MDs are not trained in plastic science. They cannot opine on exactly why a mesh implant failed. A forensic plastics expert with a PhD and decades of manufacturing experience can prove why it failed — and that's what wins bellwether trials.
We analyze explanted mesh material to prove it has degraded and turned brittle. We extract residual antioxidant additives and show they have been depleted — the scientific smoking gun that proves the device was destined to fail.
Our forensic data determines the failure mode and proves the root cause of device failure. When defense experts claim 'PP is the gold standard material for medical implants', we can scientifically confirm or refute that claim through laboratory analysis.
If an expert report can only be understood by a PhD, the expert work is wasted. We use simple demonstrations and analogies so laypersons understand. Many trials have been won simply because one side did a better job helping the jury understand. After reading one of our expert reports, an Attorney commented "this is the first expert report that I have ever read that I can actually understand".
Implantation
Antioxidant additives begin to be extracted by body fluids
Months
Fibers turn brittle as antioxidant protection is depleted
1–3 Years
Mesh fragments into small pieces embedded in organs
Revision Surgery
Difficult removal — fragments ingrown into tissue cause organ damage
PP sutures were used as the predicate device argument. The problem: sutures are used for weeks — mesh implants are meant for years. The FDA accepted this flawed substantial equivalence argument.
"Biocompatible" simply means the plastic doesn't cause inflammation or infection at implantation. It does not address long-term degradation. Inflammation doesn't occur until after the mesh degrades and breaks into pieces — months later.
A large medical device company switched from a US supplier to a Chinese supplier — then repackaged the Chinese plastic to cover up the switch. This was done to save time and money, without re-testing the device.
When serving as an expert in class action and MDL litigations, it is critical to focus only on the science of the plastic and not wander outside your area of expertise. We recommend retaining complementary experts — regulatory compliance, biocompatibility — while we focus on plastic/polymer degradation science.
In mass tort litigation, you must prove that failures are widespread and systemic — not limited to isolated cases. This requires analysis of a statistically significant number of samples. Our laboratory is equipped to process high-volume sample analysis with scientifically proven and accepted methodology.
We use the KIS (Keep It Simple) principle. We take complex material failures and make them so simple that a jury can clearly see the manufacturer's negligence. Simple demonstrations and analogies explain highly technical issues so any layperson can understand.
