches than the ones that were recalled. I believe that once the suit is filed into a circuit court it procedes. Thanks for any additional info you can give us on this.

Nansie
Bruce wrote:
Please know that the Supreme Court recently ruled that litigation against medical device manufacturers is no longer allowed. You can search this ruling on the Net. It is a blow against the public, as responsibility and liability have been diminished...Do not be surprised if you have already hired an attorney, and they drop your case.
Good luck to everyone, focus on getting better and finding the right surgeon to address your injuries. Contact me for possible referrals.
Feel better,
Bruce brosenberg1@bellsouth.net
National Meshoma Foundation
GDSM

Sewell, NJ

#914 Mar 14, 2008
Nansie,
From what I was told it may not apply to us, it is only for medical implants that went thru some kind of mass clinical trial. Seeing that absolutely no gernia mesh has undergone any clinical trial it should not apply to us.
Kimmy D

United States

#915 Mar 15, 2008
Below is the prepared letter I have writen to my doctor for my visit March 18, 2008. What the heck? After reading this site, I wonder , can I be fixed?

March 18, 2008

Dear Doctor,

Hernia info.

I had my abdominal hernia repaired thru your surgical clinic with mesh on November 13, 2007. I had a bad time with diarrhea and throwing up and I lost over 50 pounds in 6 weeks. I have gained 30lbs back, but am still hurting and the hernia is back bigger than ever. I think the mesh ripped. I seemed ok from Jan 1 to Feb 15, then it came out, the protrusion in my stomach and is now the size of a small basketball.
I get fevers and night sweats, I think I am infected in there. The BURN, I can almost feel it ripping, still. It is like a slow, hard burn all the time. I wear the hernia wrap all the time, but cannot keep the bulge in, it is so big now. It is a fresh tear.
My problem? I missed almost 8 weeks of work last time. I had to move out of my house and into a cheaper situation. I went back to work, limited hours, no heavy lifting after Christmas. I cannot afford to miss 8 weeks of work, again. I will become homeless.
Can they repair me laproscopically? The major incision and recovery, nearly killed me and I do not believe, I am strong enough for another major surgery. I am worried I will get sicker and sicker with an infection of the ripped mesh.
What do I do?
Sincerely,K
Bruce

United States

#916 Mar 15, 2008
I am unsure of the specific citation, but you can google "Supreme Court Medical Device Manufacturers" to read info on this. Still trying to learn more about the Supreme Court Decsion, and how it will affect these products, and whether any existing suits would be grandfathered (I doubt they would be). My recommendation to anyone is to focus on finding a treatment provider to get you out of this situation. Once injured, it is a tough uphill battle to get better. We will keep posting any new research or surgeons who might be more knowledgeable, as primary surgeons seem to be running scared and deny the surgery or product to be the problem. That doesn't excuse them from referring the complicated patient to an expert. They know who those experts are, but often their sense of pride prevents them from helping you.(There might be confirmation they made a mistake. It's no excuse.
Litigation against a large manufacturer, even when legal, and even when the evidence is solid (as in the Kugel or Proceed recall) is expensive and difficult. Either way don't give up.
Bruce

United States

#917 Mar 15, 2008
Kimmy D wrote:
Below is the prepared letter I have writen to my doctor for my visit March 18, 2008. What the heck? After reading this site, I wonder , can I be fixed?
March 18, 2008
Dear Doctor,
Hernia info.
I had my abdominal hernia repaired thru your surgical clinic with mesh on November 13, 2007. I had a bad time with diarrhea and throwing up and I lost over 50 pounds in 6 weeks. I have gained 30lbs back, but am still hurting and the hernia is back bigger than ever. I think the mesh ripped. I seemed ok from Jan 1 to Feb 15, then it came out, the protrusion in my stomach and is now the size of a small basketball.
I get fevers and night sweats, I think I am infected in there. The BURN, I can almost feel it ripping, still. It is like a slow, hard burn all the time. I wear the hernia wrap all the time, but cannot keep the bulge in, it is so big now. It is a fresh tear.
My problem? I missed almost 8 weeks of work last time. I had to move out of my house and into a cheaper situation. I went back to work, limited hours, no heavy lifting after Christmas. I cannot afford to miss 8 weeks of work, again. I will become homeless.
Can they repair me laproscopically? The major incision and recovery, nearly killed me and I do not believe, I am strong enough for another major surgery. I am worried I will get sicker and sicker with an infection of the ripped mesh.
What do I do?
Sincerely,K

Kimmy,
Have you seen your surgeon again? Do you have insurance?***A trip to the ER may gain you a scan you can take to the appointment, or show to the next surgeon. It is your surgeon's responsibility to treat you for the recurrance. It may be life threatening, espescially considering potential for infection or bowel injury. Be assertive when you go, make sure he has a plan to follow up on you.
**What product did you have, was it your first hernia, are you a smoker (affects healing), where was it placed, left or right or both sides?
Please update us on your progress. Writing the letter was a great idea, send it in advance of your appointment so you so won't forget what you wanted to say at the actual appointment.
Feel better,
Bruce

Since: Mar 08

Milford, NH

#918 Mar 15, 2008
Hey Bruce!

I am wondering if you know of any specialist surgeon types in the Concord, NH area? My symptoms are not as bad as everyone else but I am always wondering when they will get worse or how. I feel like I am sitting on a time bomb. My surgeeon skirts this stuff and tries to act like I should not be worried. I know that my upper abdomin has not been very good since this was done. Whenever I try to feel into the area it hurts, after every mean I have the same pain in that area, my food doesn't digest or takes forever to digest and I have disabling attacks of nausea that have no obvious cause. I am also exhausted most of the time. I don't know if you have any feedback on all of this but if you know of a specialist in my area or even in Boston, MA atleast I can set up a consult. Thanks for anything you can do and GOOD LUCK Kimmy!
Take care all!

Nansie

Since: Mar 08

Milford, NH

#919 Mar 15, 2008
Also Bruce...I wanted to mention that this law suit is based on the wrongful doing of the manufacturer because they played down the seriousness of the incidents of ring breakage and then did not acurately report to the FDA. They have proven negilgence in this process on the manufacture part and that is what the suit is being based on. More ppl died while Bard was withholding information and evidence......Just thought I would mention this piece of the lawsuits.
Nansie
Cassandra

Brooklyn, NY

#920 Mar 16, 2008
I have an open surgical wound with exposed mesh since September 7, 2008. A ct scan shows some bowel involvement but I am told the mesh can be removed. I am currently unable to undergo the abdominal repair because I am recovering from a car accident. I broke my left tib fib with a compound fracture and underwent a surgical repair (plate and 8 screws). I also broke my right clavicle and was in the hospital for three weeks. I now at home bedridden for three months. Hopefully I will walk again, My question is: can exposed mesh become hardened and crack? No physician wants to anwer this question,The mesh feels like it is leather,

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