Bard Ventralex hernia mesh, from Dotmed.com
Rosemary S. Roberts has filed a negligence lawsuit against C.R. Bard for injuries she suffered from the hernia mesh implanted in her in 2004 reports the West Virginia Record.
It was filed August 22 in Kanawha Circuit Court in Charleston, West Virginia, the same city where more than 30,000 lawsuits have been filed alleging defective transvaginal mesh, nearly 5,000 cases against Bard alone.
Roberts received the Bard Composix Mesh and Ventralex Hernia Patch. Dr. Roland E. Hamrick Jr. was repairing a ventral hernia at the Charleston Area Medical Center. The same doctor also used a Bard Ventrio to patch a spigelian hernia in July, 2011, according to the report.
Roberts claims she is experiencing physical pain and suffering and has permanent and substantial physical injuries and deformity. So far she has had had multiple surgeries and is expected to undergo more. She alleges lost income and significant medical costs as well as a loss of the enjoyment of life.
She is seeking both compensatory and punitive damages and is represented by Thomas F. Basile of Charleston. The case number is 13-C-1609.
No Health Warning
Unlike transvaginal mesh, also made of plastic polypropylene, there is no Food and Drug Administration Health Notification or Safety Warning for hernia mesh. The agency does list hernia mesh complications as:
*Adverse reactions to the mesh
*Adhesions (when loops of the intestines adhere to the mesh or each other)
*Injuries to nearby organs, nerves or blood vessels
*Additional complications with or without mesh can include infection, chronic pain and hernia recurrence.
An FDA update says “Most of the complications reported to us so far have been associated with mesh products that have been recalled and are no longer on the market.”
The most famous hernia mesh recall was the Bard Composix Kugel hernia patch. But it was redesigned and reintroduced to the market after more than 2,000 defective product lawsuits were filed against C.R. Bard.
The Proceed surgical hernia mesh made by Ethicon had 18,270 lots recalled in January 2006 when the polypropylene delaminated from the mesh opening up the patient to the possibility of fissures and adhesions.
AlloDerm, was recalled by LifeCell Corporation in September 2005, when it was determined that about one-quarter of those implanted with the donated human/cadaver skin mesh had complications including infection and rejection.
The remainder of mesh recalls have been limited to small numbers of mesh due to sterility compromises during the manufacturing process or mislabeled lots.
Tip of the Iceberg
Dr. Bruce Ramshaw, the current president of the American Hernia Society tells MDND that he believe we are just seeing the tip of the iceberg in hernia repair injuries to patients. With about a million procedures a year, even with a one percent complication rate, that leaves 10,000 patients a year with severe complications.
According to the FDA, the most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, bowel obstruction. In some cases mesh can contract and migrate and perforate other organs or the bowel, causing sepsis.
West Virginia Record
FDA on Hernia Surgical Mesh Implants
FDA- Kugel Recall 2004
Lawyers and Settlements on Bard Kugel mesh