Lawsuit Alleges Strattice “Pig Skin” Mesh Is Defective, Resulting in Need for Hernia Revision Surgery

Hundreds of injuries and several deaths have been linked to the Strattice hernia mesh made from pig skin, according to the lawsuit

A hernia mesh lawsuit recently filed by a Washington woman alleges that a Strattice “pig skin” mesh product used during her hernia repair was defective and failed, resulting in the need for two additional revision surgeries.

The Strattice Reconstructive Tissue Matrix is a hernia repair mesh introduced in 2008, which is constructed from porcine, or pig skin. The mesh is then preserved in a phosphate buffered aqueous solution. It is marketed as a cross-linked graft device, which is intended to chemically link the proteins in the tissue together. However, a growing number of lawsuits allege that the design actually increases the risk of foreign body responses, infections and other complications.

Jamie Zammito filed a complaint (PDF) this week in the U.S. District Court for the District of New Jersey, alleging that Lifecell Corporation and Allergan, Inc. knew or should have known the Strattice pig mesh was dangerous and would injure patients, yet the manufacturers continued to market and promote the product for use during hernia repair.

According to the lawsuit, Zammito had the pig skin hernia mesh implanted during a repair surgery in September 2011. However, just a couple months later, she had to return to the hospital to undergo revision surgery in December due to mesh failure. Zammito then went through another round of revision surgery in January 2012, alleging that her complications were a direct result of the Strattice mesh design, manufacturing and labeling.

Zammito notes that the FDA has received hundreds of Medical Device Reports (MDRs) linked to Strattice mesh complications prior to her surgery..

“There are at least 450 MDRs from September 1, 1990, through September 30, 2020 involving Strattice. Six reports involve death,” the lawsuit indicates, stating that another 340 reports involved injuries and 107 involved mesh malfunctions. “Had Defendants conducted proper pre and post market testing, designed, manufactured, promoted, marketed, and managed the product properly, Plaintiff would not have been injured.”

January 2023 Strattice Pig Skin Mesh Lawsuit Update

LifeCell faces dozens of similar lawsuits over Strattice pig skin mesh filed in the federal court system. However, the majority of the litigation is currently pending in the state court of New Jersey, where the company’s U.S. headquarters are located.

Since June 2021, the state court Strattice mesh litigation brought in New Jersey has been centralized and consolidated before Superior Court Judge John C. Porto in Atlantic County, as part of a multicounty litigation (MCL), which is intended to reduce duplicative discovery and avoid conflicting pretrial rulings from different judges.

Similar to multidistrict litigations (MDLs) used at the federal level, consolidating the cases as part of a New Jersey MCL transferred claims pending throughout the state to Judge Porto for all pretrial proceedings. While each lawsuit remains an individual case, the Court will coordinate discovery into common issues in the claims and hold a series of early “bellwether” trials to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

In October 2022, Judge Proto indicated that the first Strattice mesh lawsuit will go before a jury in New Jersey state court on January 29, 2024. While the outcome of this early trial will not be binding on Zammito and other plaintiffs, it is expected to have a large impact on any settlements the manufacturer offers for individuals who experienced complications from the pig skin hernia mesh.