Biologic Hernia Mesh Lawsuit Filed Over Complications Following Failure of Lifecell Strattice “Pig Skin” Implant

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.

5 Comments

  • AnandaJune 3, 2022 at 6:30 pm

    Hi, I’m a 47 y.o. female. I had biologic mesh implanted in an abdominal wall reconstructive procedure in 2018. I was back with a hematoma two weeks after. Previous to that, I had 6 prior incisional/ventral hernia repair procedures, dating back to 2006. My first hernia repair procedure in 2006 included implantation of polypropylene mesh. This mesh is now in recall. In 2021 I found out I have sever[Show More]Hi, I’m a 47 y.o. female. I had biologic mesh implanted in an abdominal wall reconstructive procedure in 2018. I was back with a hematoma two weeks after. Previous to that, I had 6 prior incisional/ventral hernia repair procedures, dating back to 2006. My first hernia repair procedure in 2006 included implantation of polypropylene mesh. This mesh is now in recall. In 2021 I found out I have several inflammatory diseases in my digestive organs, as well as an enlarged liver. And a mast cell disorder. And musculoskeletal problems that have landed me in a wheelchair. I believe the porcine mesh is responsible for the mast cell disorder, and the mast cell disorder is responsible for the visceral diseases and the foreign body reaction that I believe is the systemic mast cell disorder. Since no one wants to be accountable for diagnosis and correlation of the mesh complications, I get treated as though this is hereditary or a result of my age and lifestyle?! It’s not. It’s the porcine biological mesh. I now also have rheumatological issues because of this. I still get treated as “routine” patient and am stuck in a track of symptom management instead of chronic disease management. I cannot have the mesh removed, that procedure has a high level of morbidity in my case. I have no one to help me.

  • SueJune 2, 2022 at 8:24 am

    I had rectal cancer and ended up with a colostomy in 2015, in 2016 I developed a hernia and had it repaired at that time I did not know they were using pig skin. Almost a year later to the day, the hernia repaired failed and now I have what appears to be a head trying to protrude from my stomach . Not only is it embarrassing but it’s uncomfortable and they say that they can’t repair it.

  • amandaMay 18, 2022 at 1:50 pm

    my father had hernia mesh repair 2013 and he died not even hours later. i wish there was sonething i could do for them taking my father from me. until this day i dont know what happen to him on the death cert. it has no cause

  • MelissaSeptember 30, 2021 at 7:36 pm

    My husband had this mesh used to put his abdomen back together after pancreatitis. He ended up almost dying from infection in his abdomen- I heard his primary surgeon( who was out of town and didn’t do the surgery) say “ you got all that mesh out didn’t you?” They didn’t know I could hear them. He ended up with 3 more surgeries.

  • AREALETHEApril 19, 2021 at 8:40 am

    What is the statue of limitation for this type surgery using pig skin mesh? Mine was in 2016 ...and, do I have to had revision surgery. Its recommended because of hernia recurrence, pain, scar tissue and deformity. Unable to schedule surgery due to pandemic.

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