Strattice Hernia Mesh Trial Preparation Underway

Jane Akre
October 17, 2022
from GD Medical

A New Jersey Superior Court will be the venue for the first trials of Strattice hernia mesh.

Expect the first case to be selected from a pool of six cases by the summer of next year to prepare for trials beginning in January 2024.

New Jersey Superior Court Judge John C. Porto in Atlantic County will coordinate the discovery and case management. [See ATL L 003857-21, Superior Court of New Jersey, Atlantic County]

Strattice, made by LifeCell Corporation (Allergan, Inc.), is headquartered in New Jersey, where multicounty litigation (MCL) was coordinated last year. It will be up to Judge Porto to schedule pretrial proceedings and the Strattice mesh jury trials or return them to their original venue.  

Up to six cases will be chosen as bellwether trials to test legal theories and determine the relative values of the litigation. Bellwethers often lead to settlement for the remainder of the filed cases.

Plaintiffs complain they suffered painful injuries from the LifeCell Strattice biologic patch, composed of pig skin (porcine) preserved in a phosphate-buffered aqueous solution that chemically links together proteins in the tissue.

Cross-linking a graft device is linked to a risk of foreign body response, among other complications.

Plaintiffs claim that the manufacturer knew it had problems with Strattice since 2010 after receiving multiple reports from patients who claimed their mesh was infected. 

A Science Day will be scheduled next spring in court to educate both sides about the issues involving Strattice.

The promotional material says the average explant rate for Strattice is 0.3% with no adhesion formation. The body reportedly accepts the tissue matrix through rapid revascularization, cell repopulation, and white cell migration.


Strattice Complications

The U.S. Food and Drug Administration received at least 450 adverse event reports on Strattice from September 1990 through September 2020. Among those reports were six patient deaths and 340 patient injuries. Many patients have had to undergo mesh removal.

Unlike other hernia mesh composed of polypropylene, an inexpensive plastic, Strattice is a biologic product cleared for market by the FDA in 2008.

Strattice is the first biologic hernia mesh to be litigated as a defective device.  

Other hernia mesh litigation involves the polypropylene Ethicon (Johnson & Johnson) Physiomesh, C.R. Bard hernia mesh, and Atrium C-Qur.



Multicounty Litigation Application



New Jersey courts Strattice Hernia Mesh

PMLive Allergan Buys Lifecell for $2.9B$2.9bn_1182827

FDA 510 (k) Clearance 2008

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