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Bard Rochester - 0123460 - Bard Composix Ellipse


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Polypropylene/ePTFE prosthesis for laparoscopic ventral hernia repair.
Healthcare Professional Downloads:
- Instructions for Use
INDICATIONS
Bard Composix E/X Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.
CONTRAINDICATIONS
- Literature reports there may be a possibility for adhesion formation when the polypropylene is placed in direct contact with the bowel or viscera.
- Do not use the Bard Composix E/X Mesh, in infants or children whereby future growth will be compromised by use of such material.
- Do not use Bard Composix E/X Mesh, for the reconstruction of cardiovascular defects.
WARNINGS
- Ensure proper orientation; the solid white surface (ePTFE) must be oriented against the bowel or sensitive organs. Do not place the polypropylene mesh surface against the bowel or sensitive organs. There may be a possibility for adhesion formation when polypropylene mesh is placed in direct contact with the bowel or viscera.
- If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device.
PRECAUTIONS
DAVOL fixation devices or nonabsorbable monofilament sutures are recommended to properly secure the prosthesis. If other fixation devices are used, they must be indicated for use in hernia repair. Care should be taken to ensure that the prosthesis is adequately fixated to the abdominal wall. If necessary, additional fasteners and/or sutures should be used.
ADVERSE REACTIONS
Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation and recurrence of the hernia or soft tissue defect.
Please consult package insert for more detailed safety information and instructions for use.
DAV/CPEX/0917/002
Features
- Two distinctly different sides:
- Polypropylene Bard mesh provides optimal tissue ingrowth
- Robust sub-micronic ePTFE permanent barrier minimizes adhesions to the prosthesis or mesh erosion into viscera
- Elliptically shaped design reduces the need to trim the mesh, saving time
- Low profile mesh that is easy to manipulate for open repairs and to deploy for laparoscopic repairs
- Monofilament PTFE stitches minimize the risk of adhesions to the prosthesis
- Sealed edges provide an overhang of ePTFE without compromising the polypropylene Bard Mesh side
Manufacturer | Bard Rochester |
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Code | 0123460 |
Sold By | Each |
HCPCS | - |
Product Size | 4" X 6" |
WHSXX | GES |