What is Physiomesh?
Physiomesh Flexible Composite Mesh is a partially absorbable surgical mesh used for hernia repair. The mesh is made from polypropylene, a plastic, set between two synthetic film layers. Over time, a body absorbs the coating on the laminated layers, a controversial process that can lead to different bodily injuries.
FDA Clearance via 510(k)
The U.S. FDA cleared Physiomesh in 2010 under the auspices of its 510(k) program. By this path, Ethicon had only to claim the mesh was “substantially similar” to products already on the market. This truncated path to market saved Johnson & Johnson and Ethicon lots of money and time, but it also leaves the maker of Physiomesh subject to liability for problems caused by the device. By contrast, medical devices approved through the FDA’s regular Premarket Approval Process (PMA) are typically exempt from liability when they hurt people. Makers of those devices were made exempt from liability via the U.S. government’s gift to corporations known as the Medical Device Amendments of 1976.
Related: Physiomesh Lawsuit
Physiomesh Hernia Repair with Laparoscopic Surgery
The Physiomesh version removed from the market was for laparoscopic surgery, a minimally-invasive technique. A surgeon makes several small incisions through which surgical tools are inserted. The surgeon then uses the tools to implant and secure (in theory, at least) the mesh in place around the hernia.
Foreign Body Reaction
Like many plastic meshes, Physiomesh depends on the human body’s own defense mechanism to attack and destroy foreign bodies in order to “mesh” with the patient’s body. Therein lies both the genius and the idiocy of implanting plastic mesh in the human body. Ethicon designed Physiomesh with a coating to prevent adhesions. In theory, the body absorbs the coating over several weeks and stops absorbing where it “should” to strengthen the hernia-weakened tissue. However, the human body doesn’t always stop absorbing when and where it “should,” and the mesh doesn’t always strengthen repairs. Sometimes it meshes uncontrollably and adheres to body organs, wreaking dangerous havoc.
The most common Physiomesh complication appears to be hernia recurrence, when the hernia comes back after the mesh implant surgery.
A Polish Hernia Study Group ran a clinical trial on Physiomesh in 2015, which included included Physiomesh Flexible Composite Mesh for laparoscopic surgery. The Polish group halted the trial for ethical reasons when researchers noted a high rate of hernia recurrences.
Ethicon removed the Physiomesh laparoscopic model from the market, but doctors and patients reported even more complications to the FDA.
Physiomesh Complications Reported to the FDA
- Hernia recurrence
- Mesh folding, bunching up
- Adherence to organs
- Integration failure
- Inflammatory reactions
Physiomesh Recalls and Market Withdrawals
Ethicon pulled all units of Physiomesh for laparoscopic surgery from the global market in May 2016, then sent out an Urgent Field Safety Notice. The notice explained why Ethicon ordered the market withdrawal. The notice also affected Ethicon Laparoscopic Hernia Kits. Ethicon wrote:
“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.
FDA Actions re: Physiomesh
The FDA began receiving reports of Physiomesh failures shortly after the 510(k) clearance. Those reports detailed recurring hernias, adhesions, infections, and other problems.
A federal panel combined the first 16 Physiomesh lawsuits in June 2017. Hundreds of people have since sued Ethicon over Physuiomesh.
A federal court in the Northern District of Georgia oversees Physiomesh lawsuits. The presiding judge set the first trial date for Sept. 16, 2019. There were 1,279 Physiomesh lawsuits pending as of July 2018.
Physiomesh lawsuits accuse Ethicon of failing to warn people of Physiomesh risks. The suits also accuse Ethicon of negligence and putting a defective product on the market.