A Mississippi patient recently filed an Atrium hernia mesh lawsuit after allegedly suffering emotional distress, lost earning capacity, diminished quality of life, lost wages and severe pain.
Plaintiff David W. filed the lawsuit against hernia mesh manufacturer Atrium Medical Corporation as well as its related companies involved in the patenting, designing, packaging, manufacturing and selling of its line of C-QUR hernia mesh products.
According to the Atrium hernia mesh lawsuit, the defendants were aware of the life-threatening complications associated with its products, but still encouraged physicians to use them even after they had become aware of the risks.
Hernia Mesh Complications
Section 510(k) of the Food, Drug and Cosmetic Act allowed for a faster clearance process for the companies obtaining approval for these hernia treatments. The Atrium hernia mesh lawsuit alleges that the defendants failed to warn regulatory agencies, consumers or physicians about the high risks associated with the coating, adhering to the package of the hernia mesh..
In fact, the Atrium hernia mesh lawsuit alleges that the defendants consistently assured regulatory agencies and physicians that this mesh was still appropriate for human implantation even if part or all of the coating had been pulled away.
Coating Causes Serious Problems with Atrium Hernia Mesh Products
Research and adverse event reports indicated that the O3FA coating had a higher propensity to detach from the polypropylene of the hernia mesh. It can float in the body or ball up, causing rejection and other complications with the C-QUR mesh. It can also adhere to the patient’s underlying organs, leading to advanced and complicated surgeries to remove the mesh.
The Atrium hernia mesh lawsuit claims the defendants were aware that the coating could peel off inside of patients yet still encouraged physicians to use these medical devices..
When the coating breaks down or becomes adhered to nearby organs, the patient may begin to suffer serious pain. Upon discovery of the issues with a doctor, revision surgery is often required, but those procedures are risky and complicated depending on the level to which the hernia mesh has gotten stuck on other organs.
If the hernia mesh breaks down and migrates throughout the body, it may become difficult or impossible for a surgeon to locate the missing pieces and remove them from the patient. As with any surgery, revision procedures also increase a patient’s risk of infection.
Furthermore, the Atrium hernia mesh lawsuit argues that the defendants changed the manner in which the mesh product was packaged, representing a deviation from the first design and a change that was carried out without appropriate tests to determine the underlying effects on patient’s safety. According to the Atrium hernia mesh lawsuit, the FDA was never notified of this deviation..
Anyone who has sustained serious injuries from hernia mesh implantation due to a defective device may be eligible to file an Atrium hernia mesh lawsuit with the help of the experienced attorneys at McDonald Worley. Call today for a free case evaluation.