Although hernia mesh has been used since the 1950s to repair hernias, some of the mesh used may not be safe. The FDA recently stated, “Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market.”
Two popular brands of hernia mesh are currently under scrutiny.
Atrium C-Qur Hernia Mesh
Atrium C-Qur hernia mesh was approved by the FDA through their 510(k) process, which allows a product to be approved without clinical trials. They are able to do this by showing that their product is similar to another product already on the market.
Atrium C-Qur is made of polypropylene. Polypropylene is not meant for permanent implantation in humans, so the polypropylene used in hernia mesh is coated. Unfortunately, this coating may dissolve inside the human body, leaving the polypropylene exposed.
Atrium C-Qur used omega-3 to coat the polypropylene. It’s believed that this coating dissolved in the body, causing the polypropylene to be exposed and leading to many cases of adverse events.
Atrium C-Qur is no longer being manufactured after the FDA issued a permanent injunction stopping production of the product stating, “Patients must be assured that medical devices are safe, effective, and high quality.”
Ethicon Physiomesh Hernia Mesh
Just like the Atrium C-Qur, Ethicon Physiomesh was also approved by the FDA using their 510(k) approval process, which allowed them to avoid clinical trials for safety.
Ethicon Physiomesh is made of a lightweight polypropylene. It is believed that the polypropylene used to make Physiomesh was too weak, resulting in the mesh tearing easily after it was implanted inside of the patient.
Ethicon voluntarily recalled their surgical mesh in 2016 after 650 adverse events had been reported to the FDA.
Common Signs of a Problem With Your Hernia Mesh
According to the FDA, common signs that there could be a problem with the hernia mesh that was used include pain, recurrence of the hernia, adhesion, infection and bowel obstruction.
If you believe you or a loved one have been adversely affected by the use of hernia mesh that has been pulled from the market, contact the experienced Tennessee defective medical device lawyers at Gilreath & Associates for your free consultation today.