Home > Products > Surgery & Tissue Repair > 2P Composite Mesh for surgical use
- Product Description
- Indications
- Contraindications and Warnings
- Use and Placement, Precautions, and Additional Inf
Description
Before use, carefully read the manufacturer’s instructions for use and follow all instructions provided.
This product is made of monofilament polypropylene and is intended for the repair of abdominal and abdominal cavity tissue defects.
2P-CMC-clear (Clear Mesh)
Indicated for the repair of abdominal tissue defects and incisional hernias. The mesh may be used in both laparoscopic and open abdominal
surgery.
2P-Plurimesh PCMC-clear (Polyvalent Clear Mesh)
Indicated for the repair of abdominal tissue defects caused by parastomal or incisional hernias. The mesh may be used in both laparoscopic
and open abdominal surgery. The PCMC mesh may be trimmed along the suture pad to the appropriate size for repair of the tissue defect.
Contraindications
There are no significant contraindications when the product is placed correctly using appropriate surgical techniques.
1. Do not place the product in direct contact with the intestines or other internal organs, as this may cause tissue adhesions.
2. Do not use in pediatric patients, as the material may interfere with tissue growth.
3. Do not place the product in infected or contaminated tissue.
Warnings
．For use only by trained healthcare professionals.．Exercise particular care during use to avoid compromising patient safety and health.
．The product is supplied sterile. Before use, inspect the packaging and ensure that the package seal is intact.
．he physician and surgical assistant must visually inspect the device’s sterilization indicator before use.
．Do not use if the packaging has been opened or damaged, as product integrity may be compromised.
．Do not use after the expiration date.
．The product is intended for single use in one patient only. Reuse may compromise its physical, chemical, biochemical, and structural
integrity.
．Ensure correct orientation and positioning of the product during surgery.
．Do not place the product in direct contact with the intestines or other internal organs, to avoid serious complications.
．Potential complications associated with use include bowel obstruction, adhesions, mesh extrusion, fistula formation, abscess
, hematoma, and inflammation.
．If infection occurs, removal of the product may be necessary.
．Select and position an appropriately sized mesh over the defect.
．Placement of this permanent mesh in an infected site may result in fistula formation and mesh extrusion.
Use and Placement
Correct orientation of the mesh is essential for its intended performance. The polypropylene film is intended to reduce the potential for
adhesions and should face the side where adhesion reduction is desired, toward the intestines and other internal organs.
The monofilament polypropylene mesh surface must not be placed in contact with the intestines or other visceral structures. It should face
the tissue where tissue ingrowth is desired.
Only the PCMC mesh may be trimmed to the required size with sharp scissors along the predefined cutting lines without separating the
mesh into two layers.
Precautions
1. Read the instructions for use carefully before use.2. Open the packaging under controlled conditions in the operating room.
3. Once the packaging has been opened, do not resterilize or reuse the product.
4. Store in a clean, dry environment, away from excessive heat and intense light.
5. Handle the product using sterile gloves and surgical instruments.
Adverse Reactions
Potential complications include bowel obstruction, adhesions, mesh extrusion, fistula formation, and abscess.
Sterilization
The product is intended for single use and is sterilized with ethylene oxide.
Packaging
Do not use if the packaging is damaged.
