lawsuit filed Gynecare TVT bladder su...

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#3247 May 3, 2012
BEWARE!

DR. CARL ZIMMERMAN AT VANDERBILT UNIVERSITY in Nashville, TN has had some BAD MESH REMOVAL OUTCOMES.

I personally know women who had MESH REMOVAL SURGERY WITH DR. CARL ZIMMERMAN, who had to then HAVE ADDITIONAL SURGERY BY DR. RAZ TO REPAIR THE DAMAGE DR. ZIMMERMAN DID.

Lana Keeton

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#3248 May 3, 2012
Barb wrote:
Bard Faces First Federal Trial Over Vaginal Mesh Next Year
By Jef Feeley and David Voreacos - May 2, 2012 4:05 PM CT Wed May 02 21:05:10 GMT 2012
C.R. Bard Inc. will face its first federal-court trial next year over claims that the company’s vaginal-mesh implants injured women.
U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, set a Feb. 5 trial date for the first of about 600 federal cases contending that Bard’s Avaulta device caused organ damage. Goodwin is overseeing a consolidation of cases filed in federal courts across the U.S. against Bard, Johnson & Johnson and other makers of vaginal-mesh inserts.
The order of trials for the first federal cases over Avaulta “will be determined after completion” of pretrial information exchanges between Bard and the plaintiffs, Goodwin said in his order yesterday.
Bard, based in Murray Hill, New Jersey, and a unit of New Brunswick, New Jersey-based J&J also face litigation in U.S. state courts over their mesh products. More than 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse, or to deal with incontinence.
Scott Lowry, a Bard spokesman, didn’t immediately return a call for comment on the judge’s decision to set the trial date.
A U.S. Food and Drug Administration report in August 2011 found that vaginal-mesh products should be classified as posing a high risk to patients based on a review of side-effect reports submitted to regulators from January 2008 to December 2010. Women’s groups are demanding that the devices be recalled.
More Study
In January, the FDA ordered 31 manufacturers, including Bard and J&J (JNJ), to study rates of organ damage and complications linked to the vaginal-mesh implants. The companies must conduct three years of studies on the devices’ safety and effectiveness, regulators said. Some women contend the devices eroded and shrank over time, causing pain and injuries.
Some mesh suits blaming Bard and J&J for injuries are pending in state court in Atlantic City, New Jersey. Superior Court Judge Carol Higbee is coordinating discovery in those cases. Higbee has set a Nov. 5 trial for the first case against J&J’s Ethicon unit over claims that its Gynecare Prolift vaginal-mesh insert harmed women.
In February, the Judicial Panel on Multidistrict Litigation consolidated federal suits against pelvic mesh makers before Goodwin. The judge is overseeing evidence-gathering efforts in cases against Bard, J&J, Boston Scientific Corp.(BSX) and the American Medical Systems unit of Endo Pharmaceutical Holdings Inc.
Endo’s AMS unit also faces claims in state courts in Delaware and Minnesota over its Perigee, Apogee and Elevate surgical mesh products, according to court filings.
‘Day In Court’ Goodwin has appointed Bryan Aylstock, Fred Thompson III and Henry G. Garrard III to lead a group of plaintiffs’ lawyers who will oversee the progress pretrial information exchanges over the consolidated federal cases.
The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-MD-02187, U.S. District Court, Southern District of West Virginia (Charleston).
Barbara Martin
Consumer Advocate
“Protecting Consumers against Corporate Giants”
INFORMATION IS NOT LEGAL ADVICE
This information is designed to help victims safely cope with their needs. Information is NOT the same as legal advice. Although I go to great lengths to make sure the information is accurate and useful, I recommend you consult a lawyer if you want professional assurance, and your interpretation of it, is appropriate to your situation. You should consider all information as personal opinion only.
GOOD WORK BARB!

I like your new title as "Consumers Advocate" and your new mission,“Protecting Consumers against Corporate Giants”.

Bravo! Very helpful. Very productive!

Thank you for caring and for sharing!!

Lana Keeton
Truth In Medicine Incorporated
www.truthinmedicine.us.com
Wisemom

Proctorville, OH

#3249 May 3, 2012
Lana Keeton wrote:
BEWARE!
DR. CARL ZIMMERMAN AT VANDERBILT UNIVERSITY in Nashville, TN has had some BAD MESH REMOVAL OUTCOMES.
I personally know women who had MESH REMOVAL SURGERY WITH DR. CARL ZIMMERMAN, who had to then HAVE ADDITIONAL SURGERY BY DR. RAZ TO REPAIR THE DAMAGE DR. ZIMMERMAN DID.
Lana Keeton
Not to be confused with Dr. Philippe Zimmern in Dallas Texas....which is a wonderful surgeon trained by Dr Raz.
Meg

Port Lavaca, TX

#3250 May 3, 2012
Sorry...I read wrong. It was Dr Zimmern apparently. Would love to know if anyone knows about Dr Peggy Norton at University of Utah? Apparently a third of her practice is taking mesh. I still very nervous...
Meg

Port Lavaca, TX

#3251 May 3, 2012
Sorry, meant "taking mesh out" and "I am still very nervous". Typing too fast.
danni

Dunmor, KY

#3252 May 3, 2012
Meg wrote:
Sorry, meant "taking mesh out" and "I am still very nervous". Typing too fast.
Meg, we all know how nervous you are!! We also understand the Many trips to the many doctors! Boy does that get old And depressing!! It is very frustrating to hear what all a doctor can do only to find out after the drive to get there and the waiting AND the poking and proding...they really don't know that much after all!! Many of us have found that we actually know more than the docs:(
If you go to Dr. Norton, write down your questions before you go and wait for answers. Each time you think of something-write it down! I have an entire page and I insist they answer each one!! If you are not COMPLETLY comfortable with her answers and what she feels needs to be done don't do it!! It's your body and it has had enough abuse at the hands of docs!!
Cutting the mesh is not a good thing!! It makes it worse in the long run because it tends to break down and move! It all needs to come out!! Ask her if she has any mesh patients that had it removed that would be willing to talk to you. Maybe if you hear from someone she has preformed surgery on tell you how they feel, it will help you feel more comfortable. You have waited and suffered this long...a bit more time to make sure it's the right surgeon will be worth it!!
You stay in my prayers!! May God lift you up and direct you to the right doctor. May He guide that doctors hands and may He heal you!!
I pray that He gives you comfort and takes away the worries you have!! Amen
Meg

Port Lavaca, TX

#3253 May 4, 2012
danni wrote:
<quoted text>
Meg, we all know how nervous you are!! We also understand the Many trips to the many doctors! Boy does that get old And depressing!! It is very frustrating to hear what all a doctor can do only to find out after the drive to get there and the waiting AND the poking and proding...they really don't know that much after all!! Many of us have found that we actually know more than the docs:(
If you go to Dr. Norton, write down your questions before you go and wait for answers. Each time you think of something-write it down! I have an entire page and I insist they answer each one!! If you are not COMPLETLY comfortable with her answers and what she feels needs to be done don't do it!! It's your body and it has had enough abuse at the hands of docs!!
Cutting the mesh is not a good thing!! It makes it worse in the long run because it tends to break down and move! It all needs to come out!! Ask her if she has any mesh patients that had it removed that would be willing to talk to you. Maybe if you hear from someone she has preformed surgery on tell you how they feel, it will help you feel more comfortable. You have waited and suffered this long...a bit more time to make sure it's the right surgeon will be worth it!!
You stay in my prayers!! May God lift you up and direct you to the right doctor. May He guide that doctors hands and may He heal you!!
I pray that He gives you comfort and takes away the worries you have!! Amen
Thank you so much for the moral support Danni! xoxo.
mesh removed

Gilbert, AZ

#3254 May 4, 2012
ohio_boomer wrote:
I saw Dr. Raz today and he said he will take the mesh out, and that he will do it in one operation. He said the Boston Scientific mesh that I had implanted is, fortunately, the easiest to remove. Dr. Raz said he has done over 450 explants of mesh. He was very kind and compassionate. There was another young female doctor that is a "fellow" that did the initial pelvic exam. She is doing her fellowship explicitly on mesh removal and studying under Dr. Raz, and plans to try to study under Dr. Margolis next. It will take two weeks for their coordinator to confirm insurance coverage, and they are scheduling surgeries now for August. Depending upon my insurance, I will go in on one day for the tests (he has a special sonogram machine designed just to detect mesh), and then have the surgery the next day. The recovery period is 23 hours, he said, and considered all outpatient surgery. He will do it vaginally. The coordinator said that sometimes the insurance companies tell you they will cover it and don't since it is out of state, and sometimes they will not let you do the tests one day and surgery the next. This is why it will take two weeks for the coordinator to investigate/research what the insurance will REALLY cover so I do not have any surprise charges. Dr. Raz even gave me a hug before I left. He knew exactly what pain I felt, where I felt it, and what was causing it. He drew me pictures to illustrate what he was saying. He said he will get me off the Tramadol to get my life back. He said 90% of the time the pain is gone and there is no subsequent incontinence, but about 10% of the time a second surgery, 3 months later, is done using body tissue to create the sling to stop the incontinence.
I just wanted to update everyone as the more we all know what other steps women are taking the better off we all are.
I had mesh removed by Dr. Raz, he is a wonderful doctor. I just wanted to mention few things. The Ultrasound machine UCLA use is the exact same machine for the pregnant women and for other areas of the body. Most US is transvaginal and or transabdominal for women. To detect the mesh location he orders both in addition to transperinium. They learned from a German visiting doctor that by using the probe transperium they can see different areas.

The 23hr stay is dictated by the insurance, you stay at the hospital for 23hrs or less but you will be far from being recovered from the surgery.

You will be in good hands, I wish you fast recovery.
Barb

United States

#3255 May 5, 2012
Transvaginal Mesh Brands – Johnson & Johnson Ethicon Women’s Health

In the United States, market data from manufacturers indicate that in 2010 approximately 300,000 women underwent surgical procedures to repair POP and approximately 260,000 underwent surgical procedures to repair SUI.

According to industry estimates, approximately one out of three POP surgeries used mesh and three out of four of the mesh POP procedures were done transvaginally. Over 80 percent were done transvaginally with mesh.

Johnson & Johnson’s Ethicon Women’s Health & Urology division is responsible for manufacturing many transvaginal mesh devices. This division of Johnson & Johnson offers treatment solutions for a variety of female pelvic and reproductive organ health conditions.

More than 400 lawsuits are pending in New Jersey state court against Ethicon for injuries allegedly caused by several transvaginal mesh products. Lawsuits allege that Johnson & Johnson knew that Ethicon TVT products were unreasonably dangerous but continued to manufacture and sell them regardless.

Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh patches include:

Ethicon TVT
Gynecare TVT Sling *
Gynecare Gynemesh *
Gynecare Prolift Mesh *
Gynecare Prolene Mesh *
Prolene Polypropylene Mesh Patch Secur

* are also mentioned in the 400 lawsuits

TVT = tension-free vaginal tape, similar to a sling

All surgical procedures present some risks, so be sure to talk to a doctor about whether Gynecare TVT™ is right for you.

Complications associated with the procedure include injury to blood vessels of the pelvis, difficulty urinating, pain, scarring, pain with intercourse, bladder and bowel injury.

There is also a risk of the mesh material becoming exposed. Exposure may require treatment. Synthetic mesh is a permanent medical device implant. Therefore, you should carefully discuss the decision to have surgery with your doctor and understand the benefits and risks of mesh implant surgery before deciding how to treat your condition.

Adverse reactions:

Punctures or lacerations or injury to vessels, nerves, bladder, urethra, or bowel may occur during instrument passage and may require surgical repair.
Improper placement of the Gynecare TVT™ device may result in incomplete or no relief from urinary incontinence or may cause urinary tract obstruction.
Transitory local irritation at the wound site and a transitory foreign body response may occur. This could result in extrusion, erosion, fistula formation or inflammation.

Over the past 12 years, the original Gynecare TVT™ retropubic sling that has been used in over one million women worldwide.

According to the website,“Ethicon, Inc., a Johnson & Johnson company, is a trusted, world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the Company's vision: Restoration of body and of life.”

(continued)
Barb

United States

#3256 May 5, 2012
Transvaginal Mesh Brands – C.R. Bard

Bard is another manufacturer of transvaginal mesh. Bard manufactures, distributes, and markets numerous medical devices. By the end of July 2011, more than 100 women have filed a Bard Avaulta vaginal mesh lawsuit.

Some other Bard transvaginal mesh brands are included in the lawsuits as well. Brand names of Bard’s transvaginal mesh patches:

• Avaulta Plus™*
• BioSynthetic Support System
• Avaulta Solo™
• Synthetic Support System
• Faslata® Allograft
• Align*
• Pelvicol ® Tissue*
• PelviSoft® Biomesh*
• Pelvitex™ Polypropylene Mesh *
• Pelvilace*
• Uretex*
• Ugytex*

* Also mentioned in the Bard lawsuits

Bard-Avaulta prescription information

AVAULTA PLUS® Biosynthetic Support System is indicated with acellular dermal tissue has material derived from porcine source and should not be used in patients with known sensitivity to porcine material.

Adverse reactions: Potential adverse reactions are those typically associated with surgical implantable materials including hematoma, seroma, mucosal or visceral erosion, infection, inflammation, sensitization, dysparenunia, scarification and contraction, fistula formation, extrusion and recurrence of pelvic wall prolapse. Perforations or lacerations of vessels, nerves, bladder, bowel, rectum, or any visceral may occur during needle passage.

Precautions

The AVAULTA PLUS® Biosynthetic Support System and AVAULTA SOLO® BioSynthetic Support System should only be used by physicians trained in the surgical procedures and techniques required for pelvic floor reconstruction and the implantation of nonabsorable meshes.

Acceptable surgical practices should be followed for the management of infection or contaminated wounds.

The AVAULTA PLUS® Biosynthetic Support System and AVAULTA SOLO® BioSynthetic Support System implantation procedure requires diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, bowel, and rectum, or other viscera during needle passage.

Transvaginal Mesh Brands – American Medical Systems, Boston Scientific

SPARC® is a type of transvaginal mesh patch produced by American Medical Systems (AMS) designed to treat stress incontinence.

Lawsuits have been filed for women who had failed POP surgery.

Massachusetts-based Boston Scientific has been making medical devices for over 25 years. Boston Scientific is also responsible for making defective mesh systems, some of which are potentially fatal. Boston Scientific transvaginal mesh patch brands include:

• Advantage™ Sling System
• Lynx™ Suprapubic Mid-Urethral Sling System
• Obtryx® Curved Single,
• Obtryx® Mesh Sling,
• Prefyx Mid U™ Mesh Sling System,
• Prefyx PPS™ System

All these systems use Advantage® Mesh - The Advantage Mesh is designed to reduce the risks of mesh deformation during tensioning and irritation to the anterior vaginal wall.

Another brand – Mentor Obtape also had hundreds of lawsuits and claims for punitive damage. The company introduced the sling in 2003 and stopped manufacturing and marketing in 2006.

Boston Scientific Transvaginal Mesh Products

For the past quarter century, Massachusetts based Boston Scientific has manufactured transvaginal mesh products designed to treat women suffering from pelvic organ prolapse and stress urinary incontinence.

Recent reports indicate that some of the transvaginal mesh products are potentially defective and dangerous.

(continued)
Barb

United States

#3257 May 5, 2012
Boston Scientific Transvaginal Mesh Products

Some of the vaginal mesh implant products made by Boston Scientific include:

Advantage™ Sling System
Lynx® Suprapubic Mid-Urethral Sling System
Obtryx® Curved Single
Obtryx® Mesh Sling
Prefyx Mid U™ Mesh Sling System
Prefyx PPS™ System

Allegations Against Boston Scientific

In the months following the July 2011 FDA warning about the potentially dangerous and fatal side effects of transvaginal mesh products, allegations have been raised against Boston Scientific, as they have against other vaginal mesh manufacturers.

Sincerely,
Barb~Consumer Advocate
[email protected] om
(NEW EMAIL ADDRESS)

“Protecting Consumers against Corporate Giants”

INFORMATION IS NOT LEGAL ADVICE Any information is designed to help victims safely cope with their needs. Information is NOT the same as legal advice. Although I go to great lengths to make sure the information is accurate and useful, I recommend you consult a lawyer if you want professional assurance, and your interpretation of it, is appropriate to your situation.

You should consider all information as personal opinion only.

Since: Oct 11

Mason, OH

#3258 May 5, 2012
Lana Keeton wrote:
BEWARE!
DR. CARL ZIMMERMAN AT VANDERBILT UNIVERSITY in Nashville, TN has had some BAD MESH REMOVAL OUTCOMES.
I personally know women who had MESH REMOVAL SURGERY WITH DR. CARL ZIMMERMAN, who had to then HAVE ADDITIONAL SURGERY BY DR. RAZ TO REPAIR THE DAMAGE DR. ZIMMERMAN DID.
Lana Keeton
Not to be confused with Dr. Zimmern in Dallas, who several women on this forum have said was very good.
debbie p

Foristell, MO

#3259 May 5, 2012
hi my name is debbie i had the mesh put in 2005 i have had nothing but promblems everyone is not saying how are every day living is god forbid we get sick with a cold pads nothing works most of the time you pack a towel or somthing to sit on for when you wet your self not if it happens but when it happens mostly i stand at the door and watch the world go by if i do leave i might get where im going or i turn around go back home cause i done wet bad and cant go in stores and ect the doctor told me before i had this done i wouldnt have a promblem no more boy he lied of course johnson and johnson was not thinking of the women first they were thinking easy money my stomach hurts all the time from this cause to much scar tissue my cant be removed when it came thur my vaginal area it felt like a razor when i sat or moved and now i live with it never going to be removed it is part of me and yes you still fill it dont let no one tell you its in your head and the doctors tell you if you lose some weight that might help thats bull well i just wanted to talk thanks for listening
Barb

United States

#3260 May 5, 2012
Debbie, my heart goes out to all of you ladies! Have you checked into trying to get the mesh removed? The ladies on this blog have a wealth of information and not to mention great listeners!

Sincerely,

Barb~
Consumer Advocate
[email protected] om

“Protecting Consumers against Corporate Giants”

~INFORMATION IS NOT LEGAL ADVICE~

This information is designed to help victims safely cope with their needs. Information is NOT the same as legal advice. Although I go to great lengths to make sure the information is accurate and useful, I recommend you consult a lawyer if you want professional assurance, and your interpretation of it, is appropriate to your situation.

You should consider all information as personal opinion only.
debbie

Foristell, MO

#3261 May 5, 2012
hi barb i was told at one time that mine cant be removed to much scar tissue the doctor said there is nothing else that can be done every day you wonder if it will cut my organs up it takes a toll on me if i will die from this had a scope done in feburary of this year had two spots of trauma i know what these women feel the doctors dont they think all the pain is in are heads we spend money for help and they say cant find nothing cant work outside the home cant get insurance makes you feel like a missfit and when you dont have insurance doctors dont want to spend time to help i know this for a fact someone with insurance or medical card comes first my scarr tissue is so bad they didnt even see my ovaries well thank you for listening to me
tammy

Frankfort, KY

#3262 May 6, 2012
debbie wrote:
hi barb i was told at one time that mine cant be removed to much scar tissue the doctor said there is nothing else that can be done every day you wonder if it will cut my organs up it takes a toll on me if i will die from this had a scope done in feburary of this year had two spots of trauma i know what these women feel the doctors dont they think all the pain is in are heads we spend money for help and they say cant find nothing cant work outside the home cant get insurance makes you feel like a missfit and when you dont have insurance doctors dont want to spend time to help i know this for a fact someone with insurance or medical card comes first my scarr tissue is so bad they didnt even see my ovaries well thank you for listening to me
Have you seen Dr Raz in Calf. They say he is the best to remove mesh, Wow and you are in Calf. God bless u and remove all pain.
mesh removed

Gilbert, AZ

#3263 May 6, 2012
debbie wrote:
hi barb i was told at one time that mine cant be removed to much scar tissue the doctor said there is nothing else that can be done every day you wonder if it will cut my organs up it takes a toll on me if i will die from this had a scope done in feburary of this year had two spots of trauma i know what these women feel the doctors dont they think all the pain is in are heads we spend money for help and they say cant find nothing cant work outside the home cant get insurance makes you feel like a missfit and when you dont have insurance doctors dont want to spend time to help i know this for a fact someone with insurance or medical card comes first my scarr tissue is so bad they didnt even see my ovaries well thank you for listening to me
All doctors are not created equal. I was told by several doctors, the mesh could not be removed. Well they were wrong, Dr. Raz removed it.
Meg

Port Lavaca, TX

#3264 May 8, 2012
mesh removed wrote:
<quoted text>
Just curious why you didn't schedule the surgery during the same trip? Usually out of town patients are seen by Dr. Raz the day before in addition to having the necessary tests done. Then the very next day he performs the surgery.
I just called last week and called back again just in case I misunderstood...but Dr Raz will not see you and do surgery the next day. There is a mandatory consultation with a return visit once complete. I am going for a consultation at University of Utah because he is sooo backed up and I feel like I am getting sicker by the day. I need this stuff out sooner than later.
mesh removed

Gilbert, AZ

#3265 May 8, 2012
Meg wrote:
<quoted text>
I just called last week and called back again just in case I misunderstood...but Dr Raz will not see you and do surgery the next day. There is a mandatory consultation with a return visit once complete. I am going for a consultation at University of Utah because he is sooo backed up and I feel like I am getting sicker by the day. I need this stuff out sooner than later.
Yes, unfortunately the insurance has changed their policy on paying for the surgeries the day after consults. It's always the red tape that makes patients suffer, sigh...
Best of luck to you
Meg

Broomfield, CO

#3266 May 10, 2012
I had my consult at university of Utah today. I am very disappointed. I was prescribed gabapentin and was told the part of the sling in the obturator area cannot be removed and words like "cut" and partially remove we're used. I spoke with dr margolis office and they will do consult and surgery I'm same trip so looks like I am off to California.:(

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