C.R. Bard, Inc. (Davol) is a worldwide leader in the $600 million-dollar hernia mesh industry. They maintain one of the broadest and deepest product lines in the industry and they are a major profit source for the company making up 17% of its net total sales. Much of their market share success is the result of their innovative marketing programs that consist of surgeon training and patient education and awareness.
Many of Bard’s products use heavyweight mesh combined with Polytetrafluoroethylene (ePTFE). The intended goal of heavyweight mesh is to achieve maximum stability by closing the defect with a stiff device that maximizes scar tissue. However, physiologically the mechanical stability of heavyweight mesh it too high, exceeding that of the abdominal wall. Consequently, it results in fibrosis and leads to stiffening of the implant as oppose to increased mechanical stability. This, along with its smaller pore size causes a greater inflammatory response and exposes patients to unnecessary risks, such as greater scar tissue formation, decreased graft compliance, decreased tissue incorporation, increased graft shrinkage and increased pain and discomfort. Some animal studies have found the graft shrinkage with this type of heavyweight mesh to be greater than 50%.
Additionally, the type of polypropylene mesh that Bard uses is not intended for medical application. Different companies supply polypropylene material that is used in hernia mesh implants. Bard gets its polypropylene from the Phillips Sumika Polypropylene Company. Phillips Sumika provides a medical application caution along with its polypropylene. It specifically warns against using its material in medical applications involving permanent implantation in the human body or permanent contact with internal bodily fluids or tissues. The Phillips Sumika safety data sheet states that its polypropylene material should not be used in human implants unless it has been provided directly form the company under an agreement which expressly acknowledges such contemplated use.
In addition to being made from these harmful materials, a number of Bard implants are accompanied with specific selling features that can be harmful. For instance, Bard Kugel patches, which were FDA cleared in 2002, have memory coil rings that allow the patch to be folded and inserted through a small abdominal incision and, once in place, they spring open helping the mesh lay flat over the affected area. However, this design has been associated with many problems such as the rings buckling and rupturing. Shrinkage and migration of this mesh is also a common problem that has been reported. Another poorly designed Bard product is their Composix E/X and Composix mesh. This implant consists of two distinct sides, one that is polypropylene (PP) and the other that is ePTFE. This product is associated with a high rate of adhesions for several reasons. One, the heavy weighted PP induces a large inflammatory process that leads to fibrosis. Further, this mesh cannot be cut without widely exposing the PP layer. In addition, the holes in the ePTFE side of the mesh made by the stiches create adhesions. Bard’s Ventralex product, which was also cleared by the FDA in 2002, has similar design problems as described with its Composix products. The heavyweight PP and the ePTFE are mismatched materials because they contract at different rates making them mechanically incompatible. All of these design flaws lead to further complications and often times require the patient to undergo additional surgeries.
Goldman, Scarlato & Penny are investigating the following Bard/Davol mesh products:
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