Federally-fled hernia mesh lawsuits involving Atrium Medical Corps. C-Qur devices continue to move forward in the U.S. District Court, District of New Hampshire.
According to a Procedural Order dated March 9th, the Court convened its regular monthly status conference on March 8th, at which time, the following issues were addressed:
The Court’s rulings on these issues are summarized in the March 9th Order, which can be found here.
Atrium C-Qur hernia mesh is indicated for use in patients who have suffered abdominal hernias. The implants consist polypropylene mesh that has been covered in an Omega-3 barrier coating. This coating is supposed to reduce the risk of adhesion (scar tissue) formation and allow for better fixation of the hernia patch to the abdominal wall.
Plaintiffs pursuing hernia mesh lawsuits in New Hampshire claim that the Omega-3 barrier is actually defective and causes an inflammatory response that promotes the formation of bowel adhesions, impedes proper abdominal wall fixation, and other severe complications that may result in the need for painful and risky hernia revision surgery.
Atrium brought its C-Qur hernia mesh products to market via the U.S. Food & Drug Administration’s (FDA) 510 (K) clearance program, which does not require a new device to undergo human clinical trials if a manufacturer can demonstrate that it is substantially equivalent to a product previously cleared by the agency through its more stringent premarket approval program.
In October 2012, Atrium received an FDA Warning Letter for failing to report problems associated with C-Qur hernia mesh. Among other things, the agency said that the company failed to properly investigate several reports of infections associated with the implants. The letter also accused Atrium of ignoring numerous reports that human hair had been found in medical devices that were supposed to be sterile.
A Class 2 recall was announced for certain Atrium C-Qur hernia mesh implants in August 2013 because the Omega-3 coating was adhering to the inner packaging liner when exposed to high humidity. Though Atrium warned physicians to inspect the C-Qur mesh to ensure that it was intact prior to implantation, the company did not direct healthcare providers to return any of the potentially defective implants included in the recall.
The FDA filed a lawsuit against Atrium Medical in February 2015 that accused the company of introducing adulterated medical devices into interstate commerce. Among other things, the agency claimed that Atrium’s methods of manufacturing, packing, storing and installing were not in conformity with the current good manufacturing practice requirements.
That same month, the FDA obtained a permanent injunction that ended manufacture and distribution of the C-Qur hernia mesh at Atrium’s facility in Hudson, New Hampshire.