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Synthetic mesh Bard™ soft mesh pre-shaped

Bard® Soft Mesh Pre-shaped

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Overview

Lightweight mesh designed for open and laparoscopic hernia repair.

Bard® Soft Mesh Pre-shaped offers flexibility, smooth rounded corners and a large pore knit structure which does not lend itself to unraveling or fraying when cut. For surgeons who may prefer to implant less material, it is approximately 60% lighter than traditional polypropylene mesh, and features a soft, thin knit structure that facilitates mesh positioning.

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Features and Benefits
  • Lightweight — approximately 60% lighter weight than traditional polypropylene mesh*
  • Biocompatible
  • Low profile design to facilitate mesh positioning
  • Strong knit construction can be easily tailored without lending itself to unraveling
  • Soft, compliant knit structure
  • Allows prompt fibroblastic tissue response
  • Available as flat or pre-shaped mesh
  • Lightweight — approximately 60% lighter weight than traditional polypropylene mesh*
  • Biocompatible
  • Low profile design to facilitate mesh positioning
  • Strong knit construction can be easily tailored without lending itself to unraveling
  • Soft, compliant knit structure
  • Allows prompt fibroblastic tissue response
  • Available as flat or pre-shaped mesh
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Specification

GTIN - Case

10801741030908

3

GTIN - Each

00801741030901

1

Quantity

3/cs.

Dimensions

Pre-shaped with Keyhole, 1.8" x 4.0" (4.5cm x 10cm)

GTIN

GTIN - Case 10801741030908 3
GTIN - Each 00801741030901 1

Packaging

Quantity 3/cs.

Product Basic Specification

Dimensions Pre-shaped with Keyhole, 1.8" x 4.0" (4.5cm x 10cm)
Electronic Instructions for Use (eIFUs)
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Frequently Asked Questions
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Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
productcomplaints@bd.com
Things to Consider

If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.

To better facilitate our investigation, please include the following information in your reporting:


  • Product Name and/or Catalog Number
  • Lot Number or Serial Number
  • Any injuries and/or Harm?
  • What is the issue you experienced?
  • Is the actual sample or sample representative available? (If possible, please send affected sample)
  • Contact name and phone number
References

* As compared to other traditional polypropylene mesh, such as Classic Bard® Mesh

INDICATIONS

Bard® Soft Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.

CONTRAINDICATIONS

  1. Literature reports there may be a possibility for adhesion formation when the polypropylene is placed in direct contact with the bowel or viscera.
  2. Do not use the Bard® Soft Mesh Pre-shaped in infants or children, in whom future growth will be compromised by use of such material.

WARNINGS

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

  1. Intact Bard® Soft Mesh Pre-shaped exhibits high burst and tensile strength. However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful:
    • When cutting a notice in the mesh, a V-shape with a radiused point will withstand more force than a V-shaped which comes to a sharp point.
  2. Bard® permanent or absorbable fixation devices or nonabsorbable monofilament sutures are recommended to properly secure the prosthesis. If absorbable fixation devices are used, they must be indicated for hernia repair. Care should be taken to ensure that the mesh is adequately fixated to the abdominal wall. If necessary, additional fasteners and/or sutures should be used.

ADVERSE REACTIONS

Possible complications include seroma, pain, mesh migration, infection, adhesions, hematoma, inflammation, extrusion, fistula formation and recurrence of the hernia or soft tissue defect. Erosion and migration of the mesh have been reported in gastric banding procedures.

Please consult package insert for more detailed safety information and instructions for use.

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