A product liability lawsuit has been filed over problems with LifeCell Strattice hernia mesh, which is a surgical patch derived from pig tissue, after it allegedly became infected and failed following a hernia repair, resulting in serious injuries and the need for additional surgery to remove the biologic hernia mesh.

The complaint (PDF) was filed by Linda Lowry in the New Jersey Superior Court on December 23, indicating Allergan, Inc. and its LifeCell Corporation subsidiary designed, manufactured and sold Strattice mesh products defectively designed and which posed an unreasonable risk of complications and failure.

Lowry, of Texas, underwent ventral hernia repair surgery in July 2018, at which time she was implanted with a Lifecell Strattice Surgical Mesh product. However, in December of that same year doctors determined she had an infected mesh in her body, and a month later she was also diagnosed with a chronic abdominal wall abscess, leading to doctors surgically removing the failed biologic mesh.

The LifeCell Strattice surgical mesh was first introduced to the market in 2008. It is constructed from pig 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 been linked to a risk of foreign body response, according to Lowry’s complaint.

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 knew or should have known the product was dangerous and would injure patients, including in the ways Plaintiff was injured,” the lawsuit states. “Had Defendants conducted proper pre and post market testing, designed, manufactured, promoted, marketed, and managed the product properly, Plaintiff would not have been injured.”

Lowry presents claims of defective design, failure to warn, negligence, negligent misrepresentation, fraud, breach of warranty, and violation of consumer protection laws. She is seeking both compensatory and punitive damages.

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 that similar risks are also faced by the design of this biologic product.