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A product liability lawsuit filed over problems with LifeCell Strattice hernia mesh, indicates the biologic product made from pig skin failed after a hernia repair, causing a severe infection and additional surgery to remove the implant a few years later.
The complaint (PDF) was filed last week in New Jersey by Donna Jo, on behalf of the estate of Dale Koskinen, who died in March 2019 due to a recurrent complex ventral hernia, aspiration pneumonia and adult respiratory distress syndrome.
Koskinen was implanted with a Strattice Reconstructive Tissue Matrix mesh in June 2010, as part of a recurrent incisional hernia repair procedure. The Strattice is a xenograft hernia mesh, meaning it uses animal-based tissue matrices, specifically pig tissue.
The LifeCell Strattice “pig mesh” was first introduced to the market in 2008. It is constructed from porcine skin and preserved in a phosphate buffered aqueous solution. It is known as a cross-linked graft device, which is designed to chemically link the proteins in the tissue together. However, cross-linking has also been linked to a risk of foreign body response, according to the complaint.
As a result of complications with the Strattice biologic mesh, Koshiken had to undergo additional surgeries, including revision surgery due to recurring hernia problems. In March 2017, he returned to the hospital due to infection and had the hernia mesh removed.
The lawsuit presents claims against Lifecell Corporation and Allergan, Inc., as defendants, indicating the manufacturers knew about problems with the biologic hernia mesh since at least 2010, after receiving a number of reports involving doctors having to remove infected and failed Strattice mesh from patients.
The Lifecell Strattice mesh lawsuit alleges the manufacturers have known about problems hernia patch design since at least 2010, after receiving a number of reports of doctors having to remove failed and infected mesh from patients.
From September 1990 through September 2020 the FDA received at least 450 Medical Device Reports (MDRs) linked to problems with the Strattice mesh, the lawsuit states. Six of those reports included patient deaths, more than 340 were injury reports, and at least 107 indicated malfunctions of the mesh.
“Defendants understood that surgeons were using Strattice to reinforce tissue where weakness exists, including hernia and body wall defects with multiple comorbidities and prior hernia repair surgeries,” the lawsuit states. “Defendants failed to disclose that its product did not meet these needs as expected.”
While thousands of hernia mesh lawsuits are currently pending in courts nationwide, those complaints have largely involved polypropylene and other synthetic material designs. The lawsuit over Lifecell Strattice mesh suggests similar risks are also faced by the design of this biologic product.