The Bard Ventralex and the Bard Ventralex ST are implantable medical devices made by the company C.R. Bard for hernia procedures and treatment. However, they have been connected to patients suffering from chronic pain and other medical complications when the plastic mesh in the device erodes after implantation. Hundreds of hernia mesh lawsuits have been filed against Bard as a result.
- 1. The Bard Ventralex and Ventralex ST
- 2. Identifying a Bard Ventralex or Bard Ventralex ST device
- 3. Defects in the Bard Ventralex hernia mesh implants
- 4. No recall for the Ventralex
1. The Bard Ventralex and Ventralex ST
Bard’s Ventralex and Ventralex ST hernia mesh implants most frequently used for umbilical hernias. Both devices are made of plastic mesh that is designed to create scar tissue on the muscle that permitted the hernia. They also both contain a ring of SorbaFlex Memory material near their circumference.
The Ventralex device also contains a layer of expanded PTFE, or ePTFE, material that is supposed to reduce friction with other tissues and minimize scar tissue on the exposed side of the device.
The Ventralex ST implant, on the other hand, contains a hydrogel layer of Bard’s Sepra material. This hydrogel is also meant to reduce the scar tissue that forms on the exposed side of the Ventralex implant. However, unlike the ePTFE material used on the basic Ventralex device, the hydrogel on the ST model is designed to get absorbed in the body within a month.
Both Ventralex devices are used by surgeons to repair hernias, which are tissues that have pushed through weakened muscular walls and into areas of the body they are not supposed to be. After making an incision and correcting the hernia, a surgeon folds a Ventralex implant and pushes it through the incision to the location of the hernia. Once released inside, the ring of SorbaFlex Memory material inflates the device to its prior flattened shape.
This SorbaFlex Memory material is made to absorb in the body in six to eight months. However, the SorbaFlex material replaced a permanent plastic ring that was used in Ventralex devices until at least 2014.
Once the surgeon has positioned the Vertralex device over the hernia and closed the incision, the plastic mesh on the implant creates scar tissue on the weakened muscle that allowed the hernia. The scar tissue grows into the spaces between the threads of the mesh, fusing the implant to the muscle. The device can then support and strengthen the muscle and prevent future hernias.
2. Identifying a Bard Ventralex or Bard Ventralex ST device
You can tell if your hernia mesh implant is a Bard Ventralex or Ventralex ST using the following clues:
- The device is circular,
- It has a ring of soft but responsive material on one face of the device, near the outside edge (this ring may have absorbed, if the device has been implanted over six months ago),
- If there is a layer of smooth bluish fabric made of plastic, the device is a Ventralex ST,
- If there is a layer of white plastic fabric in the device, it is a Bard Ventralex implant,
- If there is no layer of fabric-like material, then it is likely a Venetralex ST device whose hydrogel layer has been fully absorbed,
- There are straps of plastic mesh protruding from the exposed side of the device, and
- The mesh on the exposed side of the device has a tear across the diameter.
Both devices can also be identified with a product number.
The Bard Ventralex product numbers are based on the device’s size1:
|1.7 x 1.7 inches||0010301|
|2.5 x 2.5 inches||0010302|
|3.2 x 3.2 inches||0010303|
The product numbers for the Bard Ventralex ST device also depend on the size of the implant2:
|1.7 x 1.7 inches||5950007|
|2.5 x 2.5 inches||5950008|
|3.2 x 3.2 inches||5950009|
3. Defects in the Bard Ventralex hernia mesh implants
The Bard Ventralex and Ventralex ST devices are defective because of their reliance on a plastic mesh that is made of polypropylene. Polypropylene deteriorates in oxygen, and a patient’s blood and tissues contain oxygen. When polypropylene deteriorates, it shrinks. Because the mesh is designed to create scar tissue and ingrowth, when it shrinks it pulls on the tissues that it has adhered to since being implanted. This creates chronic pain and discomfort, especially if nerves have formed in the ingrowth.
In some cases, the polypropylene mesh can erode and shrink so much that it pulls away from the tissues that it has adhered to. When the device tears away, it can create severe pain and significant medical complications as the muscle loses strength and the device migrates inside the body.
Additionally, the Ventralex implant used to use a permanent plastic ring, rather than one made of SorbaFlex Memory material. This plastic ring allowed surgeons to insert the device through a smaller incision by folding the device prior to insertion. Once released, the plastic ring would spring the Ventralex implant back to its original size and shape. However, the plastic ring could break under the pressure caused by the shrinking polypropylene mesh that surrounded it. If broken, the ring could impale or perforate tissues or organs in the patient.
4. No recall for the Ventralex
Neither Bard nor the U.S. Food and Drug Administration (FDA) has recalled the Ventralex or the Ventralex ST. The closest thing to recall has been Bard’s decision to replace the plastic ring with SorbaFlex Memory material – a decision that has been referred to as a “silent recall” that acknowledges the dangers presented by the product’s earlier design.
- Bard Ventralex Product Description.
- Bard Ventralex ST Product Description.