lawsuit filed Gynecare TVT bladder su...
Suzanne

United States

#688 Feb 27, 2009
We have to take a stand. The manufacturers are banking that we won’t, and they will never be held accountable. How they sleep at night is beyond me.

Ethicon’s Tension Free Vaginal Tape (TVT) System used the ProteGen Sling Collagen Impregnated Material as their predicate device to obtain FDA approval on January 28, 1998.
Suzanne

United States

#689 Feb 27, 2009
On January 22, 1999, the manufacturer of the ProteGen Sling pulled their device from the market citing “Use of ProteGen in the treatment of female urinary incontinence is associated with higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended” yet the FDA allowed the Ethicon Tension Free Vaginal Tape (TVT) System to remain on the market; a device that the manufacturer themselves stated was “substantially equivalent” to the ProteGen Sling. Are they idiots or what?
Suzanne

United States

#690 Feb 27, 2009
One last thing, for those of you considering revision/extraction surgery, tell both the hospital and your doctor by letter that you want any and all pieces from your surgery, and store these pieces in your freezer, until we are able to secure a law firm to fight for us. This evidence, in a court of law can be priceless.

I hope you find this information helpful, and I hope we all find relief soon, and in so many ways!

Suzanne
Suzanne

United States

#691 Feb 27, 2009
P.S.- Sorry for the multiple posts. They are not regulating our right to free speech, and limiting us to 400 characters, not words, characters. Like we can truly convey the essence of the horror done to us in 400 characters. Shameful!
Suzanne

United States

#692 Feb 27, 2009
They are NOW regulating
MySpace TVT Sling Surgery

Callington, UK

#693 Feb 28, 2009
Thank you Suzanne for all your very informative postings, this will help many.

The government agency to put in an adverse report in the UK is the MHRA, the link for reporting is here,

www.mhra.gov.uk/Safetyinformation/Reportingsa...

If the full link does not appear and you find difficulty please put in google search box

Reporting adverse incidents involving medical devices : MHRA

This will take you to the link to view how to report your experience with the TVT Medical Device.

Healing Light to all
Lorraine
Suzanne wrote:
If you live outside of the United States, you need to file an additional report with the government agency in your Country, that is "substantially equivalent" to the Food and Drug Administration in the United States.
This link is to Medwatch, a division of the FDA, and form 3500. Just copy and paste into your browser:
https://www.accessdata.fda.gov/scripts/medwat ...
MySpace TVT Sling Surgery

Callington, UK

#694 Feb 28, 2009
Hi Suzanne,

Do you have any links, article etc to support this valuable information? as it is important to me in my research for the UK. I had model number 830041B implanted inside me back in 2005 and the tape has eroded inside the midline urethral wall. You can email me or you can see me at the Yahoo Group set up by Lana.

Healing light to us all
Lorraine
Suzanne wrote:
On January 22, 1999, the manufacturer of the ProteGen Sling pulled their device from the market citing “Use of ProteGen in the treatment of female urinary incontinence is associated with higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended” yet the FDA allowed the Ethicon Tension Free Vaginal Tape (TVT) System to remain on the market; a device that the manufacturer themselves stated was “substantially equivalent” to the ProteGen Sling. Are they idiots or what?
MySpace TVT Sling Surgery

Callington, UK

#695 Feb 28, 2009
Dear Suzanne,
Thank you so much for bringing this to my attention and to others here to see for themselves.

I am finding and found the articles and links associated to this.

Healing to us all
Lorraine
Suzanne wrote:
We have to take a stand. The manufacturers are banking that we won’t, and they will never be held accountable. How they sleep at night is beyond me.
Ethicon’s Tension Free Vaginal Tape (TVT) System used the ProteGen Sling Collagen Impregnated Material as their predicate device to obtain FDA approval on January 28, 1998.
lyn

Dundee, UK

#696 Feb 28, 2009
yes many thanks suzanne info very much appreciated over here.lorraine i have already put in my report to the MHRA i like yourself had serial no 830041bl implanted last year. uk ladies please take note and action as soon as possible.we must all work together.thoughts with all suffering take care x
Laura in Ohio

Cleveland, OH

#697 Mar 2, 2009
Lee in Wisconsin wrote:
I had the TVT procedure in Wisconsin. I was hoping to correct incontenence that required wearing a poise pad all of the time. I did not have urinary tract infections at all before. I had the surgery in Oct. I stayed home 6 days. I have a very sedate sit down job so felt okay to return to work although I am of stuborn stock. Right after surgery I was notable to urinate and did not on my own for at least 5 days. I was sent home to self cath. By 6 days and return to work I was able to urinate on my own. However, I urinate very slow, weak and wonder if I am even empty after. I do not have pain (yet) but have had 3 infections since surgery and now have blood in my urine. I also have greenish discharge all of the time that I did not have before. I have been treated for infections to include Klebsillia. with my husband since surgery. The gyn I go to blames this all on not using proper procedures in the bath room, aging vaginal tissue (I am 54), and needing to urinate after sexual intercourse. I have not had sexual intercourse. I use the same bathroom behavior that I have used for the past 50 years with out problems. I wish I had looked all of this up before surgery. I am sorry I had the surgery. I am concerned for my future. Lee
I have never had a Urinary tract infection before in my life, but 5 months after the tvt surgery in February of 2008 I have had 7 UTI's . My specialist keeps saying that everything is ok with the mesh, and keeps treating me with antibiotics. The UTI'S are ruining my life. I don't know what to do.
Tammy Blythe

Hendersonville, NC

#698 Mar 2, 2009
Hi Laura in Ohio

I know just what your going through!! I've gone through 4 yrs of it. There are some things you can consider for your problem. If you would like to e-mail me please do so [email protected] I truely sympathize with you. Tammy
MaryAnn

Little Rock, AR

#699 Mar 3, 2009
Lori, I'm sorry to hear of your unfortunate outcome. I can only imagine what you are going through. Thank you for sharing your story. A few weeks ago I was elated to hear the words "you are a perfect candidate for the TVT procedure" (from a world renowned urogynecologist), as after birthing 4 kids I suffer from SUI, and have to change a pad every ten minutes if I do sports with my kids. However, when the resident healthcare provider said "I'm required to mention that there's a possiblilty of erosion" it (Thank God) triggered something in my head, which made me search TVT on the internet. I had no idea what "erosion" was, as I was so happy to know that my problem could finally be taken care of. To be honest, now when I think back, I almost feel like the resident was trying to send me a "message" when he said "are you sure you don't want to try a different type of pessary?". I still "wanted" this to be a perfect solution for myself, however my mind kept wanting another reason to decide against it. When I read your post, I read enough into it that told me that I would be having the same "world renowned urogynecologist" at the same university hospital. I was thinking that a "urogynecologist at a major university hospital would be safe and be able to make it work". I get it now. Thank you from the bottom of my heart for being my "Angel" - I just made my decision. I will keep you in my prayers.
Lori wrote:
Oh great.....I had this TVT procedure 6 weeks ago.... My mom called me today to tell me about lawsuits related to this. I've had pain ever since, had to self-cath myself after being released from the hospital because I couldn't urniate before being released and NOBODY ever told me of the complications surrounding this procedure. They totally minimized any complications and I had it done by a "World reknowned" urogyn doc at a MAJOR University medical center.... Now I'm freaking out. I go back for my 6 week checkup Friday... Should I demand they remove it immediately??? I have enough darn female problems (I've had endometriosis for 25 years), etc.....
Eadie

United States

#700 Mar 3, 2009
Has anyone thought about talking to "Opra" ? She can get something done if anyone can. This is a serious problem that women need to know about. If she will talk about the situation, on TV, it would get the word out to all those women who are thinking about getting this percedure done.
Just a thought....
Eadie
Suzanne

Miramar Beach, FL

#701 Mar 3, 2009
Hi Eadie,

Yes, I have thought of that, but as of yet I have not heard from her show. I can imagine the volume of mail that they get, and I am praying I will hear from them soon. One just never knows.

Thank you for your thoughts and recommendation. As I see it, any positive input might help.

Suzanne
Eadie

White House, TN

#702 Mar 4, 2009
Suzanne wrote:
Hi Eadie,
Yes, I have thought of that, but as of yet I have not heard from her show. I can imagine the volume of mail that they get, and I am praying I will hear from them soon. One just never knows.
Thank you for your thoughts and recommendation. As I see it, any positive input might help.
Suzanne
Suzanne,
Maybe if everyone on this forum would send an e-mail to the show it would get someone's attention. Or maybe a note to Dr. Oz could get something going.
The information really needs to get out there !!
Eadie
Suzanne

Miramar Beach, FL

#703 Mar 5, 2009
Hi Eadie,

I have done all that, and so much more. I work constantly on getting the word out and ultimately getting these mesh products off the market.

I wish all the women here would band together, take your suggestion, and email the Oprah Show, Dateline, 48 Hours, 20/20, CBS, NBC and Fox News. They also need to contact the FDA, Health and Human Services and their Senators.

Here is a link to all of these media sources except Oprah.

http://www.fair.org/index.php...

For Oprah:

http://www.oprah.com/contactus

For Dr. Mehmet Oz

https://www.oprah.com/plugform.jsp...

I wholeheartedly agree with you that the word needs to get out, and every single one of the women here deserve justice. These devices are Class II devices, approved under the 510K process through the FDA.

What that means is, no clinical trials were required for these devices, they only had to show substantial equivalence to a similar device on the market. When the device they used as their predicate device to gain approval is pulled citing failure of the device, the FDA does not pull the devices that used this device as their substantial equivalent to gain approval.

Ladies, we are their clinical trials, and unbeknownst to us, we have all been used as guinea pigs.

Stand up and fight. Together, we can move mountains, but it will take all of us, doing our part to get this big snowball rolling down the hill.

Suzanne
Suzanne

Miramar Beach, FL

#704 Mar 5, 2009
Here is the contact information for the FDA and Health and Human Services:

Frank M. Torti, M.D., M.P.H., F.A.C.P.
Acting Commissioner
U.S. Food and Drug Administration
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857

Mr. Charles E. Johnson
Acting Secretary
U.S. Department of Health and Human Services
200 Independence Avenue S.W.
Washington, D.C. 20201

Here is the link to find your State Senators:

http://www.senate.gov/general/contact_informa...

Here is the link to United States Representatives:

http://www.house.gov/house/MemberWWW.shtml

Please ladies, we have to help ourselves before anyone is going to take us seriously and help us.

Don't forget to file your adverse event reports with the FDA on their MAUDE Database.

http://www.fda.gov/medwatch/report/consumer/c...

Hope we all get the help we deserve, soon!

Suzanne
Gayle Sylvestre

Canada

#705 Mar 10, 2009
I had this procedure done in Feb,/09. It has been 5 weeks and I am still not feeling well at all. I just got finished my 2nd round of antiobiotics for a urinary track infection. I urinate constantly and am very frustrated. I am going back to my doctor today to see if I can get some answers. Also, I still have an odor and am told this is normal?? I just feel like I have flu symptoms all of the time. My lower back is very painful. I am 57 yrs. old. Any feedback would be great....
Gayle Sylvestre

Canada

#706 Mar 10, 2009
I am 57 yrs. old and I had this procedure done in Feb./09 I am very frustrated. My urinating is constant, and I don'e seem to be emptying my bladder. I ended up with a urinary track infection, and have just got finished my 2nd round of antiobiotics. My lower back is so sore, and I feel like I have flu symptoms. Very achy most of the time. I still have an odor, but they say this is normal. I am heading to my doctor today in London, Ontario. Hopefully I will get some answers.
debra

Marietta, GA

#707 Mar 11, 2009
Rene,

if you are still reading this - I am desparate to find a surgeon who has removed this tape before. We live in VA, but I am willing to get my mother to whomever she needs to go.

If you get this, please emial me at [email protected]

God Bless!

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