Source: Ethicon Product Catalog
Physiomesh Hernia Repair with Laparoscopic Surgery
The Physiomesh version removed from the market was for laparoscopic surgery. This is a minimally-invasive technique.
A surgeon makes several small incisions. He then inserts surgical tools through the incisions. The surgeon uses the tools to implant and secure the mesh in place around the hernia.
Ethicon designed Physiomesh with a coating to prevent adhesions. The body absorbs the coating over several weeks.
Tissue grows into the mesh’s pores over time. This “ingrowth” should strengthen the repair. But it did not always strengthen repairs. And the mesh sometimes adhered to organs in the body.
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. But doctors and patients reported even more complications to the FDA.
Physiomesh Complications Reported to the FDA Include
- Hernia recurrence
Mesh folding or bunching up
Failure to incorporate into the body
Physiomesh Recalls and Market Withdrawals
Ethicon pulled all units of Physiomesh for laparoscopic surgery off the global market in May 2016.
Ethicon sent out an Urgent Field Safety Notice. The notice explained why Ethicon ordered the market withdrawal. The notice also affected Ethicon Laparoscopic Hernia Kits.
“The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”
Ethicon later discontinued laparoscopic versions of Physiomesh.
Physiomesh FDA Actions
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.
Hundreds of people who suffered Physiomesh injuries sued Ethicon. A federal panel combined the first 16 Physiomesh lawsuits in June 2017.
A federal judge in the Northern District of Georgia oversees Physiomesh lawsuits.
The first Physiomesh trial is expected in late 2019 or early 2020. There were 1,417 Physiomesh lawsuits pending as of September 2018.
Another 62 Physiomesh lawsuits are pending in state court in Atlantic County, New Jersey. The New Jersey Supreme Court consolidated the cases into a multicounty litigation in August 2018.
The lawsuits accuse Ethicon of failing to warn people about Physiomesh risks. They also accuse the company of negligence and putting a defective product on the market.