Pristyn Medical Devices Benefits

A clinically proven fixation-free product for laparoscopic approaches such as TAPP, TEP, and Robotic TAPP 3DMaxTM Mesh was developed based on careful and precise anatomical research of the inguinal canal. The result is a truly unique prosthesis designed by a laparoscopic surgeon to meet the specific challenges of laparoscopic hernia surgery. The three-dimensional, anatomically curved shape, sealed edge and medial orientation marker allow for easier positioning than a conventional flat mesh and also enhance thespeed and simplicity of the placement.

A true three-dimensional, anatomically formed mesh for use in laparoscopic inguinal hernia repair
3DMax™ Mesh was developed based on careful and precise anatomical research of the inguinal canal. The result is a truly unique prosthesis designed by a laparoscopic surgeon to meet the specific challenges of laparoscopic hernia surgery. 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 the placement.
The polypropylene mesh is made of widely spaced monofilament fibers that do not harbor bacteria like multifilament polyester fibers. In a controlled clinical study of 500 3DMax™ Mesh hernioplasties, recurrence rates were found to be well below 1% and results indicated no postoperative neuralgia.

Key Benefits Bard 3D Max Surgical  Mesh
Conformability: Unique 3D design precisely conforms to the inguinal anatomy

Easy positioning: Sealed edge and medial orientation marker ensure more accurate mesh alignment and less wrinkling than conventional flat mesh

No fixation: Eliminates the need for fixation, which saves time and money

Reduced patient pain: Patients who received 3DMax™ Mesh without fixation used significantly less narcotic analgesia in the immediate postoperative period than those in whom flat mesh was fixed.

Applicable with various laparoscopic approaches
• TAPP
• TEP
• Robotic TAPP

Ordering Information
Indications: 3DMax™ Mesh is indicated to reinforce soft tissue where weakness exists, e.g., for the repair of hernia and chest wall defects.

Contraindications: Literature reports that there is a possibility for adhesion formation when 3DMax™ Mesh is placed in direct contact with the bowel or viscera.
Do not use 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 the removal of the device.

Precautions
Do not cut or reshape the 3DMax™ Mesh as this may affect its effectiveness. If sutures are used to secure the mesh in place, nonabsorbable monofilament sutures are recommended.

Adverse Reactions
Possible complications include seromas, adhesions, hemotomas, inflammation, extrusion, fistula formation and recurrence of the hernia of soft tissue defect.