Bard Hernia Mesh Lawsuits: Composix, 3DMax Linked To Severe Complications

Bard Hernia Mesh Lawsuits: Composix, 3DMax Linked To Severe Complications 2018-03-12T15:52:53+00:00
(866) 623-9135

Thousands of hernia patients have filed lawsuits against C.R. Bard, accusing the medical device company of selling defective hernia mesh products:

  • Composix
  • Kugel
  • PerFix Plug
  • Ventralex

Suffer severe side effects after receiving hernia mesh? Our experienced attorneys want to help.

24/7 Free Mesh Consultations

24/7 Free Mesh Consultations

(866) 623-9135

Medical device companies have an obligation to protect American patients.

— Laurence Rosen, Esq.

Thousands of hernia patients have filed lawsuits against C.R. Bard, accusing the medical device company of selling defective hernia mesh products:

  • Composix
  • Kugel
  • PerFix Plug
  • Ventralex

Suffer severe side effects after receiving hernia mesh? Our experienced attorneys want to help.

24/7 Free Mesh Consultations

(866) 623-9135

Medical device companies have an obligation to protect American patients.

— Laurence Rosen, Esq.
"Quick Response." Rosen Injury Lawyers always answered my call.
Rosen Injury Lawyers Reviewed by Tate on .
Rating: 5.0 ★★★★★

Over the last 15 years, tens of thousands of patients have filed hernia mesh lawsuits against C.R. Bard and its subsidiary, Davol.

The litigation kicked off between 2005 and 2007, when the US Food & Drug Administration announced a series of Class I recalls, representing the most-severe risk of patient harm, for certain lots of Bard's Composix Kugel Hernia patch. At the time, FDA researchers said they had received at least 34 reports of device failure, including 21 serious patient injuries and one death.

Composix Mesh Lawsuits Expand To All Bard Mesh Patches

The Composix Kugel mesh patches were designed to provide surgeons with an unprecedented level of control in hernia repair procedures. The product is outfitted with a "recoil ring," a circle of flexible plastic. As Bard initially sold the patch, this ring would allow the patch to "spring" back into a flat position, covering defects in muscle wall, after being folded for easier insertion through laparoscopic incisions.

Nurse During Surgery

MESH EVALUATION

  • This field is for validation purposes and should be left unchanged.
Proud Members Of The Following Trusted Organizations
Members Of American Bar Association
Members Of American Association For Justice
NTLA
24/7 Free Confidential Consultations
(866) 623-9135

In reality, the Kugel patch's memory recoil ring could break during placement, leaving patients vulnerable to severe internal injuries. In its recall notice, the FDA noted particular risks for intestinal perforation and chronic enteric fistula, two complications that can quickly become life-threatening and force patients to undergo emergency revision procedures.

Thousands File Kugel Mesh Claims In Rhode Island

Soon after, patients who had suffered severe mesh injuries began to file suit, accusing Davol and parent company C.R. Bard of using real patients as guinea pigs to test out its unproven memory ring technology.

Over 2,000 claims pending in a Rhode Island state court said the company's Composix Kugel Mesh products, many of which were recalled over a decade ago, cause severe complications and increased the risk for revision operations due to significant design flaws.

Bard Loses Two Federal Mesh Trials

A similar litigation, also involving Composix Kugel products, was consolidated in the US District Court of Rhode Island, a federal court in Providence.

The vast majority of these claims have now been settled. In 2010, two federal cases from the Composix Kugel Mesh MDL were sent to trial. Both trials ended in verdicts against the defendants, C.R. Bard and Davol. In their trials, injured patients argued that C.R. Bard allowed a defective mesh patch to hit the market without sufficiently testing its new technology, a plastic ring that, as it turns out, can break inside the body, leading to life-threatening risks.

Composix Cases Settle For $184 Million

Jurors for the District Court of Rhode Island were convinced by these arguments, awarding the plaintiffs judgments in the millions of dollars. Soon after, C.R. Bard negotiated a large settlement agreement, resolving around 2,600 Composix Kugel lawsuits for a total of nearly $184 million.

While thousands of Kugel mesh cases remained undecided, the federal Multi-District Litigation was disbanded in late-2017. The remaining claims have been transferred back to their original courts for further proceedings.

Attorneys Investigate C.R. Bard Hernia Mesh Products

At the same time, plaintiffs attorneys have turned their attention to other hernia mesh products manufactured by C.R. Bard. While the large consolidated legal proceedings in Rhode Island state court focused on mesh patches from Bard's Composix Kugel line, a number of claims involve other products.

Today, our experienced hernia mesh attorneys are investigating potential claims on behalf of patients who were implanted with any of the following C.R. Bard mesh products:

  • Composix
  • Composix EX
  • Composix Kugel
  • Kugel
  • 3DMax
  • Sepramesh
  • Ventrio
  • Ventrio ST
  • Ventralex
  • PerFix Plug
  • Spermatex
  • Visilex

In their private lawsuits, patients reported severe complications in connection to numerous hernia mesh products, including Bard's Composix E/X Mesh, Ventralex Hernia Patch, 3DMax and CK Parastomal Patch. The accusations contained in these lawsuits are varied, but the alleged misconduct of C.R. Bard lies at the heart of each claim.

Spermatex Linked To Testicle Removal Procedures

Dozens of men have filed suit over Bard's PerFix Plug, a bare, uncoated mesh of polypropylene that features a curved design to fit easily inside the inguinal canal (groin) of male patients. The PerFix Plug has been linked to debilitating nerve pain in numerous complaints to the FDA, but in their lawsuits, several men claim to have suffered worse.

A number of plaintiffs say the PerFix Plug, due to its polypropylene design, can degrade quickly after being implanted into the groin. As the patch deteriorates, patients continue, the material begins to erode surrounding body tissues, leading to extensive tissue damage and tearing at nerves. Meanwhile, the porous mesh becomes a "breeding ground" for bacteria, plaintiffs claim, allowing infections to fester and spread.

In severe cases, patients say, the Plug can actually degrade into the spermatic cord, leaving surgeons with no choice but to remove one or both testicles to solve the problem. Bard's 3DMax, another mesh designed to treat inguinal hernias, has been linked to similar problems.

Is Marlex Polypropylene To Blame?

The problem with all of these mesh products, lawyers believe, may lie in Bard's use of polypropylene, a synthetic polymer used widely in manufacturing. Many, if not most, of Bard's mesh patches are made from Marlex, a trademarked version of polypropylene created in the 1950s by chemists at the Phillips Petroleum company.

The version of Marlex used in some Bard mesh products, HGX-030-01, is not designed for permanent implantation in the human body. In fact, a Material Safety Data Sheet that accompanies HGX-030-o1 makes that point explicit: "Do not use this [...] material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues." So why, plaintiffs ask, is Bard using this material to make hernia mesh patches?

It's a pointed question. There's a good reason why Marlex manufacturers are very cautious about using the plastic inside the human body. Researchers have established that HGX-030-01, after implantation, can fragment and deteriorate, causing soft tissue damage, chronic immune system responses and other dangerous complications. Needless to say, the thousands of plaintiffs who have already filed Bard mesh lawsuits accuse the company of failing to notify the public, and the medical community, of these potential risks.

Can You File A Hernia Mesh Lawsuit?

Did you or a loved one experience severe complications after receiving a hernia mesh patch manufactured by Davol or C.R. Bard? Our compassionate medical device lawyers want to help. Bard faces serious accusations of manufacturing and marketing defective mesh products; some injured patients may be eligible to secure financial compensation.

To learn more about your own legal rights, contact our attorneys now for a free consultation. You can find more information on your options at no cost and no obligation.

Call Our Lawyers
trust us!
get justice!

(866) 623-9135

24/7 Free Confidential Consultations
(866) 623-9135