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Mesh Surgical-Basic mesh

  • Mesh Surgical-Basic mesh
  • Mesh Surgical-Basic mesh
  • Mesh Surgical-Basic mesh

Description
This product is a non-absorbable monofilament polypropylene mesh intended for the surgical repair of hernias and abdominal wall defects through
extraperitoneal placement.
 

Instructions
The mesh is intended for the surgical repair of hernias and abdominal wall defects. Correct orientation and placement are essential to ensure use in
accordance with the instructions for use.

Do not implant the mesh intraperitoneally or allow it to come into contact with the intestines or other visceral tissues.

Basic M
Intended for inguinal hernia repair and other hernia repair procedures.
 

Bulev UL
A mesh with single-color stripe markings, intended for inguinal hernia repair and other hernia repair procedures.
 

Bulev
Intended for inguinal and abdominal hernia repair.
 

Bulev B
A large-pore, lightweight mesh made of non-absorbable knitted polypropylene with blue stripes, intended for inguinal and abdominal hernia repair.

Contraindications

．Do not place the mesh in contact with the intestines or other organs, as this may cause severe adhesions.
．Do not use in patients who are still growing, pregnant patients, or patients planning to become pregnant.
．Do not use on infected or eroded tissue.
 

Warnings

．For use only by physicians trained in the use of this product.
．The product is supplied sterile. Inspect the packaging to ensure that it is intact before use.
．The physician and other users must visually inspect the packaged product for damage to the sterile barrier.
．Do not use if the packaging has been opened or damaged, as sterility may be compromised.
．Do not use after the expiration date.
．The product is intended for single use in one patient only. Do not resterilize or reuse. Reprocessing may compromise the stability of its chemical
, physical, mechanical, and biological properties.
．Ensure correct orientation and positioning of the product.
．The mesh must not come into contact with visceral organs, to avoid serious complications.
．Potential complications associated with mesh use include abscess, adhesions, damage, migration, fistula formation, erosion, seroma, hematoma
, inflammation, and infection.
．If infection or migration occurs, removal of the product may be necessary.
．Select the appropriate mesh size for the defect to avoid recurrence.
．Use in a contaminated surgical field may result in fistula formation and/or mesh removal.
．Handle the product carefully during insertion and permanent implantation to avoid damaging it.
．Patients must notify their physician immediately if they develop fever, wound redness and/or swelling, bleeding, or any other new postoperative
symptoms.

Surgical Use
For use only by physicians trained in the use of this product.

This product is a non-absorbable implantable medical material intended for use only in the operating room.

Mesh size selection must take into account good surgical practice, the size of the defect, the potential for mesh shrinkage, and the condition and
pathology of the patient’s tissue.

Mesh fixation must follow the procedures specified for the fixation system and good surgical practice.

If removal is necessary, the surgeon must follow good clinical and surgical practice and perform appropriate procedures to ensure patient safety.
 

Use and Placement
Correct orientation is essential to ensure the product’s intended function.

The polypropylene mesh surface must not come into contact with the intestines or other visceral tissues.
 

Precautions

  • Read all instructions carefully before use.
  • Open the packaging in the operating room in accordance with good surgical practice.
  • Once the packaging has been opened, do not resterilize or reuse the product.
  • Store in a clean, dry place, away from light and heat sources.
  • Handle the product using sterile gloves and sterile instruments.
  • Physicians must follow good clinical practice and advise patients on activities to avoid after surgery and precautions to take during daily
  • activities.


Adverse Reactions
Potential adverse reactions include obstruction, adhesions, damage, migration, fistula formation, erosion, seroma, hematoma, inflammation, infection
, and hernia recurrence. Other adverse reactions associated with surgery include pain, bleeding, and surgical failure.

As with other medical devices, the product may cause wound-related complications and/or a foreign body reaction.

As with any foreign material, polypropylene mesh may exacerbate an existing infection. In such cases, removal of the product may be necessary.


Sterilization
All meshes are intended for single use and are sterilized with ethylene oxide (ETO).

Do not use if the packaging is damaged.


Traceability
Each box includes an identification label for product traceability in accordance with applicable regulations.


Disposal
After use, dispose of the product and its associated packaging in accordance with hospital procedures or applicable local regulations.


Shelf Life
The product has a shelf life of 5 years.

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