Bard Medical, a renowned manufacturer in the hernia mesh industry, distributes various types of hernia meshes, including the Bard Composix E/X Mesh. Composix E/X is specifically designed for ventral hernia surgeries, aiming to provide effective repair solutions. However, like other meshes, Composix E/X has faced legal scrutiny due to reported complications and injuries experienced by patients.
The Bard Composix E/X mesh obtained FDA clearance in 2000 under the 510(k) premarket notification process.[i] This process, while common in the medical device industry, has been subject to controversy. It allows devices to enter the market based on their similarity to existing approved devices, without undergoing specific testing for safety and efficacy. Consequently, the FDA did not directly assess the safety or effectiveness of the Composix E/X mesh before its release.
Legal battles focus on why the mesh fails and causes harm. Key concerns include its unique two-sided design, incorporating layers of polypropylene and ePTFE. Both sides of the mesh can degrade over time, leading to complications such as:
These complications can cause significant pain and discomfort for patients, serving as strong grounds for a potential lawsuit.
Contact Rheingold Giuffra Ruffo Plotkin & Helman LLP today to explore your legal options.
Our firm represents clients in all 50 states, we do not refer your case to other firms and offer lower attorney fees than firms in many other states.
On February 20th, 2024, Judge Sargus mandated extensive mediations for attorneys in charge of Bard hernia mesh lawsuits. These mediations, starting in early March, aim to achieve a global settlement. With bellwether cases underway in Ohio to assess Bard’s liability, the outcomes will impact hernia mesh litigation nationwide, including in Rhode Island state court. Our firm is actively investigating potential claims related to the discussed injuries.
While no one can undo permanent damage done by an injury, a lawsuit can help the victim and their family recover losses and receive the medical treatment they deserve in the future. Our skilled New York attorneys are dedicated to investigating the cause of these injuries and doing whatever is necessary to make sure the offending products are kept away from innocent people.
If you or a loved one has suffered due to the Bard Composix E/X Hernia Mesh or another Bard Mesh product, our team at Rheingold Giuffra Ruffo Plotkin & Hellman LLP is here to help. We’re committed to advocating for individuals nationwide.
[i] Food and Drug Administration. “510(k) Premarket Notification Summary for Device K002684 – COMPOSIX E/X MESH.” October 11, 2000: 878.3300.
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