An Illinois man who experienced serious complications following ventral incisional hernia repair has taken legal action against Ethicon. Inc., the manufacturer of the Physiomesh hernia patch used in the procedure. In a complaint filed with the U.S. District Court, Southern District of Illinois, on May 22nd, Gary Goodson claims that the Physiomesh device he received was defectively designed and was not reasonably safe for use in hernia repair.
Goodson was implanted with a Physiomesh patch (25CM x 20CM) at Anderson Hospital in Maryville, Illinois. He now requires revision surgery, allegedly due to “continuous complications” with the Physiomesh device. Goodson notes that Physiomesh features a unique multi-layer coating, which is supposed to prevent or minimize adhesion and inflammation and facilitate incorporation of the mesh into the body. However, he claims that this coating creates a “breeding ground for bacteria” and cannot withstand normal abdominal forces.
“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,” the lawsuit states.
Ethicon announced a worldwide market withdrawal of Physiomesh Flexible Composite Mesh in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair. The company was unable to determine the cause of this issue but noted that it could be due to product characteristics, as well as operative and patient factors.
The market withdrawal did not include the Physiomesh Open Flexible Composite Mesh device.
While the Physiomesh market withdrawal was never officially declared a recall in the U.S., hospitals were asked to return any unused hernia patches included by the action. Ethicon indicated that it would not seek to return the affected products to the market.
At least 18 Physiomesh lawsuits are now pending in federal courts throughout the country, all of which were filed on behalf of patients who experienced adhesions, perforations, infections, mesh erosion and other debilitating complications due to the product’s allegedly defective design. The U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments tomorrow on a motion to transfer all such federally-filed claims to the U.S. District Court, Middle District of Florida, for coordinated pretrial proceedings.
Plaintiffs who motioned for centralization of the federal Physiomesh docket assert that the establishment of a multidistrict litigation will promote judicial efficiency and preserve the resources of the parties, courts and witnesses involved in these cases. However, Ethicon has argued that the pending lawsuits are too individualized to warrant centralization.