Atrium Medical Corp. recalled C-QUR Hernia Mesh because the Omega-3 (fish oil) gel coating on the mesh could peel off and stick to the inside of its package when exposed to high humidity.
C-QUR was never actually removed from the market. The recall was only issued for its packaging — not the actual mesh itself. Instead, Atrium sent out a “Recall Letter” with the following warning:
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.”
The purpose of the fish oil coating is to prevent the mesh from coming into direct contact with a patient’s organs. Lawsuits have been filed by people who were injured when the coating peeled off inside their body. By the end of 2016, nearly two dozen C-QUR lawsuits were filed.
In one lawsuit filed in October, lawyers said Atrium “stealth recalled” multiple types of C-QUR Mesh that had high rates of side effects by simply halting production without ever notifying doctors or patients.
The company is accused of marketing C-QUR as safe and effective, despite never conducting a single clinical study in humans. All of the lawsuits claim the fish oil coating on C-QUR Mesh produces an allergic or inflammatory reaction that causes severe complications.
Lawyers say the fish oil gel coating requires a “dry” sterilization process that does not prevent certain infections. In 2012, Atrium was cited for poor manufacturing practices — including 35 confirmed cases of hair being found in supposedly “sterile” devices, according to the FDA.
On December 12, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all C-QUR injury lawsuits into one federal court in New Hampshire under Judge Landya B. McCafferty — In Re: Atrium Medical Corp. C-QUR Mesh Products Liability Litigation — Multi-District Litigation (MDL No. 2753).