Every year, 1 million people have their hernia repaired. They trust their doctors that this surgery is necessary for them to relieve their constant pain. Now, many are finding the hernia mesh used in their surgeries were rushed to market and is causing more damage than their hernia ever did.
Thirty percent of hernia surgeries performed used either Ethicon’s Physiomesh Flexible Composite or Atrium C-Qur Hernia Mesh. Both are composite hernia mesh. In a hernia surgery, composite mesh sits next to the intestines and abdominal wall. The manufacturers claim the coating on the mesh prevents intestinal tissue from adhering to it. This is not the case for thousands of patients.
The design of Ethicon and Atrium’s hernia mesh actually makes the intestine adhere more. The scar tissue from the surgery connects with the intestine and the mesh to create adhesions. The mesh can also change shape after the abdomen deflates after surgery, which brings additional complications. Unlike traditional meshes, the body cannot incorporate the composite hernia mesh. Instead, it sits in the body causing severe infections and pain.
How did this happen?
Both companies rushed their hernia mesh to market without any clinical trials. They relied on an FDA loop-pole called 510k exempt. This loophole allows the FDA to approve medical devices equivalent to those already on the market without having to succumb to the market approval process. Both claimed their mesh fit this requirement. However, independent studies show Physiomesh and C-Qur are more deadly. Some studies couldn’t even finish their reporting due to concerns about adverse events in patients.
Hernia Mesh Market Removal
After increase pressure from independent researchers outlining the complications from Ethicon’s hernia mesh, the company voluntarily withdrew the product. Nevertheless, Ethicon insisted it was not a design flaw but a doctor error.
The FDA and the Department of Justice had to file a permanent injunction and official complaint against Atrium’s unsafe practices for them to address their harmful mesh design. Atrium had to pay a $6 million fine and could face another $6 million fine if they do not comply with the FDA’s regulations.
Atrium is still marketing their mesh products.
Hernia Mesh Injuries
Due to the faulty design, composite hernia mesh can cause painful side effects. These include infection, seroma, abscess, skin rash, recurrence, bowel obstruction and also adhesions. Ethicon and Atrium are getting rich off your pain. They both knew how dangerous composite products could be, yet they continued to market them.
Physiomesh & C-Qur Lawsuits
If you or a loved one experienced a complication after hernia mesh surgery, you need a knowledgeable and dedicated attorney to file your claim. The attorneys at the Michael Brady Lynch Firm are nationally regarded for representing thousands of consumers injured by defected drugs and medical devices. Our firm will tenaciously pursue compensation to cover your medical expenses and losses. Contact us today for a free no-obligation consultation.
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