Hernia mesh lawsuits continue to mount in courts throughout the country, as a woman from Tennessee became one of the most recent plaintiffs to seek compensation for injuries and complications allegedly associated with Atrium Medical Corp’s C-Qur hernia patch.
Atrium’s C-Qur products are constructed of polypropylene fibers that have been woven together and covered in an Omega-3 barrier coating. This coating is supposed to reduce the risk of adhesion (scar tissue) formation and allow for better incorporation of the hernia patch with the abdominal wall.
Like many other hernia mesh products currently in use, C-Qur devices were brought to market via the U.S. Food & Drug Administration’s (FDA) 510(k) clearance program, which does not require that a new device undergo human testing if a manufacturer can demonstrate that it is substantially equivalent to another product that was previously approved by the agency.
According to a March 29th filing in the U.S. District Court, District of New Jersey, Lynn Mizzell received the C-Qur V-Patch mesh in September 2012 during surgery to repair an incarcerated ventral hernia. She was forced to undergo a second surgery in December 2012 because of a suspected infection. During the second procedure, Mizzell’s doctors discovered that a large portion of the mesh was unincorporated and that the wound was “severely contaminated.” (Case 2:18-cv-04738)
Among other things, Mizzell claims that the polypropylene used in C-Qur products is “biologically incompatible with human tissue and promotes an immune response” in some patients, resulting in degradation of the mesh and severe adverse reactions. Her complaint further charges that the Omega-3 coating can also trigger an immune response, resulting in severe complications, such as pain, graft rejection, graft migration, organ damage, complex seroma, fistula, sinus tract formation, delayed wound closure, infection, sepsis, and death.
“As a result of having the C-Qur Mesh implanted, Plaintiff has experienced significant mental and physical pain and suffering, has sustained permanent injury, permanent and substantial physical deformity, has undergone and will undergo corrective surgery or surgeries, has suffered financial or economic loss, including, but not limited to, obligations for medical services and expenses, and present and future lost wages,” the complaint states.
Atrium C-Qur is currently the focus of more than two dozen similar hernia mesh lawsuits, the majority of which have been centralized in a multidistrict litigation now underway in the U.S. District Court, District of New Hampshire.
The company is just one of several hernia patch manufacturers facing personal injury claims over allegedly defective devices. For example, the U.S. District Court, Northern District of Georgia, currently houses nearly 700 hernia lawsuits involving the company’s Physiomesh Flexible Composite mesh products, which were withdrawn from the global market in May 2016 due to high rates of hernia recurrence and revision.
C.R. Bard, Inc. has also been named a defendant in a growing number of claims involving its polypropylene hernia mesh implants, including its VentraLight ST, VentraLex ST and Prefix devices, among others.