Atrium Hernia Mesh Lawsuit Alleges Permanent Injuries
A plaintiff who filed a lawsuit against a hernia mesh manufacturer alleges defects in the device left him with painful and permanent injuries. The plaintiff is seeking damages from the manufacturer, stating the company failed to provide proper warning about the potential dangers associated with their devices.
Missouri resident Richard Heinz states in his lawsuit that he underwent an open repair of an incisional hernia on April 18, 2012. During the surgery, a piece of C-Qur TacShield mesh was used to repair the hernia. Mesh is a device designed to support the area weakened or damaged by the hernia.
Manufacturers of mesh products — including transvaginal and hernia mesh– stand accused of making and marketing defective devices that are prone to migration, erosion and other complications.
Approval based on fast track process
Atrium Medical, the company that manufactures and distributes the C-Qur mesh, received 510(k) clearance for the product. Also known as “fast track” approval, this process allows companies to gain approval from the FDA for products that are similar in design and purpose to other products that are already on the market. However, there are features of the C-Qur mesh that have allegedly resulted in serious complications for some patients that have received the mesh, including Heinz.
The C-Qur mesh is crafted from substances that require very specific transportation and storage guidelines in order to protect the mesh from improper amounts of moisture. If too little moisture reaches the mesh, it can lead to a higher rate of infection when it is implanted. If the mesh is exposed to too much moisture, the outer barrier of the mesh can peel away even after the mesh is implanted into the body. This can lead to migration of the outer coating and allow the mesh to adhere to underlying organs.
Heinz claims that two years after the placement of his mesh, in August 2014, he began to experience abdominal pain in the area of the surgery. Upon examination by a physician, Heinz learned that the pain was due to migration and contraction of the mesh. Heinz also discovered that the mesh had adhered to the wall of his small intestine and the integration of the device into the organ prohibited the safe removal of the mesh.
Instead of receiving treatment for the condition, Heinz was given a list of symptoms to watch for that would require emergency medical treatment. He has also continued to suffer from chronic abdominal pain, recurrent infections and digestive problems as a result of the complication. The symptoms have impacted the plaintiff’s quality of life and his ability to work. He will also face future corrective surgeries in order to manage the condition that cannot be completely reversed.
Hernia mesh litigation pending against Atrium
This lawsuit, filed in U.S. District Court for the Eastern District of Missouri on October 8, is sadly not the first involving mesh devices used for hernia repair. Since the Atrium C-Qur was approved by the FDA in 2002, numerous patients have filed lawsuits claiming the device can cause serious immune reactions and other injuries. In cases like this one, the plaintiffs may have to live with ongoing pain and other complications that severely impact their ability to work and function.
In his lawsuit, Heinz lists a number of counts against Atrium, including gross negligence, unjust enrichment and negligent infliction of emotional distress. He is seeking punitive and compensatory damages from the defendant for past and future medical expenses, permanent injuries and impairment, and mental pain and suffering.
- Atrium Maquet Getinge Group, Co-Qur Mesh, http://www.atriummed.com/en/biosurgery/cqur.asp
- FDA, Class 2 Device Recall CQUR Edge Mesh, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=119924
- FDA, Hernia Surgical Mesh Implants, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm