Atrium C-Qur hernia mesh has been drawing increasing reports of serious injuries and complications.
Patients report that they have suffered infection, pain, organ damage, and allergic reactions to the mesh’s fish oil coating. Lawsuits allege Atrium was aware of the problems with the hernia mesh but did not warn the medical community or the public.
Atrium C-Qur Mesh Called Defective
Atrium Medical is accused of producing a defective product. Plaintiffs allege that the C-Qur hernia mesh caused severe pain, internal injuries, antibiotic-resistant infections and septic shock, after the mesh patch “folded up.” The lawsuits allege that C-Qur hernia mesh is not safe to use in hernia surgery. Some C-Qur recipients have had allergic reactions to the fish oil coating on the mesh.
C-Qur mesh received U.S. Food and Drug Administration (FDA) clearance in March 2006 for use in hernia repairs, chest wall reconstruction, and for the repair of traumatic or surgical wounds. According to Atrium, the C-Qur mesh combines polypropylene mesh with a natural Omega 3 gel coating. The coating is designed to reduce scar tissue while making it easier for the mesh to become, and remain affixed to the abdominal wall. The mesh is available in a variety of sizes and shapes for use in different types of surgery.
National law firm Parker Waichman notes a similar hernia mesh, Ethicon Physiomesh, has been withdrawn from the market. Physiomesh lawsuits have been filed on behalf of individuals who suffered injuries allegedly related to the Physiomesh.
In 2012, after the C-Qur mesh had been linked to serious adverse events, the FDA sent Atrium a warning letter citing the manufacturer’s failing to investigate and respond to complaints about C-QUR mesh infections and failure. Legal documents say that many patients “have been forced to undergo intensive medical treatment, including . . . operations to locate and remove the C-Qur Mesh, operations to attempt to repair abdominal organs, tissue and nerve damage.”
In December 2016, the US Judicial Panel on Multidistrict Litigation consolidated all Atrium C-Qur hernia mesh lawsuits in a multidistrict litigation (MDL). As of January 17, 2017, there were 21 C-Qur hernia mesh lawsuits consolidated in the MDL.
Lawsuits Over Hernia Mesh Injuries
In one recently filed C-Qur mesh lawsuit, legal documents describe the plaintiff’s injuries and complications as including, “foreign body reaction, rashes, infection, adhesions, organ perforation, inflammation, fistula, mesh erosion, scar tissue, blood loss, dyspareunia [painful intercourse], neuropathic and other acute and chronic nerve damage and pain, abdominal pain, nausea, vomiting, [and] kidney failure.”
An Arkansas woman who filed a C-Qur mesh lawsuit alleges that she experienced severe abdominal pain and a recurrence of the hernia. The problems continued to the point where doctors felt they should remove the C-Qur mesh, but they were not able to remove it because they discovered that the mesh had become lodged in the woman’s abdomen, trapped by scar tissue.
An Ohio plaintiff alleged that C-Qur mesh became affixed to her bowel, causing an obstruction. This woman filed a defective products lawsuit in November 2016 before consolidation to multidistrict litigation in New Hampshire.
A New Hampshire man has filed a lawsuit over the allergic reaction he suffered to the fish oil coating in the Atrium C-Qur mesh used in his 2013 hernia repair. The lawsuit alleges that Atrium knew about the risk of allergic reaction, but did not tell the FDA and “recklessly disregarded human life by lying to physicians about the possible causes of the allergic reactions.” When the C-Qur mesh was removed in January 2016, the surgeon reported a “foreign body giant cell reaction,” and fibrous scar tissue embedded in the mesh.
Complications with Surgical Mesh Products
Other surgical mesh products are also under scrutiny. Patients allege that Ethicon’s Physiomesh hernia uses plastic materials that react to human tissues and can cause infections and complications. The plastic mesh can cut into tissues and organs and the mesh can migrate to other parts of the body and become embedded in organs. Patients also allege that Physiomesh fails to perform as expected and the hernia can recur.
Mesh devices used in surgery for women’s pelvic organ prolapse (POP) and stress urinary incontinence (SUI) have been the subject of thousands of adverse event reports to the FDA and lawsuits against manufacturers including Ethicon, Boston Scientific, C.R. Bard, Endo and Coloplast. Transvaginal mesh devices provide support to pelvic organs when a woman’s pelvic structures have been weakened by childbirth, surgery, or aging.
Women implanted with transvaginal mesh have reported pelvic pain; mesh protrusion into the vagina, painful sexual intercourse, infections, urinary problems, bleeding, and recurrence of the prolapse or incontinence.
Help for People Injured by Hernia Mesh
If you or someone you know has suffered an injury that could be linked to Atrium C-Qur hernia mesh, the attorneys at Parker Waichman LLP will provide a free, no-obligation case evaluation. To contact Parker Waichman, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).