C.R. Bard, a medical products company and its Davol unit, which manufacturers surgical products, is facing thousands of lawsuits for its hernia mesh products. Bard hernia mesh may have caused serious injuries in patients who received the implant during a hernia repair procedure.
The Food and Drug Administration (FDA) has estimated that up to 90% of the near-one million hernia repair surgeries may use surgical mesh to stabilize abdominal or groin tissue. C.R. Bard, through its Bard Davol division, is one of the largest manufacturers of hernia mesh. Over the course of Bard’s involvement in hernia mesh manufacturing, the company has raised serious concerns and been subject to multiple FDA warnings and recalls for safety infractions and reports of complications caused by its hernia mesh products.
Bard hernia mesh products which may cause injury include:
- 3D Max, 3D Max Light
- Bard Mesh
- Composix, Composix EX, Composix LP
- Kugel, Modified Kugel
- Perfix Plug, Perflix Light
- Ventralex Hernia Patch, Ventralex ST Patch
- Ventralight ST
- Ventrio, Ventrio ST
Bard Hernia Mesh and the FDA
Bard manufacturers many different types of medical and surgical products but their surgical mesh has a particularly poor safety record. Bard hernia mesh products, like other surgical mesh products, are classified as Class II medical devices which means that most of the products have been eligible for marketing with little to no clinical testing. Bard hernia mesh has been allowed on the U.S. market under a 510(k) pathway for approval which allows the manufacturer to claim that a new product is similar to products already approved, and thus to skip costly clinical testing. Few Bard hernia mesh products were tested in humans before being sold to the public.
In past medical injury cases, it has been shown that Bard sold mesh devices that were constructed of a plastic that the manufacturer had stated should not be used in products intended for human implantation. Internal e-mails exhibited in federal court showed that the company hid their intent to use a Chevron Phillips resin in humans, failing to comply with Chevron’s insistence that the plastic was not suitable for such a use.
C.R. Bard was subject to recalls for Composix Kugel mesh products due to safety concerns about the plastic which would splinter and migrate away from the surgical site. The recall, issued by the Food and Drug Administration (FDA) was a Class 1 recall, the highest level of concern and had to be issued twice in 2005 and 2007. The company has faced additional concerns over several of its transvaginal mesh products and surgical mesh products manufactured using the Marlex plastic which had not been intended to be used in humans.
In the case of the Kugel mesh, splintering of the device may have caused intestinal perforation and fistula occurrence in multiple recipients.
Other victims of Kugel or other Bard hernia mesh injuries have been subjected to complications such as:
- Bowel obstruction
- Severe pain
- Mesh migration
- Organ perforation
- Hernia recurrence
People who develop complications from Bard hernia mesh are most commonly required to undergo revision surgery to remove and repair the mesh and hernia tissue. In some cases, multiple surgeries will be required, each of which poses an additional risk of pain, infection and lengthy recovery time.
Filing a Bard Hernia Mesh Lawsuit
More than $1.1 billion has been paid in various vaginal and hernia mesh lawsuits but most lawsuits have not been settled. Estimates show that more than 50,000 hernia mesh lawsuits may remain in federal, state and local courts. Specifically, C.R. Bard and Davol are facing hundreds, possibly thousands of lawsuits for a number of products.
The federal cases against Bard and Davol for hernia mesh injuries have been consolidated into multidistrict litigation (MDL 2846) in U.S. District Court for the Southern District of Ohio. A date for the first trial has not been announced and more individual cases are expected to be added to the MDL which allows for plaintiffs to consolidate legal efforts and information.
Bard and Davol have been accused of producing defective medical devices, failing to adequately test their products, failing to warn the public and medical community about the risks of their hernia mesh products and of putting profit ahead of safety. Victims of Bard hernia mesh injuries are asking for compensation for medical costs, lost wages, pain, and suffering and in some cases, wrongful death.
Each case is unique and must be considered separately but anyone who experienced complications after getting Bard hernia mesh implanted during a hernia repair surgery should seek medical advice.