Strattice Mesh Lawsuit Filed Over Complications From Biologic Graft Hernia Repair
According to allegations raised in a recently filed product liability lawsuit, the LifeCell Strattice biologic graft is defective and unreasonably dangerous, causing a painful and disfiguring hernia mesh complications when the implant failed and had to be surgically removed.
The complaint (PDF) was filed by Robert Sandoval in the Superior Court of New Jersey for Morris County on September 9, naming LifeCell Corporation and Allergan as defendants, for manufacturing and selling the Strattice mesh without disclosing problems with the biologic graft used for hernia repairs.
LifeCell Strattice mesh was first introduced to the market in 2008, as an alternative to synthetic mesh, since 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 and infections, according to allegations raised in a growing number of Strattice mesh lawsuits now being filed by individuals who received the product.
According to the lawsuit, Sandoval was implanted with Strattice Mesh during hernia repair surgery in December 2008. However, nearly 10 years later, he was hospitalized with infected mesh, after the biologic graft failed. As a result, doctors had to remove the hernia mesh, causing him to suffer severe physical injury, pain and suffering, as well as leaving him with permanent disfigurement.
A number of similar lawsuits have been filed over the past few years, which claim the manufacturer knew about problems with the Strattice mesh design since at least 2010, after receiving a number of reports of doctors having to remove failed and infected mesh from patients.
“Defendants failed to design, manufacture, market, promote, and manage the product post-market in a reasonable, safe manner, “Sandoval’s lawsuit states. “Defendants knew or should have known the product was dangerous and would injure patients, including in the ways Plaintiff was injured.”
From September 1990 through September 2020 the FDA received at least 450 Medical Device Reports (MDRs) linked to problems with the Strattice mesh. Six of those reports included patient deaths, more than 340 were injury reports, and at least 107 indicated malfunctions of the mesh.
In June 2021, several plaintiffs proposed that all Strattice Mesh lawsuits should be consolidated before one judge in New Jersey state court, for pretrial proceedings as part of a multi-county litigation (MCL).
Similar to multidistrict litigations (MDLs) used at the federal level, consolidating the cases as part of a New Jersey MCL would transfer claims pending throughout the state to one judge 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.
TerryNovember 19, 2022 at 6:13 pm
My wife had a hernia repair using a STRATTICE mesh performed on April 4, 2014 The product failed to perform and another hernia developed. It had to be surgically removed and replaced with another product. A week following that surgery (prior to hospital release) my wife died at age 58.
DianeSeptember 26, 2022 at 5:58 pm
I had removal of my hernia mesh in April 2021. My original surgery was 9/16. I had stomach pains and got to the point that it hurt to eat. I need a lawyer for the strattice mesh..
TheresaSeptember 23, 2022 at 11:23 pm
I have a broken strattice mesh which has caused a hernia under my stoma
ChrisAugust 1, 2022 at 1:37 pm
Sharon, I too am currently in Florida looking for a law firm to take a Strattice mesh lawsuit. I have had complications including suture granuloma, abdomen wall absessed, MRSA infection with wound vac and home care, and currently have infected Strattice mesh, and another hernia with absessed abdomen wall.
CandiJuly 21, 2022 at 3:12 pm
My husband went through this twice and it failed with so much infection and organ issues ( liver) abdominal adhesions and abscesses, which all had to be treated with long term antibiotics and some were given via picc line Iv for over a month 3 times a day one made especially for some of the infections he had.
SharonJune 8, 2022 at 3:11 pm
I am trying to find an attorney to handle a lifecell mesh implant in Florida. Was told by my emergency surgery surgeon my mesh could not be removed. I've suffered severe pain with additional surgeries to keep infections in check. Is there any help out there before I surcum to one of these lifecell, pigskin complications.. In Florida .
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