Bard Sold Vaginal Mesh Plastic Deemed Unfit for Humans

Transvaginal mesh lawyers at Pintas & Mullins Law Firm report on troubling recent findings that manufacturer CR Bard knowingly used plastic unfit for human implantation in its vaginal mesh devices. This was revealed during court proceedings concerning Bard’s Davol unit.

Over the past decade, thousands of women have experienced serious, often life-changing medical complications from vaginal mesh devices. These products are used to correct certain female reproductive organ issues, such as pelvic organ prolapsed (POP), stress urinary incontinence (SUI), and weakened muscles in the pelvis.

Although there was an estimated 75,000 POP vaginal mesh surgeries in 2010 alone, the FDA affirms that there is not any scientific evidence that these devices work any better to repair these issues than non-mesh methods. Similarly, there was more than 200,000 mesh surgeries to correct SUI in 2010, again without any evidence of its true benefits.

Not only were these devices deemed medically unnecessary, but they were also incredibly dangerous inside the human body. Tens of thousands of women were forced to undergo multiple surgeries to remove the mesh once it had eroded in their bodies – erosions, it is now clear, that were largely caused by defective plastic. Chevron’s warning stated that the resin-based plastic may react with oxygen and other bodily agents, causing reactions that could cause the mesh to erode. Both Chevron and Bard knew this plastic would likely cause injury to women, and sold it anyway. The only people not informed of this potential risk were the women and doctors it most directly affected.

CR Bard is just one company that manufactured these defective, inherently dangerous devices, however, one hopes it was the only one that did so using unsafe, toxic plastic (other manufacturers include Johnson & Johnson’s Ethicon, Boston Scientific, American Medical Systems, and Island Biosurgical). The most recent controversy stems from court proceedings surrounding the Bard subsidiary’s product, which used resin-based plastic made by Chevron Phillips Chemical Co in its Avaulta line of implants.

According to e-mails and documents from 2004 and 2007, Chevron officially issued a warning to Bard/Davol stating that the plastic should not be permanently implanted in people. The e-mails reveal that a Davol executive warned colleagues not to tell Chevron or other resin manufacturers that it planned to use the material in medical devices placed in humans.

The Davol executive in question, Roger Darois, is now a Bard vice president. In a 2004 e-mail he went on to say that Chevron likely did not know about the plastic’s use in medical implants, and asked executives to please “not mention Davol’s name in any discussion with these manufacturers.”

It is now clear and obvious that Davol knowingly and maliciously used resin-based mesh plastic in its Avaulta implants, despite knowing it was improper and unfit for human implantation, and then tried to cover up its use of the toxic material. The judge in this case affirmed that these emails raise a genuine issue about whether or not Bard was aware that its device was likely to cause injuries.

The case focuses on one woman, Donna Cisson, who claims the Avaulta design was defective, and that Bard failed to warn patients of its true risks. Among her injuries include chronic pain, bleeding, and bladder spasm problems that necessitated multiple follow-up surgeries. Hers is the first case against the vaginal mesh manufacturer to go to trial – more than 20,000 are soon to follow.

Three other bellwether trials pertaining to Bard’s vaginal meshes are scheduled after Cisson’s case, which will be used to gauge the validity of both parties’ claims. The other plaintiffs claim that the Avaulta implants eroded internally, causing organ damage, bleeding, and making sexual intercourse extremely painful. They also fault Bard for failing to test the devices in humans before selling it.

In 2012, in response to the mass influx of injury claims, the FDA required Bard and other mesh manufacturers to conduct three-year studies detailing the rates of damage, infection, and painful sex. After this, Johnson & Johnson promptly announced that it was going to stop selling four lines of its vaginal mesh implants altogether. Bard announced a similar market withdrawal of its Avaulta products after the FDA order.

Like Bard, Johnson & Johnson is subject to intense, mass litigation surrounding its vaginal mesh, the Gynecare Prolift. In fact, a jury in New Jersey recently ordered it to pay a woman more than $11 million in damages for her injuries.

Transvaginal mesh lawyers at Pintas & Mullins Law Firm affirm that Bard / Davol’s conduct is unconscionable, and we continue to advocate on behalf of their victims. If you or a loved one was seriously injured by a vaginal or hernia mesh, you have important legal rights, and may be entitled to compensation for past and future medical bills, lost wages, and emotional distress.

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