As common a condition is hernia is, some of the products used to treat them are causing complications that are anything but common. In fact, some patients who were implanted with Ethicon’s Physiomesh are entitled to seek justice and compensation for the injuries they suffered through a hernia mesh lawsuit. Talk to one of our attorneys today to learn more.
Physiomesh Approval and Problems
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Johnson & Johnson subsidiary Ethicon is named in more than a thousand lawsuits filed on behalf of patients who say they suffered adverse events and complications after being implanted with the Physiomesh hernia repair mesh. Some of these injuries include debilitating pain, bacterial infections, organ and tissue perforation, adhesions, and unplanned operations.
Physiomesh was approved for sale under an FDA program called the 510(k) approval process that allows medical devices to get to the market quicker than devices that go through the traditional approval process. Traditional approvals require a device manufacturer to conduct large clinical trials on the safety and effectiveness of a device prior to receiving approval. But Physiomesh was approved through a shortcut, or loophole that allowed Ethicon to bypass those large clinical trials. Physiomesh was approved based on the premise that it is substantially similar to a device that has already been approved for the market.
Unfortunately, when the FDA approves a device based on the previous approval of another device, it does not check to see if the approved device has been recalled from the market and it doesn’t check it’s adverse event database to see if patients are reporting injury or harm. It just makes sure the devices are similar.
The FDA approved Physiomesh in 2010, and a second version was approved four years later despite the fact that adverse event reports and complaints were continuing to mount, including reports of bacterial infection and an unexpected amount of reports of patients having to endure additional, unplanned operations to have the mesh removed from their bodies and to have internal damage repaired. Finally, in 2016, Physiomesh was recalled from the market, but this move did nothing to help the patients who had already been implanted with the device.
Patients who suffered injury after being implanted with Physiomesh are filing lawsuits seeking to hold Ethicon accountable for their injuries. These patients want to know when Ethicon knew or should have known about the increased risks of Physiomesh and why they chose not to warn the healthcare community and their patients.
More than 1,200 Physiomesh injury lawsuits that were filed across the country have been centralized to multidistrict litigation under U.S. District Judge Richard W. Story in Georgia. Judge Story recently ordered that patients preserve the Physiomesh used in their hernia repair as evidence.
If you or a loved one were implanted with Physiomesh for hernia repair and suffered serious complications and side effects such as mesh erosion, chronic pain, bacterial infection, organ perforation, adhesions, and additional surgeries, contact us today. You may be eligible to seek compensation for your injuries and losses. We can help.