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Important Issues Highlighted Prior to Upcoming Bard Ventralex Hernia Mesh Bellwether Trial in March

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The second bellwether trial in the Multidistrict Litigation (MDL) concerning the Bard Ventralex hernia mesh is set to begin on March 21, 2022.  The judge overseeing the MDL and this pending trial issued an order in which he explained the plaintiff’s case in detail.  Some of these facts are peculiar to the individual plaintiff (Mr. Antonio Milanesi) while other matters are common to all those in the MDL.

The most important fact concerns knowledge the manufacturer of the Ventralex hernia mesh had related to the potential problems with the hernia mesh’s design.  This knowledge included the fact that the polypropylene resin oxidatively degrades in vivo and Bard knew about this as attested to in the  Material Safety Data Sheet  which noted that the polypropylene material should not be used for human implantation because it can oxidize in the body.

Second, Plaintiffs contend that the ePTFE layer contracts more quickly than the polypropylene, which in combination with the too-weak memory coil ring causes the device to fold or buckle or “potato chip”.  This in turn leads to the Ventralex patch pulling away from the abdominal wall exposing the polypropylene side to the bowel. 

Third, Plaintiffs argue that the ePTFE layer was prone to infection due to the ePTFE layer’s small pore size, which is big enough for bacteria to grow in but too small for white blood cells to enter to intercept the bacteria.  This can lead to infection as in the instant case with Antonio Milanesi.

The most damning fact in this case is that Bard’s own internal documents demonstrate they had knowledge of these issues and continued to sell the defective hernia mesh without notifying regulatory authorities or the public about them.

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