In C.R. Bard Transvaginal Mesh Federal Trial Tempers Flare

//In C.R. Bard Transvaginal Mesh Federal Trial Tempers Flare

In C.R. Bard Transvaginal Mesh Federal Trial Tempers Flare

Judges mallet 200With more than 27,000 cases naming six transvaginal mesh makers consolidated in a Charleston, West Virginia federal courtroom, the Donna Cisson v. C.R. Bard is the first to go to trial.

The first Cisson trial, which began July 8, ended in a mistrial two days later.

Drugwatch reports on the second day of testimony in the trial which began July 29. See the story here.

Donna Cisson Facebook page

Donna Cisson Facebook page

Lawyers for Donna Cisson, 55, say her Bard Avaulta Plus Posterior BioSynthetic Support System is defective in its manufacture, design and in a failure to warn doctors who are considered the end users.  Defendant C.R. Bard and its division Bard Urological designed marketed packaged labeled and sold the product which is made in Covington, Georgia and Bard’s principal place of business is New Jersey.

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

The Honorable Judge  Joseph R. Goodwin is overseeing this, the first of more than 4,000 cases consolidated in the Charleston, West Virginia federal court naming C.R.  Bard and its mesh products.

On the stand Tuesday was Dr. Brian Raybon, Cisson’s implanting surgeon. She received the mesh May 8, 2009 in Toccoa, Georgia at Stephens County Hospital. Cisson suffered from pelvic organ prolapse, specifically a rectocele.

MDND covered the initial trial of Cisson v. Bard before it ended in a mistrial July 10. See background story here. Just as in the first at the trial, Dr. Raybon was qualified as an expert in women’s urogynecology.

Dr. Brian Raybon

Dr. Brian Raybon

Dr. Raybon testified he should have been told by defendant C.R. Bard that the polypropylene material used to make petroleum-based plastic mesh should never be implanted in humans. He was particularly adamant because he was a consultant for the company and a “preceptor,”a doctor trained to teach other doctors on the use of a particular medical device.

He is credited as the first surgeon to implant the Avaulta mesh in the U.S.

Drugwatch quotes Dr. Raybon “I liked it,”  “I felt like it was a good system at the time, and I thought it was appropriate for Mrs. Cisson.

The doctor told the 8 jurors after patients began experiencing complications he discovered the mesh resin was not intended to be used in medical devices implanted in humans.

“How could (Bard) use it with that (warning)?  “That’s the part that really concerns me about this. I was astounded when I saw (the warning).”

Lori Cohen, attorney for Bard

Lori Cohen, attorney for Bard

Lori Cohen, an attorney for Bard asked Dr. Raybon why he didn’t ask Bard about the warning once he was alerted to it.  Drugwatch says that’s when Dr. Raybon became visibly agitated.

“As someone who spent four or five years at Bard teaching other physicians (about Bard products), and there’s this MSDS sheet around, I’m really concerned I’ve put something in these patients that shouldn’t have been put in. I’m sorry … it was a little irritating to work with someone four or five years, and they didn’t tell me.”

MSDS is a Material Safety Data Sheet that was uncovered in the discover process pre-trial.  Executives for Bard knew the resin they were using was not intended for medical implants and discuss not revealing that to the source of the raw material, Chevron Phillips.

marlexmesh 500 warning

Material Safety Data Sheet

Just as in the first trial, Dr. Lennox Hoyte was also called to the stand on behalf of Ms. Cisson.

The professor of urogynecology and pelvic reconstructive surgery at the University of South Florida, used 3 –D model he develop to explain to the jury how a mesh is placed.

The doctor said increasingly he is explanting mesh procedures gone wrong, about 400 so far with approximately 100 of them involving the Bard Avaulta products.

Dr. Hoyte says the mesh arms are the problem and most difficult to remove because they are anchored deep within a woman’s pelvis in muscle, tissues and frequently in or near nerves.

Armed transvaginial mesh is a bad idea. It never made sense to me, I always had a feeling the mesh would shrink and cause pain to patients.”

Dr. Lennox Hoyte

Dr. Lennox Hoyte, drawing by Jane Akre

The Bard Avaulta Plus was taken off the market last year by the company. It was that revelation by Dr. Hoyte during the first trial that resulted in the mistrial. Both the defense and plaintiffs had filed motions asking to limit testimony about the U.S. Food and Drug Administration or its 510(k) process that allows mesh on the market with no clinical trials. Judge Goodwin agreed.

When the FDA announced in January 2012 that it was ordering 33 mesh makers to post-approval monitoring of transvaginal and incontinence mesh, (see story here) both Bard and Ethicon (J&J) removed their mesh kits from the market. Mesh kits are thought to be largely responsible for the five-fold jump in complications the FDA noted in 2011 before issuing its stern warning about the use of mesh.

Bard Avaulta from website 200Bard manufacturers Avaulta synthetic surgical mesh, Avaulta BioSynthetic, Avaulta Plus and Avaulta Solo, as well as pelvic repair meshes, including PelviSoft, PelviLace, Pelvitex, Uretex, Align, Acellular Collagen Matrix, Faslata Allograft and Pelvicol.

As of July 15 there were 4,135 cases filed against just Bard in this multidistrict litigation. The Cisson trial is expected to take 12 days.

Learn More:

Motions in Limine

So. District of West Virginia

Drugwatch report, July 31, 2013

See Documents in the case: Motions in Limine Docket #302

Bard Doc 302 Motions in Limine concerning 510k 20113282424

July 10 Mistrial declared, Mesh Medical Device News Desk

Opening Arguments in Bard Case July 9, Mesh Medical Device News Desk


By |2013-08-01T16:12:27+00:00August 1st, 2013|Legal News|8 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Teresa Jones August 1, 2013 at 6:02 pm - Reply

    Thank you for your coverage.

  2. terri white August 2, 2013 at 8:24 am - Reply

    How can Bard not face criminal charges. Like Teresa and David have reported Bards deceit and reckless behavior,has perpetrated genocide against thousands of innocent woman.

    • George August 2, 2013 at 4:32 pm - Reply

      Hi Terri W.,

      Yup – in a private case you are probably correct about the criminal charges.

      However from what I have read charges of any kind are unlikely;

      1) The medical device manufactures are regulated by the FDA. With the current mesh devices it is called the 510K process, which means, since the 70’s when polypropylene mesh was approved for human implants and the hundreds of mesh application are just “simple modifications” of the original FDA approval process, even as the decades have rolled by. In many cases the 510K mesh approval was based on a handful of lab animals.

      2) Very difficult for a “corporation” to be a criminalized. This is the crux of our creed based economy that asks the question; are corporations people? Remember Romney stumbled over this one last year.

      The combination of 1 and 2 makes it very hard to bring charges – who do you charge and the FDA is still saying all is good with mesh, just do a better job of warning the patients of the possible complications.

      I do not agree with these concepts but that is where we stand today. Also realize, that neither mesh chemicals or mesh implants have been found flawed in any judgement that I am aware of. We mesh victims are also victims of a failed medical process, not just creed based corporations and but the medical “professionals” that are in their pockets.

      Personally I simply do not have the energy to fight the good fight, while keeping my family stable and a demanding job. Need the good mojo for mesh complication surgery #9, in 5 years, as I get a total abdominal reconstruction to fix a hernia trifecta : umbilical, hiatial, incisional, and mesh removal, the culmination of a CR Bard broken ring in a hernia patch. But I am alive, which is a very good thing! G

      • Paula August 2, 2013 at 6:56 pm - Reply

        well said…It sucks…this whole counties system is broken.. and as usual the Victim is the one who is left to suffer again and again and again….so on and so on

      • Betty August 4, 2013 at 10:28 am - Reply

        Hi George,

        I understand your argument. And I along with you do not agree with it.

        1. The FDA should be held accountable and if I had enough money I’d sue them.

        2. Corporations are people, they’re a large group of “peoples”. Of every color and sex. A Group of rapists are held accountable. The people in “Corporations” should not rise above the law.

        3. Yes, I know how hard the fight is! We need a national movement for human rights in the US. We who as a huge country think we provide it!

        4. We need to vote every individual out of our government and start over with the constitution. I know it isn’t possible.

  3. Betty August 4, 2013 at 10:11 am - Reply

    This is making me so angry!! Lori Cohen asked why the Dr. who worked for them why he didn’t call Bard. She is laying the ground to say – if he did, he would have found out that they removed all the impurities during the manufacturing of the product. The other Dr. claims it’s the arms well to me it seems like Lori Cohen will be able to say see they don’t even know the real problem, it’s impure – it’s the arms, etc. I don’t believe this, right now I don’t believe in anything except God. My life is ruined physically. My husband is very stressed because his work load went way up. No one seems to be doing much. They’re talking about POP repair right here. I had a SUI repair. I have many of the same complications Donna Cisson has. Yesterday I didn’t make it into the house, the largest pad on the market didn’t cut it and I ended up with wet pants. I am praying the real truth will just come out. This is too much!!!

    Thank you again Jane!

  4. Noni September 20, 2013 at 12:19 pm - Reply

    I just got scheduled for removal (hopefully possible) of a TVT mesh (Ethicon) but also must have other diagnostic procedures prior to that just to reveal the full extent of the damage done by the eroding mesh. The more I learned about the games played by the manufacturers of these ‘medical’ devices, the angrier I become. Now I’ve joined the legions of other sufferes who’ve brought legal action against the maker. Sad fact that these greedy opportunists (the manufacturers) only speak the language of $$$; they’ve apparently built the production budget with potential payouts on lawsuits built right in. If I planned ahead to murder anyone, it would be called premeditated; however, tap dancing with words in legal documents that permitted these unethical production standards and negligent ommission-of-pertinent-vital-info marketing practices is surely just as criminal. I would hope that every patient who ever did or eventually will experience complications from the deteriorating mesh wins hefty judgements against the manufacturers. I am happy to have my attorney/s take their percentage from the award just as long as they are successful.

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