This is Michael Brady Lynch, Lead Trial Attorney for The Michael Brady Lynch Firm.
Every year, surgeons perform around 150,000 ventral hernia repairs in the United States. Doctors can perform the operation laparoscopically or by opening the site surgically. During surgery, it is very common for surgeons to stitch a mesh patch over a hernia to strengthen the abdominal wall. This makes sure the hernia will not reopen. For thousands of patients, this is exactly what happened while using Physiomesh flexible
composite.
A Johnson & Johnson subsidiary, Ethicon has denied they recalled Physiomesh. They insist it was a voluntarily withdrawing. For years, Ethicon received over 600 surgeon complaints of high rates of patient complications, yet they did nothing. In fact, they created Physiomesh Open in hopes to save their profits.
The company did not remove the product from the shelf until two unpublished studies from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair. The study noticed more patients experienced higher rates of hernias re-opening and additional surgery compared to similar products.
Documents revealed that the FDA approved Physiomesh in 2010 without pre-market research or vigorous clinical trials. Ethicon filed a 510(k) application. This allowed the mesh on the market without new safety studies, because it was “similar” to Proceed. Proceed is another hernia patch manufactured by Ethicon.
Now, thousands face an array of painful and complicated side effects from the hernia reopening. These include infection, mesh migration or shrinkage, intestinal blockage, adhesion and more surgery to repair the area. With additional surgeries, more risk is at stake for the patient.
The FDA could have avoided these horrible adverse events if they insisted Ethicon perform clinical studies. In an urgent field safety noticed distributed by Ethicon in May 2016, they admitted complications with the Physiomesh were related to specific characteristics of the mesh. However, Ethicon claimed it was unable to identify which characteristics were causing issues.