Strattice Mesh Complications Resulted In Hernia Revision Surgery, Lawsuit Alleges

The manufacturer received hundreds of injury reports linked to the Strattice mesh years before the plaintiff was implanted with one that ultimately failed, requiring revision surgery, the lawsuit claims.

A Missouri woman claims she suffered painful and disfiguring Strattice hernia mesh complications, which required her to undergo revision surgery to have the failed biologic patch removed less than two years after it was used during a hernia repair.

The complaint (PDF) was filed by Karlin R. Bennett in the U.S District Court for the District of New Jersey on January 21, indicating that LifeCell Corporation and Allergan, Inc. designed a defective hernia mesh product, and then doubled down on the mistake by failing to warn patients or the medical community of the risks.

LifeCell’s 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 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 Strattice mesh lawsuits now being filed by individuals who received the product.

According to the lawsuit, Bennett underwent hernia repair surgery in January 2012, at which time she was implanted with a Lifecell Strattice mesh. However, by October 2013, she had to undergo revision surgery to have the Strattice mesh removed after experiencing severe pain and other complications.

The lawsuit notes the manufacturers received numerous medical device reports (MDRs) on the Strattice mesh, but failed to act or add additional label warnings. Bennett indicates the defendants received at least 450 MDRs on Strattice mesh complications between September 1, 1990 and September 30, 2020. More than 340 of those were injury reports, with 107 classified as Strattice mesh malfunctions, and six involving fatal injuries.

“These reports include peer-reviewed studies reported in scientific journals. Defendants identified some of these articles while conducting literature reviews later in the product lifecycle,” the lawsuit notes. “Had Defendants conducted proper pre and post market testing, designed, manufactured, promoted, marketed, and managed the product properly, Plaintiff would not have been injured.”

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 lawsuits over hernia mesh filed in recent years over products made with polypropylene; a thermoplastic polymer. There are tens of thousands of Ethicon Physiomesh lawsuits, Atrium C-Qur mesh lawsuits, Bard hernia patch 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 product.