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Transvaginal Mesh Makers in Deeper Trouble

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Dallas, TXHow do women with transvaginal mesh implants react when they discover that the faulty medical device was cleared by the FDA without ordering sanctions? It must be especially egregious to those women who had a vaginal mesh implant made by Ethicon, a subsidiary of Johnson & Johnson.

“I am just so angry about getting implanted with this transvaginal mesh,” says victim and patient advocate Lana Keeton. “I am an educated woman and I am aware of the issues surrounding TVM, but I believe they are being kept under wraps because of the huge liability—for doctors, hospitals and insurers.”

And the transvaginal mesh manufacturers.

The largest healthcare company was told by the FDA (8/24/07) to stop selling its Gynecare Prolift until the agency decided whether the device was "substantially equivalent" to other products on the market. The FDA’s doubts were clear: the device had a "potential high risk for organ perforation". Despite the letter telling J&J it will be in violation of the Federal Food, Drug and Cosmetic Act, the company went ahead and sold its transvaginal mesh for the next nine months.

Re. Edward Markey introduced a bill in February that would allow the FDA to reject faulty vaginal mesh, but he did not get enough support to adopt this amendment to the Senate Bill. The Sound Devices Act was introduced because of complications caused by vaginal implants products and hip replacements. (It will be tried again when the bill moves to the Senate floor).

Markey introduced legislation to close the loophole in the flawed 510 (k) process, which allows a new device to be marketed based on its similarity to an earlier product—even if that earlier product was pulled from the market for causing serious harm to patients.

According to Markey’s website, the SOUND Devices Act:

• Provides FDA the ability to reject a device application based on a predicate that has been recalled or is in the process of being removed from the market for major safety problems;
• Requires companies to inform FDA if any products in their new device’s “predicate lineage” have caused serious harm and to explain how theirs avoids past mistakes;
• Instructs FDA to maintain a publicly accessibly database that companies can use to determine whether a device can be used as a predicate;
• Strengthens reporting requirements so that companies and the public can easily determine why a recall occurred (information that is often missing in the case of voluntary recalls);
• Calls for FDA to review the safety of high-risk devices if a product in their “predicate lineage” is recalled due to major safety problems.

Johnson & Johnson Lawsuit

Meanwhile, at the end of July 2012, Atlantic County Superior Court judge Carol Higbee ordered J&J’s new CEO, Alex Gorsky, to provide a videotaped deposition regarding the upcoming Ethicon transvaginal mesh lawsuits pending before a New Jersey Superior Court, where more than 1,000 transvaginal mesh cases have been filed. As well, extensive electronic searches of executives’ computers have been ordered.

(It won’t be Gorsky’s first time he has testified in court. In January 2009 he testified in a court case alleging that J&J marketed its drug Risperdal for off-label uses. The Department of Justice fined J&J $1.1 billion after it determined the company hid the dangers of the drug and marketed it illegally.)

“We look forward to questioning the most senior J & J executives in order to find out what was known at the highest levels, and to gain an understanding for why these pelvic mesh products have been marketed to patients and physicians despite the company’s knowledge of serious safety problems from the outset,” said attorney Adam Slater, who filed the first New Jersey case in 2008, claiming these products are defective.

Ethicon still markets vaginal mesh products as “safe, effective and reliable”, despite thousands of reports from women who have suffered irreversible and life-threatening injuries from its products.

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READER COMMENTS

Posted by

on
in 1907 i was implanted with a sling and transvaginal tape, when implanted in my body not one doctor told me they put the mesh inside my body, about two years later i came down with problems. bleeding from bowels,bleeding from my vaginal, so sick it was unreal,nobody know what was wrong with me,after 20 E.R visits and two colon tests and 6 pap tests,still nobody knew,they never heard of mesh implants problems at my E.R and had no idea what was wrong,they was beginning to think it was in my head,on my 6th pap test. the doctor tolded me she saw the mesh coming out vaginal and bring my organs with it, i was so shock, that was my problems, i went to the doctor that put the mesh in,i told her about all that sickness and that i was dying,my body was shutting down, could not take any more pain,she said there was nothing wrong,i felt really nuts by that time,i made her to do a what was right, as i was gone in to surgery ,the doctor try to talk me out of it,i told her if she didn't do the surgery ,i would find somebody to do that surgery,she went in my vaginal area and flipped out after what she seem,my hold body was messed up. the mesh was everywhere, on bowels, colon , vaginal , all over my insides, scar tissues everywhere, i was dying from all that mesh problems, the doctor took out 4in. of mesh out and close me up and sent me O.S.U in ColumbusOhio,by then this was my 4th surgery , DR. said a complete mesh removed , he done another surgery to removed a 8 year old vaginal mesh,rectum rebuild, vaginal rebuild. by then the pain was unreal, all my organs has been cut on ,i couldn't raise my head and the pain unreal, so i went to a nursing home for a week, lose 16 pounds doing all of this,today i have nerve damage in my legs,walking became a problem,i hoped nobody had to go though what i been throw,it was a nite mare.

Posted by

on
I have had 8 Surgeries related to severe Endometrious, then for deep Adhesions.
My forth and fifth Surgeries were in 1989 nd 1990,that I have a copy the Surgical report documented that ,"Interceed"-a Johnson and Johnson product was used .I had issues with increased pelvic and back pain about 2 months after surgery.
The next Surgery 1994, the TAH, was 5 1/2 hrs. of grueling surgery. They found massive adhesions and scar tissue but -very little Endometrious. So the issue were extremely bad Adhesions, a complication of failed Interceed.
Now fast forward,2 more surgeries and a blood clot during surgery...At age 56, I have been experiencing symptoms of Pelvic Floor dysfunction.
Most of the Lawsuits are aimed at newer cases.There is a population of women like myself who recieved Mesh,(even sometimes two different types are used if there was multiple surgeries);that are in need.
The women who have recieved mesh in the 1980's and 1990's like myself have dealt with Chronic Pain for 20 or more years after.And at times acute. We the were the first Patients who were the pioneers in this struggle and deserve to have our cases heard as well as compensated.
Thank you for your advocating on our behalf.

Posted by

on
I am not sure how long medical records are kept but I would request copies of all of them. Also current copies from any and all doctors you have seen since then. Contact the hospital that did the surgery for any records.
I am so sorry you are also going through this "horrible" ordeal but know we can't fight this on our own. Get a lawyer that will help you. I obtained one through this site. My heart goes out to you and I hope we can all win this fight together. They have ruined my life and I pray yours isn't ruined also.
But let's keep our chins up and fight so that NO other woman has to go through with this and suffer as we have.

Good luck Sandi!

Posted by

on
WHAT ABOUT SOMEONE WHO HAS THE SAME SAME SYMPTOMS OF THE MESH BUT IT WAS YEARS BEFORE JOHNSON & JOHNSON WERE SUPPOSEDLY USING THE MESH DOES ANYBODY KNOW WHAT THEY WERE USING 25 YEARS AGO

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