Johnson and Johnson subsidiary Ethicon is already being sued by plaintiffs who are accusing the company of selling a defective hernia mesh implant. Physiomesh™ Flexible Composite Hernia Mesh was removed from the American market in May and recalled in Europe and Australia because studies comparing it to similar devices found that Physiomesh had higher rates of recurring hernias and need for re-operation.
The mesh has also been linked to more post-operative pain than similar devices and an increased risk of additional surgeries, organ perforation, mesh migration, sepsis and even death. A trial date is set for Jan. 22, 2018, in Illinois.
Now another hernia mesh manufacturer is facing litigation. Atrium Medical Corp. is accused of hiding the dangers of its allegedly negligently designed C-Qur mesh product.
Law360 reports on a recent lawsuit filed in federal court by 56-year old New Hampshire man James Brown and his wife, Kimberly. Brown had an umbilical hernia surgically repaired using Atrium’s C-Qur mesh around December 2013. Within months he was experiencing abdominal pain that would not be connected to the mesh until late 2015. When the mesh was removed in January 2016, pathology reports indicated a “foreign body giant cell reaction” in his body and scarring of the tissue around the mesh implant. Removal of the mesh did not cure the abdominal pain.
“As Brown tells it, Atrium was well aware that its product could cause that reaction, yet continued to promote the mesh to doctors and even lied to the U.S. Food and Drug Administration [FDA] about changes to the product’s design,” said Law360.
The suit includes allegations that when the company was alerted by doctors of adverse even deadly reactions to the Omega 3 fatty acid fish oil coating on the C-Qur mesh, the company, rather than reporting to the FDA as required, made changes to the way it applied the fish oil coating to the device. Similar allegations were made that other adverse reactions were not properly tracked, investigated or disclosed to the FDA and that the company, rather than facing a recall, halted production on multiple types of mesh, without notifying physicians, the FDA or consumers. Other accusations include that the device was packaged without sufficient moisture which puts the device at high risk of carrying infection and causes the fish oil coating to separate from the mesh, causing problems once implanted.
“James Brown and his wife, Kimberly, contend Atrium negligently designed and fraudulently convinced doctors that its C-Qur mesh product was safe when in fact the company knew the polypropylene surgical netting was biologically incompatible with human tissue and carried the risk of causing serious medical complications in patients,” reported Law360.
Other polypropylene mesh products have been making headlines the last several years, with tens of thousands of women suing the makers of transvaginal mesh devices used to treat pelvic organ prolapse and stress urinary incontinence. These women allege the mesh can migrate within or erode inside the body, and perforate or puncture organs, causing chronic pain, infections and even death. In January 2016 after receiving thousands of reports of complications the FDA reclassified transvaginal mesh devices used to treat pelvic organ prolapse as high-risk devices.