Bard’s Composix E/X and Composix Kugel products are implantable hernia mesh devices made by C.R. Bard. They are designed to treat incisional hernias as well as inguinal hernias, and to minimize the consequences of the contact between the implant and the tissues it touches. The Kugel device was also designed to be folded for insertion so it could spring into place over the hernia area. This design is defective, though, and has caused serious complications and chronic pain when the plastic mesh erodes and breaks the metal ring that springs it back to its original shape. Both devices are the subject of numerous current hernia mesh lawsuits.
- 1. What are Bard Composix E/X and Bard Composix Kugel devices?
- 2. How to identify Bard’s Composix E/X and Composix Kugel devices
- 3. Defects in the Composix E/X and Composix Kugel implants
- 4. Recalls for Bard Composix E/X and Composix Kugel devices
1. What are Bard Composix E/X and Bard Composix Kugel devices?
The Bard Composix E/X and the Bard Composix Kugel devices are hernia mesh implants. They both look like oval-shaped pads. On the outer side of the pad is a plastic fiber cloth. On the inner side of the pad is plastic mesh made of polypropylene. Between the two sides of the Composix Kugel device is a circular metal ring that allows the device to be folded and then released into its original shape.
Both the Composix E/X and the Composix Kugel are used to treat incisional hernias and inguinal hernias.
Incisional hernias are eruptions of tissue through a muscle, often in the abdominal wall, that has been weakened from the incision of a prior surgery. Pressure from inside pushes tissue through the weakened muscle. The tissue then protrudes in a bubble on the wrong side of the muscle.
Inguinal hernias are hernias of tissue from the intestinal area into the inguinal canal, where the spermatic cord is located. The size and precise location of these hernias can cause infertility.
Bard’s Composix E/X and Composix Kugel devices are made to be implanted over these hernias. Surgeons make a small incision and push the hernia back through the weakened muscular wall. The surgeon then folds the pad-like device in half and pushes it through the incision. Once released inside the patient at the spot of the hernia, the metal ring inside the Composix Kugel implant springs the device back into its original circular or oval shape. The Composix E/X device can be crumpled and pushed through the incision, and then manipulated to cover the hernia location.
The design of the Composix E/X and Composix Kugel devices allow for a hernia surgery that requires only a small incision.
The side of the device with the polypropylene mesh faces inwards, towards the location of the hernia. The mesh creates scar tissue that coalesces with the threads of the mesh, strengthening the muscular wall.
The other side of the device faces outwards. It minimizes friction between other tissues and the mesh, and reduces the chances that the tissue facing the hernia will combine with the mesh to create a fistula.
2. How to identify Bard’s Composix E/X and Composix Kugel devices
Bard’s Composix E/X and Composix Kugel implants are different from other hernia mesh products in several ways:
- They both have a fibrous, cloth-like layer on the outside of the device to cover the mesh on the inside, and
- The Composix Kugel device has metal memory rings between the fibrous layer and the mesh.
The Bard Composix E/X device has the following product ID numbers, depending on the size and shape of the device1:
|4 x 6 inches||Elliptical||0123460|
|6 x 8 inches||Elliptical||0123680|
|7 x 9 inches||Elliptical||0123790|
|8 x 10 inches||Elliptical||0123810|
|10 x 13 inches||Elliptical||0123113|
|10 x 14 inches||Rectangular||0123114|
The Bard Composix Kugel device is no longer sold in the United States after being recalled in 2007.
3. Defects in the Composix E/X and Composix Kugel implants
Both the Composix E/X and Composix Kugel hernia mesh implants use polypropylene plastic threads to form the mesh. This type of plastic slowly erodes when it comes in contact with oxygen, including the oxygen in a patient’s tissues and blood. When it erodes, the mesh shrinks. This compromises both the tissues that it has attached to, as well as the rest of the implantable device.
These defects were especially problematic for the Bard Composix Kugel device. The shrinkage of the polypropylene plastic mesh put pressure on the metal ring between the two layers of the device. When this pressure overcame the ring, it would break – most frequently at the point where the ring was molded together. The ring would often break with enough force that it would pierce the Composix Kugel device and impale the patient.
However, the defects also compromised the effectiveness of Bard’s Composix E/X device, as well. The erosion and shrinkage of the polypropylene plastic mesh can tug on the muscles and tissues it was designed to protect, causing chronic pain and discomfort. Worse, the shrinkage can cause the mesh to tear off the muscles it was supposed to support, weakening the muscles and migrating elsewhere in the body.
4. Recalls for Bard Composix E/X and Composix Kugel devices
There has not yet been a recall for the Bard Composix E/X device.
Bard recalled its Composix Kugel implant in two separate recalls – one in February, 2006,2 and another in January, 2007.3