The Federal Court issued the 11th Practice and Procedure Order on May 29 involving Ethicon Inc.'s Physiomesh Lawsuit. The order requires the hernia mesh and tissue samples to be preserved from plaintiffs who have been or will be requiring surgical removal and have a case pending in the proceeding.
The order also demands plaintiffs to inform their healthcare provider that any mesh or tissue removed must be preserved and sent to Steelgate, Inc., biomedical specimen storage, and management company. A ‘Preservation Notice’ has to be sent whenever the mesh removal process takes place. The further shipment of the explanted samples will be arranged by Steelgate, in Florida, which will act as a third-party storage unit for such materials.
In May 2016, Ethicon announced the withdrawal of its Physiomesh Flexible Composite Mesh from the worldwide market, considering reports that the device led to a lot of revision surgeries when used in laparoscopic ventral hernia repair.
The mesh products named in the lawsuits contain polypropylene material, which can easily break, shrink or wear off. This often leads to device migration, organ perforation, infection, and several other complications. Lawsuits allege the defective design of the hernia mesh often required the patients to undergo additional correction surgeries.
Over 900 Hernia Mesh lawsuits are pending against Ethicon; similar cases are consolidated as a part of multidistrict litigation MDL No. 2782 ( In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation) before the U.S. District Judge Richard Story in the Northern District of Georgia. The MDL is steadily moving forward with respect to the legal proceedings.
