The much anticipated hernia mesh trial involving Bard subsidiary Davol has settled on the eve of trial. The plaintiff in the case had been implanted with Ventralex six years earlier to repair an umbilical hernia. He claims he was not informed of the risks associated with the polypropylene (PP) mesh implant.
In spite of the litigation and the settlement, Ventralex is still on the market as is the Ventralex ST Hernia Patch.
Ventralex is a polypropylene product which is what most hernia mesh medical devices are made from.
It has two layers of polypropylene (PP) mesh on one side and an expanded layer of polytetrafluoroethylene (ePTFE) on the other.
That coated side is supposed to face the intestines. PP mesh has been known to entangle and/or perforate the intestines and bowel causing sepsis and death so avoiding perforating the intestine is important.
You may know PTFE, a thermoplastic polymer, as the formula of Teflon cookware with its non-stick coating because of its high heat resistance, (see the history of Teflon). The “e” means that ePTFE is softer and requires support.
In addition, Ventralex contains an ePTFE memory recoil ring which opens up once its inside the body, theoretically flattening the mesh into place.
Ventralex was designed to be a permanent implant but over time complications have arisen in many mesh patients that require complex and often unsuccessful revision surgery. Earlier versions of mesh products were designed to be temporary and were made of animal byproducts that were designed to be absorbed into the body. There were very few complications from these earlier non-permanent medical devices.
In the early 2000's the new, supposedly better polypropylene product was introduced to the market place to much fanfare. Since that time, medical device companies selling these new mesh products have faced waves of lawsuits.