Ventrio and the VentrioST Hernia Patches - Litigation Update

The Ventrio and the VentrioST Hernia Patches are hernia mesh implants manufactured by C.R. Bard for use in hernia repair procedures. Patients who have had them implanted, though, have been known to suffer medical complications and chronic pain as the implant erodes. Hundreds of hernia mesh lawsuits have been filed over the injuries these implants have caused.

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1. Bard's Ventrio and VentrioST Hernia Patches

Bard's Ventrio Hernia Patch and its VentrioST Hernia Patch are devices that surgeons can implant to repair a hernia.

Hernias happen when internal muscles in the abdominal wall weaken so much that internal tissue can push part way through them. Surgeons fix this eruption of tissue by making an incision near the hernia and pushing the tissue back through the abdominal wall. Once this is done, surgeons can implant a hernia mesh device like the Ventrio or the VentrioST on the inside of the muscle where the eruption occurred.

The side of the Ventrio or VentrioST patch that faces outwards towards the weakened muscle is made of a mesh of plastic called polypropylene. Polypropylene mesh is designed to irritate the weakened muscle so it creates scar tissue. This scar tissue grows into the pores of the polypropylene mesh, incorporating the hernia patch into the muscle over time. To help the surgeon maneuver the patch into place over a hernia, there is a small slit in the polypropylene to accommodate a surgical tool.

On the Ventrio Hernia Patch model, the side of the implant that faces inwards towards the abdominal tissue is made of expanded polytetrafluoroethylene, or ePTFE. ePTFE is designed to prevent the polypropylene mesh from incorporating into internal tissues. This is why the ePTFE side of the Ventrio Hernia Patches extends further than the polypropylene mesh: It prevents tissues on the side of the implant from fusing, as well.

On the VentrioST Hernia Patch, the inward-facing side of the implant is made of a hydrogel safety coating that is based on Bard's Sepra technology and used in its Sepramesh IP hernia mesh model. This material is designed to keep the implant from adhering to other tissues inside the abdomen, but then get absorbed by the body once the device has incorporated to the weakened abdominal muscle.

On both Ventrio models, there is a ring of polydioxanone monofilament in between the polypropylene and either the Sepra material or the ePTFE layers. Polydioxanone is an absorbable material that can return to its original shape after it has been folded. Bard has trademarked the material as SorbaFlex. The SorbaFlex in the Ventrio and VentrioST implants allows surgeons to fold or roll the implant before inserting it through the incision. This allows the surgeon to make a smaller incision or even implant the device in a laparoscopic procedure.

2. Identifying a Bard Ventrio or VentrioST implant

The Bard Ventrio implant can be identified using the following clues:

  • It has been implanted between the abdominal wall and intestinal tissues, rather than between the abdominal wall and the skin,
  • The patch is either oval or circular,
  • One side of the patch is made of a white plastic mesh, while the other side is made of a smooth white fabric that feels like plastic,
  • There is a cut in the center of the plastic mesh that does not extend through the rest of the implant, and
  • The fabric side of the implant extends past the edge of the mesh side of the implant.

If the device was implanted within the past year, there may also be one or more darker rings visible on the side of the implant that is made of mesh. These are the SorbaFlex memory rings.

The Bard Ventrio can also be identified using the device's product number1:

Shape

Size

Product Number

Circular

3 inches diameter

0010213

Circular

4.5 inches diameter

0010214

Oval

3.1 inches x 4.7 inches

0010211

Oval

4.3 inches x 5.5 inches

0010215

Oval

5.4 inches x 7.0 inches

0010212

Oval

6.1 inches x 10.1 inches

0010219

Oval

7.7 inches x 9.7 inches

0010218

Oval

8.7 inches x 10.7 inches

0010216

Oval

10.8 inches x 13.7 inches

0010217

The Bard VentrioST implant can be identified with these clues:

  • The device was implanted on the inside of the abdominal wall rather than the outside of it, touching intestinal tissues rather than the inside of the skin,
  • It is either circular or oval,
  • The patch is a bluish color,
  • One side is made of plastic mesh, while the other side is made of a somewhat smooth fabric, and
  • There is a cut in the center of the mesh, though it does not penetrate the rest of the implant.

If the VentrioST was implanted more than a month ago, the smooth fabric side of the device may have already dissolved. If it was implanted more than a year ago, the SobraFlex memory rings between the two layers may also have dissolved.

Additionally, the product numbers for the Bard VentrioST implants depend on their size and shape2:

Shape

Size

Product Number

Circular

3 inches diameter

5950010

Circular

4.5 inches diameter

5950020

Oval

3.1 inches x 4.7 inches

5950030

Oval

4.3 inches x 5.5 inches

5950040

Oval

5.4 inches x 7.0 inches

5950050

Oval

7.7 inches x 9.7 inches

5950070

Oval

8.7 inches x 10.7 inches

5950080

Oval

10.8 inches x 13.7 inches

5950090

“Midline” Oval

6.1 inches x 10.1 inches

5950060

3. Why Bard's Ventrio and VentrioST Hernia Patches are defective

Both the Bard Ventrio and VentrioST implants are defective because the materials they use can all cause serious medical complications and pain.

3.1 Defects in the Bard Ventrio Hernia Patch

The Bard Ventrio is defective because both the polypropylene mesh and the ePTFE oxidize, erode, and shrink.

Polypropylene is a cheap type of plastic that was never meant to be implanted in the human body because it oxidizes, or deteriorates in the presence of oxygen. Even if polypropylene has been treated with an antioxidant, it will still erode over time; the antioxidant merely delays the deterioration process.

The polypropylene in hernia devices like the Ventrio, once implanted, are in constant contact with the oxygen in the bloodstream and the tissues it adheres to.

When polypropylene mesh erodes, it shrinks. As it shrinks, it pulls on the abdominal muscles that it has fused into, due to the scar tissue that the mesh has created. Constricting abdominal muscles can cause discomfort, as well as chronic pain if the ingrowth into the mesh's pores includes nerves.

If the polypropylene in the Bard Ventrio Hernia Patch shrinks enough, it can peel away from the abdominal wall and migrate elsewhere, potentially causing serious medical problems. Without the mesh implant, the scar tissue that it has created, and whatever muscle has peeled away with the migrating mesh, the abdominal wall will likely be left too weak to prevent another hernia.

Meanwhile, the ePTFE that forms the interior face of the Bard Ventrio Hernia Patch also oxidizes. However, the ePTFE erodes and shrinks at a faster pace than the polypropylene mesh. The shrinking ePTFE can deform the patch, pull the outsides of the implant away from the abdominal wall, and make the patch wrinkle, fold, and roll up on itself.

Together, the eroding ePTFE and polypropylene can create chronic pain and discomfort that can be exacerbated with certain movements, like walking.

Throughout this process, the large pores in the ePTFE plastic are breeding grounds for bacteria. This can cause chronic infection and inflammation at the point of the implant.

3.2 Defects in the Bard VentrioST Hernia Patch

The Bard VentrioST is also made of polypropylene, so it suffers from the same erosion, shrinking, and potential for chronic pain as the Bard Ventrio implant. However, the hydrogel coating that replaces the ePTFE has problems of its own.

The most serious problem with this hydrogel material is that it contains lipids that can drastically increase the amount of inflammation from the hernia repair procedure. This can both slow down the healing process and inflame internal and intestinal tissues, potentially causing medical complications. It can also cause chronic infection.

4. No recalls for the Ventrio Hernia Patch or the VentrioST Hernia Patch

Despite the potential problems caused by the implants, neither the Ventrio nor the VentrioST Hernia Patch has been recalled by Bard or the U.S. Food and Drug Administration (FDA) aside from a minor recall in 2010 related to a labeling error.3

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