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Bard Ventralex Hernia Patch Mesh Trial Set to Start on January 10th

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

The Hernia Mesh Litigation filed by Antonio Milanesi and Alicia Morz De Milanesi is scheduled to begin this Monday on January 10th. The trial is set to take place before Judge Edmund A. Sargus in the Southern District Court of Ohio. Our firm is following this trial closely as we have significant Bard Hernia mesh cases filed in the same court.

Antonio Milanesi’s lawsuit is the second bellwether trial selected among 14,295 others filed in the Ohio multidistrict litigation against Bard. An additional 14,000 similar cases are currently pending in Rhode Island’s state court.

Antonio Milanesi’s litigation is the first case surrounding Ventralex, one of the many types of hernia meshes produced by Bard.

Mr. Milanesi had the Ventralex Hernia Patch mesh implanted on July 11, 2007, at Sacred Heart Hospital in Pensacola, Florida. He stated that neither he nor his surgeon, Dr. Karanbir Gill, was informed of any known complications associated with Ventralex.

Mr. Milanesi underwent the initial surgery to repair an approximately two-centimeter umbilical hernia. Dr. Karanbir Gill decided to use a large Ventralex patch for the repair because there was “undue tension”, and he was unable to do a primary repair.

Ten years later on May 26th, 2017, Mr. Milanesi was subject to another surgery performed by Dr. Caluda to remove the infected Ventralex in addition to a small bowel fistula. He wrote in his operative notes that he had discovered “purulent material”, and that “a loop of the small bowel was densely adherent to the overlying mesh and an erosion of the bowel was evident into an abscess cavity involving a portion of the mesh, which had turned to expose the polypropylene to the bowel at some point, causing an area of adherence”.

Dr. Caluda further explained that there was “an opening in the abdominal wall fascia which could be construed as a recurrent hernia but more accurately should be described as part of the infectious process in the small intestinal fistula which had eroded from the abdominal cavity into the subcutaneous space”. The “purulent material resulted from intestinal contents contacting tissues where they do not belong”.

Dr. Caluda was able to remove the infected Ventralex from Mr. Milanesi’s abdominal wall and resected the bowel, ultimately removing nine centimeters of Mr. Milanesi’s small intestine.

Dr. Caluda described the removed Ventralex mesh as “distorted”, “firm”, “not pliable”, and in a buckling” shape.

Several days later, Mr. Milanesi returned for emergency surgery to repair a high-grade small bowel obstruction. Dr. Caluda was able to successfully remove the adhesions.

Afterward, Mr. Milanesi developed recurrent incisional abdominal wall hernias near his previous sites of surgery. The hernia defects were two and three centimeters large respectively. Both Dr. Caluda and a surgeon who performed a second opinion recommended an additional surgical repair.

The Ventralex Hernia Patch Mesh was cleared by the FDA on July 16th, 2002. Bard claims that the Ventralex Mesh is “substantially equivalent” to the Bard Composix Kugel Mesh Patch, which contains the same memory recoil ring. Bard settled 2,600 Kugel Mesh defective product cases for $184 million in 2013.

Ventralex Mesh contains two layers of polypropylene mesh and a memory recoil ring component which is left implanted alongside the polypropylene mesh. In this case, Mr. Milanesi stated that the ring was used to place the mesh, however the presence of the ring can cause the mesh to deform and buckle, resulting in the ring breaking. When this happens, Bowel perforations are likely to occur.

The plaintiffs point to three specific product design defect issues with Ventralex.

  • The polypropylene resin oxidatively degrades in vivo.
  • The ePTFE layer contracts more than the polypropylene which in combination with the weakened memory coil ring causes the device to buckle.
  • The ePTFE layer was prone to infection due to the layer’s small pore size, which allowed bacteria to grow but did not permit white blood cells to enter in order to intercept the bacteria.

Ventralex is similar to Bard’s three other products that are the subject of defective product claims – Ventralight ST, Prefix, and 3D Max.

Here at Rheingold Giuffra Ruffo Plotkin & Hellman LLP, we regularly represent hundreds of hernia mesh victims with medical complications like this.

If you or someone you know has suffered complications from hernia mesh, contact the New York product liability lawyers at Rheingold Giuffra Ruffo Plotkin & Hellman LLP for help exploring your legal options.

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