Day Two- Ethicon Defends Questionable TVT Transvaginal Tape Science

Feb 11th, 2014 | By | Category: Legal News
So District WV federal court

So District WV federal court

Day Two Lewis v Ethicon ~
Fortunately jurors are allowed to take notes in this federal product liability lawsuits that puts Johnson & Johnson’s Ethicon unit and its popular tension-free tape, TVT, on the defensive. It was the war of scientific studies that may have had the overall effect of muddying the issue of whether the plastic implantable sling to treat incontinence is the “gold standard” accepted by most surgeons or not.
On this Day Two of the Lewis v. Ethicon in federal court in Charleston, WV, the ten jurors were presented with evidence of how polypropylene’s heavy weight and small pores reacts in the body and whether there are better alternatives.

Dr. Bernd Klosterhalfen

Dr. Bernd Klosterhalfen

Researcher and consultant, Dr. Bernd Kloserhalfen continued his testimony on videotape from yesterday. The surgical pathologist from Germany was revered in his field, pointed out plaintiffs’ attorney Tom Cartmell. Even Ethicon’s former Medical Director of Gynecare Women’s Health and Urology, Piet Hinoul, in an email shown to the jurors, called him a “God of surgical pathology” for the opinions that he shared with Ethicon.

Klosterhalfen had made explanted mesh his specialty removing or explanting more than 1,000 hernia meshes from patients and 500 meshes gone wrong from women suffering complications with their transvaginal implants.

ethicon logoMesh, especially polypropylene (PP) is regularly implanted in a woman’ pelvic floor to shore up sagging organs. The TVT or tension-free tape, the kind implanted in plaintiff Carolyn Lewis in 2009, is inserted through a woman’s vagina and hooked into her tissues to cradle a sagging urethra that allows urine to leak during exercise, coughing, or stress urinary incontinence (SUI).

Dr. Klosterhalfen said the TVT mesh, a heavy mesh with small pore,s has not changed since its inception in 1998 and it can incite a foreign body reaction, inflammation and shrinkage. Add biomechanical tension to the tape from exercise, stress, coughing or exertion and the mesh mess can shrink up to 64%.

The TVT mesh is the worst, said Dr. Klosterhalfen as he referred to images that showed enlarged microscopic images of cracking and degrading mesh. As the mesh degrades in the body small particles of polypropylene have been found in a woman’s vagina causing irritation and infection as the body tries to rid itself of the foreign invader. Nerves coming into contact with this mesh mess create the chronic pain seen in many women suffering transvaginal mesh complications.

explanted mesh

explanted mesh

Under cross examination the lawyer for Ethicon, David Thomas, asserted there is no difference between small pore and large pore mesh as a cause of chronic pain.

“Do you believe the biocompatibility of mesh is more important than tissue reaction?” Yes, answered the doctor. “Do you believe a biomechanical mismatch enhances tissue reaction?” Again the answer was in the affirmative.

Klosterhalfen agreed lightweight mesh can have the same complications as heavyweight mesh. And no one has done any studies on how the pores of the mesh can change and collapse under biomechanical pressures, further exacerbating the complications by shrinking pore size and creating even more rigid scar tissue.

Meanwhile Dr. Klosterhalfen had nothing but a glowing report for a new pelvic floor mesh made by FEG Textiles of Aachen, Germany which he said had the “highest porosity of any mesh” and is “stable under mechanical stress” and it doesn’t degrade said the scientist.  Under questioning Thomas establish the doctor is a paid consultant for the company who receives one percent of sales and is paid 20,000 Euros annually. When he spoke at an FEG conference to other surgeons, Dr. Klosterhalfen did not reveal his association with the company.

Under re-direct attorney Henry Garrard for the plaintiffs showed Dr. Klosterhalfen Ethicon’s own document about the future of mesh – “to change the material to fix the pelvic floor issues.”

Garrard: “Please tell the jury what Ethicon says about large pores?”

Klosterhalfen:  “Large pore mesh significantly decreases foreign body reaction and decreases connective tissue reaction.  Lower weight mesh integrates into humans, decreases shrinking and bridging of mesh.”

Channel 13, Charleston WV

Channel 13, Charleston WV

Media Absent

Even though Channel 13, the CBS affiliate is literally out the backdoor of the courthouse, there were no television reporters, no reporters of any kind in the courtroom of Judge Joseph Goodwin today. Six manufacturers face more than 50,000 lawsuits filed making it perhaps the largest  mass tort litigation ever filed.

Adam Slater, Mazie, Slater

Adam Slater, Mazie, Slater

Adam Slater

It seemed oddly out of place to hear attorney Adam Slater’s voice fill the federal courtroom this afternoon. Slater is the New Jersey attorney who successfully concluded the first transvaginal case against Ethicon with an $11.1 million award, $7.76 of it punitive damages.

While that case is under appeal, plaintiffs’ firms around the country have shared videotaped depositions with experts working within and for Ethicon.

Dr.  Piet Hinoul, former Ethicon Medical Director

Dr. Piet Hinoul, former Ethicon Medical Director from Linda Gross trial

In a taped deposition shown to the WV jurors, Dr. Piet Hinoul told Slater that marketing and sales were important to Ethicon. In fact, the positive message it had to sell was all that would be heard when the company presented a a meeting of the American Urogynecology Society.

Slater: “Did your company provide internal documents to AUGS and SUFU (Society for Female Urology & Urodynamics)?”

 Hinoul: “I’d think not.”

In a statement that seemed surprisingly contrary to the facts, Hinoul added he considers TVT to be a lightweight mesh.  “Today no one would bring a heavy weight micro-pore mesh to the market,” he told Slater.

Dr. Bruce Rosenzweig dr bruce rosenzweig

Dr. Bruce Rosenzweig took the stand in the afternoon. The urogynecologist with Rush University and in private practice in Chicago used to use TVT in his practice.  That was after he was chosen among an elite group of doctors who were flown by Ethicon to Belgium where he could attend a cadaver clinic to learn  and eventually promote the use of TVT.

But Dr. Rosenzweig told jurors after about 15 to 20 TVT implants and 40TVT-O implants he stopped. Instead he turned to removing meshes and now has explanted about 200 from women with complications. What has he found?

“Curling, frayed edges, making a “U” or circle with tension,” he said. Dr. Rosenzweig related the mesh changes to a garden hose, when it kinks water will stop just like an altered mesh will slow a woman’s flow of urine.

“She can’t urinate, she can’t completely eliminate her bladder,” he said to the jurors. Mesh shrinkage of 30 to 50% is not uncommon he said and not all mesh shrinks to the same degree. Chronic pain can also be incited from particle flakes from the polypropylene that get in a woman’s tissue. “We don’t know what kind of impact that has in the future” he said.

Other plaintiff attorneys have called that a “ticking time bomb” because no one knows the long-term implications of a mesh implant or fragments that remain behind from a partially removed mesh.

The doctor said the complication rate did not comply with his personal risk- benefit analysis.  Dr. Rosenzweig has gone back to a Burch colosuspension or using a woman’s own tissue to craft a pubo-vaginal sling. See his website video here.

Dr. Tom Margolis, another doctor in the San Francisco Bay area who removes mesh, will be on the stand Thursday.  #

16 Comments to “Day Two- Ethicon Defends Questionable TVT Transvaginal Tape Science”

  1. Paula says:

    Thank you Jane….

  2. Linda says:

    Thank you!

  3. Kristine says:

    Thank you Jane

  4. Thank you Jane …. again you came to our defense, reporting what needs to be heard …. shame on the rest of the news reporting journalist who have missed the boat on this one,,,, what will it take for them to report our story… I am gonna start in my state and write to my Governor see what happens.

  5. Dawn says:

    I actually met with Dr. Bruce prior to my mesh removal at UCLA … Great Dr. . He just couldn’t promise to get all of the mesh out of me . He said he could get about 80%.
    Well big KUDOS to him for taking a stand against mesh for us all !!
    I sure hope the jurors are really listening hard to how much damage this mesh is causing.

  6. karen says:

    Thank you Jane! god bless us all.

  7. Sandy says:

    With all these doctors saying mesh were and are bad news I would think someone would get the point and just stop trying to defend them. Thank you Jane so much!

  8. Jaramillo says:

    Ethic cons is the appropriate name for this company. Ladies I wrote to our local KOB station requesting coverage. Perhaps if we all rally, someone will listen and get the information out. This is a great opportunity to help those that have not been victimized yet. Mention MDND because reporters can obtain quick information from the site. This may enhance their interest. I also brought up FDA warnings and the 6 companies accused. WE have to make them aware that this is a global problem and not just one persons personal problem. It is up to us to gain their interest. We all have different messages. I am optimistic someone will listen. We can do this if we all reach out to our local station. On my local station they had a site to submit an idea for story coverage. if they get thousand of requests ,just maybe one reporter will find it necessary! Have a good day. Jane, thank you ou

    • Bejah Notrettu says:

      I suspect it is not so much a problem of newsworthiness as it is orders from senior management and parent corporations to avoid coverage, especially now. We’ll see. I think we need to reach to higher levels and journalists who have a reputation for covering what no one else will cover, those who have a measure of independence because of their ratings. There is a certain journalist who I think is affiliated with MSNBC who has an evening news program and she is a tough take no prisoners reporter. I think we should ask her to cover this. The power of the world wide web has, as we have seen, a power that can bring down governments. Don’t you think it can cause Johnson & Johnson to be a little uncomfortable? We can do this. Let’s rock and roll.

  9. jade says:

    Good reporting, Jane. Thank you much for all you do – these updates are so important to victims as it continues the thread of hope. Were any of your followers able to make it to Charleston with you to offer support?

  10. Barb Vance says:

    Jane~Thank you for representing all of us mesh
    victims. It occurred to me today that I have a friend
    that works at Bluefield State College in the Admin
    Dept not far from Charleston. She has been in the local news
    various times. I am going to contact her today
    to see if she can help me with any media leads.
    I will keep you posted. I also have a FB friend that works
    for a local TV channel here in Tyler. We are not
    close friends but I thought it would be worth trying
    to reach out to her and tell our story. Please help me
    pray that doors will be opened. Blessings~

    • Jane Akre says:

      Thank you Barb… the State Journal reporter was here for a little bit yesterday…! sent her to my site in that it is a lot to take in without a background…

  11. Mary blanks says:

    Thank you so much Jane for your continued reporting. I was wondering if Dr. Raz would be called to testify on our behalf!

  12. Barbara Dykes says:

    My husband drove me over 200miles each way to see a Uro/Gyno Doctor. On his first exam he just looked down and shook his head.Told me to go home and use Premarin (Estrogen) cream vaginally and come back in 2 months. Went back and he said shrinkage was little better and he scheduled surgery. Went back home to await my surgery. On the day of surgery(nurses had me prepped and ready to go and he says “I won’t be able to remove all the mesh, I am sorry but ” I don’t want you to go home with an upside down Vagina”.So, he did surgery but was “sad he could not get all the mesh. I take antibiotics for constant UTIs…My life is changed forever.I am a RN and I cannot understand why this mesh was only tested on small animals.

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