Atrium C-Qur Mesh “Stealth” Recall Issued Over Risk of Hernia Repair Complications, Lawsuit Alleges

According to allegations raised in a product liability lawsuit filed last week against Atrium Medical, a “stealth” recall was issued for certain types of C-Qur mesh due to the risk of hernia mesh complications, simply halting production for products linked to high levels of adverse events, without notifying doctors or consumers.

In a complaint (PDF) filed in the U.S. District Court for the Western District of Arkansas on December 5, Terry McLain indicates that she is one of the individuals who have suffered severe pain and problems after Atrium C-Qur mesh was used during an open repair of her incisional ventral hernia in July 2011.

About two years after her hernia surgery, McLain indicates that she began to experience severe abdominal pain and a recurrence of the hernia, ultimately resulting in the need for surgery to remove the Atrium C-Qur mesh.

Surgeons found that the hernia mesh had balled up inside of McLain’s body, and could not replace it with a new mesh due to the amount of scar tissue. She underwent additional surgery in August 2015, due to recurrent hernia, which she indicates never healed from the revision surgery.

According to allegations raised in the lawsuit, the use of an Omega 3 fish oil gel coating on Atrium C-Qur caused the hernia mesh to be rejected by her body, which is a similar problem experienced by many other consumers who have received the device.

The case joins a growing number of Atrium C-Qur mesh lawsuits filed in courts throughout the U.S., each raising similar claims that Atrium knew or should have known about the risk of problems associated with the hernia patch and large number of adverse events reported. However, the manufacturer has not issued any warnings or any official Atrium C-Qur recalls, instead choosing to withhold information from consumers and quietly remove certain products from the market, according to the complaint filed by McLain.

“Defendants ‘stealth recalled’ multiple types of C-Qur Mesh that were experiencing high levels of adverse events, by simply halting production of multiple types of C-Qur Mesh without notifying physicians, regulatory agencies or consumers of the recall or high levels of adverse events,” claims McLain in the lawsuit.

Problems with the Atrium C-Qur mesh may stem from the fish oil coating, which is marketed as a unique feature of the hernia patch. However, McLain points out that it has been linked to reports of allergic reactions, and that the manufacturer has known that the coating has a tendency to detach from the polypropylene mesh. If this occurs once implanted, McLain indicates the mesh can float in the body and ball up, causing an even more intense foreign body reaction among the patient. This can also cause the Atrium C-Qur mesh to adhere to internal organs, resulting complex and risk surgery to remove the hernia patch.

Given the similar questions of fact and law raised in dozens of cases filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate all lawsuits filed against Atrium earlier this month, centralizing claims before U.S. District Judge Landya McCafferty in the District of New Hampshire, for coordinated pretrial proceedings.

As additional Atrium CQur cases are filed in U.S. District Courts nationwide, they will be transferred to Judge McCafferty for coordinated handling during discovery and a series of early “bellwether” trials, which are designed to gauge how juries are likely to respond to certain evidence and testimony that is likely to be repeated throughout the litigation. However, if Atrium CQur hernia mesh settlements or another resolution is not reached following the MDL proceedings, each individual case may be remanded back to the U.S. District Court where it was originally filed for a separate trial date.