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COMPOSIX KUGEL MESH


Medical Device Lawyer investigates hernia mesh injury for injured plaintiffs nationwide
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Composix Kugel Mesh Injury Lawsuits

investigating hernia mesh defects & injuries

As early as December, 2005, Davol, a subsidiary of C.R. Bard, initiated a series of recalls for its Composix Kugel mesh due to problems with the “memory ring” minimally-invasive surgery.

Following several reports of the plastic memory ring splintering and migrating away from the surgical site, Davol recalled the mesh. Another recall was initiated in 2007 for similar issues with the mesh devices.

The recall was classified as a Class 1 recall, the highest level of recall observed by the U.S. Food and Drug Administration (FDA), indicating how potentially dangerous the implanted devices can be to personal health.

The Composix Kugel mesh patches were designed with a “memory recoil ring” that allowed the patch to be inserted through a small abdominal incision. However, that ring was found to buckle or break after placement, causing painful and potentially fatal complications.

Attorneys and victims have argued for over a decade now that hernia Bard’s mesh devices, including the Composix Kugel Mesh patches are not properly tested before they are used in patients who expect safe and effective medical care.

As a result, C.R. Bard and other mesh manufacturers have paid millions to settle injury lawsuits. The company still faces thousands of pending Composix Kugel Mesh lawsuits.

If you have had surgery to treat a hernia using a device after January 1, 2006, and you experience any signs or symptoms of recurrence of the hernia, consult with medical and legal experts to investigate. The Lyon Firm has experience litigating cases against mesh device manufacturers.

Joe Lyon is a highly-rated product liability attorney and Bard mesh injury lawyer representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.  

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ABOUT THE LYON FIRM

Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.

The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.

NO COST UNLESS WE WIN

The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.

Mesh Implant Complications

Based on the U.S. Food and Drug Administration’s (FDA) analysis of medical device adverse event reports and scientific literature, the most common adverse events for all hernia repair operations are pain, infection, hernia recurrence, adhesion, bowel obstruction, bleeding, fistula, seroma, and tissue perforation.

Other common adverse events following mesh hernia repair include the following:

•    Chronic pain
•    Infection
•    Fistula
•    Hernia recurrence
•    Adhesion
•    Bowel obstruction
•    Mesh or ring migration
•    Mesh shrinkage (contraction)
•    Seroma
•    Abdominal abscess formation
•    Pelvic inflammatory disease
•    Peritonitis
•    Sepsis


Symptoms associated with hernia mesh complications:

•    Pain
•    Abdominal tenderness
•    Distended abdomen
•    Fluid in abdomen
•    Fever
•    Nausea


Composix Kugel Mesh Recall


Bard recalled over 100,000 Composix Kugel Mesh devices, and the FDA received reports of 34 memory rings breaking, 21 of which caused serious injuries.

The Bard recall notice was expanded several times, classified by the FDA as Class I, the highest level of recall for medical products considered to be dangerous or defective and may cause serious health problems or death.

Bard surgical mesh products intended for hernia repair did not undergo the usual FDA approval process required for Class III devices because they passed under the 510(k) Premarket Notification, as they were similar devices the FDA has already approved.

Studies showed the mesh effective at preventing hernia recurrence, but were ultimately recalled after patients reported suffering from complications including infections, bowel obstructions, and mesh removal surgery.


Bard Hernia Mesh Lawsuits


Bard has a poor safety record for its medical devices, and has faced legal trouble in the past. A California state court jury awarded $3.6 million to a woman who claimed Bard’s Avaulta Plus implant injured her. The Avaulta inserts were subsequently pulled off the market.

But many of Bard’s devices still exist on the market, even as dangerous as they may be. Attorneys say CR Bard Inc. has sold mesh devices in the past that were made of a plastic that its manufacturer warned wasn’t suitable for human implantation.

Internal e-mails from 2004 and 2007, filed in federal court, show an executive warning colleagues not to tell Chevron Phillips or other resin makers that the company was using the material in medical devices placed in humans.

Despite the warning, Davol/Bard used the material as the base for hernia-repair and vaginal-mesh devices because the mesh was cleared through the FDA 510(k) system, which allows medical devices to reach the market without human testing.

Composix Kugel Mesh Injury

By 2005, C.R. Bard, knew of potential complications and patient risks involved with the Composix Kugel mesh device. After a string of negative port-op reports of the plastic memory ring splintering and migrating away from the surgical site, the company issued a recall, followed by more reported injured and another recall in 2007 for similar revision surgeries and complications.

The Composix Kugel Mesh patches were originally designed with a “memory recoil ring” that allowed the patch to be folded, inserted through a small abdominal incision and open to cover a wider surface. Unfortunately, the ring had risks of buckling and breaking, leading to a number of painful and serious complications.

Bard Mesh Lawsuits

Attorneys claim several of Davol/Bard’s hernia mesh devices were not properly tested before they were marketed and distributed as safe medical instruments. Medical device companies like Bard and others have agreed to pay million to settle lawsuits. The companies currently face thousands of pending lawsuits.

If you have had surgery to treat a hernia using a device and you experience any signs or symptoms of recurrence of the hernia, please consult with a medical and legal expert. Joe Lyon is a Mesh Injury Lawyer with experience litigating cases against several large medical device manufacturers.

photo of attorney Joe Lyon reviewing composix kugel mesh
A Voice for Those who have suffered

Why are these cases important?

Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.

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FAULTY MEDICAL DEVICES

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