An Alabama man has filed a lawsuit against the maker of his hernia repair mesh, blaming the defective device for complications that required an additional surgery.
The lawsuit was filed by Bill Tedford, who received the Physiomesh hernia mesh device made by Ethicon, a subsidiary of Johnson & Johnson.
According to the Daily Hornet, Tedford’s hernia repair surgery was performed in December 2013. The lawsuit alleges Mr. Tedford’s complications and reactions to the mesh device were so severe, an additional surgery and further medical treatment was required. The complaint says he now suffers permanent scarring as well as other injuries associated with the device.
The lawsuit accuses Ethicon of making and selling a defective medical device without warning doctors or patients of the dangerous potential for complications.
The unique five-layer design is intended to be the device’s most helpful feature, but has been named in more 80 lawsuits that claim the multiple layers are one of the biggest problems. Lawsuits also point out that the mesh device was approved by the FDA using the 510(k) process to fast-track the product into the market. This approval method allows a medical device to be distributed and sold, marked as safe by the FDA, as long as it is similar enough to a device previously sold.
“The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between two undyed polyglecaprone-25 films,” the device’s 510(k) approval summary states. “An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh. The polypropylene component is constructed of knitted filaments of extruded polypropylene.”
The multiple layers were created to reduce risk of infection and encourage proper incorporation into the body. But Tedford, as well as many others, allege the device failed.
Tedford’s lawsuit states, “Instead, the multi-layer coating prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response.”
Because the mesh did not incorporate into Tedford’s body properly, the mesh migrated and damaged the surrounding tissue, resulting in sclerotic, granulomatous, and/or fibrotic tissue formation an improper healing, his lawsuit alleges.