Biologic Hernia Mesh Linked To Increased Risk of Hernia Recurrence, Study Warns

The findings of a new study suggest there are higher rates of hernia recurrence and complications with biologic hernia mesh products when compared to synthetic counterparts.

Biologic hernia mesh, or biomesh, is a type of surgical repair mesh made from organic material, such as pig skin, human cadaver skin or other materials, which is promoted as a way to reduce the risk of hernia repair infections associated with synthetic mesh. However, biologic hernia mesh is often substantially more expensive, and there remain many open questions about the clinical effectiveness.

In a report published last week in the medical journal JAMA Surgery, researchers with the Cleveland Clinic found that biologic mesh had a hernia recurrence rate of more than 20%, compared to just under 6% among patients who received synthetic hernia mesh implants at two years following surgery.

The findings come as a growing number of biologic hernia mesh lawsuits are now being filed against the makers of Lifecell Strattice mesh, and other products, alleging that the cross-linked graft device has caused users to experience foreign body responses, infections and other complications, often resulting in the need for risk hernia revision surgery.

To compare the rate of hernia recurrence between biologic and synthetic mesh in this new study, researchers conducted a multicenter, single-blinded randomized clinical trial from December 2012 to April 2019, with a follow-up duration of two years. The study involved 253 patients with a median age of 64. Half were implanted with a synthetic mesh and the other half with a biologic mesh.

According to the researchers, synthetic mesh, which is 200 times cheaper, had only 31% of the rate of hernia recurrence as biologic mesh after two years. The recurrence risk with biologic mesh was 20.5%, compared to only 5.6% recurrence among patients with synthetic mesh implants. The average biologic mesh cost $21,539, while the average synthetic mesh cost only $105, the researchers noted.

“Synthetic mesh demonstrated superior 2-year hernia recurrence risk compared with biologic mesh in patients undergoing single-stage repair of contaminated ventral hernias, and both meshes demonstrated similar safety profiles,” the researchers concluded. “The price of biologic mesh was over 200 times that of synthetic mesh for these outcomes.”

Biologic hernia mesh products like the Strattice tissue matrix, which is often referred to as pig skin hernia mesh, is designed to chemically link the proteins in the tissue together. However, the cross-linking mesh has been tied to reports of painful and debilitating complications after the biologic mesh was used during a hernia repair.

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.

Given common questions raised in Strattice mesh lawsuits brought throughout the state of New Jersey, where the manufacturer’s U.S. headquarters are based, centralized pretrial proceedings were established before New Jersey Superior Court Judge John C. Porto in Atlantic County in October, which is intended to reduce duplicative discovery and avoid conflicting pretrial rulings from different judges.