lawsuit filed Gynecare TVT bladder su...
Lauren

Scottsdale, AZ

#2125 Jul 25, 2011
I'm 24 years old and have had the along now for three months. My appendix ruptured two weeks ago and had to have surgery. Reading all these stories has me worried. I'm 24. I don't want to have this removed in six years because it cut into my uterus. God help me if I'm pregnant then as well. What am I supposed to do?

“Public Consultant”

Since: Dec 10

Location hidden

#2126 Jul 25, 2011
If any of you ladies need assistance on getting to a law firm that will handle your case please email me.The law firm takes your case on a contingency basis,therefore if they don't get you a settlement then you owe no money! If you don't go through me PLEASE make sure the law firm you do hire does your case on a contingencey contract.

Please put TVT in the subject line of email.

Sincerely,

Barb~
barbmartin_2000@yahoo.com

“Public Consultant”

Since: Dec 10

Location hidden

#2127 Jul 25, 2011
News Update:

Ethicon Gynecare Transvaginal Mesh Lawsuits Filed By More Than 400 in NJ

Published: July 25th, 2011

More than 400 people have filed a transvaginal mesh lawsuit in New Jersey state court against Ethicon, Inc. and Johnson & Johnson over problems with their Gynecare mesh products used for treatment of pelvic organ prolapse and stress urinary incontinence.

All of the cases involve complaints filed by women who received Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling or another pelvic mesh product manufactured by Ethicon, which is a wholly owned subsidiary of Johnson & Johnson.

The transvaginal mesh products are used reinforce weakened or damaged tissue during surgery to repair pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). Pelvic organ prolapse occurs when the pelvic floor tissues that hold organs in place become weakened or stretched, which can occur following childbirth. Female stress urinary incontinence occurs when the muscles that support the bladder and urethra become weakened, and the surgical mesh may be implanted to act as a bladder sling or hammock to reinforce the muscle.

Although the products were marketed as a safe and effective alternative to traditional products and procedures, a number of women allege that Ethicon Gyncare mesh problems caused them to experience pelvic pain, infections, urinary problems, erosion of the mesh and other complications.

All of the Ethicon Gynecare mesh lawsuits filed in New Jersey state court are centralized for pretrial proceedings before Judge Carol E. Higbee in Atlantic County. At the time the cases were centralized in September 2010, about 60 women had filed a lawsuit over Ethicon Gynecare mesh products. However, according to information released by the court this month, there are now at least 402 cases that have been filed
The complaints allege that Johnson & Johnson knew the products were unreasonably dangerous, but continued to manufacture and sell them. The plaintiffs are charging the company with manufacturing a defective product, negligence, failure to warn, strict liability, fraud and other theories.

According to a study published in August 2010 in the Journal of the American College of Obstetricians and Gynecologists, researchers concluded that there was a high rate of vaginal mesh erosion with Gynecare Prolift mesh, while providing no difference in cure rates.
Earlier this month, the FDA issued a warning about the risk of problems from transvaginal mesh when used for pelvic organ prolapse, indicating that the agency was unable to find any significant benefit for the products over other available means of treatment.

Between 2008 and 2010, the FDA has received more than 1,500 reports of problems with Ethicon Gyncare pelvic mesh and other products placed transvaginally to treat pelvic organ prolapse.
In addition to Johnson & Johnson’s Ethicon mesh products, problems have also been associated with transvaginal mesh sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies.

“Public Consultant”

Since: Dec 10

Location hidden

#2128 Jul 25, 2011
Melanie wrote:
Please email me about a lawyer...want to ask questions
Susan,
I am not sure who your speaking to when you said "Email me directly", therefore I wanted to check with you before I emailed you. So if your speaking to me please let me know.
Sincerely,
Barb
Melanie,

If you need to speak to me concerning hiring an attorney please feel free to email me and put TVT in the subject line of your email.

Sincerely,

Barb~
barbmartin_2000@yahoo.com

“Public Consultant”

Since: Dec 10

Location hidden

#2129 Jul 25, 2011
Cindy M wrote:
Looking for an attorney in Maryland (or Virginia I suppose) that might take my case. I haven't made a post in awhile - but lets just say things haven't gotten better since the removal of my mesh in Nov 2009.
Thanks
Cindy,

If you still need assistance in locating a law firm to take your case please email me.

Sincerely,

Barb~
barbmartin_2000@yahoo.com
Jaye

United States

#2131 Jul 25, 2011
FDA Warning part 2:

FDA recommends that health care providers:

• Recognize that in most cases, POP can be treated successfully without mesh;
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

The FDA recommends that patients:

• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

The FDA also announced that an outside panel of experts in obstetrics and gynecology will meet on Sept. 8-9, 2011, to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence (SUI), a leakage of urine during physical activity. The panel will discuss the risk of transvaginal POP repair, clinical studies that may be necessary to address risks and benefits of this type of surgery, and the FDA’s interim recommendations for health care professionals and patients.

“Input from the clinicians, manufacturers and other experts will help the FDA better understand the safety and effectiveness of surgical mesh for POP and SUI repair, including any changes that would improve our oversight,” Maisel said.

Today’s safety communication is limited to the transvaginal placement of mesh to repair POP. It does not address the safety and effectiveness of mesh used to treat SUI or mesh implanted abdominally.
Tina

Belle Center, OH

#2132 Jul 26, 2011
Lana Miami wrote:
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
I also had the gyenecare tvt back in 2008 I have had nothing but trouble since I really started having bad pains blood during sex missing work a lot suffering bad when i ask my doctor if she used this mesh and could it be that? she said no she never used that type of mesh well I walked over to hospital and got my records. sure was the type of mesh she used. now I am going to Cleavland clinic at the end of Aug. I hurt so bad I have to call everyday just to see if they have a cancellation so I can get in sooner, so far no luck. Help.

Since: Mar 11

United States

#2133 Jul 26, 2011
Finally may have possibly found I doctor to listen to my issues but unfortunately can't get in til the end of September. Hopefully can get some relief. Told then I can't get my urogyn to listen to my problems. It's all in my head, has nothing to do with the sling even though the problems didn't exist before the sling implantation.
Julia

Sioux City, IA

#2134 Jul 27, 2011
I had bladder taping in 2003. Is that the same thing as this mesh you're talking about? I had to go back to surgery the next year since it eroded through my vagina. Sexual intercourse is painful and my husband has actually gotten scratched by a peice that is still able to be felt. I have just been living with it because it did help with my incontinence a lot and my Doctor is so nice. Is this the same thing do you thing?
Tina

Lima, OH

#2135 Jul 27, 2011
I have been having a lot of problems i had Gynecare TVT put in 2008 and missing work I am in pain, bleeding and can't get into a doc. till late Aug. It;s getting worst. The doc. that put the mesh in did a test and my bladder is spasming so she wanted me to do a interstim surgery to stop the bladder from spasm I ask if it could be the mesh this doc. said no they never used that kind of mesh
I have picked up my records from hospital that is what they used so now I am going to Cleavland to have them take a look. I am fighting for my health and can't get no help fast. I don't want to have this for the rest of my life. I feel like a out cast
Sue Texas

Vernon, TX

#2136 Jul 27, 2011
Databases
Adverse Event Reporting Data Files1
MAUDE Database Search2
MDR Database Search3
--How and Where to Report
Reporting Adverse Events (Medical Devices)4
Medical Device Reporting (MDR)- Contact Information for User Facilities and Manufacturers5
Medical Device Reporting for User Facilities (PDF Only)(PDF - 313KB)6
Amendments to the MDR Regulation to Implement FDAMA Changes7
MedWatch: The FDA Safety Information and Adverse Event Reporting Program8
--Resources
Medical Device Reporting - Federal Register Notices9
HERE IS HOW TO REPORT THE MESH TO FDA, IF U CANT GET IT BY CLICKING ON THE ABOVE JUST TYPE IT IN
From AZ

Gilbert, AZ

#2137 Jul 27, 2011
Lauren wrote:
I'm 24 years old and have had the along now for three months. My appendix ruptured two weeks ago and had to have surgery. Reading all these stories has me worried. I'm 24. I don't want to have this removed in six years because it cut into my uterus. God help me if I'm pregnant then as well. What am I supposed to do?
OMG! TVT is supposedly for women who finished having children. If you get pregnant with the sling, your life is in danger. I've read the mesh was introduced as a last resort for elderly who are not sexually active and regular fascia sling or stitching did no good for them and the mesh had to be used because their bladder and uterus was literally falling out of their bodies. So it should've never been used for any women under 70, let alone childbearing age. The greed from this medical industry is just too outrageous. I can't believe this is going on in the USA of all countries! I can believe it if we lived in China...
I'm not a doctor but from my own experience, you need to get the poisonous mesh out of your system ASAP, it doesn't get better only worse. FDA just published 3rd warning and probably will recall it soon enough. Thousands of doctors will implant it but only handful can explanted properly without damaging your most sensitive area of women's body. May God help you....fellow "Meshie"
From AZ

Gilbert, AZ

#2138 Jul 27, 2011
lap67 wrote:
Finally may have possibly found I doctor to listen to my issues but unfortunately can't get in til the end of September. Hopefully can get some relief. Told then I can't get my urogyn to listen to my problems. It's all in my head, has nothing to do with the sling even though the problems didn't exist before the sling implantation.
Your story is just like mine. I am shocked how these doctors can bold face lie to us about the awful mesh. I have a feeling it will be recalled soon enough. Doctors are meeting and talking of beginning clinical trial in Sept 2011, I'm like what! After this crap has been implanted into women for 13 yrs, they NOW think they should do the clinical trials? It makes me sick. I hope you have yours out ASAP, it only gets worse as time passes. May God help you during these terrible ordeal...I feel for your pain literally.
From AZ

Gilbert, AZ

#2139 Jul 27, 2011
Julia wrote:
I had bladder taping in 2003. Is that the same thing as this mesh you're talking about? I had to go back to surgery the next year since it eroded through my vagina. Sexual intercourse is painful and my husband has actually gotten scratched by a peice that is still able to be felt. I have just been living with it because it did help with my incontinence a lot and my Doctor is so nice. Is this the same thing do you thing?
Yes Gynecare TVT stands from Transvaginal Tensionfree TAPE, but believe me, there is lots of tension and pain and erosion. Mine eroded into the urethra to bladder, some through vaginal and other rectally. You probably have more UTI's since the implant as well. You should check out truthinmedicine.us.com , the site can answer many of your questions.

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#2141 Jul 28, 2011
“We’ve been talking to them since ‘07 and we’re not going away. Our public pressure has been instrumental in raising the awareness of enormity of the problem,” said Keeton.“Ultimately there is no added value to synthetic surgical mesh and a huge downside” said Keeton who would like the FDA to recall the medical device from the market. Keeton recommends doctors follow the lead of Dr. Shlomo Raz, world renowned UCLA pelvic floor repair specialist and Professor of Urology who presented his non-mesh procedure for suture only pelvic organ prolapse repair at the American Urological Association (AUA) in May of this year.

The FDA reported that between 2008 and 2010 there were 1,500 adverse event reports of mesh complications, a number that increased 50% from the prior three years. More than 75,000 women had mesh implanted for pelvic organ prolapse last year and approximately 200,000 had mesh surgery for incontinence, though the warning issued July 13 only addresses mesh implanted for POP surgeries.

Most women experience pain and bleeding within a year after their surgery. Patients often must undergo multiple surgeries to remove the mesh which Keeton says is like cutting gum out of your hair.“Any complication is devastating,” says Keeton who knows from personal experience having endured 17 procedures/surgeries to remove the mesh placed in her in 2001.

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#2142 Jul 28, 2011
Dr. Maisel, the FDA scientist, said the traditional surgery performed by a skilled, experienced surgeon using stitches only may be a better alternative for women suffering from POP and SUI.

Manufactured by at least nine different companies,“plastic” mesh is used to reinforce the pelvic organs in a patient suffering from incontinence and/or prolapsed organs. Surgeons typically insert the mesh through the vagina, though some surgeons prefer placement through an incision in the abdomen.

The agency is reviewing the use of mesh for incontinence and will hold a two-day meeting in September to determine if there is any benefit to synthetic surgical mesh and whether it should be reclassified from a low to a high-risk device. Synthetic surgical mesh is considered to be low-risk.

“Something that is implanted in your body permanently can never be considered low-risk” says Keeton who also points out that the agency is currently reassessing the controversial 510 (k) clearance process that allows untested, unsafe medical devices on the market.

A manufacturer only need claim that a similar “predicate” device is already on the market to obtain clearance for a new medical device. In the case of surgical mesh, the predicate device for all current bladder suspension meshes was taken off the market after it was found to be “adulterated and misbranded” and led to problems such as vaginal erosion or dehiscence and did not appear to function as intended. The FDA does not require the agency to re-review the medical mesh currently on the market that used the recalled mesh as a predicate device.

The 510 (k) fast-track system has gone largely unchanged since the 1970s.#

Link to Truth in Medicine Website:

http://www.truthinmedicine.us.com/pressreleas...

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#2143 Jul 28, 2011
LINKS TO RECENT MEDIA ON SYNTHETIC MESH FOLLOWING FDA UPDATED WARNING ON TRANSVAGINAL MESH ON JULY 13, 2011:

MSNBC.COM HEALTH July 26, 2011...Good article, Janet Holt interviewed:
Risky pelvic mesh highlights worries about FDA process

http://www.msnbc.msn.com/id/43886793/ns/healt... #

WSVN FOX AFFILIATE CHANNEL 7 MIAMI July 14, 2011….Good follow up television interview, Lana Keeton and Bob Hopkins, to Feb 2010 interview:

http://www.wsvn.com/search...

CBS INTERVIEW……July 15, 2011 television interview, Lana Keeton and Dr. Lisa Dabney:

DR. DABNEY SAYS EROSION IS MESH "PEEKING" THROUGH THE TISSUE. I HAVE HAD 17 SURGERIES/PROCEDURES FOR "PEEKING" MESH. MY MESH IS NOT "PEEKING", IT IS CUTTING MY TISSUE. I COMPLETELY DISAGREE WITH HER DESCRIPTION AND WAS NOT HAPPY TO BE IN THIS INTERVIEW WHICH GIVES SUCH A MISCHARACTERIZATION OF THE COMPLICATION "EROSION".

http://www.wcax.com/story/15090619/a-warning-...

CHICAGO TRIBUNE….July 25, 2011 newspaper article, Jane Pennington interviewed, lots of quotes from medical consultants/advisors to industry, in my opinion it minimizes the severity of the complications in my estimation:

http://www.chicagotribune.com/health/ct-nw-pe...
Valerie

Exeter, UK

#2144 Jul 29, 2011
If you have had a problem with your TVT mesh sling (tape) in the UK, please report it on the UK's Medicines and Healthcare products Regulatory Agency (MHRA) website by clicking the following link :
http://aic.mhra.gov.uk/mda%5CMDAFormsV3.nsf/w...
OR go to the MHRA website on
www.mhra.gov.uk
and follow links for: Safety Information - Reporting Safety Problems - Devices - Patients and other members of the public
Do not worry if you don't know the name of the manufacturer etc. We are not usually told this when we have the operation! Just fill in what you can and then the MHRA can follow up. This is the only way of alerting the relevant people of the problems that many of us or facing after this TVT surgery. May be then the UK authorities will also issue warnings about the risks of this so called TVT "tape".
Norma

Lake City, FL

#2145 Jul 30, 2011
I had this surgery April 2006 and now I cannot stand up without leakage. Could it be possible for the mesh to have rubbed my large intestine causing it to rupture? I had a rupture Oct. 2008
nitalee

Saint Joseph, MO

#2146 Jul 30, 2011
i also have had this sugery twice, first time i had it, i thought i was growing a tail after about 3 weeks, i told my dr. he said " it just the swelling from the sugery". went to another dr.......... he did the sugery again.......still having pain, spotting, an numbness down my right leg.

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