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Problems with the design of Ethicon Physiomesh allegedly caused a severe complications following hernia repair, allegedly resulting in the need for surgery to remove the hernia mesh years after it was implanted, according to a lawsuit filed against the manufacturer.
In a complaint (PDF) filed late last month in the U.S. District Court for the Middle District of Tennessee, Rhiannon Flair indicates that Johnson & Johnson and it’s Ethicon subsidiary sold a defective and dangerous hernia mesh product, which was removed from the market last year amid reports of Physiomesh problems nationwide.
Flair had a 20cm by 30cm patch of Ethicon Physiomesh implanted in September 2011, during repair of a ventral incarcerated incisional hernia. However, in March 2016, she had to undergo revision surgery due to complications, which resulted in the return of the original hernia, adhesions and severe pain.
Ethicon Physiomesh featured a unique design, with two layers of polyglecaprone-25, also known as Monocryl, and two underlying layers of polydioxanone film. The coating was applied to the polypropylene mesh to minimize adhesion and inflammation and help the mesh incorporate into the body. However, the hernia mesh design has been associated with numerous reports of problems.
“The multi-layer coating was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation of the mesh into the body, but it did not,” Flair’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 resulting in an adverse tissue reaction including migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic tissue and improper healing.”
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.
The case filed by Flair joins a growing number of hernia mesh removal lawsuits filed in recent months by individuals who received the Ethicon Physiomesh product, raising nearly identical allegations.
Given the similar questions of fact and law presented in cases 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 earlier this week, which will result in the transfer of Flair’s case, as well as future complaints 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.