With more than 50 years of clinical experience, Bard® Mesh Pre-Shaped is the Gold Standard product to be used in a "tension-free" hernia repair technique. Bard® Mesh Pre-Shaped reinforces the weakened area, allowing for tissue ingrowth and resiliency. Bard® Mesh Pre-Shaped can be tailored preoperatively and customized to any unique situation.
More than 50 years of clinical experience
Can be tailored and trimmed to address surgeon needs
Available in four convenient sizes
Optional precut shapes provide opening for the spermatic cord, and the rounded edges accommodate to the anatomy of the inguinal canal
Well tolerated by the body1
Monofilament fibers are less prone to harbor bacteria than multifilament fibers1
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.
BD-14784
References
Amid, Shulman, Lichtenstein. “Selecting Synthetic Mesh for the Repair of Groin Hernia.” Postgraduate General Surgery. 1992:4:150-155.
Disclaimers
Not all products, services, claims or features of products may be available or valid in your local area. Please check with your local BD representative.
Please consult product labels and instructions for use for indications, contradictions, hazards, warnings, and precautions.
Indications
Bard® Mesh Pre-shaped is indicated for the repair of inguinal hernias.
Contraindications
Do not use this mesh in infants, children, or pregnant women, whereby future growth may be compromised by use of such mesh material.
The use of this mesh has not been studied in breastfeeding or pregnant women.
Literature reports there may be a possibility for adhesion formation when polypropylene is placed in direct contact with the bowel or viscera.
Warnings
The use of any synthetic mesh or patch in a contaminated or infected wound can lead to fistula formation and/or extrusion of the mesh.
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 mesh.
If unused mesh 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 viral infections.
To prevent recurrences when repairing hernias, the mesh should be sized with appropriate overlap for the size and location of the defect, taking into consideration any additional clinical factors applicable to the patient. Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.
The mesh is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use.
This mesh has been designed for single use only. 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 mesh and may lead to mesh failure which may result in injury to the patient.Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the mesh 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 mesh may lead to injury, illness, or death of the patient or end user.
To avoid injury, careful attention is required if fixating the mesh in the presence of nerves, vessels or the spermatic cord. Fastener penetration into underlying tissue containing nerves or blood vessels may result in the need for medical/surgical intervention, cause serious injury or permanent impairment to a body structure.
This mesh is not for the use of repair of pelvic organ prolapse.
This mesh is not for the use of treatment of stress urinary incontinence.
Precautions
Please read all instructions prior to use.
Only physicians qualified in the appropriate surgical techniques should use this mesh.
Adverse Reactions.
Possible complications may include, but are not limited to, seroma, adhesions, hematomas, pain, infection, inflammation, extrusion, erosion, migration, fistula formation, allergic reaction and recurrence of the hernia or soft tissue defect.
BD- 51745 (09/22)
