Ethicon Physiomesh Hernia Repair Product Recall and Litigation
10/30/2016 On May 25th 2016, Ethicon, a division of Johnson and Johnson, issued an URGENT FIELD SAFETY NOTICE related to its hernia repair product ETHICON PHYSIOMESH Flexible Composite
Mesh.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, (Canadian FDA) issued a recallo f the Physiomesh products as well. The Australian Therapeutic Goods administration followed suit in June issuing a hazard alert.
The recall of "one the shelf" product 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.
At least two lawsuits have already been filed due to injuries allegedly caused by Physiomesh:
Matthew Huff filed a complaint (See Huff vs Ethicon) in the Southern District of Illinois in April of 2016. The Huff Complaint alleges that after being implanted with Physiomesh he was hospitalized due to 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 of 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.
About Ethicon Physiomesh
Physiomesh Composite Mesh was approved by the United States Food and Drug Administration in 2010 via the 510k market approval pathway. 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. As of the date of this post an estimated 650 AE Reports have been filed via the FDAs Maude Adverse event reporting System. Despite this alarming number of adverse event reports, the FDA took no action prior to the manufacturers recall of all Physiomesh Products in May of 2016.
More About the Emerging Physiomesh Litigation
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. 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.