Injured by Ethicon's Prolene Hernia/B...

Injured by Ethicon's Prolene Hernia/Bladder Mesh?

Created by Lana Keeton on Jul 14, 2008

1,550 votes

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Have Mesh Erosion

Multiple Mesh Repair Surgeries

Constant Pain from Mesh

Mesh Cannot Be Removed

Cannot Walk from Mesh

Cannot Have Sex from Mesh

Cannot Urinate from Mesh

Doctors Deny Mesh is Problem

Doctors Unable to Repair Mesh

Mesh has devastated your life

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K from Michigan

Ann Arbor, MI

#1 Jul 15, 2008
Had this mesh put in just over three years ago to help with stress incontinence - a very simple, easy fix the surgeon said. From the beginning I knew something wasn't right - had lots of pain and bleeding - and even ended up in the hospital with Ischemic Colitis which I'd never had before. About a year after the surgery I started have constant urinary tract and kidney infections, again something I'd never had before, along with severe low back pain. After two years of tests, numerous trips to the ER, and seeing several specialists, a new doctor finally saw this mesh had eroded through my vaginal wall. He palpated about a 3" erosion! No wonder I've had so much pain and bleeding. Now facing surgery next week to get this stuff removed, but from what I hear it may take several surgeries to remove it all, and there's a high risk for injuring healthy tissue and organs during this procedure. I wish I had never, ever agreed to having this product implanted in my body. It should be banned!!!
Lana Keeton

Los Angeles, CA

#2 Jul 15, 2008
Anti-Surgical Mesh Patient Group Formed

A group of patients who have been harmed by complications from surgical mesh have formed an advocacy group, "Truth in Medicine".

One of its aims is to move surgeons away from synthetic meshes, which it says cause more harm than doctors and device companies let on, and towards biocompatible ones.

The goals of "Truth in Medicine" are:

* To stop the implantation of all petroleum-based synthetic medical/surgical meshes in humans. To get Congress involved because it is unlikely the medical device industry would take the initiative on its own.

* To require changes in surgical consent forms regarding implantable foreign bodies to include: the name of the implantable; whether it was a Pre Market Approval or Pre Market Notification 510(k) product; results of clinical trials, if any; and all known risks and complications.

* To provide patients, upon discharge, with adverse event reports that they could directly send to FDA if necessary. Information about the implantable would already be filled in by the hospital.

* To set up a Superfund by taxing all Pharmaceutical Companies to help those harmed by surgical meshes, which would alleviate the need for some patients to sue.

Every single day, there are new victims. This has to be stopped.

Please join us in this fight. Every American needs to know about the dangers of sythetic surgical meshes.

peace and blessings, Lana

Lana Keeton
P.O. Box 491754
Los Angeles, CA 90049

[email protected]
www.theladyisachamp.blogspot.com

PLEASE GO TO THE LINK BELOW AND ASK TO JOIN MEDICAL MESH...THERE ARE ANSWERS THERE!

Medical Mesh Yahoo Group: http://health.groups.yahoo.com/group/medicalm ...
Lana Keeton

Los Angeles, CA

#3 Jul 15, 2008
K from Michigan wrote:
Had this mesh put in just over three years ago to help with stress incontinence - a very simple, easy fix the surgeon said. From the beginning I knew something wasn't right - had lots of pain and bleeding - and even ended up in the hospital with Ischemic Colitis which I'd never had before. About a year after the surgery I started have constant urinary tract and kidney infections, again something I'd never had before, along with severe low back pain. After two years of tests, numerous trips to the ER, and seeing several specialists, a new doctor finally saw this mesh had eroded through my vaginal wall. He palpated about a 3" erosion! No wonder I've had so much pain and bleeding. Now facing surgery next week to get this stuff removed, but from what I hear it may take several surgeries to remove it all, and there's a high risk for injuring healthy tissue and organs during this procedure. I wish I had never, ever agreed to having this product implanted in my body. It should be banned!!!
Hi K,

Please join Medical Mesh before you have your surgery next week. There are lots of mesh sufferers who have shared their experiences with each other regarding their own mesh removals. I myself am waiting right now to have another mesh removal. I know what you are going through. It's awful. All the best, peace and blessings, Lana

Link to Medical Mesh Yahoo Group: http://health.groups.yahoo.com/group/medicalm...
Suzanne McClain

Pinola, MS

#4 Jul 16, 2008
I filed a complaint with the FDA about the Transvaginal Taping device. You can too! Here is their website information.

http://www.fda.gov/comments.html

I have also contacted an attorney, and depending on what he or she thinks is best, we may open this to a class action lawsuit. I will let you know more, as information becomes available.

I am angry about what is happening with me, and I want any and all of my surgeries paid for, in addition to being compensated for my pain and suffering. A device, such as the TVT, which has the potential to affect women in such an adverse way, really needs to be pulled from the market. United, we may be able to get something done about this.
Mary Bruffett

Springfield, MO

#5 Jul 17, 2008
I had to vote on several things. I couldn't have sex, mesh ruined my life,constant pain from mesh, multiple surgeries to remove mesh, and doctors deny that mesh is the problem.

If only I had known about this a year and a half ago!

I had Gynecare's TVT and Posterior Prolift surgery in 4/07, and have been miserable ever since. I had explant / reconstruction surgery 04/08 with autologous rectus fascia sling repair (4 hr surg)and still face more surg to remove a missed tuft of mesh and later a wound revision.
The incontinence is now gone, and the pain is MUCH better. The cheese grater and serrated knife sex is gone. But the medical bills remain. The lost wages, the suffering, the TIME spent agonizing whether life was worth living...

I have filed complaints, written letters and it seems that nobody can or will help me. By myself I am powerless. I have contacted an attorney who said this was a good case but not enough money to make it worthwhile (!!!!), and I feel exactly like the person who posted right before me: "I am angry about what is happening with me, and I want any and all of my surgeries paid for, in addition to being compensated for my pain and suffering. A device, such as the TVT, which has the potential to affect women in such an adverse way, really needs to be pulled from the market. United, we may be able to get something done about this."

Please join our group at http://health.groups.yahoo.com/group/medicalm...
Lana Keeton

Lakewood, CA

#6 Aug 6, 2008
K from Michigan wrote:
Had this mesh put in just over three years ago to help with stress incontinence - a very simple, easy fix the surgeon said. From the beginning I knew something wasn't right - had lots of pain and bleeding - and even ended up in the hospital with Ischemic Colitis which I'd never had before. About a year after the surgery I started have constant urinary tract and kidney infections, again something I'd never had before, along with severe low back pain. After two years of tests, numerous trips to the ER, and seeing several specialists, a new doctor finally saw this mesh had eroded through my vaginal wall. He palpated about a 3" erosion! No wonder I've had so much pain and bleeding. Now facing surgery next week to get this stuff removed, but from what I hear it may take several surgeries to remove it all, and there's a high risk for injuring healthy tissue and organs during this procedure. I wish I had never, ever agreed to having this product implanted in my body. It should be banned!!!
K,

So sorry that you are another mesh sufferer like so many of us. Then you wind up in the revolving door of doctors who can not or will not do anything.

How did your surgical mesh removal procedure go? Are you okay? Are you happy with your doctor? Would you recommend him to other mesh victims based on your own results?

Hope all is well...peace and blessings, Lana
Suzanne McClain

United States

#7 Aug 8, 2008
August 8, 2008

Potential Dangerous Products Class Action Lawsuit

Dear Ma’am or Sir:

I am interested in the possibility of filing a class action lawsuit against Johnson & Johnson/Ethicon/Gynecare for a defective product, and wonder how many people it would take to facilitate this request?
The product in question is the TVT device # 810041B. In June of 2004, I had this device implanted due to a persistent incontinence issue that I was experiencing. In June 2008, this device eroded through my tissue,(much as a cheese grater grates cheese) into my vaginal wall. The mesh was visible to the naked eye, and it required surgery to remove the visible portion. I underwent this surgery on July 23, 2008. Part of the mesh was left in my body, as my doctor said it would be complicated to remove since it was firmly enmeshed in my tissue. He said it was better left alone, unless the remaining mesh shifted, and created additional problems for me, in which case, it would have to be removed through my abdomen.

Since finding I had this problem in June of 2008, I began researching the internet for information, and was able to locate a few website blogs where many, many other women have indicated that they are experiencing the same thing, erosion; or that the device had embedded itself in nerves. Many of these women, me included, have not been able to find a lawyer who would take on an individual case against this company, and many have said they would like to file a class action lawsuit. What we don't know, is how to go about this.

Please see the attached letter that I wrote to my family after talking to my doctor the day after surgery for explant. He indicated that the device broke. When I went back to see him this past Tuesday, I asked him to show me a TVT device. He showed me what he indicated was an "updated" version of the one implanted in me, and when he applied tension to the sling, pieces of it were crumbling onto his table. It was disintegrating before my eyes. How safe can it be to implant this particular device in a human being, when it has the potential to break and/or disintegrate? He said that the sling that was implanted in me also had wire in addition to the mesh. I have the explanted pieces from my surgery in a jar in my freezer.

I have done a multitude of research in the last month, and I have found multiple articles pertaining to this both independently and on the Medical Mesh website.
http://health.groups.yahoo.com/group/medicalm...

These articles were published in Urology & Gynecological Journals, some dated prior to my initial implant surgery. I have copies of these articles, and will be happy to provide them to you upon request.

I also filed an adverse event report with the FDA on July 16, 2008, and a follow-up report post op on July 29, 2008. I was able to save the copy for the July 16th. Report, but forgot to save the follow-up report.

I was never made aware of the type of potential complications that I am now experiencing. My doctor ONLY told me how terrific this device was, how minimally invasive, how it would take less than an hour to implant, how I could go back to work in just a few days, how I might experience minimal bleeding or discomfort for a brief period, and how I could expect not to suffer from any further incontinence issues. Prior to this surgery, I was suffering from embarrassment, now, I find myself in constant physical discomfort, and that doesn’t even come close to describing what this has done to me and my husband emotionally.

Any consideration and information you might be able to provide to me, on my behalf and on behalf of the multitude of other women who are truly suffering because of this defective device will be greatly appreciated.

Respectfully yours,

Suzanne XXX
Suzanne McClain

United States

#8 Aug 8, 2008
Letter I just sent to a law firm in San Francisco: If interested in becoming a part of a class action lawsuit (provided I secure a lawyer to take on the case) against Johnson & Johnson/Ethicon/Gynecare, in regards to the TVT device, please respond to this post with your email address, and I will contact you.

(See Previous Post)

Suzanne
Wendy Watertown SD

Watertown, SD

#9 Aug 13, 2008
I would warn anybody and everybody NOT to have any mesh product placed in their body. I had a Gynecare Prolift Kit placed by an obgyn in Sep of 06, it was unsuccessful so then he stuck in a TVT sling in Dec of 06, that was unsuccessful also. I had a five hour sugery, performed by a uro-gynocologist, in April 07 at Mayo in Rochester, MN. He removed as much eroding mesh as possible along with mesh protruding into my bladder. I had to go back again in Nov of 07 for more surgery. I currently have pain again and will be returning to Mayo soon. I don't think they can ever remove all of the mesh. This begs the questions "What will happen to the mesh as it remains in my body? Will it migrate? If so, what will it damage while migrating? Will it encapsulate? If so, what does this mean for my future health? PLEASE think about this BEFORE you have any mesh placed inside your body.
50sgirl

Philadelphia, PA

#10 Aug 16, 2008
Is there a class action lawsuit going on this? My life has been ruined by this procedure, I have had 5 surgeries thus far to try to undo all the damage this procedure caused me. How do we get a suit going on this horrible product?
Lana Keeton wrote:
Anti-Surgical Mesh Patient Group Formed
A group of patients who have been harmed by complications from surgical mesh have formed an advocacy group, "Truth in Medicine".
One of its aims is to move surgeons away from synthetic meshes, which it says cause more harm than doctors and device companies let on, and towards biocompatible ones.
The goals of "Truth in Medicine" are:
* To stop the implantation of all petroleum-based synthetic medical/surgical meshes in humans. To get Congress involved because it is unlikely the medical device industry would take the initiative on its own.
* To require changes in surgical consent forms regarding implantable foreign bodies to include: the name of the implantable; whether it was a Pre Market Approval or Pre Market Notification 510(k) product; results of clinical trials, if any; and all known risks and complications.
* To provide patients, upon discharge, with adverse event reports that they could directly send to FDA if necessary. Information about the implantable would already be filled in by the hospital.
* To set up a Superfund by taxing all Pharmaceutical Companies to help those harmed by surgical meshes, which would alleviate the need for some patients to sue.
Every single day, there are new victims. This has to be stopped.
Please join us in this fight. Every American needs to know about the dangers of sythetic surgical meshes.
peace and blessings, Lana
Lana Keeton
P.O. Box 491754
Los Angeles, CA 90049
[email protected]
www.theladyisachamp.blogspot.com
PLEASE GO TO THE LINK BELOW AND ASK TO JOIN MEDICAL MESH...THERE ARE ANSWERS THERE!
Medical Mesh Yahoo Group: http://health.groups.yahoo.com/group/medicalm ...
Cindy

Philadelphia, PA

#11 Aug 17, 2008
I have also been injured. I have had 5 surgeries. I had TVT-O and ProLift A and P. Had a fistula form that is on it's 3rd repair attempt. They removed all mesh they could find in 1-08. Have been turned down by 2 lawyers who say that too hard to pursue? I would like to be in a class action lawsuit. I am unsure about the SOL on this since my surgery was 11-06. I feel for anyone who has gone though this. We were all trying to improve our situation and made it 100X worse.
Suzanne McClain wrote:
I filed a complaint with the FDA about the Transvaginal Taping device. You can too! Here is their website information.
http://www.fda.gov/comments.html
I have also contacted an attorney, and depending on what he or she thinks is best, we may open this to a class action lawsuit. I will let you know more, as information becomes available.
I am angry about what is happening with me, and I want any and all of my surgeries paid for, in addition to being compensated for my pain and suffering. A device, such as the TVT, which has the potential to affect women in such an adverse way, really needs to be pulled from the market. United, we may be able to get something done about this.
pugmom

Lennon, MI

#12 Aug 19, 2008
I too have had the prolene mesh bladder repair.
In 2004 I had this done with a cystocele and rectocele.
I have had nothing but problems, it has also imbedded into my tissue. I just had a repair from a different urologist, he could not remove any of the netting as it is inbedded into my tissue.
I wish I would've never done this.
I also heard that it has been recalled. Still checking on that.
contact me if you wish.
Thanks
[email protected]
Rhonda Brown

Carrollton, GA

#13 Aug 20, 2008
Hello my name is Rhonda Brown
[email protected]
I found this site after going to the surgen today and finding out that i am to have my 5th surgery because of this mesh.
If you have info please contact me
Suzanne McClain wrote:
I filed a complaint with the FDA about the Transvaginal Taping device. You can too! Here is their website information.
http://www.fda.gov/comments.html
I have also contacted an attorney, and depending on what he or she thinks is best, we may open this to a class action lawsuit. I will let you know more, as information becomes available.
I am angry about what is happening with me, and I want any and all of my surgeries paid for, in addition to being compensated for my pain and suffering. A device, such as the TVT, which has the potential to affect women in such an adverse way, really needs to be pulled from the market. United, we may be able to get something done about this.
Suzanne

United States

#15 Sep 5, 2008
I am still working to secure an attorney for a mass tort, and hopefully, an international mass tort. I am also working to find expert witnesses willing to assist us in our pursuit for justice.

It is harder than I thought it would be to find a law firm to take this on. The first step for all of us is to file an adverse event report with the FDA. We need to force a recall, in order to be able to proceed faster and further.

Surgical Mesh has ruined so many lives, but we first have to help ourselves by filing these reports, in order to find someone to intervene on our behalf.
Debbie

Louisville, KY

#16 Sep 8, 2008
ALL YOU EVER WANTED TO KNOW ABOUT SYNTHETIC SURGICAL MESH --for all who are suffering with mesh complications and/or are considering undergoing surgery with a mesh implant....we are conducting a meeting in the Nashville, Tn area to educate the public-at-large on the risks and complications of these mesh products and procedures. Dr Richard Miller, Professor of Trauma at Vanderbilt University, will be guest speaker. He specializes in mesh removal and complicated hernia repairs with biological mesh. We are in the process of trying to have the meeting streamlined for viewing. However, if you or loved ones are experiencing post-surgical complications of mesh or are contemplating a surgery requiring the use of synthetic mesh....this is a must see. For more info email me at [email protected]
Holly

Piedmont, KS

#17 Sep 10, 2008
I am also having multiple problems with this mesh. I don't exactly know what is happening, just that I am in pain and feel as though I have stitches poking me in my insides. My lower abdomen aches all the time my lower back hurts constantly, it hurts to sneeze cough or laugh. I am scared. I talk to a lawyer tomorrow but I don't know what will happen. Please let me know what I can do for us here in Kansas
Suzanne

United States

#18 Sep 13, 2008
Holly,

Hope you have found some answers. What I have found, regarding attorneys, is that they,(due to the Supreme Court Justices ruling of February 20, 2008, saying that we cannot sue the manufacturer of a medical device that was approved by the FDA) are unable to take us on. Senator's Kennedy, etal have submitted a bill to have this decision over turned.

Let's pray that they succeed for many reasons. If we the consumers no longer have the ability to sue a manufacturer whose device has caused us harm, the manufacturer then has the ability to become lax on safety issues, saving them millions of dollars.

Please keep us posted on what you find as well.

I hope you find relief soon. I strongly recommend a urogynecologist for extraction. Just make sure to check his/her credentials, to make sure they are experienced in this.

Peace,

Suzanne
Racyro

Miami, FL

#19 Sep 17, 2008
I feel for all you out there going through this problem. I had my first surgery in July, the mesh eroded and attached and obstructed my urethra. The second surgery was in August and now I've found out that I have obstruction of my bladder and fistula in my urethra. I'm going to yet another doctor, specialist this time to see what he can do. I'm tired all the time and have discomfort. Please tell me how I can join this class action.
thanks, and good luck to all !
Kathryn

AOL

#20 Sep 30, 2008
I just had this surgery in May of 08. My whole vaginal floor had to be rebuilt. So far, I haven't had trouble with mesh erosian, but I was in constant pain and I, too, felt as if a needle was constantly poking me in the side. I also had a large amount of blood and protein in my urine. After my GYN kept poo pooing my complaints I went to a urologist. Guess what was found?! When the GYN slung my bladder with the mesh, she brought the mesh into the bladder instead of around it! My surgery is 12:30 today to cut into my bladder and remove the mesh. My husband is meeting with a lawyer during my surgery. Good luck to us all!
Carla

Wilmington, NC

#21 Oct 9, 2008
Dear Suzane,
Please contact me asap, I just walked out of an attorney appt1 hour ago. I had a TVT O done in 2005 and a TVT done April of this year.
I have expeirenced almost every symptom that I have read on here, not just your blog but all of them. I have been sent in enless circles from Dr.s around the Country and Im told the device is in too much of a dangerous location in my body to remove. I have permaneant damage and my life has been turned upside down from day one of my 1st TVT-O surgery.

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