J&J Vaginal Mesh Faces FDA Safety Panel as Number of Lawsuits Rise

Sep 7, 2011 | Posted by: roboblogger | Full story: Bloomberg

Johnson & Johnson logos are displayed for a photograph in Tiskilwa, Illinois, U.S., on Monday, April 11, 2011.

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FROM AZ

Gilbert, AZ

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#1
Sep 8, 2011
 

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This is so ridiculous! This petroleum plastic mesh (TVT) have been implanted and maiming women's bodies for over a decade and FDA is just NOW questioning J&J for this crap? Why didn't they require clinical trial before hurting and ruining so many women's lives? J&J sent out their marketing sales people to pitch the mesh as the "Gold standard" for SUI and POP corrective surgery without doing any clinical trials. This is so wrong I can not believe this is happening in the U.S. Everytime I use J&J baby wash to bath my preschooler, it makes me so upset that because of the J&J's product's(bladder-sling mesh) horrible complications, I can't take him to the park and couldn't and can't even hold him. J&J product has virtually taken my husband's wife and my three kid's mother and my mother's daughter...ME! I wish I never trusted my Urogyn to implant these crap inside of my most private part of my body, where there are so many nerves and any movement could/are causing excruciating pain.

Dear J&J and all other pharma/medical device makers, please put patient's healthcare first and making money secondary. It is so apparently wrong to make so much money, while causing so much harm and damaging women's lives and their families. This is so wrong in so many ways...may God help us all.
Also from AZ

Phoenix, AZ

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#2
Sep 11, 2011
 

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"FDA Recommends Patients Should Consider Alternatives To Transvaginal Mesh

On July 13, 2011, the U.S. Food and Drug Administration (“FDA”) issued a transvaginal mesh warning*** advising patients and doctors to consider alternative treatments to transvaginal mesh. At the time, the FDA also announced that it would convene to discuss whether transvaginal mesh should be removed from the market or reclassified as a high-risk device. Although the advisory panel did not officially vote on the matter during yesterday’s meeting, a majority of the committee members agreed with the FDA’s recommendation to reclassify transvaginal mesh implants as high-risk devices"

According to various rescources I've been reading on the internet, the manufacturers do not want to have the meshes reclassified as high-risk as this would pose "hardship" for them.

If the mesh is left as a Class II device (moderate risk), they would be in control of the trials themselves, not under FDA scrutiny. Also it means they can still continue to sell them under the 510K process, meaning the product can be sold for experimentation without proven to be safe or effective. They just have to prove their product is equivalent to a predicate device that has already been tested. This predicate device HAS ALREADY BEEN RECALLED years ago (protogen sling). RECALL is the only ethical thing to do. We are talking thousands if not hundreds of thousands of women world-wide who could be affected with SHORT and LONG-TERM complications. Scientific data is showing that polypropylene, the synthetic material it is made of, breaks down in and out of the human body. Once the implant starts to degrade, the pieces can break off and infiltrate other body organs causing chronic inflammation, pain, nerve damage, infection and autoimmune diseases. The body can't heal. The only clinical trial done was conducted in 2010 that showed erosion complication rate 15.6% after 3 months. The trial was stopped. Do YOU want to participate in a clinical trial when the device is considered permanent, meaning you could be in pain for the rest of your life, facing multiple surgeries to remove it? Is that a risk you are willing to take?
jessiein gilbert too

Phoenix, AZ

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#4
Sep 23, 2011
 
FROM AZ wrote:
This is so ridiculous! This petroleum plastic mesh (TVT) have been implanted and maiming women's bodies for over a decade and FDA is just NOW questioning J&J for this crap? Why didn't they require clinical trial before hurting and ruining so many women's lives? J&J sent out their marketing sales people to pitch the mesh as the "Gold standard" for SUI and POP corrective surgery without doing any clinical trials. This is so wrong I can not believe this is happening in the U.S. Everytime I use J&J baby wash to bath my preschooler, it makes me so upset that because of the J&J's product's(bladder-sling mesh) horrible complications, I can't take him to the park and couldn't and can't even hold him. J&J product has virtually taken my husband's wife and my three kid's mother and my mother's daughter...ME! I wish I never trusted my Urogyn to implant these crap inside of my most private part of my body, where there are so many nerves and any movement could/are causing excruciating pain.
Dear J&J and all other pharma/medical device makers, please put patient's healthcare first and making money secondary. It is so apparently wrong to make so much money, while causing so much harm and damaging women's lives and their families. This is so wrong in so many ways...may God help us all.
Please where are you in gilbert I am in gilbert too, and I am walking through this right now, need a doctor to get this out of me, can I please contact you my email is jtreola@q.com
From AZ

Gilbert, AZ

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#5
Sep 30, 2011
 
jessiein gilbert too wrote:
<quoted text>
Please where are you in gilbert I am in gilbert too, and I am walking through this right now, need a doctor to get this out of me, can I please contact you my email is jtreola@q.com
\

I emailed you several times...
greyp

Los Angeles, CA

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#7
Nov 23, 2011
 
If you need a good vaginal mesh lawyer I recommend http://www.transvaginalsurgicalmesh.com
KathleenHennis

Anonymous Proxy

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#8
Jan 19, 2012
 
This is a responsible move taken by the U.S. FDA. There is really a need for a reclassification of these vaginal mesh products, since these have been found out to cause health risks. There are even thousands of vaginal mesh lawsuits filed in the United States recently. Mesh recall can bring justice to those who were victimized by these deadly complications. http://www.vaginalmeshlawsuit.com
Sheila

Clarks Summit, PA

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#9
Jan 25, 2012
 
Vaginal mesh implants are not the only implants that are causing people to file lawsuits. Hip replacements were also found to have severe complications like metallosis. This has been one of the reasons why most people, who had hip replacement, are filing lawsuits against the manufacturer. You can read more about it at http://www.depuyhipreplacementlawsuit.com/hip... .
KathrynDawkins

New York, NY

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#10
Feb 2, 2012
 
These deafening issues of the vaginal mesh have not only caused women to suffer physically. It also affected their psychological health and their social relationships. Mesh manufacturers are being blamed by many, and in effect, they are faced with the massive volume of vaginal mesh lawsuits.
http://www.vaginalmeshlawsuit.com/
Carlos Romano

Clarks Summit, PA

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#11
Feb 16, 2012
 
This is a logical move done by the FDA. Products reported to cause adverse effects on the health of consumers such as surgical mesh must be subject to surgical mesh recall.Manufacturers must also be held liable because they are accountable to the consumers.Consumers are rightfully entitled to file a surgical mesh lawsuit. http://www.rotlaw.com/transvaginal-placement-...

Since: May 12

Philadelphia, PA

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#12
May 3, 2012
 
What's the point of simply recommending other products? I mean, I get it, but just the pull the darn things from the market. If there are other, better, more effective alternatives, why even make these things available. Especially after causing so much grief.

Hopefully, these lawsuits, will force the products manufacturers to take some type of action. http://www.anapolschwartz.com/practices/trans...

Also, this FB group gives up to date information on TVmesh and similar products if you want to check it out. http://www.facebook.com/groups/14236833920705...
Rina

Dallas, TX

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#13
Dec 21, 2012
 

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It's good to know that the FDA safety panel is actually considering a more stringent pre-market testing for pelvic sling implants. More and more women are filing lawsuits because of serious injuries and it is daunting to know that these complications could even be life-threatening. Check http://www.bladderslingrecall.us/what-is-vagi... for more information about the potential harmful effects of bladder slings.
Arianne

United States

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#14
Feb 1, 2013
 
Some of the vaginal or bladder mesh products marketed by J&J have been associated with a string of controversies in recent years. The company even issued a voluntary recall on some of these mesh devices as they have been reported to cause serious complications in a number of women at some point after surgery. There is further information at http://www.bladdermeshlawsuit.us/transvaginal... that could be of great help to people concerned and interested.
Kelly

Phoenix, AZ

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#15
Feb 2, 2013
 
Very similar to vaginal mesh devices, these products may very well cause similar complications. It has injured thousand of women which has prompted them to take other actions. For more information about this, you may visit http://www.prweb.com/releases/rottenstein-law...
Shane

Phoenix, AZ

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#16
Feb 3, 2013
 
Women have purportedly incurred serious injuries from some of these surgical sling devices. Some had to go through multiple revision surgeries and are still dealing with chronic pain due to complications stemming from mesh slings. We can only hope patients who decided to pursue a legal claim get the compensation they deserve. There is added information at http://www.bladderslingrecall.us that could be a great reference to people concerned and interested.
Melinda

Matawan, NJ

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#17
Feb 15, 2013
 
You may be right that the FDA may also be faulted for these failures since these devices were sold due to their 510(K) process. Even with the recommendations of the panel to do away with this provision, it seems no action has been taken so far. These vaginal mesh device were "cleared" even without clinical trials and now thousand of women are complaining of severe complications. More on this discussion in www.sacbee.com/2013/02/05/5168401/plaintiff-i...
Dawn

Phoenix, AZ

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#18
Mar 4, 2013
 
It's good to know that the FDA is now considering a tougher stance on the regulation of these devices. I also came across this article on the net bladdermeshlawsuit.us/what-mak es-transvaginal-mesh-dangerous / and found how risky and even life-threatening mesh devices may be to women. This move from the FDA may have been a little too late for some women though, especially those who may have developed complications from surgical mesh implants.
Nonie Wideman

Edmonton, Canada

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#19
Mar 5, 2013
 

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Dear Diary,
I have a dream. In this dream high ethical standards and moral obligations are held up...a giant that stepped on little people and hurt them, when berated by the gods felt remorse. The giant could have argued with the gods' tribunal and continued to stomp around in an indignant huff while arguing it was not his tracks in the villages where the injuries were devastating.

But instead of arguing the giant truly opened his eyes and saw the pain of a small wee child weeping over his now crippled mother. The giant thought about the race he had joined with other giants to reach a most wonderful prize. He saw the other giants with noses in the air denying there had been an unsanctioned race with no thought of the small creatures in their path to rumoured wealth beyond their imaginations. The giant leaned down and listened to the quiet sobs of weeping families.

The giant once had a reputation of being a gentle giant, a family friendly giant to be trusted and respected by all in the land. He hung his head in shame. Then he rememberd the words of his long departed mother. "Do no harm with your power and might, for to be a noble giant one must adhere to the giant code of ethics." The giant looked up to the tribunal gods frowning down upon him. He spoke with a humble voice. " I have hurt the little people. It is my duty to rebuild the homes I carelessly destroyed. It is my duty to use my treausures to pay for the finest physicians in all the kingdoms to tend the wounded victms that were in my path..It is my duty to pay the widows and widowers who cannot pay their taxes and have had to sell all their wordly possessions in order to seek healers and their services.

The giant staightened his shoulders and looked to the tribunal ... The gods were shocked, for giants seldom showed empathy when caught harming the smaller creatures of the world. The other giants waiting their turns before the tribunal groaned and muttered amongst themselves. The dragons hired by the little people to protect them from the giants groaned.. the dragons hired by the giants to protect them from armies of angry little people groaned. The tribunal put their heads together and pondered what their response would be ...for all the creatures were watching and waiting. Finally the spokeperson for the gods stepped forward. A pregnant silence filled the air. "The giants will be commanded from this day forth to follow rules and regulations that protect the little people. Any giant caught breaking these rules shall be turned into a midget at the mercy of the little people, to learn empathy and compassion.

The dragons may collect reasonable compensation for their services but no dragon may demand sacrifices of children, or virgins. No dragon shall take more than a quarter of a little persons compensation from a giant." ...the little people cheered and bowed before the gods.... the giants were still in shock from the idea of being turned into midgets.

Alas it is a dream, but without a dream it cannot come true....dragons and giants, if my voice could be heard you would hear me say, "dragons and giants in reality you know who you are.....why wait for the powers to be to threaten you with dire consequences and punitve measures to do the right thing....the little people need expensive healers, you caused harm with your reckless races to gain wealth...now make restitution and send the dragons back to their lairs with a little jingle in their pockets for their firey services.......... yours sincerely the optomistic dreamer...."

Well diary , did you enjoy my dream? I wish you could take this dream and force the giants to view this dream over and over.... and if their hearts show no remorse ..turn the bastards into midgets!!
Sam

United States

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#20
May 10, 2013
 
Well, the FDA already issued Public Health Notifications about these vaginal mesh devices that it may have risks to its users. While the FDA is doing thorough research about these vaginal mesh devices, lawsuits continue to pile up against these devices. You may want to check out http://avaultavaginalmeshlawsuit.com for articles about the complications of a vaginal mesh surgery

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