PerFix™ Light Plug, Small, 2.5 cm x 3.4 cm (1.0" x 1.4"), 6/case

1. Millikan KW, Doolas A. A Long-Term Evaluation of the Modified Mesh-Plug Hernioplasty in Over 2,000 Patients. Hernia. 2008 June; 12(3): 257-260.

INDICATIONS

The PerFix™ Light Plug is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, of groin hernia defects.

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 that there may be a possibility for adhesion formation when polypropylene mesh 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 could 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 the 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. This 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. 

PRECAUTIONS

Please read all instructions prior to use. Only physicians qualified in the appropriate surgical techniques should use this mesh. 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. Monofilament sutures are recommended to properly secure the mesh. When two or more plugs are used for large direct or pantaloon hernias, they should be joined together with sutures where the plugs abut. 

ADVERSE REACTIONS

Possible complications include, but are not limited to seroma, adhesions, hematoma, inflammation, extrusion, infection, pain, erosion, mesh migration, fistula formation allergic reaction, and recurrence of the hernia or soft tissue defect.

Please consult package insert for more detailed safety information and instructions for use.