The Bard Composix L/P and the Bard Composix L/P with Echo are implantable hernia mesh devices. They are manufactured by the company C.R. Bard and are used during hernia repair surgeries. Patients who have had the Composix L/P and the Composix L/P with Echo, however, have been known to suffer chronic pain and other medical complications if their implant erodes. As a result, hundreds of hernia mesh lawsuits have been filed against Bard.
- 1. The Bard Composix L/P and Composix L/P with Echo
- 2. How to identify a Bard Composix L/P implant
- 3. Why is the Bard Composix L/P defective?
- 4. No meaningful recalls of Bard’s Composix L/P
1. The Bard Composix L/P and Composix L/P with Echo
The Composix L/P is one of Bard’s hernia mesh implant models. It can come with or without an Echo positioning system.
The Composix L/P mesh has two different sides. One side is made of a light polypropylene mesh. The other is made of expanded polytetrafluoroethylene, or ePTFE. The polypropylene side has a small border of ePTFE.
Both the standard Composix L/P and the Composix L/P with Echo models are used by surgeons to repair hernias, or internal tissues that have pushed through weakened muscles. After making a tiny, laparoscopic incision and correcting the hernia, surgeons can insert the Composix L/P hernia mesh through the incision to the spot of the hernia. Over time, the Composix L/P produces scar tissue on the weakened muscle. This scar tissue strengthens the muscle, and also grows into the pores of the mesh. As the mesh combines with the muscle, it strengthens it, as well.
The polypropylene side of the Composix L/P mesh is designed to quickly build scar tissue, so surgeons implant the device with the polypropylene side facing the muscle that permitted the hernia. The other side of the Composix L/P mesh is made of ePTFE, which is supposed to minimize scar tissue, muscular irritation, and ingrowth. It faces outward from the weakened muscle so tissues on the backside of the device do not stick to the implant.
The Composix L/P can come with an Echo Positioning System, or Echo PS. The Echo PS is a thin balloon attached to the ePTFE face of the Composix L/P implant. Once the implant is close to the site of the hernia, the balloon can be inflated to flatten the mesh. Once the surgeon has maneuvered the implant to the site of the hernia, the Echo PS is deflated and removed.
Bard estimates that the Echo PS can speed up the hernia procedure by 39%, and claims that it reduces the size of the necessary incision by allowing surgeons to roll up the mesh before implanting it.1
2. How to identify a Bard Composix L/P implant
The following clues can help you figure out if the implant you have received to treat your hernia is a Bard Composix L/P or a Composix L/P with Echo:
- The device has two sides: One made of plastic mesh, the other made of a plastic-feeling type of white fabric,
- The side with the plastic mesh is framed with a thin strip of the white fabric, and
- The plastic mesh is especially porous.
Product numbers for the Composix L/P depend on the shape and size of the implant, as well as on whether the implant came with an Echo PS or an optional “introducer tool” that is supposed to help surgeons insert the device through the incision2:
|Shape||Size||Includes Echo PS||Includes Introducer Tool||Product Number|
|Oval||6.2 x 10.2 inches||No||Yes||0134610|
|Elliptical||4.2 x 6.2 inches||No||No||0134460|
|Elliptical||6.2 x 8.2 inches||No||No||0134680|
|Elliptical||7.2 x 9.2 inches||No||Yes||0134790|
|Elliptical||8.2 x 10.2 inches||No||Yes||0134810|
|Elliptical||10.2 x 13.2 inches||No||Yes||0134113|
|Rectangular||10.2 x 14.2 inches||No||Yes||0134114|
|Oval||6.2 x 10.2 inches||Yes||No||0144610|
|Elliptical||6.2 x 8.2 inches||Yes||No||0144680|
|Elliptical||7.2 x 9.2 inches||Yes||No||0144790|
|Elliptical||8.2 x 10.2 inches||Yes||No||0144810|
|Elliptical||10.2 x 13.2 inches||Yes||No||0144113|
|Rectangular||10.2 x 14.2 inches||Yes||No||0144114|
3. Why is the Bard Composix L/P defective?
Bard Composix L/P hernia mesh implants are defective because both the polypropylene and the ePTFE deteriorate and erode in the body.
Polypropylene is a cheap type of plastic that oxidizes, or deteriorates when it comes into contact with oxygen. Of course, the blood and the muscles that hernia mesh implants touch everyday are rich in oxygen. Even if the polypropylene is treated with an antioxidant coating, it will still deteriorate over time.
When polypropylene deteriorates, it erodes and shrinks. Because the polypropylene in hernia mesh products like the Composix L/P is designed to irritate the underlying muscle to create scar tissue that then grows into the mesh’s pores, when the polypropylene erodes and shrinks, it tugs on the tissue that it has created. When the underlying muscle constricts because of the shrinking mesh, it creates discomfort. If nerves have grown into the mesh implant, it can lead to chronic pain.
If the polypropylene shrinks far enough, the whole mesh implant can tear away from the wall of the muscle it had adhered to. Not only can this be incredibly painful; it can drastically weaken the muscle, again, and lead to another hernia. The detached hernia mesh device can also migrate elsewhere in the body and create serious medical complications wherever it goes.
Additionally, ePTFE can erode and shrink after it has been implanted, too. ePTFE, though, shrinks at a faster rate than polypropylene. This can deform the mesh, causing it to fold and even roll up on itself. When this happens, it can cause chronic pain that can intermittently become severe. It can also make certain movements, including walking, incredibly painful as it feels like the implant has become sandpaper in your lower abdomen.
Worse, bacteria can grow easily and quickly in the pores of ePTFE, which can lead to serious and chronic infections.
4. No meaningful recalls of Bard’s Composix L/P
In spite of the risks that ePTFE and polypropylene pose, Bard has not issued a major recall of its hernia mesh devices and the U.S. Food and Drug Administration (FDA) has not forced them to take action. Instead, there were only been two minor recalls in 2014 over packaging problems.