Atrium Medical faces nearly 850 product liability lawsuits filed over the company’s C-QUR line of hernia mesh products. In their hernia mesh lawsuits, plaintiffs accuse Atrium of concealing the risks of its polypropylene mesh patches from the public, hernia patients and the medical community at large.

The cases have been consolidated in the U.S. District Court for the District of New Hampshire. As of October 23, 2018, 847 cases are consolidated under the guidance of experienced District Judge Landya B. McCafferty.

Atrium C-QUR Mesh Lawsuits Allege Severe Injuries

Plaintiffs have joined the product liability litigation from across the country. In court documents, these patients and families describe horrific injuries, detailing how mesh-related complications have left them in severe and chronic pain. Atrium Medical, along with parent companies, Maquet Cardiovascular US Sales and Getinge AB, are named as co-defendants.

Atrium Medical’s popular line of C-QUR surgical mesh products are defective, plaintiffs claim, alleging, “defendants’ C-QUR Mesh was defectively designed and / or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design.” The plaintiffs identify numerous mesh products, all of which, they assert, share a similarly-defective design:

These plaintiffs assert they received one of the above-listed mesh products and that the mesh failed after implantation, leading to severe and in many cases irreversible complications. Court records filed on behalf of the plaintiffs claim that the alleged C-QUR mesh defects increased the risk for a litany of severe injuries, including chronic pain, hernia recurrence, life-threatening infections, foreign body response and rejection of the implant.

Many patients claim to have undergone multiple costly and invasive revision procedures. In fact, plaintiffs accuse Atrium of failing to design “a safe, effective procedure for removal of the C-QUR Mesh.” In the event of a product failure, plaintiffs claim, “it is impossible to easily and safely remove the C-QUR Mesh.”

Plaintiffs assert that Atrium, Maquet and Getinge AB “committed or allowed to be committed tortious and wrongful acts, including the violation of numerous safety standards relating to device manufacturing, quality assurance / control, and conformance with design and manufacturing specifications.”

Plaintiffs Outline Alleged C-QUR Mesh Defects

As plaintiffs note, the C-QUR mesh is manufactured using polypropylene, a form of plastic, that is then coated with a “unique Omega 3 fatty acid gel […] derived from fish oil.” This fish-oil derived fatty acid gel, the plaintiffs allege, is not used in any other hernia repair product sold in America. “The Omega 3 coating was represented by the Defendants to prevent or minimize adhesion and inflammation, and to facilitate incorporation of the mesh into the body, but it did not,” plaintiffs claim. Instead of promoting the incorporation of the mesh into body tissues, the Omega 3 fatty acid “caused an intense inflammatory and chronic foreign body response,” the plaintiffs write, “resulting in an adverse tissue reaction, including damage to surrounding tissue in the form of sclerotic, granulomatous and / or fibrotic tissue, and improper healing.”

In their lawsuits, plaintiffs assert that the Omega 3 fatty acid coating can lead to numerous problems inside the body, including seroma formation, in which fluid collects under the patch because the Omega 3 coating is impermeable to water. Plaintiffs claim that the Omega 3 coating serves as an “ideal bacteria breeding ground[,] which allows infection to proliferate.” They also claim that the Omega 3 coating is “cytotoxic, immunogenic, and not biocompatible,” leading to delayed wound healing, chronic inflammation and rejection.

According to the plaintiffs, things only get worse when the Omega 3 coating is disturbed or degraded, leaving the “naked” polypropylene mesh exposed to nearby tissues and organs. Left exposed inside the body, plaintiffs claim, the bare mesh “can become adhered to organs,” resulting in severe infections, abscesses and fistula formation.

Allegations Of “Stealth Recalls” & Manufacturing Defects

The plaintiffs accuse Atrium Medical of failing to adequately test the C-QUR mesh products prior to their entrance into the stream of commerce. Plaintiffs claim the company knew or should have known that the product’s design would lead to severe complications. In fact, the defendants are accused of initiating multiple “stealth recalls,” in which production was halted on several C-QUR products “that were experiencing high levels of adverse events.”

Plaintiffs also assert issues in the manufacturing process. “Due to serious problems with sterilization and quality control in the Atrium manufacturing facilities,” plaintiffs write, “the Omega 3 coating was not uniformly applied to the C-QUR Mesh devices.” Applied inconsistently to the bare polypropylene mesh, the Omega 3 coating “contributed to the propensity of the C-QUR Mesh to roll, curl and deform upon insertion into the body,” plaintiffs claim. “The Omega 3 coating,” plaintiffs continue, “was also unreasonably susceptible to deterioration and degradation, and even separation from the polypropylene mesh, both in the packaging and inside the body.”