Surgical mesh came under fire several years ago, beginning with the Kugel mesh complaints. All those lawsuits have been settled but new meshes have been introduced that seem to be a repeat performance. “These newer surgical meshes have been approved despite their defective design,” explains Malik. “They are causing infection because the hard mesh acts as a bacterial breeding ground.”
Why do mesh manufacturers continue to use plastic materials with a track record of failure? The Ethicon Physiomesh is made from polypropylene: “plastic-like” non-absorbable fibers sandwiched between two layers of polyglecaprone, a synthetic absorbable suture. An Ethicon mesh lawsuit filed by a woman in Florida alleges that the product “prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response.”
“Medical device companies are looking for scaffolding material to repair hernias. A variety of products are available, however companies continue to produce mesh knowing they may be defective,” says Malik. “Both Atrium and Ethicon fall short of the mark.”
Atrium C-QUR Mesh
Fish oil is purported to have health benefits when digested, but it apparently doesn’t work so well when placed inside the body. (It is advertised as an “anti-adhesion barrier” to prevent scar-tissue from attaching organs together during the healing process, which can happen after hernia surgery.)
Case in point: Hernia Mesh called Atrium C-QUR, which is the only hernia mesh implant on the market coated in fish oil. And it was approved by the FDA in 2006 by the 501k process—without clinical trials—because it was “equivalent’ to other hernia mesh implants already approved.
But Atrium quietly recalled its mesh in 2013 and by December 2016, about two dozen C-QUR lawsuits had been filed. Hernia patients allege that the fish oil peeled off inside their body. According to the Daily Hornet, Atrium didn’t remove its C-QUR from the market, Instead, the company sent out a recall letter with a warning that the mesh, if exposed to “excessive humidity for an extended period of time” (in the human body?) could allow the coating on the mesh to “strongly adhere to the inner handling sleeve”.
Atrium and Ethicon Lawsuits
Atrium C-QUR injury lawsuits have been consolidated 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).
READ MORE SURGICAL MESH LEGAL NEWS
If you have been implanted with surgical mesh, particularly Ethicon Physiomesh, Malik advises that you follow up with your implanting surgeon—even if you aren’t experiencing any symptoms of mesh side effects. “If you need to have the mesh removed do it sooner than later because the statute of limitations is running,” he adds. If you get the mesh removed, make sure to obtain the implanting record, product ID explanation and your medical record. “There is still time to seek legal help.”