A California man has filed a new hernia mesh lawsuit against C.R. Bard, Inc. for injuries and complications allegedly caused by the VentraLight ST hernia patch.
Though hernia mesh complications continue to plague Jesus Nunes, a complaint filed on his behalf in the U.S. District Court, District of New Jersey, on March 21st indicates that doctors have been unable to remove the device from his body. (Case No. Case 2:18-cv-03925)
VentraLight ST mesh is manufactured by C.R. Bard’s Davol, Inc. subsidiary and is indicated for use in laparoscopic (minimally invasive) hernia repair.
The device is constructed from polypropylene monofilaments that are knitted together to form a patch. VentraLight ST also features Davol’s Sepra® technology, a “hydrogel barrier” coating one side of the mesh that is supposed to minimize tissue attachment and provide internal protection during the healing process. The Sepra barrier is designed to swell upon implantation and is usually absorbed by the body within 30 days.
VentraLight ST hernia mesh can be ordered as a large sheet, allowing doctors to customize its shape and size for each individual patient.
Like many other hernia mesh patches currently on the market, the VentraLight ST device was granted regulatory clearance via the U.S. Food & Drug Administration’s (FDA) 510(k) program, which does not require that a new device undergo human clinical trials if a manufacturer can demonstrate that it is “substantially equivalent” to another product that was previously approved by the agency.
According to his hernia mesh lawsuit, Mr. Nunez was implanted with a VentraLight ST patch during surgery to repair a ventral hernia in March 2016. He subsequently experienced chronic pain, several infections and fluid drainage from the umbilicus.
The complaint alleges that VentraLight ST is made from materials that are incompatible with the human body. It further charges that Bard and Davol failed to conduct adequate and research in order to evaluate its risks and benefits.
“The Product was not reasonably safe for its intended uses and was defective due to its lack of appropriate and necessary warnings,” the complaint states. “Specifically, Defendants did not provide sufficient or adequate warnings regarding, among other things, the serious risk of bodily harm posed by the incompatibility of the material used to make the mesh and human blood and tissue or the serious risk of infection or serious scarring. “
Mr. Nunez continues to suffer from chronic abdominal pain, infections and fissures. However, the Ventralight ST patch has become entangled in his tissue, preventing its removal.
C.R. Bard and Davol are among several medical device makers currently facing litigation over allegedly defective hernia mesh products.
Johnson & Johnson and its Ethicon, Inc. subsidiary are currently named defendants 700 hernia mesh lawsuits, following a worldwide market withdrawal of certain Physiomesh Flexible Composite mesh implants in March 2016. The majority of those claims have been centralized in a multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia.
A multidistrict litigation has also been established in the U.S. District Court, District of New Hampshire, for product liability claims involving Atrium Medical’s C-Qur hernia mesh implant.