Atrium C-Qur Hernia Mesh Allegedly Defective, Leads to RecurrenceMar 2, 2017
Atrium Medical Continues to Face C-Qur Hernia Mesh Injury Lawsuits
A new C-Qur (pronounced "secure") hernia mesh personal injury lawsuit was filed against Atrium Medical in the U.S. District Court for the Western District of Arkansas. The plaintiff alleges that the hernia mesh is defective and caused injuries, including abdominal pain. The lawsuit also alleges that, due to the faulty nature of the C-Qur, the plaintiff's hernia returned and caused further complications. The plaintiff alleges that Atrium Medical failed to disclose the risks of the mesh to patients or the medical community.
Parker Waichman LLP is closely monitoring the Atrium Medical C-Qur hernia mesh litigation. The firm continues to offer free legal consultations to individuals with questions about filing a hernia mesh lawsuit.
According to court records, the plaintiff was implanted with the C-Qur in 2011 during an open ventral (abdominal) hernia repair. The complaint states that she suffered abdominal pain after the surgery, and her hernia returned. To address these complications, doctors decided to perform a surgery to remove the mesh. During the operation, however, physicians discovered that the mesh had become lodged within the plaintiff's body. Surgeons also found significant scar tissue, and were unable to place a new mesh repair product as a result.
This lawsuit joins a growing body of litigation against Atrium Medical regarding the C-Qur hernia mesh. Injuries alleged in C-Qur lawsuits include abdominal injuries and complications, hernia recurrence, adhesions, infections and allergic reactions to the fish oil coating.
The C-Qur is coated with fish oil (omega-3 fatty acids) as an anti-adhesion, anti-inflammatory barrier. Adhesions are a type of surgical complication where tissues and organs stick to one another while a patient heals following an operation. Lawsuits allege that C-Qur hernia mesh is defective, causing plaintiffs to suffer abdominal adhesions.
Atrium Medical C-Qur Hernia Mesh MDL
Parker Waichman comments that C-Qur litigation against Atrium Medical moving forward. In December 2016, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a federal multidistrict litigation (MDL) for C-Qur hernia mesh lawsuits. Cases were consolidated before U.S. District Judge Landya McCafferty in the District of New Hampshire. Court records show that, as of Jan. 17, 2017, there were 21 C-Qur lawsuits pending in the MDL.
The JPML creates MDLs to make large, complex litigation proceed more efficiently. An MDL is a type of mass tort where lawsuits with common questions of fact are grouped together in one court before one judge. Consolidating similar lawsuits together eliminates duplicate discovery and other proceedings. Ultimately, the consolidation frees up more court time and resources so that legal parties can move towards resolution.
Allegedly, defective devices include the Atrium C-Qur mesh, C-Qur TacShield and C-Qur V-Patch.
Plaintiffs in the Atrium Medical C-Qur litigation similarly allege that the hernia mesh is defective and caused injuries, such as adhesions, allergic reactions, organ damage, infections, and recurrence. Lawsuits allege that the device is designed defectively and is unreasonably dangerous for use.
Another C-Qur lawsuit, for example, was filed on behalf of an Ohio woman who alleges that the mesh adhered to her small bowels and caused an intestinal obstruction. The plaintiff was implanted with an 11.4 x 11.4 cm piece of Atrium C-Qur Tacshield that contains a unique fish-oil coating. Two years after the mesh was implanted, the plaintiff was diagnosed with an incarcerated hernia that required surgery and a five-day hospital stay.
Atrium Medical received a U.S. Food and Drug Administration (FDA) warning letter in 2012 stating that certain products, including the C-Qur hernia mesh, were adulterated due to violations at the company's facility. Among other things, regulators said the sterile hernia mesh contained foreign substances such as human hair.
In 2013, Atrium Medical recalled its C-Qur Edge Mesh because the coating can stick to the inner lining of the packaging under humid conditions. However, the product was not removed from the market even though the action was technically a recall. Instead, Atrium Medical sent letters to physicians, stating "The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve,"
Ethicon Physiomesh Hernia Mesh Lawsuits
Hernia mesh personal injury lawsuits are also being filed over the Physiomesh, manufactured by Johnson & Johnson's Ethicon unit. Litigation has grown since the Physiomesh was withdrawn from the market in May 2016.
Ethicon pulled the Physiomesh off the market because the hernia mesh repair device was associated with a higher rate of recurrence and reoperation compared to other devices in two large, independent hernia mesh registries.
The company said the issue can likely be attributed to a combination of factors, stating "Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,"
"Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market," Ethicon said in its Urgent Field Safety Notice. "Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide."
The Physiomesh and the C-Qur hernia mesh were approved through the FDA's 510(k) process, which means device makers did not need to perform clinical testing to obtain approval. Products cleared through 510(k) only need to be "substantially equivalent" to a previously approved product, known as a predicate.
The FDA has a stricter approval process called premarket approval (PMA), which mandates clinical testing for safety and efficacy. 510(k) has come under some criticism, in light of the fact that some controversial medical devices (including metal-on-metal hip implants and transvaginal mesh) were approved through this route.
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).