The 3DMax™ Mesh was developed based on careful and precise anatomical research of the inguinal canal. The three-dimensional, anatomically curved shape, sealed edge and medial orientation marker allow for easier positioning than a conventional flat mesh and also enhance the speed and simplicity of placement.1
TEP Laparoscopic Inguinal Hernia Repair with 3DMax™
GTIN - Case
00801741030765
1
Quantity
1/cs.
Dimensions
Large, Right 3DMax™ Mesh, 4" x 6" (10.8cm x 16.0cm)
| GTIN - Case | 00801741030765 | 1 |
| Quantity | 1/cs. |
| Dimensions | Large, Right 3DMax™ Mesh, 4" x 6" (10.8cm x 16.0cm) |
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:
1. Bell, Price. “Laparoscopic Inguinal Hernia Repair Using an Anatomically Contoured Three-Dimensional Mesh.” Surgical Endoscopy. 2003:17:1784-1788.
2. Koch et al. “Randomized Prospective Study of Totally Extraperitoneal Inguinal Hernia Repair: Fixation Versus No Fixation of Mesh.” Journal of the Society of Laparoendoscopic Surgeons. 2006:10:457-460.
Indications
Bard 3DMax™ mesh is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects.
Contraindications
Literature reports that there may be a possibility for adhesion formation when Bard 3DMax™ mesh is placed in direct contact with the bowel or viscera. Do not use Bard 3DMax™ mesh in infants and children, whereby future growth will be compromised by use of such material.
Warnings
The use of any permanent mesh or patch in a contaminated or infected wound could 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.
Precautions
Do not cut or reshape the Bard 3DMax™mesh as this may affect its effectiveness. If fixation is used, 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. If sutures are used to secure the mesh in place, nonabsorbable monofilament sutures are recommended.
Adverse Reactions
Possible complications include seromas, adhesions, hematomas, 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.
