lawsuit filed Gynecare TVT bladder suspension tape (Prolene mesh)

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Lana Miami

Saluda, NC

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#1
Aug 12, 2007
 

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WOMEN UNITE!
Now is your chance to stand up and shine like a star!

Has your life and body been irrevocably changed (and not in a good way) by the Gynecare TVT System?

Tell it to the judge!
Stand up in a court of law and tell it like it is. I'm calling on all women who have been injured by this product and procedure to speak their piece.

Stand up and be counted! Let's unite to make certain no other innocent person has to suffer in pain for the rest of their lives because of a product and procedure that should not even be in the marketplace.

My lawsuit is the ideal platform from which to strike a blow at the company that manufactures and distributes the Gynecare TVT System.

I have filed a product liability lawsuit against Ethicon, Inc, Gynecare and Johnson & Johnson in the United States District Court for the Southern District of Florida.

Lana C. Keeton, Plaintiff Pro Se vs. Ethicon, Inc.(d/b/a Gynecare Worldwide) and Johnson & Johnson, Case #06-21116-Civ-Ungaro-Benages.

I do not have an attorney. I am doing this by myself. I really need your support.

It is set for trial for October 1, 2007.

Will you, and anyone else reading this with problems from the Gynecare TVT tape, please testify at trial? We have to help each other to stop this from happening to other women.

Please send me your contact info: name, e-mail address and phone number to:

Lana Keeton
Miami, Florida

e-mail: miamiblog@bellsouth.net
blog: http://www.theladyisachamp.blogspot.com

August 17, 2007 is the deadline for my witness list, so please contact me now, or I will not be able to put you on the witness stand to tell your story.

A huge issue for all women, this procedure, if done at all, should only be done by an experienced urogynecologist. The procedure is blind. The doctor sticks a needle into your vagina and brings it out through the abdominal skin. They then look through a cystoscopy to make sure it is not in your bladder. The only thing they know from this, is that it is (problably) not in your bladder. No one knows where that tape is once it is inside of you.

That is, unless you have problems from it, of course. Problems that includes cutting into your bladder, your vagina, your urethra. Then, believe me, you definitely know where it is. You can feel it hurting you. At the same time, however, your doctor still does not know where the tape is for sure.

The Gynecare TVT System and its TVT Device (Prolene mesh tape) are inherently defective for more than one reason.

1. The tape itself has abrasive edges that cut human tissue. Sensitive, living tissue in organs like the bladder, the vagina, the urethra. It is a process that will not stop unless your doctor surgically intervenes in some manner.

I have reports from an expert witness that the edges of the tape are defective. Please contact me at miamiblog@bellsouth.net if you would like me to send you the information.

2. The plastic sheaths that cover the tape for the purpose of implanting it in your body have to be pulled out after the tape is put inside you. Any movement of that tape after implantation is undesirable based on a patent that Ethicon filed in 2004.

3. There is much more....

There is a way to conservatively manage the complications so as not to further damage your healthy tissue. Dr. G. Willy Davila of the Cleveland Clinic Florida in Weston, Florida has been treating me now for almost 5 years removing parts of the sling. He will be able to refer you to a competent urogynecologist if you do not live in Florida.

This has been a long arduous painful process for me. I hope I will be able to help other women not to suffer as I have. Please contact me.

Peace and Blessings,

Lana
Dottie Leech

Foley, AL

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#2
Aug 20, 2007
 
I had this or a similar procedure. Dr. said if I did the "bladder graft" of puting the bladder in a mesh swing, no more problems. Now it's half in, half out, and that was with in the first six months. and urologist says its much tougher the 2nd time than the first. and more dangerous. Do I know if is the fault of the doctor, or the graft itseld, no, I don't. And where in the world could I find a doctor to testify? They stick together, right or wrong.
I wish you well. God bless!
Lana Miami

United States

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#3
Aug 20, 2007
 

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Dottie Leech wrote:
I had this or a similar procedure. Dr. said if I did the "bladder graft" of puting the bladder in a mesh swing, no more problems. Now it's half in, half out, and that was with in the first six months. and urologist says its much tougher the 2nd time than the first. and more dangerous. Do I know if is the fault of the doctor, or the graft itseld, no, I don't. And where in the world could I find a doctor to testify? They stick together, right or wrong.
I wish you well. God bless!
Thanks for writing Dottie,
The sling (graft) is the problem. The doctor is right. It is harder and more dangerous the second time. The manufacturer does nothing to help you deal with the problem once it is inside of you. But it is important to see an experienced urogynecologist. There is a way to manage it conservatively and get at least part of it out of you. Write me at miamiblog@bellsouth.net thanks, Lana
Lana Miami

Clover, SC

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#4
Aug 24, 2007
 

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Check out the Bladder Forum for other people suffering with bladder slings, in particular the Gynecare TVT Sling...there are some heartbreaking complications.

women go for bladder surgery being told none of the long term complications that result from a piece of Ethicon's Prolene mesh cutting through your bladder, your vagina, your urethra...

There needs to be a national registry of complications so that we can stop Ethicon and Johnson & Johnson from hurting other women...

write me at miamiblog@bellsouth.net with questions or ideas...peace and blessings, Lana
carolyn reggio

Atlanta, GA

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#5
Aug 31, 2007
 

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I agree there should be a national registry for people having problems. That might bring attention to how many of us there are and maybe someone would begin to care. So far I've seen 6 surgeons in my 4 months post surgery and none will admit my problems are due to the mesh implants. They all know each other and all stick together. My surgeon implanted 2 separate meshes into my abdomin. How do we prove the problems we're experiencing are due to the implants? Each attorney I've spoken to tells me I don't have a lawsuit. What a nightmare! It really seems hopeless. FYI: The hospital bill shows the cost of the AMS Monarc as $4,373.00 The 5 associated sutures were separate and added up to be $468.00 The Gynecare mesh GPS was $2,508.00 There are other alternatives. Are these dangerous mesh implants being used more for financial gain that our health? Is the FDA and the manufacturers in bed together? Yes, I'm angry! How do you find a doctor who will help? Do we have to live in pain the rest of our lives? How do find anyone who will even listen?
Robyn

Spicer, MN

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#6
Sep 10, 2007
 
What is the best thing for the doctors to use then? I am getting ready to have bladder suspension surgery and stumbled across this blog.

Please advise asap.
Lana Miami

United States

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#7
Sep 16, 2007
 

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Robyn wrote:
What is the best thing for the doctors to use then? I am getting ready to have bladder suspension surgery and stumbled across this blog.
Please advise asap.
There is no simple answer. It is better to be incontinent than to have irreversible complications from a piece of mesh that you live with for the rest of your life. Even if the surgery, cures your stress incontinence, there is a 30 - 40% chance that you will develop, urge incontinence or urgency/frequency. You simply change one problem for a different problem.
Write me at miamiblog@bellsouth.net and I will give you my phone number so that we can talk.
Or go to my blog, www.theladyisachamp.blogspot.com
peace and blessings, Lana
kevin

United States

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#8
Oct 19, 2007
 
Hi,
My wife is probably going to have this surgery. Her doctor has not informed her of any of these complications. In my mind this is not informed consent and God help him if one of these complications happen. Is there a 40% chance of urge incontinence? I also read a site that reported 40% chance of insufficient voiding requiring self cathiteriztion on regular basis. Is this true? Please let know so I can get this info to her. Do you know the incidence of the tape/mesh cutting organs or tissue? She is excited and under the impression you go in for a 60 minute procedure take it easy for six weeks and all the problems are solved.
Thanks
JCC

Saint Simons Island, GA

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#9
Oct 24, 2007
 
Thank goodness I stumbled onto this. I was just causally told by my urologist that 'oh there's a new great little procedure inserting a mesh sling - outpatient - no problem' Luckily I have a GP who worries about gen anesthesia anytime for me since I have had a heart attack. It will be interesting to see if he objects to this one. They are colleagues. I plan to look into this more. It's interesting that when I searched Mayo Clinic site for 'sling' nothing came up. Now I will try Cleveland Clinic, my favorite . Thanks for alerting us to possibilities. Good luck.
Lana Miami

United States

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#10
Oct 28, 2007
 
kevin wrote:
Hi,
My wife is probably going to have this surgery. Her doctor has not informed her of any of these complications. In my mind this is not informed consent and God help him if one of these complications happen. Is there a 40% chance of urge incontinence? I also read a site that reported 40% chance of insufficient voiding requiring self cathiteriztion on regular basis. Is this true? Please let know so I can get this info to her. Do you know the incidence of the tape/mesh cutting organs or tissue? She is excited and under the impression you go in for a 60 minute procedure take it easy for six weeks and all the problems are solved.
Thanks
Kevin,

The internet is full of tragic stories of lives completely ruined over a piece of plastic mesh.
All the things you read are true. It is pathetic the sales job the pharmaceutical companies do on the doctors and patients. Most of the doctors don't really know of all the complications, including DEATH!

Want the medwatch reports of the women who died from the Gynecare TVT procedure. I have them. I got them from Ethicon in discovery in a lawsuit I filed against Gynecare/Ethicon/Johnson & Johnson. They are public record and I will be happy to send them to you.

They also don't mention the kickbacks they give the doctors to use their products. 4 major pharmaceutical companies just paid $311 million to avoid prosecution for paying doctors to use only their hip and knee implants. Check the FDA Gray Sheet, dated October 1, 2007 for all the details.

There is an epidemic of corruption and greed in these companies. Johnson & Johnson admitted on their 2006 annual report that they bribed public officials in foreign countries. Just google annual report 2006 and look toward the end at #18 legal proceedings...it's there!

Do you think they care for one second if they ruin your wife's health and your life? They Don't!!

I lost my American Dream because of a piece of Prolene mesh used in a Gynecare TVT bladder suspension surgery...don't lose yours!

peace and blessings, Lana

Lana Keeton
Miami, Florida

E-MAIL: miamiblog@bellsouth.net
BLOG: www.theladyisachamp.blogspot.com
YAHOO GROUP:
www.health.groups.yahoo.com/group/medicalmesh
Lana Miami

United States

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#11
Oct 28, 2007
 
JCC wrote:
Thank goodness I stumbled onto this. I was just causally told by my urologist that 'oh there's a new great little procedure inserting a mesh sling - outpatient - no problem' Luckily I have a GP who worries about gen anesthesia anytime for me since I have had a heart attack. It will be interesting to see if he objects to this one. They are colleagues. I plan to look into this more. It's interesting that when I searched Mayo Clinic site for 'sling' nothing came up. Now I will try Cleveland Clinic, my favorite . Thanks for alerting us to possibilities. Good luck.
"Oh there's a great little new procedure inserting a mesh sling - outpatient - no problem." Same thing my doctor told me.

Did not tell me that his training was to watch the procedure done 3 times.

Did not tell me that I was only the 10th patient he had done it on.

Did not tell me that one of the other 10 had to be redone because she could not void.

Did not treat me for necrotizing fasciitis, the flesh eating bacteria, that I got at the site of the exit incision of the tape. Sent me home to die. My next door neighbot, a resident at Jackson Memorial Hospital at that time, saved my life.

Did not tell me that the tape could erode into my bladder for the rest of my life.

Did not tell me that almost 6 years later I would be having operations to remove the tape from the inside of my bladder.

Yea...that's a great little new procedure! Are you kidding? It is a life threatening procedure for a non-life threatening condition.

Save yourself a lot of heartache. Stay incontinent! They are praying on social stigma to sell a surgical procedure. Plastic does not belong in your body!

peace and blessings, Lana
Elza

AOL

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#12
Nov 5, 2007
 

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Hi;
To all concerned: I too am a victim of medical malpractice that no doctor or lawyer wants to be part of, due to the vast complications I've had.
in May 2003 I had my uterus removed and the doctor suggested that my bladder shoul be raised. The reason was supposedly I told the doctor that sometimes when I laughed very hard a little urine would leak. So she had me see the urologist. He said I should have the bladder secured it was a very simple procedure wit a TVT sling. Not informed there would be any complications. I trusted his expertise. After the hysterectomy and the bladder being slinged. I was catherizing for 8 weeks, going back and forth to the urologists office. He performed lot's of tests fillin my bladder and emptying it. No improvement. At this time I was getting very tramatized thinking I would have to catherize the rest of my life. The urologist assured me that I would be able to urinate again, but he had to perform another procedure to cut the sling. So then back int the hospital to have the sling cut. I then came home again not knowing that he was unable to find the TVT sling to cut. He told my husband that he cut tissue aroud to relieve the pressure and she would be urinating in no time. For two more weeks still catherizing. So we went back to his office to see why this was continuing and we insisted he find a doctor to see if this could be fixed. Naturally we were very upset. At this time he made some calls and found some doctor in Ohio adn had us call. jkKThe doctor was actually very nice and suggested a colleage in NYU medical center. We made an appointment and went down to see Dr Nitti who was very accomodating being he was going on vacation, dhe said this has been going on for too long and he set up to have this proceedure to cut sling ASAP. At the hospital he said that he would resolve the problem 95% sure. He said that if he could not find the sling thru the vaginal opening he would go thru the abdomen. One hour later he came out with the good news> I found the sling was too tight and rolled up and I cut it. He said by tommorrow she shoul be urinating. We wnt hopme same day and no urination that night. But the next day she stated urinating by herself> She thought this doctor was sent by GOD. The rest does not stop here approx 10 months later she had a complete prolapse everthing collapsed. kSo she had to have reconstructive surgery. Since the second procedure of the cutting of tissue, she has alwas had a tremendous burning sensation unable to sit for any lenghty period of time, Carries a doughnut pillow everywhere she goes to sit. Travels laying down everywhere we go. This has been going on for 4 years. KWKe've had 3 Law firms and none of them can find a doctor to admit (someting is wrong or what caused it) This Dr. oath has to stop.
Hope this is of help to readers Be Carefull
Living like this is pure hell. And NO SEX.
S Yoder

Augusta, GA

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#13
Nov 9, 2007
 

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I had a "simple bladder slind put in three years ago almost to the day. I am about to have my 6th surgery in the past twelve months. This is the last time my urologist will attempt to remove the tape that is eroding my vaginal wall, etc. If he can't do it this time I will have to go see a special "specialist." I am about at the end of my proverbial rope. This is effecting every part of my life. I had the sling put in up north right before moving south and I do not know what type of sling was put in. I am interested in securing a laywer and making sure the manufacturer or whoever pay for this disaster, but I do not know where to start. Does anyone have any ideas? Also, I would not recommend a bladder sling surgery to anyone. I say run as fast as you can in the opposite direction. This is ruining my life. I am on Darvocet and an antibiotic daily until my next surgery in a week. I have a large amount of bleeding and discharge daily. My job is in jeopardy and my medical expenses are absurd. My body is constantly in pain and tired from fighting a persistent infection. I just want to get well, have sex with my very patient husband, get my life back, and warn other women to not have this "minimally invasive, simple surgery" done to them.
S Yoder
Tammy Robinson

Hamilton, Canada

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#14
Nov 26, 2007
 
I am so grateful that I found this site. I am a Canadian and just went for incontinence testing...think the whole incontinence testing is a farce to be quite honest with you...who knows better than the one who is incontinent...just to make more money. So surgery has been suggested to me and I knew in my gut that this was not all what is said to be. I have had complications from self disolving vicryl stitches before and needed to investigate this miracle called gynecare tvt...I am definitely not having anything of the sort. I am only 41, endured a hysterectomy at 34 and multiple bladder infections since. Does anyone have any experience with other forms of incontinence surgeries? If not I think I will stay incontinent instead of risking my life.

Please contact me at tamrobinson@sympatico.ca
nnodg

Corby, UK

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#15
Dec 2, 2007
 
Tammy Robinson wrote:
I am so grateful that I found this site. I am a Canadian and just went for incontinence testing...think the whole incontinence testing is a farce to be quite honest with you...who knows better than the one who is incontinent...just to make more money. So surgery has been suggested to me and I knew in my gut that this was not all what is said to be. I have had complications from self disolving vicryl stitches before and needed to investigate this miracle called gynecare tvt...I am definitely not having anything of the sort. I am only 41, endured a hysterectomy at 34 and multiple bladder infections since. Does anyone have any experience with other forms of incontinence surgeries? If not I think I will stay incontinent instead of risking my life.
Please contact me at tamrobinson@sympatico.ca
I am in the UK and read this forum with great interest after a major botched tvt was placed through my bladder at time of insertion. I was then left for 6 months as surgeon refused to believe there was anything wrong with me eventhough I was in chronic pain, severe urgency/frquency/bleeding/spas ms and incontience at times. Its too long and upsetting to go into but basically I lost it mentally as noone would believe /investigate me. Eventually I did find a surgoen who would listen in a completely different part of the country and I had to have major surgeries to try and remove the tape from the bladder.
It has been a long hard road and am I now left with horrible complications, scar tissue and a bladder that is angry and abnormal at 32 years old, so I'm not happy.

All I wanted to say is please think carefully for those of you who want this surgery, most surgeons do not have a great deal of experience in this. In answer to your questions about other surgeries they are trialing lots of procedures using botox around the bladder depending on your incontinence situation. Overactive issue then the botox can be injected into the bladder to help control the spasms and leakage. SI then the botox can be used underneath around the urethra as a bulking agent. It is short term and can be topped up but its got to be worth a try before doing what i consider to be the unthinkable.
I continue to look for answers
best wishes nnodg
MONTANAN WETS HER PANTS

United States

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#16
Dec 30, 2007
 
Today I picked up the Sunday paper and found this ad, "One Day yo have urine loss and The next day hou don't, END OF STORY" PLACED BY THE HELENA obv/gyn ASSOC., PC, 45 MEDICAL PARK DR., WWW.OBGYNOFFICES.COM I was so excited I decided that I would make an appointment this next week and be rid of this long standing, wet, wet, wet problem. Since it was Sunday I decided to check out the web and see more about the procedure and product and cost. Thank you for the unselfesh effort you have made to inform the innocent. If you have the time please forward your information to www.obgynoffices.com Because these professionals have taken the oath to not intentionally harm....I am sure these doctors would like to know about this product's potential danger to their women patients and their possible liability if they are made aware of these dangers. They may have to weigh this against their kick-back incentives so blindly taken. I cannot understand how they could do this to women....other than every doctor in this clinic is a male and they are the only show in town. I realize how popular whistle blowers are so my advise is be very careful and may God bless. Thoes who do not pee alone....
MONTANAN WETS HER PANTS

United States

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#17
Dec 30, 2007
 
Today I picked up the Sunday paper and found this ad, "One Day you have urine loss and The next day you don't, END OF STORY" ..98% of women treated seven years ago are still dry, or report significantly less leakage......Although all medical procedures involve risks ....has a long safety record....hummmmmm....They may still be dry but are they alive, NOT IN PAIN and healthy...TO SAY THE LEAST this is deceptive advertising to say the least.....This ad in the Sunday IR City/State was PLACED BY THE HELENA OB/GYN ASSOC., PC, 45 MEDICAL PARK DR., WWW.OBGYNOFFICES.COM I was so excited I decided that I would make an appointment this next week and be rid of this long standing, wet, wet, wet problem. Since it was Sunday I decided to check out the web and see more about the procedure and product and cost. Thank you for the unselfesh effort you have made to inform the innocent. If you have the time please forward your information to www.obgynoffices.com Because these professionals have taken the oath to not intentionally harm....I am sure these doctors would like to know about this product's potential danger to their women patients and their possible liability if they are made aware of these dangers. They may have to weigh this against their kick-back incentives so blindly taken. I cannot understand how they could do this to women....other than every doctor in this clinic is a male and they are the only show in town. I realize how popular whistle blowers are so my advise is be very careful and may God bless.
Tina

United States

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#18
Jan 1, 2008
 
My husband & I waited 4 week, the recomended time, and had sex after the TVT procedure. I didnt notice any change but my husband said he could feel the tape at the top of my vagina. We waited another week but he states he can still feel it. I will call the Urologist tomorrow. Has anyone had this problem. As far as the leeking, gone, nothing, much better. In that aspect I'm so glad I had it done. I had this done on a Thursday and went back to work that following Monday. No problems....
Lori

Neenah, WI

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#19
Jan 4, 2008
 
Thanks to all of you who are sharing your stories. Lana and I met online this past year when I was researching to see if anyone else had similar problems to mine. I am a nurse and have been suffering from a botched TVT surgery from 6 years ago. Please continue to encourage your friends/colleagues to NOT have this surgery. Also, we all need to thank Lana for her tireless efforts in this. Happy New Year to you all.
Kevin

Saint Louis, MO

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#20
Jan 6, 2008
 
Well even after showing my wife this site she wants this surgery. Does anyone knoe the incidence of complications per 1000 surgerys done or any other statistical data. My opinion is this is horrible and hopefully something can be done to help all of you. I know I will not deal with complications well. This Dr has told my wife he has done over 600 of these with no complications. I hope he is not lying.

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