Federally-filed hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite mesh implants continue to move forward in the multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia.
The Court issued its 11th Practice and Procedure Order on May 29th, which address the preservation and handling of hernia mesh and tissue samples that have been or will be surgically removed from any plaintiff with a case pending in the proceeding.
Among other things, the Order requires plaintiffs undergoing mesh removal to notify their health care provider that any explanted mesh or tissue must be preserved and sent to Steelgate, Inc., a biomedical specimen storage and management company.
Plaintiff’s counsel must present a Past Surgery preservation notice to the appropriate health care facility for any plaintiff who has already undergone hernia mesh removal. A Future Surgery preservation notice will be presented to the appropriate facility when a plaintiff is scheduled to undergo a future removal procedure. In either case, Defendants’ counsel is to be copied on the correspondence.
Once a preservation notice has been sent, Steelgate will arrange shipment of the explanted mesh and tissue samples to its facility in Florida and will then act as a third-party repository for any such materials.
Ethicon’s Phyisomesh Flexible Composite mesh patches feature a multi-layer design constructed of non-absorbable polypropylene (plastic) filaments that are woven into fabric and laminated with an absorbable film coating. This construction is supposed to reduce inflammation and ensure incorporation of the mesh into the body.
Ethicon announced a worldwide market withdrawal of all Physiomesh Flexible Composite Mesh implants in May 2016, after unpublished data from two European hernia registries suggested that the devices were associated with higher average recurrence and revision rates when used in laparoscopic ventral hernia repair compared to other mesh products.
The company was unable to determine the reason for the high rates of revision and recurrence and indicated that it would not be returning the affected Physiomesh implants to the market.
There are now more than 900 hernia mesh lawsuits pending in the Northern District of Georgia, all of which were filed on behalf of individuals who experienced chronic pain, hernia recurrence, infection, scarring and adhesions, tissue damage, and other complication, allegedly due a defective Physiomesh hernia patch.
Among other things, the complaints allege that the polypropylene used to manufacture Physiomesh is biologically incompatible with human tissue and that the multi-layer design actually serves as a breeding ground for bacteria, increasing the likelihood that patients implanted with the devices will experience severe complications and adverse reactions.