The notice included a recall of existing stock currently held by health care facilities for all variations (product codes) of the Physiomesh Product Line.
- On the same day, Health Canada, (the Canadian FDA) issued a recall of the Physiomesh products as well.
- The Australian Therapeutic Goods administration followed suit in June issuing a hazard alert.
The recall of “on the shelf” products should serve to prevent future hernia repair patients from being implanted with Physiomesh however, this recall does not help those already implanted with the defective hernia mesh product.
We estimate that as many as 300,000 individuals may have been implanted with Physiomesh since the product was approved by the FDA via the 510k process in 2010.
MDL Motion Expected
A large number of lawsuits are expected to be filed resulting from injuries alleged to be caused by Ethicon Physiomesh. It is probable that, as more cases are filed, a motion to consolidate will be filed before the Judicial Panel on Multidistrict Litigation (JPML). Given the fact that Ethicon has recalled the Physiomesh product line, this litigation may move rapidly. It is possible that an MDL could be formed as early as 2017.
The emerging litigation related to injuries caused by Physiomesh will be discussed in the November 11th – November 14th Four Days to Mass Tort Success Course in Fort Lauderdale. We will continue to update our subscribers on this emerging litigation. If you are not already a subscriber to the Mass Tort Nexus App, please sign up today at this link: Sign Up
Matthew Huff filed a complaint (See Huff vs Ethicon) in the Southern District of Illinois in April 2016. The Huff complaint alleges that after being implanted with Physiomesh he was hospitalized beause of an infection in and around the mesh, which caused two abdominal abscesses and an intestinal fistula. These complications from the Physiomesh implant required extensive surgery.
Joanne Quinn filed a complaint (See Quinn vs Ethicon) in the Middle District of Florida in September 2016. The Quinn complaint alleges that the implanted Physiomesh did not improve her condition and in fact resulted in further complications including bowel obstruction. Quinn alleges that due to complications related to Physiomesh she was required to undergo a significant surgical procedure in an attempt to correct the complications allegedly caused by Phsyiomesh.
Shortly after the FDA approved Physiomesh, surgeons and other medical providers began filing adverse event reports, by the end of 2012 an estimated 90 adverse event reports had been filed related to Physiomesh. Today an estimated 650 Adverse Event Reports have been filed in the FDA’s Maude Adverse event reporting System since Physiomesh Composite Mesh was approved by the FDA in 2010 via the 510k market approval pathway. Despite this alarming number of adverse event reports, the FDA took no action prior to the manufacturer’s recall of all Physiomesh Products in May.