The Bard Sepramesh IP is an implantable medical device made by the company C.R. Bard that is used to treat hernias. However, the materials used in the implant can be defective and can cause serious harm to patients: The plastic mesh is known to erode after implantation, causing chronic pain and other medical complications. Meanwhile, the absorbable lipid coating can cause chronic inflammation and infections. These conditions have made the Bard Sepramesh IP device the subject of countless hernia mesh lawsuits.
- 1. The Bard Sepramesh IP
- 2. How to identify a Sepramesh IP
- 3. Why the Sepramesh IP is defective
- 4. No recalls for the Bard Sepramesh IP
1. The Bard Sepramesh IP
The Bard Sepramesh IP is one of C.R. Bard’s newer hernia mesh products. One face of the implant is made of a plastic polypropylene mesh, while the other is made of a hydrogel safety coating that is supposed to get absorbed in the body over time.
The Sepramesh IP mesh is designed for use in hernia operations. Once surgeons have pushed the herniating tissue back through the weakened muscle, they can implant a Bard Sepramesh IP device with the plastic mesh facing towards the hernia location. The plastic mesh is designed to create scar tissue that forms ingrowth between the mesh’s threads, fusing the Sepramesh to the tissue and strengthening the muscle. The hydrogel coating is designed to prevent tissue on the other side of the Sepramesh IP from sticking to it and creating an unwanted fistula.
2. How to identify a Sepramesh IP
The Bard Sepramesh IP has several characteristics that can be used to distinguish it from other hernia mesh devices:
- It is bluish in color, and
- It has two distinct sides – one with plastic mesh, the other made from a smooth fabric material.
While the Sepramesh is rectangular in shape in the box, it is designed to be cut to appropriate size and shape before insertion.
The Sepramesh can also be identified using its product identification number, which depends on the size of the implant1:
|3 x 6 inches||5959360|
|4 x 8 inches||5959480|
|6 x 8 inches||5959680|
|8 x 12 inches||5959812|
|12 x 14 inches||5959124|
3. Why the Sepramesh IP is defective
Both of the materials that make up the Bard Sepramesh IP have problems that can cause significant medical complications in the patients who have had them implanted.
The plastic mesh that forms the face of the Sepramesh that goes towards the hernia location is made of a cheap plastic called polypropylene. Polypropylene slowly erodes when it comes into contact with oxygen, and a patient’s blood and tissues contain oxygen. When polypropylene erodes, it shrinks. This can cause problems when the Sepramesh device has already tightly fused to a patient’s tissues and muscles through the scar tissue and ingrowth that it has created. The shrinkage can cause tugging, which in turn can create discomfort and chronic pain if nerves have formed in the ingrowth.
Additionally, the absorbable hydrogel material on the outer face of the Sepramesh IP contains lipids that cause lots of inflammation after being implanted. The inflammation can be bad enough that it slows down the healing process and causes chronic infections in the area.
4. No recalls for the Bard Sepramesh IP
Unfortunately, neither Bard nor the U.S. Food and Drug Administration (FDA) has decided that these dangers have warranted a recall of the Bard Sepramesh IP. It is still in use to treat hernias, today.