Operating Room

Physiomesh Trial Postponed Fueling Settlement Speculation

With 3,500 Ethicon Physiomesh lawsuits pending throughout the federal court system, a US district court judge has postponed the bellwether June 7, 2021 trial fueling speculation that a global settlement may be in the near future.

Ethicon Physiomesh was a multi-layered, flexible composite hernia mesh product introduced by Johnson & Johnson’s Ethicon subsidiary in 2010. However, the manufacturer removed the product from the market only six years later, amid a large number of complaints involving complications with the hernia mesh, often resulting in the need for additional surgery to remove it from individuals’ bodies.

The recalled mesh has caused untold suffering for patients who had the medical device implanted.  What the patients didn't know at the time was that Physiomesh was a defective medical device that would likely cause revision surgery to have it removed after implantation. 

According to Drug Watch, "Hernia recurrence was the most common Physiomesh complication requiring surgery. Recurrence is when a hernia comes back after surgery.

The Polish Hernia Study Group ran a clinical trial with Physiomesh in 2015. The trial included Physiomesh Flexible Composite Mesh for laparoscopic surgery. The group terminated the trial when researchers noticed higher than expected recurrences.

Ethicon then removed Physiomesh’s laparoscopic version from the market. In addition to high recurrence rates, doctors and patients reported other complications to the FDA."

Ethicon removed the defective medical device from the market in May 2016 after numerous complaints of failure.  The device should have never been allowed to enter the marketplace.  However, it was approved after a streamlined process because Ethicon said it was similar in design to already tested devices. 

The FDA approved Physiomesh in 2010 through its 510(k) process. The process allows for less stringent testing. Ethicon only had to show the mesh was “substantially similar” to a device already on the market.

Ethicon declared Physiomesh substantially equivalent to three other products Ethicon made.

The FDA started receiving reports of Physiomesh failures shortly after the approval. The reports detailed recurring hernias, adhesions and infections.

Categories