An Alabama man has filed a Physiomesh lawsuit against Ethicon, Inc., claiming he suffered severe hernia complications due to its “unreasonably dangerous” multi-layer design.
According to his August 15th filing in the U.S. District Court, Southern District of Alabama, Bill Tedford was implanted with an Ethicon Physiomesh Composite mesh patch (Catalog/Reference No. PHY1520V) in December 2013 to repair a hernia. He later required additional invasive procedures due to complications allegedly associated with Physiomesh’s unique, multi-layer design.
That design is supposed to helps the hernia mesh incorporate into the body and reduce inflammation. However, Tedford alleges that it actually causes a number of problems, including chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation/ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage; and even death.
“Plaintiff’s severe adverse reaction, and the accompanying medical treatments which were required, directly and proximately resulted from the defective and dangerous condition of the Defective Device and Defendants’ defective and inadequate warnings about the risks associated with the Defective Device, and the frequency, severity and duration of such risks,” Tedford’s lawsuit alleges. “Plaintiff has suffered, and will continue to suffer, both physical injury and pain and mental anguish, permanent and severe scarring and disfigurement, lost wages and earning capacity, and has incurred substantial medical bills and other expenses, resulting from the defective and dangerous condition of the Defective Device and from Defendants’ defective and inadequate warnings about the risks associated with Physiomesh.”
Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes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. Because Ethicon was unable to determine the reason for these issues or identify a solution, the company stopped selling the affect Physiomesh product and has indicated it will not be returning those devices to the market.
Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federally-filed Physiomesh lawsuits in the U.S. District Court, Northern District of Georgia, for the purpose of coordinated pretrial proceedings. The litigation convened its Initial Conference on August 1st, and has grown include more than 100 hernia mesh cases.