Strattice Biological Mesh Failed After Hernia Surgery, Resulting in Need for Revision Surgery: Lawsuit

Manufacturers received hundreds of reports of problems where the Strattice biological mesh failed, but took no action to warn the public or recall the pig skin hernia mesh

According to allegations raised in a recently filed product liability, a Strattice biological mesh failed after hernia repair surgery, due to dangerous defects associated with the surgical mesh made from pig skin tissue.

The complaint (PDF) was filed in the U.S. District Court for the District of New Jersey on May 23, pursuing damages against Allergan, Inc. and Lifecell Corporation, indicating that manufacturers knew about problems with the Strattic hernia mesh for years, but failed to fix the design or recall the mesh from the market.

Strattice Reconstructive Tissue Matrix is a pig skin mesh product that was introduced in 2008, for use during hernia repair procedures.

The biological mesh is constructed from pig skin, and preserved in a phosphate buffered aqueous solution. It is known as a cross-linked graft device, which is intended to chemically link the proteins in the tissue together. However, cross-linking has been linked to a risk of foreign body response and infections, according to allegations raised in a growing number of lawsuits over infected Strattice mesh now being filed by individuals who received the product.

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Cases reviewed for problems with several types of hernia repair products.

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Cohn indicates she underwent hernia repair surgery in February 2013, at which time a Strattice hernia mesh product was placed in her body. However, the lawsuit notes the Strattice mesh failed less than two years later, requiring revision surgery to have it removed in October 2014.

The Strattice mesh failure and revision surgery left Cohn with permanent physical injuries and disfigurement, according to the lawsuit.

Cohn indicates Lifecell and Allergan knew about problems with the mesh for years, but failed to take any meaningful action or warn patients or the medical community about the potential risks.

“There are at least 450 MDFs (Medical Device Reports) from September 1, 1990, through September 30, 2020, involving Strattice. Six reports involve death,” Cohn’s lawsuit notes. “Over 340 of those reports are injury reports. At least another 107 were characterized as malfunction reports. These reports include peer-reviewed studies reported in scientific journals.”

Cohn says had the manufacturers tested and designed the devices properly, and marketed them truthfully, she would not have been injured.

In addition to a number of similar claims filed throughout the federal court system, Allergan and Lifecell face dozens of complaints brought in the state court of New Jersey, where the manufacturers’ U.S. headquarters are located.

Given common questions raised in complaints brought throughout the state, the Strattice mesh litigation was centralized and consolidated before New Jersey Superior Court Judge John C. Porto in Atlantic County in October, 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 likely schedule 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.

The allegations presented in the litigation are different than those raised in other hernia mesh lawsuits filed in recent years over products made with polypropylene; a thermoplastic polymer. There are tens of thousands of Bard hernia patch lawsuits, Ethicon Physiomesh lawsuitsAtrium C-Qur mesh lawsuits and similar claims alleging that design defects with the polypropylene products resulted in painful and complications. However, the Strattice mesh lawsuits allege that similar problems have been linked to this biologic pig skin mesh product.

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