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.

Patty

Eugene, OR

#5495 Feb 26, 2012
justme wrote:
<quoted text>
When the dr finall dignoised me with MRAS, I of course was sent to an infection specilist, right from the start she told me my patches were in fected I had four of them. She Started me on antibotics she would give me three monts and see where I was at, I of course wanted them out. She did not recommend that, because the doctors in my are had no esxerience in explant nor was there a phycility do do such a major surgery. after threee months I was still complaing ablut the pain aroung the one patch. She had me check in with my surgon he though it was another hernia and schedule surgery, my infection dr said no I could not have surgerie until I was free of infection for atlest six months, that could happen she had no idea if I was every going to free of infection. Nightmare, Lucky for me I had a family friend had the same issues I went to california his dr saw me the next day and preformed emerency surgery I was in the hospital ten day and in home health care for another 5 weeks before I returned home to Idaho. When I returned I continued the IV treatment for another two week but as soon as it stoped I could feel the infection again
Justme- you got MRSA too? Amazing! My husband got it as well. You will now always have MRSA present in you. It never goes away. My husband became infected within 8 days after the Atrium was removed and the new one implanted. Did you take probiotics to recover the good bacteria which is destroyed by the antibiotics used to treat MRSA? My husband was on Vincomycin IV home infusion for a long time too, and spent 8 days in the hospital too for MRSA, amazing similarities with you and him. I feel so bad for you!!
Patty

Eugene, OR

#5496 Feb 26, 2012
justme wrote:
<quoted text>
NO it is not right, I received the new redesigned kugle patch shortly after the recall. My problems with the new redesigned kugle mesh were the same as the original kugle mesh recalled. It was explanted in emergency surgery. My ordeal could have been avoided had there been a proper recall.
Yes, 501K is a fast track.
Patty

Eugene, OR

#5498 Feb 26, 2012
Medical Device summit 2012- March 6-7, Boston MA. Id love to be a fly on that wall!
Lorraine Van

Hood River, OR

#5499 Feb 26, 2012
I had inguinal hernia surgery on left side without mesh in 2004. it healed right up with no problems.
I had inguininal surgery on my RIGHT side with a Bard Daval Ventralex mesh in May 2011.
I've had problems with inflamation ever since.
It's getting worse. Not Better.
I am not a doctor. That's why I went to a professal.
1.I should not have been sold a medical device that I did not need at a time I was under stress.
2. The medical device should not be sold to everyone whether they need it or not just for the purpose of selling a product.
3.

Since: Jan 12

Halifax, Canada

#5500 Feb 26, 2012
Lorraine Van wrote:
I had inguinal hernia surgery on left side without mesh in 2004. it healed right up with no problems.
I had inguininal surgery on my RIGHT side with a Bard Daval Ventralex mesh in May 2011.
I've had problems with inflamation ever since.
It's getting worse. Not Better.
I am not a doctor. That's why I went to a professal.
1.I should not have been sold a medical device that I did not need at a time I was under stress.
2. The medical device should not be sold to everyone whether they need it or not just for the purpose of selling a product.
3.
I to have the same mesh,i am going in may to have it OUT..
emgee

Chico, CA

#5501 Feb 26, 2012
I had an abdominal/incisional hernia repaired in 2006. After the surgery I was told they used a large piece of Kugel mesh with a memory ring to repair the hernia. Eight months later the product was recalled yet I was never notified by either the surgeon or hospital. For years I had pain but since Dr.s couldn't figure out why I guess they decided it was in my head. I think I started to believe it too. Finally a couple of years ago I had an eight hour emergency surgery to remove the pieces of the broken ring and balled up mesh from my body. I was extremely septic and almost died. Some days I wish I had. Having not had insurance for several years and being tired of no one being able to find out why I was suffering I hadn't been under the care of a doctor and had suffered in silence; self-medicating with alcohol to ease the pain. A treatment plan that I don't recommend. It was when the mesh was removed that I learned of the recall.
Even though the mesh has been out for awhile I am still in constant pain. With no abdominal wall muscles to hold things in place, there is a constant pressure intermingled with sharp pains. I appear to be nine months pregnant which is embarrassing for a 55 year old woman! Recently I have had several consults with surgeons to repair the hernia again. None were willing to take on the job locally and I have been referred to UC Davis. I've been told not only will mesh have to be used again but all my muscles from my back will need to be pulled forward to minimize the size of the mesh. Local surgeons estimated a 50% success for the surgery; hence the referral. I'm on SDI right now so have insurance.
Last July I was informed by my law firm that Davol/Bard was settling. In October I was informed of the settlement amount and monies were anticipated to be distributed by Christmas. In December I received notice that the disbursement wasn't going to happen in December, but in February. February is almost over and still nothing. I want this to be over.
I do feel that hospitals and surgeons should be morally and legally required to notify their patients if, and when a medical product or device is recalled that was put in their patient's body. They are notified so you would think it would make sense to notify the person that the product may adversely effect. If I had known maybe I would had been able to get it fixed before it got to the point that it has.
This whole ordeal has been a "lose-lose" situation!
mom54

Riverside, CA

#5502 Feb 26, 2012
Does anyone out there feel comfortable and confident with there doctor that removed there mesh. Please let me know where and who. I'm new to this site...but it pertains to my 36 year old son who is also going through a severe mesh problem since 2004...my heart goes out to all of you who's stories I've read...I knew this mesh was bad and the after has been tramatizing, but reading everyones stories has opened a new nightmare for me. My son is infected and has been for awhile. His doctor says "HE'S Afraid to go back in",very confident doctor wouldn't you say. Were willing to travel anywhere as long as the doctor feels comfortable. This will be his5th surgery. Any advice will help.
Blair

Montague, Canada

#5503 Feb 27, 2012
tammy-l wrote:
<quoted text>I to have the same mesh,i am going in may to have it OUT..
Best of luck in May. Who is taking out your mesh. This is your second mesh removal, be very carefull to ask a lot of questions. This would be a great time to ask your doctor about component separation. Taking the mesh out is one thing but you need to have a tissue repair to support your abdominial wall without using mesh. You have rights don't be afraid of your doctor,ask him if there is anyone in Halifax that can do this tissue repair. I had it done in Halifax but the plastic surgeon moved to the USA. Just Me had it done and it is a complex surgery but the results are great. I would like to see the look on your doctors face because most surgeons in Canada do not know what Component separation is.
Chuck

AOL

#5504 Feb 27, 2012
emgee wrote:
I had an abdominal/incisional hernia repaired in 2006. After the surgery I was told they used a large piece of Kugel mesh with a memory ring to repair the hernia. Eight months later the product was recalled yet I was never notified by either the surgeon or hospital. For years I had pain but since Dr.s couldn't figure out why I guess they decided it was in my head. I think I started to believe it too. Finally a couple of years ago I had an eight hour emergency surgery to remove the pieces of the broken ring and balled up mesh from my body. I was extremely septic and almost died. Some days I wish I had. Having not had insurance for several years and being tired of no one being able to find out why I was suffering I hadn't been under the care of a doctor and had suffered in silence; self-medicating with alcohol to ease the pain. A treatment plan that I don't recommend. It was when the mesh was removed that I learned of the recall.
Even though the mesh has been out for awhile I am still in constant pain. With no abdominal wall muscles to hold things in place, there is a constant pressure intermingled with sharp pains. I appear to be nine months pregnant which is embarrassing for a 55 year old woman! Recently I have had several consults with surgeons to repair the hernia again. None were willing to take on the job locally and I have been referred to UC Davis. I've been told not only will mesh have to be used again but all my muscles from my back will need to be pulled forward to minimize the size of the mesh. Local surgeons estimated a 50% success for the surgery; hence the referral. I'm on SDI right now so have insurance.
Last July I was informed by my law firm that Davol/Bard was settling. In October I was informed of the settlement amount and monies were anticipated to be distributed by Christmas. In December I received notice that the disbursement wasn't going to happen in December, but in February. February is almost over and still nothing. I want this to be over.
I do feel that hospitals and surgeons should be morally and legally required to notify their patients if, and when a medical product or device is recalled that was put in their patient's body. They are notified so you would think it would make sense to notify the person that the product may adversely effect. If I had known maybe I would had been able to get it fixed before it got to the point that it has.
This whole ordeal has been a "lose-lose" situation!
I have agree with you. I feel that both the hospital and surgeon both should send a notice to the party when a mesh device is recalled. I wonder also think if you have health insurance if they also have a record of the mesh used, isn't their a detailed bill sent to them ? You know when a car or truck is or has been recalled a notice is sent out to you from the dealer. Yet in the medical field nothing is done. You find out by attorneys on tv wanting to sue!
All Meshed Up

Boulder, CO

#5505 Feb 27, 2012
mom54 wrote:
Does anyone out there feel comfortable and confident with there doctor that removed there mesh. Please let me know where and who. I'm new to this site...but it pertains to my 36 year old son who is also going through a severe mesh problem since 2004...my heart goes out to all of you who's stories I've read...I knew this mesh was bad and the after has been tramatizing, but reading everyones stories has opened a new nightmare for me. My son is infected and has been for awhile. His doctor says "HE'S Afraid to go back in",very confident doctor wouldn't you say. Were willing to travel anywhere as long as the doctor feels comfortable. This will be his5th surgery. Any advice will help.
Dr Kevin Peterson in Las Vegas has a web site "No Insurance " Surgery. He specializes in mesh removals and is highly recommended. I hope this helps.....Good Luck!
Jaybird

Chesapeake, VA

#5506 Feb 27, 2012
Emgee, our attorney told us that the holdup was on the negoiatins with the payoffs to the insurance companies and medicare. Our attorney has already negoiated some but MR still has not released the money. If not paid in 60 days interest starts accumulating and guess who has to pay that. That is right WE do!
Motley-Rice has hired some third party to negoiatate these medical bills and some attorneys are doing their own negoiations.Our attorney has held up doing any more because of the 60 day thing and no guarantee when money will be released on cases already completed.What a crock this whole thing is!The only reason we consented to this crummy settlement was my husbands age. Since he is already in his 70's, I would like to see him get something before he dies.

Since: Feb 12

Riverside, CA

#5507 Feb 27, 2012
All Meshed Up wrote:
<quoted text>Dr Kevin Peterson in Las Vegas has a web site "No Insurance " Surgery. He specializes in mesh removals and is highly recommended. I hope this helps.....Good Luck!
Thank you,I'll look him up..theres another Dr Richard Miller at Vanderbilt Med Ctr. in Nashville that I'm calling to inquire about...My son has very good insurance, it's just finding a good Doctor to do this surgery.
emgee

Chico, CA

#5508 Feb 27, 2012
Jaybird wrote:
Emgee, our attorney told us that the holdup was on the negoiatins with the payoffs to the insurance companies and medicare. Our attorney has already negoiated some but MR still has not released the money. If not paid in 60 days interest starts accumulating and guess who has to pay that. That is right WE do!
Motley-Rice has hired some third party to negoiatate these medical bills and some attorneys are doing their own negoiations.Our attorney has held up doing any more because of the 60 day thing and no guarantee when money will be released on cases already completed.What a crock this whole thing is!The only reason we consented to this crummy settlement was my husbands age. Since he is already in his 70's, I would like to see him get something before he dies.
I was told the delay was due to not enough people getting their paperwork back in a timely matter if they were accepting the settlement. In October when I received the settlement amount it was minus the attorney fees and court charges, as well as a $1000 deduction that was going to a firm to investigate Medicare claims. Then the letter in December said that an additional, mandatory 35% was going to be withheld for the Gerritson Firm to use for Medicare and private insurance negotiations and "may" be returned if found that no payments were issued for your behalf. Now that was irritating as Medicare and insurance companies never paid a penny for me. A simple matter of inputting my name and social security into a computer and a quick look at my medical bills would prove it. Yet I still have to pay the $1000 and wait for even longer to get the 35% back. That is if what is left of the settlement amount ever does get sent out!
nikki

United States

#5509 Feb 27, 2012
All Meshed Up wrote:
<quoted text> And apparently from what I am being told there are NO more claims to be brought to court. So if you were not able to get in on the court case that was settled then you are S.O.L..(?) As in my case that I can't seem to get a lawyer to represent me that will take it to court even though it is a slam dunk. NOT HAPPY!
i just called an attorney who is going to send me out some paperwork and it still working on these mesh settlements....i would keep looking...jus my opinion tho...

“United States”

Since: Feb 12

Llano

#5510 Feb 27, 2012
Blair wrote:
<quoted text>
Best of luck in May. Who is taking out your mesh. This is your second mesh removal, be very carefull to ask a lot of questions. This would be a great time to ask your doctor about component separation. Taking the mesh out is one thing but you need to have a tissue repair to support your abdominial wall without using mesh. You have rights don't be afraid of your doctor,ask him if there is anyone in Halifax that can do this tissue repair. I had it done in Halifax but the plastic surgeon moved to the USA. Just Me had it done and it is a complex surgery but the results are great. I would like to see the look on your doctors face because most surgeons in Canada do not know what Component separation is.
I'm going to have a Component Seperation at the end of March. Are the results really as Justme posted yesterday?
Patty

Eugene, OR

#5515 Feb 27, 2012
mom54 wrote:
Does anyone out there feel comfortable and confident with there doctor that removed there mesh. Please let me know where and who. I'm new to this site...but it pertains to my 36 year old son who is also going through a severe mesh problem since 2004...my heart goes out to all of you who's stories I've read...I knew this mesh was bad and the after has been tramatizing, but reading everyones stories has opened a new nightmare for me. My son is infected and has been for awhile. His doctor says "HE'S Afraid to go back in",very confident doctor wouldn't you say. Were willing to travel anywhere as long as the doctor feels comfortable. This will be his5th surgery. Any advice will help.
Best of luck to you and your son. Poor guy! Ive not had one but my husband has had several. One thing you may have your son consider, many hospitals will allow the use of video recording of the surgery. If there is strong evidence that the mesh has caused damage, video would be your sons best tool in seeking damages if that needs to happen. As you have probably noted, there are many patients who's doctors tell them that its not the mesh causing the problem. One cannot dispute video evidence with a surgeons operative report. I do not mean to say that your son would intend to seek litigation. However, having a video would help him if he does, the damage can last for years, as I am sure you have read in this forum. Here's to a speedy recovery and good health to your son. And ease for you mom! Peace in knowing your son will be fine.
Patty

Eugene, OR

#5516 Feb 27, 2012
justme wrote:
<quoted text>
I think Alloderm is one of the three mesh that davol has that is made with pig Skin. Alloderm, Zen matrix and Collamend. the alloderm and zen matrix has already been recalled and the collmend hasent, but it should. My friend and I both received the collmend after our Kulge mesh were explanted he died and mine was removed before the year was up. Other than physcial thearpy my ordeal with pain and infection is over, the medicine the pain manager used instead of narcotics was Gabapentin. of course i had vicodine and flexeril for break through pain , but the gabapentin work most of the time. It takes about three weeks for you body to adjust to it but is works rather well.
justme - he did have the alloderm! We were not sure what it was until his surgeon sent a note along with his medical records to his attorney noting the mess that the alloderm did make, it was recalled but guess what! He was never notified! So the surgonn implanted the CQUR which lasted 8 weeks! Whoopie! I am praying that a doctor can find a way to do repairs without the use of mesh. People deserve better!
LWR

Lisle, IL

#5517 Feb 28, 2012
justme wrote:
<quoted text>
I think Alloderm is one of the three mesh that davol has that is made with pig Skin. Alloderm, Zen matrix and Collamend. the alloderm and zen matrix has already been recalled and the collmend hasent, but it should. My friend and I both received the collmend after our Kulge mesh were explanted he died and mine was removed before the year was up. Other than physcial thearpy my ordeal with pain and infection is over, the medicine the pain manager used instead of narcotics was Gabapentin. of course i had vicodine and flexeril for break through pain , but the gabapentin work most of the time. It takes about three weeks for you body to adjust to it but is works rather well.
who were the doctors that helped you
Blair

Montague, Canada

#5518 Feb 28, 2012
mbushey wrote:
<quoted text>
I'm going to have a Component Seperation at the end of March. Are the results really as Justme posted yesterday?
I am glad to see you done your home work and yes the results are great. In my case they could not repair the damage the mesh did to my bowels. Because the mesh was stuck to them and when they went to remove the mesh it had torn,causing a resection. My abdominal wall is firm and it has been three years. I can no longer do heavy lifting and still deal with a bowel issue and adhesive disease. Medicare would not pay to have my belly button replaced and if i did it over i would have payed for it but i was to sick at that time to even think of it. The plastic surgeon that did mine was young and knowledgeable and he did burn victims in a sick kid's hospital. He moved to the USA for more money and only does breasts. Good luck!
emgee

Chico, CA

#5519 Feb 28, 2012
Patty wrote:
Medical Device summit 2012- March 6-7, Boston MA. Id love to be a fly on that wall!
They have a Summit every year but nothing ever happens to change things. They have seminars to discuss training and products but it's not designed to help people like us. Probably just an excuse for a bunch of people to get together and socialize. Last year's was in Vegas.

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