Atrium Medical is being accused of manufacturing a defective product by plaintiffs who maintain that their C-Qur hernia mesh caused them internal injuries, severe pain, an antibiotic-resistant infection, adhesions from the omega-3 fatty acid (fish oil) coating, and septic shock following implantation of the mesh device.
In addition, plaintiffs who have filed lawsuits maintain that Atrium had knowledge of the problems with the mesh but did nothing to warn the medical community of these issues. The plaintiff’s complaint is that the C-Qur (pronounced “secure”) hernia mesh is not safe to use for its intended purpose.
Atrium C-Qur Mesh Background
The U.S. Food and Drug Administration (FDA) approved the Atrium C-Qur in March 2006 for use in hernia repair, chest wall reconstruction, and to repair traumatic or surgical wounds. However, Atrium C-Qur has been associated with an array of medical adverse events and side effects.
As a result, the FDA issued a warning letter in October 2012 to Atrium, citing the manufacturer for neglecting to investigate and respond to complaints about C-Qur mesh failures and infections. Among other issues, the FDA said that Atrium changed its manufacturing and sterilization process for the C-Qur without testing to validate it. The FDA also said the company did not address complaints of human hair and other foreign materials allegedly found in the sterile mesh.
Complaints Filed Regarding the Atrium Mesh Device
A complaint recently filed describes the allegedly adverse health effects as follows: “The injuries, conditions and complications suffered due to Defendants’ C-Qur Meshes include, but are not limited to, foreign body reaction, rashes, infection, adhesions, organ perforation, inflammation, fistula, mesh erosion, scar tissue, blood loss, dyspareunia, neuropathic, and other acute and chronic nerve damage and pain, abdominal pain, nausea, vomiting, [and] kidney failure.”
In addition, “[I]n many cases the patients have been forced to undergo intensive medical treatment, including but not limited to operations to locate and remove the C-Qur Mesh, operations to attempt to repair abdominal organs, tissue and nerve damage, the use of narcotics for pain control and other medications, and repeat operations to remove various tissues that are contaminated with the C-Qur Mesh.” Court records show at least 15 lawsuits have been filed.
Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in lawsuits regarding allegedly defective medical devices, including transvaginal mesh, bladder slings, and metal-on-metal hip implants, as well as hernia repair mesh implants.
Potential MDL for Atrium C-Qur Hernia Mesh Lawsuits
Plaintiffs in the Atrium Medical hernia mesh litigation filed a motion on October 10, 2016, to transfer federal lawsuits into a multidistrict litigation (MDL) in the U.S. District Court, District of New Hampshire. The U.S. Judicial Panel on Multidistrict Litigation (JPML) will hear Oral Arguments concerning consolidation on December 1, in Charlotte, North Carolina.
MDLs are formed to streamline the legal process, eliminate duplicate discovery and generally conserve court time and resources. In an MDL, lawsuits with similar allegations are moved to one court before one judge. In the C-Qur hernia mesh MDL, plaintiffs have similar allegations that the mesh device was the reason for complications and that Atrium Medical neglected to warn patients or physicians about the potential dangers. Plaintiffs allege that the hernia mesh may cause injuries such as infection, rejection, inflammation, organ perforation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
In addition, plaintiffs have a problem with the manner that C-Qur was FDA approved. The device, introduced in 2006, was cleared through 510(k). This “fast track” method allows devices to be approved without undergoing clinical testing for safety or efficacy. Manufacturers need only to show that the devices are “substantially equivalent” to a previously FDA approved product, or predicate. Devices can be approved through 510(k) even if the predicate it is based on was removed from the market due to safety issues, a point strongly emphasized by patient advocates. The 510(k) process has received an increased amount of criticism after several medical devices, including transvaginal mesh and metal-on-metal hip implants, generated headlines.
It is believed that the number of people to have suffered adverse events as a result of having the C-Qur Mesh implant is in the thousands.
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries associated 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, please contact Parker Waichman attorneys at 1-800-YOURLAWYER (1-800-968-7529).