Bard Mesh Implants
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 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.
CR Bard Settlements
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
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 Hernia Mesh Injury Lawyer with experience litigating cases against several large medical device manufacturers.
