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Problems with the design of Ethicon Physiomesh used during a hernia repair allegedly caused a South Carolina man to require additional surgery to remove the mesh after it became infected, according to a product liability lawsuit filed last week against the manufacturers.
The complaint (PDF) was filed by Larry Slice in the U.S. District Court for the District of South Carolina on July 6, indicating that Johnson & Johnson and its Ethicon subsidiary sold a defectively designed and manufactured hernia mesh product, which was not safe for its intended purpose.
Slice had a 15cm by 20cm Physiomesh patch implanted for hernia repair in December 2013. However, due to an infection following surgery, he required revision surgery to remove the patch in August 2016.
The lawsuit indicates that a multi-layered film which covers Ethicon Physiomesh patch was one of the main reasons for the hernia mesh infection.
“When affixed to the body’s tissue, the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection, abscess formation and other complications,” Slice’s complaint states. “The multi-layer coating provides a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”
In June 2016, Ethicon recalled Physiomesh products from the market worldwide, due to a high rate of problems and revisions among individuals who had the patch implanted, since the manufacturer was unable to identify or correct the underlying cause of the complications.
Although the action was classified as a “market withdrawal” in the United States, Ethicon asked hospitals to return all unused implants and indicated that it does not intend to return the product to the market.
Given the similar questions of fact and law presented in dozens of Ethicon Physiomesh lawsuits pending throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to establish coordinated pretrial proceedings in the federal court system last month, transferring all cases filed nationwide to U.S. District Judge Richard Story in the Northern District of Georgia to reduce duplicative discovery, avoid contradictory pretrial rulings and to serve the convenience of the parties, witnesses and the courts.
As hernia mesh lawyers continuing to review and file additional lawsuits in the coming weeks and months, it is expected that several thousand complaints will be included in the MDL proceedings.