Hiatal or Paraesophageal
Hiatal Hernia Repair Options
Hiatal Hernia Repair with Bard® Crurasoft® Patch
The Bard Crurasoft™ Patch can be used for a tension-free repair technique to repair or reinforce the repair of esophageal hiatal defects during open or laparoscopic fundoplications and parasophageal hernia repairs. Fundoplication is a technique where part of the stomach is wrapped around the esophagus and sewn into place. The products can also be used to reinforce or buttress the hiatal hernia that has been closed primarily with sutures. There is always a chance for complications with surgery such as infection, hematoma (blood collection), pain or hernia recurrence. Your physician will discuss these with you prior to surgery.
The CruraSoft™ Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of chest wall defects and hernias, including diaphragmatic/hiatal hernias.
Do not use the CruraSoft™ Patch in infants and children, whereby future growth will be compromised by use of such material.
Do not use the CruraSoft™ Patch for the reconstruction of cardiovascular defects.
Literature reports that there is a possibility for adhesion formation when the porous PTFE mesh surface is placed in contact with the bowel, esophagus or other sensitive organs.
The use of permanent mesh in a contaminated or infected area can lead to fistula formation and/or extrusion of the mesh. If an infection does develop, your surgeon should treat the infection aggressively and consider removing the mesh.
Possible complications include erosion resulting in fistula formation and leakage, seroma, adhesions, hematoma, inflammation, extrusion, migration and recurrence of the hernia or soft tissue defect. If the recoil ring is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection.
Please consult the package insert for more detailed safety information and instructions for use.
CruraSoft Patch Instructions for Use