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C.R. Bard’s Pelvic Mesh Removed From the Market

Mesh Medical Device News Desk, June 13, 2017 ~ Bard relieves its website of all pelvic mesh products with no fanfare or notice.

In April, it was announced that C.R. Bard, a medical device manufacturer, was to be sold to Becton Dickinson (BD) for $24 billion.

In what could be surmised to be a house cleaning move, Bard appears to have cleared all of its pelvic meshes from its inventory.

At one time, medical device maker, C.R. Bard of Murray Hill, New Jersey, had a dozen or so transvaginal pelvic mesh devices on the market.

From its Covington, Georgia plant Bard made:

Bard Avaulta mesh

      Avaulta Plus™ BioSynthetic Support System for POP ( Pelvic organ prolapse)

      Avaulta Solo™ Synthetic Support System for POP

      Faslata® Allograft – human graft tissue 

      Pelvicol® Tissue for SUI (stress urinary incontinence) 

      PelviSoft® Biomesh for SUI

      Pelvitex™ Polypropylene Mesh for SUI 

Today, they are all gone from the website.

The last day Bard could sell all of its SUI products was December 31, 2016, but according to the company, hospitals and facilities may use up any products remaining on the shelf.
The reason given was “economic.”

With more than 15,000 product liability cases pending against Bard consolidated in multidistrict litigation (MDL) in federal court in West Virginia, and nearly 1,000 cases pending against Bard in multidistrict litigation in New Jersey, economic reason is as good an excuse as any.

Not only does the company website have no mention of products under the Women’s Health category, but the revelation that Align was taken off the market was uncovered during a recent case management conference.

“They stopped selling all Align products in the summer of 2016,” trial attorney Adam Slater told Mesh News Desk, who adds that he has discovery on that issue as he prepares to take Bard to trial over its pelvic mesh implants.

See a MND story here.

In terms of mesh, the company continues to sell hernia mesh through its Bard Davol division.

Two requests for comment from the Bard company headquarters went unanswered.

The removal of products may not have a substantial impact on current mesh product liability litigation.

 

IS IT A SOFT RECALL? 

This isn’t the first time the company has quietly removed problematic meshes from the market.

Bard stopped selling Avaulta Plus, used to treat pelvic floor prolapse, in July 2012, around the same time it lost a product liability case against plaintiff, Christine Scott, who was eventually awarded $3.6 million by a Bakersfield, California jury.  The Scott case was the first transvaginal mesh case to go to trial.

The U.S. Food and Drug Administration (FDA) has received a number of adverse event reports on Bard Avaulta. See one here.  

Last week, the federal court entered an order to create the Fleming, Nolen & Jez Bard Qualified Settlement Fund, the Wagstafff & Cartmell Qualified Settlement Fund and last month the Aylstock, Witkin, Kreis & Overholtz Qualified Settlement Fund.

Bard is one of six manufacturers with claims gathered in Charleston, West Virginia where there are more than 102,000 pelvic mesh trials consolidated and pending. The first Bard trial in this federal MDL was the bellwether case by Plaintiff Donna Cisson, who was awarded $2 million by a jury in 2013.

In August 2015, Bard agreed to settle 3,000 mesh cases for $200 million. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.

According to its 10-K SEC report, so far Bard has agreed in principle to settle about 11,000 claims including 560 in 2014; 6,285 in 2015;  and 4,155 in 2016.  These number include unfiled and previously unknown claims held by various plaintiffs’ law firms.

The company anticipates additional transvaginal mesh trials over the next 12 months, which may include consolidated trials.

Since early 2013, Bard has received subpoenas from a number of State Attorneys General seeking information related to the sale and marketing of certain products such as hernia and women’s health that are being litigated. (p. 19, SEC report). These matters are pending. There can be no assurance that a resolution will be reached or what the terms of any such resolution may be.

HERNIA MESH

Bard’s 10-K form says As of December 31, 2016 approximately 25 federal and 65 state lawsuits involving individual claims by approximately 90 plaintiffs, as well as one putative class action in the United States are currently pending against the company regarding Composix Kugel and certain other hernia repair products.

The company voluntarily recalled certain sizes and lots of the Composix Kugel products beginning in December 2005.

In June 2000, the Composix Kugel lawsuits were transferred to an MDL in US District Court for the District of Rhode Island.  That court stopped accepting new cases in the second quarter of 2014 and it was terminated in November 2016. ###

 

25 Comments

  1. Still Standing says:

    Well, goodbye Bard. Not soon enough. They walk away, move on to more lucrative pursuits, leaving a trail of tears. I have chronicled my mesh journey in poetry the past ten years. I wrote this a couple of years ago but it appears to be a suitable requiem for the death of a monster.

    Blood Dripping

    The cries of thousands of women
    Unheard, untended
    Blood of the corporate secrets
    Dripping from their wombs

    Fertile no more
    Unable to feel the intimate
    Caress of their partners
    Sex becoming the profane

    There is no end
    Day in, night in, forever in
    Pain, unyielding, leaving
    A simple breath too much to bear

    Blinded by the desperate thought of living one more day
    Not me, I scream at the reality
    Turn my eyes away
    Waiting to wake from this twisted dream

    Yet they persist
    The corporate rapists
    Blood dripping from the wombs
    Of their broken covenants

    • Jane Akre says:

      Wow- Still, you are really inspiring….

    • Jenna says:

      Wow.

      Just beautiful.

    • Karen Pike says:

      Incredible poem! You’ve captured our darkest feelings, our collective nightmare.

      • Still Standing says:

        Karen, Jenna, Jane, and Bejah. Thank you for your kind words about my poem. It is hard to put yourself out there in such an emotionally naked way. I’m happy that it touched you in a personal way.

    • Kitty says:

      CR Bard was one of the biggest and well known names In Hospital equipment. My thought it is a very sad day to see the end of THIS BRAND.. It is sad that this tragic invention by some obsessive PSCYOPATHIC inventor would destroy the legacy of the name CR BARD.

      • Still Standing says:

        kitty, obviously you were not implanted with a Bard device, but don’t cry too many tears for the legacy of Bard. Go to drug watch.com and search for the history of CR Bard. Mesh women were not Bards first medical device failure and will not be their last. Their legacy lives on quite well in the stories of individuals and families whose lives were changed forever.

        But don’t despair. Bard is alive and well. It merged with BD International and now is a separate division of this medical device company. They are great chameleons, changing themselves so that they can hide from their public scrutiny. See story below. Bard reaped a huge financial reward when they merged, and so they still have enormous ability to continue to make such wonderful contributions to the world of medical devices. Here is the link.
        http://www.bd.com/en-us

        • Kitty says:

          My dear lady…i slept in a CRBard bed..i had IV fluids infused from CRBard IV bags. I hydrated and gave chemotherapy to hundreds of Cancer patients using tubing from CRBard. I wouldnt tell u if my life depended on it what kind of mesh I have in my body.

        • Bejah Butterton says:

          Darling, Did you say they “reaped” a reward or “raped” one? Funny, my mind read it as “raped” initially.

          Bejah

      • Still standing says:

        Here is a short but revealing history of Bard. You know, that wonderful company that left such a tremendous legacy. The employees who were criminally charged and sentenced to jail must have been one of their proudest moments. Check it out if you are interested in the truth about this company.

        https://www.recallreport.org/dangerous-drugs-products/c-r-bard/

    • Bejah Butterton says:

      Dear SS, Thank you. This is so deeply personal…the courage to share is something I can not find yet when I read your poem (Read it aloud people) it occurs to me that we have become one person, all of us, one soul and the the burning fires of this evil have made us so…I pray we become then like the mythological Phoenix and rise again! I expect we would all benefit from the Mothers milk of your other poetry/prose if you feel comfortable honoring us with your soul’s songs.

      Love, Bejah

  2. Kitty says:

    Jane. U .mentioned this will impact trials.. how so? THANKS Kitty

    • Jane Akre says:

      I don’t believe it should, you were still damaged by the product whether it is on the market or not. As you know i’m not an attorney. In the past, there has been no mention that the Prolift was taken off the market, for example. It might unfairly prejudice the jury …. as they say. (cough, cough)

    • Bejah Butterton says:

      Kitty, Methinks it is evident that polypropelene mesh is bad news no matter what color it is, what weave it is, what sort of box it comes in, or who is selling it and THAT has to be bad news for the other players.

      Bejah

  3. Jenna says:

    Jane – Thank you for providing the link to the 10K-SEC report for Bard. I just sat down and scrutinized the entire report. Good information to know, indeed.

  4. Kitty says:

    We are all screwed…so. get a job..what ever u can crawl to …

    • Bejah Butterton says:

      I always had this fantasy about working at MacDonald’s and getting all the chocolate milk shakes and fries I wanted…..but they would have to let me design new costumes.

      Bejah

  5. Bejah Butterton says:

    Imagine, Life after ProLift. My skills…I think I can be barefoot and pregnant (Maybe), housekeeping, cooking, babysitting, mowing the lawn…sure there are lots of things I can do, just give me a lobotomy first.

    Bejah

    PS But make no mistake, I am coming for you JnJ and I will keep coming until your skin rots.

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