Summary
This article outlines how the first trials relating to harm caused by the LifeCell Strattice biologic patch will proceed. The Strattice patch is a form of surgical mesh used to treat hernias, but unlike other polypropylene mesh devices, it is composed of pig skin preserved in a solution that chemically links together proteins in the tissue. Patients involved in the US litigation complain that they suffered painful injuries from the Strattice patch. They claim that the manufacturer knew it had problems following multiple reports from patients, but failed to act to stop its use.
The US Food and Drug Administration (FDA) received at least 450 adverse event reports on Strattice from September 1990 until September 2020. Among those reports were six patient deaths and 340 patient injuries, and many patients have had to undergo mesh removal.
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