Physiomesh is a flexible polypropylene mesh designed to reinforce the abdominal wall, preventing future hernias from occurring. Studies of Physiomesh have shown not only that it is related to significantly more recurrent hernias and postoperative pain than similar devices, but it has also been linked to an increased risk of additional surgeries, organ perforation, mesh migration, sepsis and even death.
The U.S. Food and Drug Administration (FDA) cleared Physiomesh through a 510k submission, known as a Traditional or Abbreviated Premarket Notification Submission in April 2010. The submission classifies a product as “substantially equivalent” to other products on the market and allows it to forgo providing the extensive safety and efficacy testing required of new products or products determined to have undergone significant changes. Ethicon maintained the mesh was substantially similar to Proceed mesh it already had on the market at the time, though Proceed mesh was recalled in October 2010 due to layers of the mesh separating once implanted.
Many reported complications in hernia surgeries, according to the FDA, are associated with the now-recalled surgical mesh, which it credits as the main cause of bowel perforation and obstruction complications. Defects in Physiomesh were found only after it was put on the market.
Suffering from Physiomesh Complications? Talk to Our Defective Medical Device Lawyers
The defective medical device lawyers at Roberts & Roberts are currently reviewing claims from people who have suffered complications from Physiomesh.