Bard^® Mesh Pre-shaped

1 Amid, Shulman, Lichtenstein. “Selecting Synthetic Mesh for the Repair of Groin Hernia.” Postgraduate General Surgery. 1992:4:150-155.

INDICATIONS

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

CONTRAINDICATIONS

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

WARNINGS

This device must be sterile before use. Please inspect the packaging to be sure it is intact and undamaged.

This device is for single use only. Do not resterilize or reuse any portion of Bard® Mesh Pre-shaped.

Careful attention to Bard® Pre-shaped mesh handling, fixation, and suture technique is most important in the presence of known or suspected wound contamination or infection. The use of any permanent mesh or patch in a contaminated or infected wound can lead to fistula formation and/or extrusion of the prosthesis.

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.

To prevent recurrences when repairing inguinal hernias, the mesh should be large enough to extend beyond the pubic tubercle and should fit securely around the spermatic cord at the internal ring. Many surgeons cut a keyhole in the mesh to allow for easier placement around the cord.1

Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user. If unused prosthesis has been in contact with instruments or supplies used on a patient or contaminated with body fluids, discard with care to prevent risk of transmission of infection.

PRECAUTIONS

Please read all instructions prior to use.

Only physicians qualified in the appropriate surgical techniques should use this prosthesis.

Intact Bard® Pre-shaped mesh 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 notch in the mesh, a V-shape with a radiused point will withstand more force than a V-shape which comes to a sharp point.

DAVOL™ 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 use in hernia repair.

Care should be taken to ensure that the mesh is adequately fixated to the uncompromised tissue of the inguinal floor. If necessary, additional fasteners and/or sutures should be used.

ADVERSE REACTIONS

Possible complications include seroma, adhesions, hematoma, 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.

1 Amid, Shulman, Lichtenstein. “Selecting Synthetic Mesh for the Repair of Groin Hernia.” Postgraduate General Surgery. 1992:4:150-155.

INDICATIONS

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

CONTRAINDICATIONS

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

WARNINGS

This device must be sterile before use. Please inspect the packaging to be sure it is intact and undamaged.

This device is for single use only. Do not resterilize or reuse any portion of Bard® Mesh Pre-shaped.

Careful attention to Bard® Pre-shaped mesh handling, fixation, and suture technique is most important in the presence of known or suspected wound contamination or infection. The use of any permanent mesh or patch in a contaminated or infected wound can lead to fistula formation and/or extrusion of the prosthesis.

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.

To prevent recurrences when repairing inguinal hernias, the mesh should be large enough to extend beyond the pubic tubercle and should fit securely around the spermatic cord at the internal ring. Many surgeons cut a keyhole in the mesh to allow for easier placement around the cord.1

Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user. If unused prosthesis has been in contact with instruments or supplies used on a patient or contaminated with body fluids, discard with care to prevent risk of transmission of infection.

PRECAUTIONS

Please read all instructions prior to use.

Only physicians qualified in the appropriate surgical techniques should use this prosthesis.

Intact Bard® Pre-shaped mesh 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 notch in the mesh, a V-shape with a radiused point will withstand more force than a V-shape which comes to a sharp point.

DAVOL™ 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 use in hernia repair.

Care should be taken to ensure that the mesh is adequately fixated to the uncompromised tissue of the inguinal floor. If necessary, additional fasteners and/or sutures should be used.

ADVERSE REACTIONS

Possible complications include seroma, adhesions, hematoma, 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.