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

Anne- Houston

Rosenberg, TX

#42 Dec 18, 2008
CME- Houston wrote:
What surgeon did you see, I was told I needed a second opinion and just not sure if I want to have the surgery done but I don't know what to do about my POP (give me your e-mail I' d like to get in contact) <quoted text>
Email me at [email protected]
I have seen Dr. Cathey, who surgically removed about a 1.5" sq. of mesh. It had eroded into my vagina. I finally found out from hospital implant records that it is Gynecare Gynemesh. I still don't know where it was placed due to denials by the original surgeon. I have chronic and sever lower abdominal pain. It feels like the worst menstrual cramps you can imagine...but I have no uterus. I have an appt the day after Christmas with a colo/rectal surgeon (consult for a colonoscopy). Dr. Cathey says the pain in my belly isn't related to the mesh implant. I don't know that I believe her. It actually feels like some kind of blockage...
Anyway: that's the story to date. I am miserable!
Chronic pain makes a person very irritable!
sunboundconnie

AOL

#44 Jan 26, 2009
i had bladder repair in dec 2007, i have had major problems since. my life is a disaster. i have infection after infection, bleeding, and intercource is impossible. i almost lost my mind and my relationship. it is not fair to us to do this to our lives. we need help.
Suzanne

Montgomery, AL

#45 Jan 27, 2009
sunboundconnie,

We, the members of Truth in Medicine, a patient advocacy group licensed in the State of California are working fervently to get polypropylene mesh off the market. You are absolutely right, we are in need of help.

May I ask what type of product was used in your bladder repair? Was it mesh of some sort or another? I had Ethicons' Transvaginal Tension Free (TVT) Mesh, model #810041B implanted in June of 2004 and in June of 2008, it eroded through my vaginal wall. This device grated my healthy tissues as if it were a cheese grater. Polypropylene mesh does not belong in the human body, and many peoples bodies reject it, and try to expel it through any means.

If you don't know this information, the type of product used should be listed on your hospital records. Once you get this information, file an adverse event report on the Food and Drug Administration's Maude Database.

It is imperative that you begin to gather all your medical records, hospital and doctor for this particular surgery, as we soon hope to be in the fight of our lives to hold the manufacturer accountable for what their product did to us.

If you had mesh implanted, and have to have extraction surgery, write a letter to both the hospital and your doctor instructing them that you want the extracted pieces. Keep them in your freezer until the time we can all file a lawsuit, and get some justice for what has been done to us.

If you need further information, or if you are interested in joining Truth in Medicine, please let me know and I will forward the information to the group's founder.

Hope you get some relief soon!

Suzanne
whholmes

Columbia, SC

#46 Feb 4, 2009
Suzanne wrote:
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
That US Supreme Court ruling did NOT cover these mesh products
Suzanne

United States

#47 Feb 5, 2009
wwhholmes,

I stand corrected. You are absolutely right. The Supreme Court Ruling was only suppose to cover devices that had Class III approval, or (PMA) Pre Market Approval. That being said, lawyers are no longer willing to take on cases against the Pharmaceutical giants for any medical device regardless of their approval classification.

These mesh devices hold a Class II status, and obtained approval using the 510K process. This process, by which a manufacturer only has to show that a device is equivalent to a device already on the market, and proposed for the same use, regardless of whether or not they have conducted clinical trials is ludicrous. These devices are usually granted approval within a 90-day period.

I have had several lawyers tell me I have a case, but they can't take it on citing the Supreme Court's Ruling of February 20, 2008. Because of this ruling, they don’t think they can win, which leaves us, the injured parties holding the bag physically, emotionally and fiscally. How is this fair? Several other firms are looking into the possibility of filing suit and are presently gathering information, but as yet will not commit to filing a case.

The device implanted in me obtained approval using a predicate device that was pulled from the market by a firm initiated recall a mere 14 months after my device gained approval. The predicate device’s manufacturer cited complications with a “higher than expected rate of vaginal erosion and dehiscence,” and further stated “and does not appear to function as intended.”

Wouldn't it stand to reason that if the predicate device was pulled from the market, that any and all devices that had cited said predicate devices as substantially equivalent to the aforementioned predicate device would also have been pulled? How can we expect the FDA to handle such a tumultuous task, when they can't even maintain a uniform MAUDE Database? The FDA has failed miserably, and eight of the nine the Supreme Court Justices failed us, American Citizens, with this idiotic ruling. Our Country needs to totally revamp the FDA, eliminate the 510K process, and make sure that all medical devices are required to have substantial clinical trials over at least a five-year period, prior to obtaining approval. The FDA’s approval process for Class I & II medical devices are seriously putting the lives of the average American citizens at tremendous risk, and I for one am angry as hell! I’m not a guinea pig, but yet the manufacturer, the FDA and the doctor used me as one, and the Supreme Court gave them carte blanche to do so!
Carol

Phoenix, AZ

#48 Feb 9, 2009
I am having surgery tomorrow to remove as much of the eroded mesh as possible from my vagina. The Prolene mesh was put into my vagina during a hysterectomy in 2003, and I have not been able to have intercourse since that time. I have pressure, constant pain, infections, etc. The surgeon tells me I may be facing additional surgeries since this mesh is synthetic and therefore stays in the body and continues to erode into the surrounding areas. Someone should have to pay for the pain and suffering and change in lifestyle I have had to endure.
patricia

Whitland, UK

#49 Feb 12, 2009
I had a tape fitted nearly three years ago and now I have lost confidence when out as I have no real feeling or warning that I need to pass urine so accidents happen. I also find I cant wee when passing stools, it takes about ten minutes before I can pass urine after emptying my bowels. I have lost all feeling in my clitoris which has badly effected my sex life, I wish I had never had it done. I dont want to go back to the lady who performed the operation but am so fed up I am thinking of seeing my doctor to see if I can have it removed, although I think the damage is not reversable.
whholmes

Beaufort, SC

#50 Feb 23, 2009
Suzanne

Montgomery, AL

#51 Feb 23, 2009
whholmes,

I am assuming you are you talking to me, as when the page pulled up it listed one reply to my message, and yours was the only new message.

The link you sent may refer to Prolift, but it wasn't what was implanted in me. I have my hospital records, and I know how to read them. I know EXACTLY what was implanted in me, and it most certainly was not the Prolift as you suggest, it was Ethicon's Transvaginal Taping (TVT) Device.

You really have a lot of nerve trying to second guess my intelligence. I do not write of things unless I have great knowledge of them.

I suspect you work for Ethicon and that you all are trying to cover your behinds. Heck, if you can't blame the doctors, lets try to push it off on another manufacturer.

I really don't know how the hell you sleep at night!
Jap-Houston

United States

#52 Mar 4, 2009
CME- Houston wrote:
What surgeon did you see, I was told I needed a second opinion and just not sure if I want to have the surgery done but I don't know what to do about my POP (give me your e-mail I' d like to get in contact) <quoted text>
I would not have the prolift done. I had a total prolift in June 2007. I don't have mesh erosion, but have pelvic pain and it is very painful to have sexual relations with my husband in which I feel bad for my husband because I try to aviod having sex because of the pain. He seems to understand, but I feel it's not fair to him. My Doctor told me people react differantly to the mesh. I think that's a bunch of bull. I had no pain before I had this surgery.
EthelArlene

Salem, OR

#53 Mar 16, 2009
Take heart all you victims of synthetic mesh and other nasy medical devices! Just this month -- March 2009 -- Senator Edward Kennedy, Rep. Henry Waxman (Calif), Patrick Leahy and others submitted the 2009 MEDICAL DEVICE SAFETY ACT -- and it is expected to pass in Congress. This Act was initiated to overturn the Supreme Court ruling in the medical device "Medtronics" case (which favored the medical device manufacturer, and not the injured plaintiff). Shame on the U.S. Supreme Court for ruling in favor of the Big Medical Device Corporations. Well, ethical members of Congress are working to overturn the biased Supreme Court Ruling. The 2009 Medical Device Safety Act is expected to pass in Congress. Please do a "Google" search and you will pull up more details and info on the 2009 Medical Device Safety Act explained on a government website. I also found (and signed) an online petition (started by a medical device victim)which will be sent to Congress in support of the 2009 Medical Device Safety Act.
EthelArlene

Salem, OR

#54 Mar 16, 2009
Here is the link to the online petition that will be sent to Congress in support of the 2009 Medical Device Safety Act. Please click on the link below and sign the petition!...

http://www.petitiononline.com/mod_perl/petiti...
Suzanne

Montgomery, AL

#56 Apr 10, 2009
All of you mesh victims may want to migrate over to the topix forum "lawsuit filed Gynecare TVT bladder suspension tape, Prolene Mesh."

This is where the majority of the mesh suffers are posting. There are over 800 comments posted there, and you can get more information and advice from this page.
Suzanne

Montgomery, AL

#57 Apr 10, 2009
Not sure if I am allowed to post a link from topix, but if not I guess it will be deleted.

http://www.topix.com/forum/com/jnj/TTE0RAIRMP...
Rosyday

San Jose, CA

#58 Apr 17, 2009
I too am am a victim of this issue and found the blog yesterday doing a search. I will be having my second surgery next month to remove and replace the tape that
gives me freedom from the leaks. After I had the surgery a year ago the tape started to show in my vagina and the doctor prescribed hormone cream and said that if it got worse he could cut some skin and cover it.....that was a year ago and since then it has gotten worse. I have a slight discharge and and sex has become impossible due to pain. I know what is happening on the outside but not on the inside which concerns me.
I trust my Doctor and he advised me there have been issues but not compared to the number of the successes. I am not sure what to do. If I have the tape removed, I will leak like before and that was hell. I can't risk my health so I am in an quandary.
Peggy

Animas, NM

#59 Apr 18, 2009
I had the vaginal mesh inplanted in September 2007. It states "Prolift mesh for anterior vaginal prolapse". I just had my second surger for erosion. My medical report also states the mesh appeared to be rolled and balled up indicating the proximal tail of the mesh had been rolled and is possibly contributing etiology. I am trying to find out if the "prolift mesh" is the recalled mesh or if this is strictly a medical error on behalf of the doctor. I have all the symptoms listed by everyone and more! Someone please contact me at [email protected] I need a good attorney if anyone has located one for a class action or even on their own. Thank you and WOMEN FIGHT BACK !!!!!!

“BEWARE- DOCTOR'S PUSHING MESH!”

Since: Apr 09

Maben, MS

#60 May 1, 2009
“Suffering in Silence from a Medical Device - Surgical Mesh”(Part 3) has been posted to the Injury Board website.

The third article in the four-part series written by Ms. Jane Akre, is where “The Experts Weigh In.” Three doctors share their views on these mesh devices.

Ms. Akre is the editor for the Injury Board, and a former CNN and Fox News reporter, and this wonderful woman is trying to help us blow the lid sky high on the dangers of polypropylene mesh in the human body, and the FDA’s 510K approval process under which this permanently implanted device obtains approval, usually within 90 days, and with no clinical trials being conducted.

Please email me for instructions on getting to this site/these pages at: [email protected]

Thank you,

Suzanne McClain
Peggy

Animas, NM

#61 May 2, 2009
So I am wondering, has anyone found an attorney to take their case against Johnson and Johnson? Class action or otherwise? I have attorneys calling me day and night and I am so confused on what to do next. How do you know you have an attorney that is going to work for you. How do you know a "good" attorny. Please help me. [email protected]
Peggy

Animas, NM

#62 May 2, 2009
Suzanne I am interested in filing a lawsuit as i am a victum of Johnson and Johnson also. Did you get any positive response from the law firm in San Francisco? Please let me know ASAP. [email protected]

Thank you
Arizona
Suzanne McClain wrote:
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
Stephanie

Blue Ridge, GA

#63 May 6, 2009
I had a bladder sling operation in May 2001. The doctor used prolene sling 2 x 7 cm material. I have had nothing but pain and problems sine the operation. The Prolene material is the culprit. I need a an attorney who knows about this.

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