Hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh products continue to mount in the multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia.
According to an update issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on July 17th, there are at least 84 Physiomesh lawsuits pending in the centralized proceeding. That represents an increase of 18 filings since June 15th, when the Panel reported 66 cases.
Plaintiffs pursuing these lawsuits claim that Physiomesh hernia patches suffer from design defects that resulted in adhesions, perforations, infections, mesh erosion and other debilitating complications. The JPML transferred all federally-filed Physiomesh lawsuits to the Northern District of Georgia in June to allow the cases to undergo coordinated pretrial proceedings, including discovery.
The multidistrict litigation is scheduled to convene an Initial Conference on August 1st, at 2:00 p.m. ET. All outstanding disclosure and discovery proceedings have been stayed pending the conference.
Ethicon Physiomesh is constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric. Each side of the polypropylene mesh is covered with an absorbable film coating, which purportedly facilitates incorporation of the patch into the body and reduces inflammations. However, Physiomesh lawsuit plaintiffs claim that this design actually increases the risk of serious complications.
“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,” the complaints state. “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.”
Ethicon announced a worldwide market withdrawal of its Physiomesh Flexible Composite Mesh products in May 2016, following an analysis of unpublished data from two European registries which indicated that the products were associated with higher average recurrence and revision rates compared to other hernia meshes used in laparoscopic ventral hernia repair.
Ethicon was unable to determine what was behind these issues, but suggested the problems could be related to several factors, including possible product characteristics, operative and patient factors.
The company indicated it would not be returning the Physiomesh Flexible Composite Mesh to the market.